declaraciÓn de conformidad de modificaciÓn – pm …p18130 catéter de aterectomía phoenix,...

Ministerio de Salud

Secretaría de Regulación y Gestión SanitariaA.N.M.A.T.

2018 - AÑO DEL CENTENARIO DE LAREFORMA UNIVERSITARIA

ANEXO II

DECLARACIÓN DE CONFORMIDAD DE MODIFICACIÓN – PM CLASE I- II

Número de revisión: 01

Fecha de Emisión de la Declaración revisión 00-Disposición Autorizante o su reválida:02/10/2017

Número de PM:

1991-157

Nombre Descriptivo del producto:

SISTEMA DE ATERECTOMÍA

Código de identificación y nombre técnico UMDNS:

15-209 CATÉTERES, DE OTRO TIPO

Clase de Riesgo:Clase II

Marca de (los) producto(s) médico(s):

VOLCANO

Modelos (en caso de clase II y equipos):

P18130 Catéter de aterectomía Phoenix, 1,8mm x 130cmP18149 Catéter de aterectomía Phoenix, 1,8mm x 149cmP22130 Catéter de aterectomía Phoenix, 2,2mm x 130cmP22149 Catéter de aterectomía Phoenix, 2,2mm x 149cmPD24127 Catéter de desviación de aterectomía Phoenix, 2,4mm x 127cmP18130K Sistema de aterectomía Phoenix, kit 1,8mm x 130cmP18149K Sistema de aterectomía Phoenix, kit 1,8mm x 149cmP22130K Sistema de aterectomía Phoenix, kit 2,2mm x 130cm

Página 1 de 9PM Número: 1991-157 Página 1 de 9

El presente documento electrónico ha sido firmado digitalmente en los términos de la Ley N° 25.506, el Decreto N° 2628/2002 y el Decreto N° 283/2003.-

P22149K Sistema de aterectomía Phoenix, kit 2,2mm x 149cmPD24127K Sistema de desviación de aterectomía Phoenix, kit 2,4mm x 127cmAccesorios : P00633 Mango Phoenix con clavija de soporte de alambre

Composición cuali-cuanti porcentual exacta (si corresponde):

NO APLICA

Indicación/es autorizada/s:

El sistema de aterectomía Phoenix está diseñado para uso en procedimientos de aterectomía enlos vasos periféricos. El sistema no está diseñado para ser empelado en los vasos coronarios,carotídeos, ilíacos o renales.

Período de vida útil (si corresponde):

2 AÑOS

Método de Esterilización (si corresponde):

Esterilizado por óxido de etileno

Forma de presentación:

Envasado en pouch Tyvek y Poliéster/Polietileno contenido en un estuche. Envase conteniendo 1unidad.

Condición de venta:

Venta Exclusiva a Profesionales e Instituciones Sanitarias

Nombre del fabricante:

Volcano AtheroMed Inc.

Lugar/es de elaboración:1530 O'Brien Drive, Suite AMenlo Park, CA USA 94025

En nombre y representación de la firma MTG GROUP S.R.L. , el responsable legal y elresponsable técnico declaran bajo juramento que los productos médicos enumerados en elpresente Anexo, satisfacen los Requisitos Esenciales de Seguridad y Eficacia (R.E.S.E.)previstos por la Disposición ANMAT N° 4306/99, que cumplen y se encuentra a disposición de laAutoridad Sanitaria la documentación técnica que contenga los requerimientos solicitados en losAnexos III.B y III.C del Reglamento Técnico aprobado por Disposición ANMAT N° 2318/02 (TO2004) y Disposición ANMAT Nº 727/13.



