(68 days)
The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
The 6 French Concierge Guiding Catheter is a single lumen catheter that incorporates a nylon body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 6F size and 100cm length and in a variety of shapes.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the 6 French Concierge® Guiding Catheter.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Performance Tests: The device "met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." The specific numerical or qualitative acceptance criteria for each test (e.g., maximum air leak rate, minimum tensile strength) are not explicitly detailed in the provided text, but it is stated that the device successfully met them.
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
| Air Leak | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
| Liquid Leak | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
| Catheter Tip Support and Attachment | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
| Tensile | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
| Shaft Kink | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
| Shaft Stiffness | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
| Ink Adherence | Not explicitly stated (pre-determined standards) | Successfully met pre-determined acceptance criteria |
Acceptance Criteria for Biocompatibility Tests: These tests are based on the requirements of ISO 10993 series and ASTM F756-08.
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Not explicitly stated (ISO 10993-5) | Successfully met pre-determined acceptance criteria |
| Sensitization | Not explicitly stated (ISO 10993-10) | Successfully met pre-determined acceptance criteria |
| Irritation | Not explicitly stated (ISO 10993-10) | Successfully met pre-determined acceptance criteria |
| Acute Systemic Toxicity | Not explicitly stated (ISO 10993-11) | Successfully met pre-determined acceptance criteria |
| Genotoxicity | Not explicitly stated (ISO 10993-3) | Successfully met pre-determined acceptance criteria |
| Hemocompatibility | Not explicitly stated (ISO 10993-4, ASTM F756-08) | Successfully met pre-determined acceptance criteria |
| Physicochemical Tests | Not explicitly stated (relevant standards) | Successfully met pre-determined acceptance criteria |
Overall Conclusion: The results of the testing demonstrated that the subject 6 French Concierge Guiding Catheter met the pre-determined acceptance criteria applicable to the safety and efficacy of the device, leading to a determination of substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for each of the performance or biocompatibility tests. It only lists the types of tests conducted.
The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned in the provided text. The tests appear to be laboratory verification tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing described. The tests performed are engineering design verification and biocompatibility tests, not studies requiring expert interpretation of clinical data or images to establish a 'ground truth'.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" is not applicable to the type of testing described (design verification and biocompatibility). These tests involve objective measurements and analyses against established standards and criteria, not subjective expert reviews that would require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes engineering performance tests and biocompatibility evaluations, not clinical studies involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical catheter, not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is the pre-determined acceptance criteria based on established industry standards and regulatory guidance documents. These include:
- ISO 10555-1:1995 (Sterile, single-use intravascular catheters - Part 1: General requirements)
- ISO 10555-2:1996 (Sterile, single-use intravascular catheters - Part 2: Angiographic catheters)
- ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide)
- ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part-1) and FDA Modified ISO 10993 Test Profile
- ASTM F756-08 (Assessment of Hemolytic Properties of Materials)
- ISO 10993-3 :2003 (Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity)
- ISO 10993-4:2002 (Selection of tests for interaction with blood)
- ISO 10993-5:2009 (Tests for in vitro cytotoxicity)
- ISO 10993-10:2010 (Tests for irritation and skin sensitization)
- ISO 10993-11:2006 (Tests for systemic toxicity)
- ISO 2233:2000 (Packaging - conditioning and testing)
- ASTM D4169-08 (Performance testing of shipping containers and systems)
The ground truth is these standards and the criteria derived from them, which the device must meet to be considered safe and effective.
8. The Sample Size for the Training Set
Not applicable. This document describes the testing of a physical medical device (catheter), not the development or training of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is not a study involving machine learning or algorithms with training sets.
