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Timestamp: 2019-11-20 16:49:05
Document Index: 410429926

Matched Legal Cases: ['art 1', 'art 1', 'arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 803', 'art 21', 'art 0']

510(k) Summary Special Premarket Notification 510(k) Section 6 - PDF Free Download
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1 K1 3323O p. I of 4 Merit Medical Systems. Inc. Section 6 Merit InQwire QQ) Diagnostic Guide Wire Special Premarket Notification 510(k) DEC Section 6 General Provisions Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan Telephone Number (+353) (3061) Fax Number: (+353) Contact Person: Mark Mullaney Registration Number Correspondent Name: Merit Medical Ireland Ltd. Address: Parkmame Business Park West Galway, Ireland Telephone Number: (+353) (3052) Fax Number: (+353) Contact Person: Siobhan Ki(ng Date of Preparation: 10/16/2013 Registration Number Sbet Trade Name: lncwr Subece CommonA~sual Namne:Merit Medical Guide Wine Device Classification Name: 21 CFR Catheter guide wire Trade Name: lnqwirep Predicate Classification Name: 21 GFR Catheter guide wire Device Premarket Notification: K Manufacturer Merit Medical Systems, Inc. - Class It Clasifcaton21 CFR Catheter guide wire Clasifcaton FDA Product Code: DOX Review Panel: Division of Cardiovascular Devices Intended Use Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures. 29
2 K p. 2 of 4 Merit Medical Systemsa, Inc. Section 6 Merit InOwirP (10) Diagnostic Guide Wire Special Pretnarket Notification 510O(k) In~Wre" Diagnostic Guide Wires are intendled to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires have a continuous PTIFE (Polytetraifluoroethylene) coated coil, inside core wire and a safety wire. The core wire is fixed at the proximal end only and extends to a specified distance from the distal end. The distal segment of the core wire has a profiled taper. The core wire enhances the stiffness of the guide wire. The safety wire extends the full length of the guide wire and is welded at both the distal and proximal end. The safety wire is designed to provide integrity and ensures that the guide wire components remain together. Device Description The lnqwirtp Diagnostic Guide Wires are offered in inch or inch outer diameter with different tup configurations (straight or J-tip), single ended or double ended (either end of the wire can be piaced into the patient), standard or firm shaft, and are available In lengths from 50cm to 260cm. The wire is placed inside a loop flush dispenser, also referred to as a hoop. The dispenser has a female Luer connection which facilitates solution flushing through the hoop to hydrate the guide wire. The guldewires are secured in the hoop dispenser by a locking J-tip straightener. This modification details a supplier process change relating to removal of perfluorooctanoic acid (PFOA), used in the manufacture of the PTFE (Polyttrafluoroethylene) coating. More specifically PFOA is a processing aid used for the polymerization process of PTFE, which is flashed off during the oven curing process and therefore not part of the finished ln~wre Diagnostic Guidewire. Due to environmental concerns relating to PFOA, the U.S. Environmental Protection Agency has instnucted that all processors of PTFE no longer make, buy or use PFOA( PFOA Stewardship Program). PFOA mateial is used in the manufacture of both the intermediate layer and top layer of the PTFE(Polytetrafiuoroethylene) coating. Technological characteristics of the subject Merit lnowire Diagnostic compaio arsn Guide Merit lnqwirep Wire are Diagnostic substantially Guide equivalent to those of the predicate, the to Predicate Wire [1(002289]. the devices The relates difference to the between guide wire coating. The guide wire design and indications remain unchanged. 30
3 K p. 3 of 4 Merit Medical Systems, Inc. Section 6 Merit inowirt (30) Diagnostic Guide Wire Special Premarket Notification 510(k) No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Merit ln~wirt Diagnostic Guide Wire was conducted based on risk analysis. A battery of testing was conducted In accordance with protocols based on requirements outlined In guidance's -and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence. Where appropriate, the tests were based on the requirements of the following documents: Safety & Performance Tests * FDA guidance Coronary and Cerebrovascular Guide Wire Guidance January * ISO 11070:1998, Sterile Single-Use Intravascular Catheter Introducers. * ISO :2007 Stenilization of health care products-ethylene oxide- Part 1: Requirements for the development, validation and routine control atea sterilization process for medical devices. " ASTM F Standard Guide for Accelerated Aging of Stenle Barrier Systems for Medical Devices " ISO :2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO Test Profile FDA Memo G95-1. The Merit In~wire Diagnostic Guide Wire was compared to the predicate device for various performance attributes that support substantial equivalence of the device. The difference in coating between the modified device and the cleared device [1(002289] has raised no new Issues. The following Is a list. of all significant testing that was successfully completed: " Surface * Coating Adherencelntegrity o Fracture Test o Flexing Test a Coil Lubricity Test " Catheter Compatibility " Biocompatibility All test results were comparable to the predicate devices and the subject Merit lnqwire* Diagnostic Guide Wire met the predeaterminded acceptance criteria applicable to the safety and effectiveness of the device. This has' demonstrated the subject device is substantially equivalent to predicate device. 31
4 K p. 4 of 4 Merit Medfical Sy stems, Inc. Section 6 Merit ln~wire (10) Diagnostic Guide Wire Special Premarket Notification 510(k) Summary of Substantial Equivlence Equivlence Based on the Indications for Use, design, safety and performance testing, the subject Merit Medical ln~twire~ Diagnostic Guide Wire meets the requirements that are considered essential for its intended use and Is substantively equivalent to the predicate device, the cleared Merit In~wires Diagnostic Guide Wire manufactured by Merit Medical Systems Inc. 32
5 DEPARTMENT OF HEALTH & HUMAN SERVICES Ptmwc Hlth Scenee Food end Drug Adminmion 1093 New f~pshfrcavenu December 12,2013 Doni an a OG00 Merit Medical Systems% Inc. Ms. Siobhan King Parkmore Business Park West Galway, Ireland Re: K Trade/Device Name: InQwire Diagnostic Guide Wire Regulation Number: 21 CFR Regulation Name: Guide Wire Regulatory Class: Class HI Product Code: DQX Dated: November 7, 2013 Received: November 12, 2013 Dear Ms. King: We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The* general controls provisions of the Act include requirements for annual registration, listing of devices, goad manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be tuthful and not misleading. If your device is classified (see above) into either class 11 (Special Controls) or class Ill (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Feraml agegr* Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections of the Act);-21 CFR
6 Page 2- Ms. Siobban King If you desire specific advice for your device on our labeling regulation (21 CER Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) or (301) or at its Internet address httoi:/ Also, please note die regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to btto:/iwww.fdsseovmedicadevicessafetvlfteoortaproblenmjdefaulti for the CORN's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-flee number (800) 63S 2041 or (301) or at its Internet address htto:// Enclosure Sincerely yours. Brain D. 0 mn- Brain D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
7 Kl 3323O p. I of I Merit Medical Systems, Inc, Merit inowrtp Diagnostic Guide Wire Special Premarktl Notification 510(k) Section S Indications for Use Statement Section 6 Indications for Use Statement 51 0(k) Number (if known): Device Name: Merit InQwlreP Diagnostic Guide Wire Indications for Use: Merit Medical guide wires are used to facilitate the placement of devices durwing diagnostic and Intezventionall procedures. Prescription Use Mj AND/OR Over-The-Counter Use ED (Part 21 CFR 801 Subpart 0) (21 CFR 801 Subpart C) (PLEASE DO NOT-WRITEE1ELOW THIS LINE-CONTINUE.ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bra r-t aker 28