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510(k) Data Aggregation
(149 days)
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications as described in the Indication for Use statement. The Serranator® has a nylon semicompliant balloon with three embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to modify the plaque by creating linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.
This document is a 510(k) summary for the Serranator® PTA Serration Balloon Catheter. It describes non-clinical testing performed to demonstrate that the device meets design input requirements and is substantially equivalent to predicate devices. It does not contain information about acceptance criteria or a study with human readers with or without AI assistance. It also does not discuss standalone algorithm performance, or ground truth for training data in the context of an AI-powered device.
1. A table of acceptance criteria and the reported device performance
Based on the provided document, the acceptance criteria are implicit in the "Pass" results for various tests. The reported device performance is that it met all these acceptance criteria.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Shipping, environmental stresses | Device maintains integrity and function after exposure to shipping and environmental stresses. | Pass |
| Flex/Kink | Device maintains patency and integrity when subjected to flexing and kinking. | Pass |
| Visual Inspection | Device meets visual quality standards (e.g., no defects, proper assembly). | Pass |
| Delivery, Deployment, Retraction | Device can be safely and effectively delivered, deployed, and retracted. | Pass |
| Fatigue | Device maintains integrity and function over its expected lifespan under repeated stresses. | Pass |
| Rated Burst/Compliance | Balloon inflates to specified pressure and dimensions without bursting prematurely and complies as expected. | Pass |
| Torsion | Device can withstand torsional forces without damage or loss of function. | Pass |
| Corrosion | Device materials do not corrode under specified conditions. | Pass |
| Tensile Test of Joints | Joints of the device meet specified tensile strength requirements. | Pass |
| Cytotoxicity | Device materials are not toxic to cells. | Pass |
| Sensitization | Device materials do not cause allergic reactions. | Pass |
| Irritation | Device materials do not cause irritation. | Pass |
| Systemic Toxicity (acute) | Device materials do not cause acute systemic toxicity. | Pass |
| Pyrogenicity | Device materials do not cause fever (are non-pyrogenic). | Pass |
| Hemocompatibility | Device materials are compatible with blood. | Pass |
| Thrombogenicity (P. Porcine Study) | Device does not induce thrombus formation. | Confirmed (No thrombus formation or other adverse events) |
| Usability, Performance (Porcine Study) | Device is usable and performs as intended in vivo. | Confirmed (No adverse events) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Testing/Performance & Biocompatibility: The document states that "Bench testing... was performed on sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples" and "Biocompatibility testing was conducted on sterile, finished devices". Specific sample sizes for each bench or biocompatibility test are not provided. The data provenance is from laboratory testing, not human subjects or real-world clinical data.
- Animal Studies: A total of two porcine test subjects were used for the animal study. This is a prospective animal study.
- Cadaver Studies: A diseased cadaver study was not performed for this specific device. However, a cadaver study was performed for the reference device (Serranator® Alto PTA Serration Balloon Catheter, K163380) to determine medial thickness of non-diseased infrapopliteal arteries. The sample size for this cadaver study is not specified, nor is the provenance beyond "cadaver artery assessment."
- Data Provenance for device performance: Lab/bench testing, animal studies, and cadaver studies (for reference device). No country of origin is specified for the animal or cadaver studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is not an AI/ML device, and therefore, there is no mention of experts establishing ground truth for a test set in the context of diagnostic or interpretive performance. The "ground truth" for the non-clinical and animal studies would be the objective measurements and observations made by laboratory personnel and veterinarians/pathologists during the respective tests, based on established protocols and standards. No specific number or qualifications are provided as this is a traditional medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring human adjudication of results for a test set. The non-clinical and animal studies are assessed against predefined pass/fail criteria.
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
Not applicable, as this is not an AI/ML device and there is no mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- Objective measurements and observations from bench testing against engineering specifications and regulatory standards (e.g., burst pressure, tensile strength, dimension checks).
- Biological responses observed in biocompatibility tests (e.g., cell viability, immune response, blood compatibility).
- In vivo observations in animal studies (e.g., absence of thrombus, dissection, perforations, successful deployment/retraction).
- Anatomical measurements from cadaver studies (for the reference device) to inform design parameters.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no concept of a "training set" for physical device testing as described.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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