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| Section 5510(k) Summary | ||
|---|---|---|
| GeneralProvisions | Submitter Name:Address: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095 |
| Telephone Number: | (801) 208-4196 | |
| Fax Number: | (801) 253-6932 | |
| Contact Person: | Michaela Rivkowich | |
| Date of Preparation: | April 5, 2012 | |
| Registration Number: | 1721504 | |
| SubjectDevice | Trade Name: | 6 French Concierge® Guiding Catheter |
| Common/Usual Name: | Guiding Catheter | |
| Classification Name: | Percutaneous Catheter | |
| PredicateDevice | Trade Name: | Concierge® Guiding Catheter |
| Common/Usual Name: | Guiding Catheter | |
| Classification Name: | Percutaneous Catheter | |
| Premarket Notification: | K043387 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II21 CFR § 870.1250Cardiovascular | |
| Intended Use | The Concierge Guiding Catheter is intended for the intravascularintroduction of interventional/diagnostic devices into the coronary orperipheral vascular systems. | |
| DeviceDescription | The 6 French Concierge Guiding Catheter is a single lumen catheterthat incorporates a nylon body reinforced with stainless steel wirebraid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It isavailable in 6F size and 100cm length and in a variety of shapes. | |
| TechnologicalCharacteristics | The technological characteristics of the subject 6 French ConciergeGuiding Catheter are substantially equivalent to those of thepredicate device, the Concierge Guiding Catheter, 510(k) K043387. | |
| Safety &PerformanceTests | No performance standards have been established under Section514 of the Food, Drug and Cosmetic Act for these devices.Performance testing of the subject 6 French Concierge GuidingCatheter was conducted based on the risk analysis and based onthe requirements of the following FDA guidance document andinternational standards:ISO 10555-1:1995, Sterile, single-use intravascular catheters -Part 1: General requirements ISO 10555-2:1996, Sterile, single-use intravascular catheters -Part 2: Angiographic catheters ANSI/AAMI/ISO 11135-1: 2007, Sterilization of health careproducts - Ethylene oxide - Part 1: Requirements fordevelopment, validation and routine control of a sterilizationprocess for medical devices ISO 10993-1: 2009, Biological Evaluation of Medical DevicesPart-1: Evaluation and Testing within a risk managementprocess, and the FDA Modified ISO 10993 Test Profile ASTM F756-08, Standard Practice for Assessment of HemolyticProperties of Materials ISO 10993-3 :2003, Biological Evaluation of Medical DevicesPart 3: Tests for Genotoxicity, Carcinogenicity and ReproductiveToxicity ISO 10993-4:2002, Biological evaluation of medical devices -Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices –Part 11: Tests for systemic toxicity ISO 2233:2000, Packaging - complete, filled transport packagesand unit loads - conditioning and testing ASTM D4169-08, Standard practice for performance testing ofshipping containers and systems The following is a list of all significant testing that was successfullycompleted: | |
| Safety &PerformanceTests cont. | Design VerificationDimensionsAir LeakLiquid LeakCatheter Tip Support and AttachmentTensileShaft KinkShaft StiffnessInk AdherenceBiocompatibility TestsCytotoxicitySensitizationIrritationAcute Systemic ToxicityGenotoxicityHemocompatibilityPhysicochemical Tests | |
| Safety &PerformanceTests cont. | The results of the testing demonstrated that the subject 6 FrenchConcierge Guiding Catheter met the pre-determined acceptancecriteria applicable to the safety and efficacy of the device. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, and safety andperformance testing, the subject 6 French Concierge GuidingCatheter meets the requirements that are considered essential for itsintended use and is substantially equivalent to the predicate device,the Concierge Guiding Catheter, manufactured by Merit MedicalSystems, Inc. |
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is likely part of a document or sign.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 3 2012
Merit Medical Systems, Inc. c/o Ms. Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K121051
Trade/Device Name: 6 French Concierge Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 10, 2012 Received: May 14, 2012
Dear Ms. Rivkowich:
We have reviewed your Section 510(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, good 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 truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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Page 2 - Ms. Michaela Rivkowich
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 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH'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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bran D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Concierge® Guiding Catheter Section 4, Indications for Use Special Premarket Notification 510(k)
Section 4
Indications for Use K121051 . 510(k) Number (if known): Device Name: 6 French Concierge® Guiding Catheter Indications for Use: The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Prescription Use _ X ____
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
21051 5 . k) Numbe
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).