(90 days)
The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.
This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The BrosMed Medical Co., Ltd.'s Parafleet SC 014, Parafleet SC 018, and Parafleet SC 035 PTA Balloon Dilatation Catheters underwent various performance tests to ensure substantial equivalence to predicate devices and suitability for their intended use.
1. Acceptance Criteria and Reported Device Performance:
The document lists several performance tests conducted, implying that the acceptance criteria for these tests were met to demonstrate substantial equivalence. The reported device performance is that "The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use."
While specific numerical acceptance criteria and precise performance values are not provided in the summary, the general categories of tests and their "met" status serve as the reported performance against inferred acceptance criteria derived from FDA guidance and predicate device characteristics.
Here’s a table summarizing the types of tests (representing categories of acceptance criteria) and the reported performance:
| Category of Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Bench Testing | |
| Dimensional Verification | Met acceptance criteria |
| Simulated Use | Met acceptance criteria |
| Balloon Rated Burst Pressure | Met acceptance criteria |
| Balloon Fatigue | Met acceptance criteria |
| Balloon Compliance | Met acceptance criteria |
| Balloon Inflation and Deflation Time | Met acceptance criteria |
| Catheter Bond Strength | Met acceptance criteria |
| Tip Pull Strength | Met acceptance criteria |
| Flexibility and Kinking | Met acceptance criteria |
| Torque Strength | Met acceptance criteria |
| Radiopacity | Met acceptance criteria |
| Coating Friction | Met acceptance criteria |
| Coating Integrity | Met acceptance criteria |
| Particulate Evaluation | Met acceptance criteria |
| Catheter Body Burst Pressure | Met acceptance criteria |
| Balloon Rated Burst Pressure (in stent) | Met acceptance criteria |
| Balloon Fatigue (in stent) | Met acceptance criteria |
| Biocompatibility Testing | |
| Cytotoxicity | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Intracutaneous Reactivity | Met acceptance criteria |
| Systemic Toxicity | Met acceptance criteria |
| Hemolysis | Met acceptance criteria |
| Thrombosis | Met acceptance criteria |
| Complement Activation | Met acceptance criteria |
| Pyrogenicity | Met acceptance criteria |
| Sterilization Packaging and Shelf Life | Met acceptance criteria |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the performance tests. The data provenance (e.g., country of origin, retrospective/prospective) for these tests is also not explicitly stated in the provided text. However, it's typical for such bench and biocompatibility tests to be conducted in a laboratory setting by the manufacturer (BrosMed Medical Co., Ltd. in China) or a contract research organization.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to the provided document. The submission pertains to a medical device's performance characteristics (e.g., mechanical, material, biocompatibility) rather than an AI/ML-driven diagnostic or prognostic device that would require expert-established ground truth for interpretation of images or patient data. The tests performed are objective, physical, and chemical evaluations.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reasons as point 3. No subjective interpretation requiring adjudication is mentioned for the performance testing of these physical medical devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable as the device is a PTA Balloon Dilatation Catheter, not an AI-assisted diagnostic tool. Therefore, there is no human-in-the-loop performance or comparison with AI assistance.
6. Standalone Performance (Algorithm Only):
This section is not applicable as the device is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" for the performance tests in this context is established by objective engineering specifications, material standards, and regulatory guidance documents (e.g., FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff' and ISO 10993-1 for biocompatibility).
For example:
- Dimensional verification checks against the device's design specifications.
- Balloon Rated Burst Pressure tests against the manufacturer's specified burst pressure and regulatory safety limits.
- Biocompatibility testing assesses against established biological safety endpoints defined by ISO standards.
8. Sample Size for the Training Set:
This section is not applicable as the device is a physical medical device and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reasons as point 8.
§ 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).