CUMPLIMIENTO DE R.E.S.E. DISPOSICIÓN ANMAT N° 4306/99 Y GESTIÓN DERIESGO

ENSAYO/VALIDACION/GESTION DE RIESGOLABORATORIO/N° DEPROTOCOLO

FECHA DEEMISIÓN

Punto 1:EN ISO 13485:2012, Quality Management systems –Requirements for regulatory purposesEN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN ISO 10555-1:2009, PART 1: Sterile, single use intravascularcatheters general requirementsISO 11135:2014 Medical Devices – Validation and routinecontrol of ethylene oxide sterilizationEN ISO-10993-1:2009/AC:2010, PART 1: Evaluation & Testing;Biological Evaluation of Medical DevicesEN ISO-10993-4:2009PART 4: Selection of Tests for Interactions with Blood, BiologicalEvaluation of Medical DevicesEN ISO-10993-5:2009, PART 5: Tests for In Vitro Cytotoxicity,Biological Evaluation of Medical DevicesEN ISO 10993-7:2008/AC:2009, PART 7: Ethylene OxideSterilization Residuals, Biological Evaluation of Medical DevicesEN ISO-10993-10:2010, PART 10: Tests for Irritation &Sensitization, Biological Evaluation of Medical DevicesEN ISO 10993-11:2009, PART 11: Tests for systemic toxicityISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performanceEN 60601-1-2:2007/AC:2010 Medical electrical equipment -- Part1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic compatibility- Requirements and testsEN 60601-2-37:2008 Medical electrical equipment -- Part 2-37:Particular requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoringequipmentPunto 2:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performanceEN 1041:2008, Information Supplied by the Manufacturer with

NO APLICA N/A



Medical DevicesEN ISO 15223:2012 Medical Devices – Symbols to be used withmedical device labels, labeling and information to be supplied –Part 1: General requirementsPunto 3:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performanceEN 60601-2-37:2008 Medical electrical equipment -- Part 2-37:Particular requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoringequipmentEN ISO 10555-1 Sterile, single-use intravascular catheters – Part1: General requirementsPunto 4:ISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN ISO 11135:2007 Medical Devices – Validation and routinecontrol of ethylene oxide sterilizationEN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesPunto 5:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN ISO 10555-1:2009, PART 1: Sterile, single use intravascularcatheters general requirementsISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN ISO 11135:2007 Medical Devices – Validation and routinecontrol of ethylene oxide sterilizationEN 1041:2008, Information Supplied by the Manufacturer withMedical DevicesEN ISO 15223:2012 Medical Devices – Symbols to be used withmedical device labels, labeling and information to be supplied –Part 1: General requirementsPunto 6:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical Devices

Punto 7.1:EN ISO 10993-1:2009/AC:2010, PART 1: Evaluation & Testing;Biological Evaluation of Medical DevicesEN ISO 10993-4:2009, PART 4: Selection of Tests forInteractions with Blood, Biological Evaluation of Medical DevicesEN ISO 10993-5:2009, PART 5: Tests for In Vitro Cytotoxicity,Biological Evaluation of Medical DevicesEN ISO 10993-7:2008/AC:2009 PART 7: Ethylene OxideSterilization Residuals, Biological Evaluation of Medical DevicesISO 10993-10:2002, PART 10: Tests for Irritation & Sensitization,Biological Evaluation of Medical Devices



