(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.
§ 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).