(230 days)
The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.
The PTA 14 Balloon Dilatation Catheter OTW is a 0.014" Over-The-Wire (OTW) PTA Balloon Dilatation Catheter with a semi-compliant inflatable balloon mounted on the distal end of the catheter. It is designed for carrying out percutaneous transluminal angioplasty (PTA) in the peripheral vessels. The balloon catheter has a coaxial shaft design. The outer lumen is used for balloon inflation and the inner lumen (guide wire lumen) permits the use of a guide wire with a maximum outer diameter of 0.014 inch. The proximal segment of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock for the guide wire lumen. The PTA 14 Balloon Dilatation Catheter is compatible with a 4 Fr. introducer sheath. The device is supplied sterile and is intended for single use.
The document is a 510(k) premarket notification for the "PTA 14 Balloon Dilatation Catheter OTW". This type of submission is for medical devices, and focuses on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy or diagnostic accuracy for an AI/ML product. As such, the information typically requested for AI/ML device evaluations (e.g., sample size for test/training sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance) is not applicable or provided in this document.
The document details performance and safety testing directly related to the physical characteristics and interaction of the catheter with the human body.
Here's the information parsed from the document based on the provided categories, with a clear indication that many categories relevant to AI/ML are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "Testing Summary" (Section 7) and a "Bench Testing Table" (Table 7.1.1) along with a "Summary of Biocompatibility Testing" (Table 7.2.1). For each test, the acceptance criteria are implied by the "Pass" result and the "Applicable Standard or Internal Test Method" column. The reported device performance is that all tests "Passed" the predetermined acceptance criteria. Specific quantitative acceptance criteria are not detailed in this summary, but are referred to by the internal test methods or referenced standards.
| Test # | Test Name | Applicable Standard or Internal Test Method | Test Results (Reported Device Performance) | Acceptance Criteria (Implied by Pass and Standard) |
|---|---|---|---|---|
| 1 | Dimensional Analysis | Internal Test Method | T=0 Pass, T=2 Pass | Met specified dimensions (details not provided) |
| 2 | Trackability | Internal Test Method | T=0 Pass, T=2 Pass | Met specified trackability requirements (details not provided) |
| 3 | Kink Resistance | Internal Test Method | T=0 Pass, T=2 Pass | Met specified kink resistance requirements (details not provided) |
| 4 | Balloon Performance | Internal Test Method | T=0 Pass, T=2 Pass | Met specified balloon performance requirements (details not provided) |
| 5 | Balloon Fatigue and Leakage | Internal Test Method | T=0 Pass, T=2 Pass | No fatigue or leakage observed within specified limits (details not provided) |
| 6 | Balloon Burst Pressure | Internal Test Method | T=0 Pass, T=2 Pass | Withstood specified burst pressure (details not provided) |
| 7 | Shaft Burst Pressure | Internal Test Method | T=0 Pass, T=2 Pass | Withstood specified shaft burst pressure (details not provided) |
| 8 | Catheter Joint Strength | Internal Test Method | T=0 Pass, T=2 Pass | Met specified joint strength requirements (details not provided) |
| 9 | Hub Durability and Compatibility | ISO 594-1, ISO 594-2 | T=0 Pass, T=2 Pass | Complied with ISO 594-1 and ISO 594-2 standards |
| 10 | Torque Strength | FDA Guidance 1608 | T=0 Pass, RT=5 Pass | Met specified torque strength requirements (details not provided) |
| 11 | Coating Durability | Internal Test Method | T=0 Pass, T=2 Pass | Met specified coating durability requirements (details not provided) |
| 12 | Coating Integrity | Internal Test Method | T=0 Pass, T=2 Pass | Met specified coating integrity requirements (details not provided) |
| 13 | Radiopacity | Internal Test Method | T=0 Pass, T=2 Pass | Met specified radiopacity requirements (details not provided) |
| 14 | Corrosion Resistance | Internal Test Method | T=0 Pass, T=2 Pass | Met specified corrosion resistance requirements (details not provided) |
| 15 | Packaging Integrity | ASTM F88-09, ASTM F1929-98, ASTM D4169-05 | T=0 Pass, T=2 Pass | Complied with ASTM F88-09, ASTM F1929-98, and ASTM D4169-05 standards |
| 16 | Sterilization Validation | ISO 11135-1 | T=0 Pass, T=2 Pass | Complied with ISO 11135-1 standard (Sterility Assurance Level (SAL) of 10^-6) |
Biocompatibility Tests (All Met Predetermined Acceptance Criteria)
| Test Name | Test Description | Acceptance Criteria (Implied by Pass and Standard) |
|---|---|---|
| Cytotoxicity - Test | Cytotoxicity – MEM Elution Test (ISO 10993-5:1999) | No evidence of cytotoxicity (as per ISO standard) |
| Cytotoxicity - Test | Cytotoxicity – MTT Quantitative Evaluation (ISO 10993-5:2009) | No evidence of cytotoxicity (as per ISO standard) |
| Sensitization - Test | Murine Local Lymph Node Assay (LLNA) (ASTM F2148) | No evidence of sensitization (as per ASTM standard) |
| Irritation - Test | Intracutaneous Study (ISO 10993-10:2002) | No evidence of irritation (as per ISO standard) |
| Systemic Toxicity - Test | Acute Systemic Toxicity Test (ISO 10993-11:2006) | No evidence of systemic toxicity (as per ISO standard) |
| Hemocompatibility Test | Hemolysis (ASTM F756-00 and ISO 10993-4:2002) | No significant hemolysis (as per ASTM and ISO standards) |
| Hemocompatibility – Test | Partial Thromboplastin Time (ASTM F 2382 and ISO 10993-4:2002) | No significant effect on coagulation (as per ASTM and ISO standards) |
| Complement Activation - Test | Complement Activation C3a and SC5b-9 (ISO 10993-4:2002, 2006) | No significant complement activation (as per ISO standards) |
| In vivo Thrombogenicity - Test | Four Hour Thromboresistance Evaluation in Dogs (ISO 10993-4:2002, 2006) | No significant thrombogenicity (as per ISO standards) |
| Pyrogenicity - Test | Pyrogen (USP 30 NF 25 and ISO 10993-11:2006) | No pyrogenic response (as per USP and ISO standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is Not Applicable as this document describes performance testing for a physical medical device (catheter), not an AI/ML software. The "test set" refers to physical samples of the device itself (both unaged and aged), which were subjected to various bench and biocompatibility tests. No human patient data or imaging data is involved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is Not Applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. For a physical device, performance is evaluated against engineering specifications and established standards, not expert consensus on data interpretation.
4. Adjudication method for the test set
This information is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies among expert readers when establishing ground truth for data interpretation. This is not relevant for the bench and biocompatibility testing of a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is Not Applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic accuracy of a reader (human or AI) on multiple cases, often comparing different reading paradigms (e.g., with or without AI assistance). This document is for a physical medical device and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is Not Applicable. This concept applies to AI/ML algorithms where performance is evaluated without human intervention. The device in question is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is Not Applicable in the AI/ML sense. For this device, the "ground truth" aligns with the acceptance criteria derived from engineering specifications and recognized international standards (e.g., ISO, ASTM, FDA Guidance). Device performance is measured directly against these defined physical, mechanical, and biological benchmarks.
8. The sample size for the training set
This information is Not Applicable. "Training set" refers to data used to train an AI/ML model. This device is a physical product and does not involve AI/ML.
9. How the ground truth for the training set was established
This information is Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.
§ 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).