EN ISO 10993-11:2009, Biological evaluation of medical devices– Part 11: Tests for systemic toxicityEN ISO 10993-1:2009/AC:2010, PART 1: Evaluation & Testing;Biological Evaluation of Medical DevicesEN ISO 10993-4:2009, PART 4: Selection of Tests forInteractions with Blood, Biological Evaluation of Medical DevicesEN ISO 10993-5:2009, PART 5: Tests for In Vitro Cytotoxicity,Biological Evaluation of Medical DevicesEN ISO 10993-7:2008/AC:2009 PART 7: Ethylene OxideSterilization Residuals, Biological Evaluation of Medical DevicesISO 10993-10:2002, PART 10: Tests for Irritation & Sensitization,Biological Evaluation of Medical DevicesEN ISO 10993-11:2009, Biological evaluation of medical devices– Part 11: Tests for systemic toxicityEN ISO 10993-1:2009/AC:2010, PART 1: Evaluation & Testing;Biological Evaluation of Medical DevicesEN ISO 10993-4:2009, PART 4: Selection of Tests forInteractions with Blood, Biological Evaluation of Medical DevicesEN ISO 10993-5:2009, PART 5: Tests for In Vitro Cytotoxicity,Biological Evaluation of Medical DevicesEN ISO 10993-7:2008/AC:2009 PART 7: Ethylene OxideSterilization Residuals, Biological Evaluation of Medical DevicesISO 10993-10:2002, PART 10: Tests for Irritation & Sensitization,Biological Evaluation of Medical DevicesEN ISO 10993-11:2009, Biological evaluation of medical devices– Part 11: Tests for systemic toxicityPunto 7.2:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN ISO 10993-1:2009/AC:2010, PART 1: Evaluation & Testing;Biological Evaluation of Medical DevicesEN ISO 10993-4:2009, PART 4: Selection of Tests forInteractions with Blood, Biological Evaluation of Medical DevicesEN ISO 10993-5:2009, PART 5: Tests for In Vitro Cytotoxicity,Biological Evaluation of Medical DevicesEN ISO 10993-7:2008/AC:2009 PART 7: Ethylene OxideSterilization Residuals, Biological Evaluation of Medical DevicesISO 10993-10:2002, PART 10: Tests for Irritation & Sensitization,Biological Evaluation of Medical DevicesEN ISO 10993-11:2009, Biological evaluation of medical devices– Part 11: Tests for systemic toxicityISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performancePunto 7.3:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN ISO 10993-1:2009/AC:2010, PART 1: Evaluation & Testing;Biological Evaluation of Medical DevicesEN ISO 10993-4:2009, PART 4: Selection of Tests for



Interactions with Blood, Biological Evaluation of Medical DevicesEN ISO 10993-5:2009, PART 5: Tests for In Vitro Cytotoxicity,Biological Evaluation of Medical DevicesEN ISO 10993-7:2008/AC:2009 PART 7: Ethylene OxideSterilization Residuals, Biological Evaluation of Medical DevicesISO 10993-10:2002, PART 10: Tests for Irritation & Sensitization,Biological Evaluation of Medical DevicesEN ISO 10993-11:2009, Biological evaluation of medical devices– Part 11: Tests for systemic toxicityISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performancePunto 7.4: No aplicaPunto 7.5:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN ISO 10993-1:2009/AC:2010, PART 1: Evaluation & Testing;Biological Evaluation of Medical DevicesEN ISO 10993-4:2009, PART 4: Selection of Tests forInteractions with Blood, Biological Evaluation of Medical DevicesEN ISO 10993-5:2009, PART 5: Tests for In Vitro Cytotoxicity,Biological Evaluation of Medical DevicesEN ISO 10993-7:2008/AC:2009 PART 7: Ethylene OxideSterilization Residuals, Biological Evaluation of Medical DevicesISO 10993-10:2002, PART 10: Tests for Irritation & Sensitization,Biological Evaluation of Medical DevicesEN ISO 10993-11:2009, Biological evaluation of medical devices– Part 11: Tests for systemic toxicityPunto 7.6:EN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performancePunto 8.1:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN ISO 11135:2007 Medical Devices – Validation and routinecontrol of ethylene oxide sterilizationPunto 8.2: no aplicaPunto 8.3:EN ISO 10555-1:2009, PART 1: Sterile, single use intravascularcatheters general requirementsEN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN ISO 11135:2007 Medical Devices – Validation and routinecontrol of ethylene oxide sterilizationPunto 8.4:ISO 11607:2006, Packaging for Terminally Sterilized Medical



DevicesEN ISO 11135:2007 Medical Devices – Validation and routinecontrol of ethylene oxide sterilizationPunto 8.5:ISO 11607:2006, Packaging for Terminally Sterilized MedicalDevicesEN ISO 11135:2007 Medical Devices – Validation and routinecontrol of ethylene oxide sterilizationPunto 8.6: no aplicaPunto 8.7:EN ISO15223-1:2012EN1041:2008EN980:2008Punto 9.1:EN 1041:2008, Information Supplied by the Manufacturer withMedical DevicesEN ISO 15223:2012 Medical Devices – Symbols to be used withmedical device labels, labeling and information to be supplied –Part 1: General requirementsEN 60601-1:2006/AC:2010 Medical electrical equipment -- Part1: General requirements for basic safety and essentialperformanceEN 60601-1-2:2007/AC:2010 Medical electrical equipment -- Part1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic compatibility- Requirements and testsPunto 9.2:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performanceEN 60601-1-2:2007/AC:2010 Medical electrical equipment -- Part1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic compatibility- Requirements and testsEN ISO 10555-1:2009, PART 1: Sterile, single use intravascularcatheters general requirementsEN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical DevicesEN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performanceEN 60601-1-2:2007/AC:2010 Medical electrical equipment -- Part1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic compatibility- Requirements and testsPunto 9.3: no aplicaPunto 10 a 11: no aplicaPunto 12.1 a 12.4: no aplicaPunto 12.5:EN 60601-1-2:2007/AC:2010 Medical electrical equipment -- Part1-2: General requirements for basic safety and essential



performance - Collateral standard: Electromagnetic compatibility- Requirements and testsPunto 12.6:EN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performancePunto 12.7:12.7.1:EN ISO 14971:2012, Medical Devices – Application of RiskManagement to Medical Devices12.7.3: no aplica12.7.4:EN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performance12.7.5:EN 60601-1:2006/AC:2010 Medical electrical equipment Part 1:General requirements for safety and essential performanceEN 60601-2-37:2008 Medical electrical equipment -- Part 2-37:Particular requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoringequipmentPunto 12.8 a 12.9: no aplicaPunto 13:EN 1041:2008, Information Supplied by the Manufacturer withMedical DevicesEN ISO 15223:2012 Medical Devices – Symbols to be used withmedical device labels, labeling and information to be supplied –Part 1: General requirements

El responsable legal y su responsable técnico son responsables de la veracidad de ladocumentación e información presentada y declaran bajo juramento mantener en suestablecimiento y a disposición de la autoridad sanitaria la documentación allí declarada y la queestablece la Disposición 727/13, bajo apercibimiento de lo que establece la Ley N° 16.463, elDecreto N° 341/92 y las que correspondan del Código Penal en caso de falsedad.En caso de inexactitud o falsedad de la información o documentación, la Administración Nacionalpodrá suspender, cancelar, prohibir la comercialización y solicitar retiro del mercado de lo yaautorizado e iniciar los sumarios que pudieran corresponder.

LUGAR Y FECHA: Argentina, 14 noviembre 2018

Responsable LegalFirma y Sello

Responsable TécnicoFirma y Sello



Ministerio de Salud

Secretaría de Regulación y Gestión SanitariaA.N.M.A.T.

La presente DECLARACIÓN DE CONFORMIDAD ha sido emitida de acuerdo con las previsionesde la Disposición ANMAT Nº 727/13 y N°5706/17, quedando inscripta la modificación en elRegistro Nacional de Productores y Productos de Tecnología Médica (R.P.P.T.M.) a favor deMTG GROUP S.R.L. bajo el número PM 1991-157 en la Ciudad de Buenos Aires a los días 14noviembre 2018Se autoriza la comercialización del/los producto/s identificados en la presente declaración deconformidad, la cual mantendrá la vigencia que consta en la Declaración inicial revisión 00 oDisposición Autorizante o su reválida.

Dirección de Evaluación de RegistroFirma y Sello

Dirección Nacional de Productos MédicosFirma y Sello

Tramitada por Expediente N°: 1-0047-3110-006441-18-8



declaraciÓn de conformidad de modificaciÓn – pm …p18130 catéter de aterectomía phoenix,...

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