(99 days)
A surgical instrument used to occlude a blood vessel temporarily.
The Vein Clamps and Artery Clamps are small clamps used in surgery on small blood vessels. This Special 510(k) is being done to expand on the pressures, add a curved design, and change the sterilization process. There are no other changes and the original products cleared under K961100 remain unchanged and are still being sold.
The provided text describes a 510(k) premarket notification for "Vein Clamp and Artery Clamp" and discusses the changes from a previous clearance (K961100). However, the document does not contain specific acceptance criteria, comprehensive study details, or quantifiable performance data in the format requested. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Based on the provided information, here's what can be extracted and what is missing:
Acceptance Criteria and Study Details for AROS Surgical Instruments Corporation's Vein Clamp and Artery Clamp (K161315)
The provided document describes a Special 510(k) submission for the Vein Clamp and Artery Clamp, which expands on pressures, adds a curved design, and changes the sterilization process from the original K961100 clearance.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Not Explicitly Stated as AC in Doc) | Reported Device Performance (as updated) |
|---|---|---|
| Closing Pressures | Original: 19.8 to 60.1 gms (Implied benchmark from predicate) | 15 to 120 gms (Expanded range) |
| Design | Original: All clamps were straight (Implied benchmark from predicate) | Adds curved design |
| Sterilization Method | Original: Ethylene Oxide (Implied benchmark from predicate) | Radiation (New method) |
| Biocompatibility | ISO 10993 and FDA guidance document compliance | Successfully completed (Statement of compliance) |
| Sterilization Validation | ISO 11137 compliance | Successfully completed (Statement of compliance) |
Note: The document explicitly states the changes from the predicate device (K961100) rather than setting up formal acceptance criteria. The "acceptance criteria" above are inferred from the previously cleared device's characteristics, and the "reported device performance" reflects the modifications being introduced and tested.
2. Sample Size for Test Set and Data Provenance
The document does not specify the sample size used for any of the non-clinical tests (e.g., in a "test set" for closing pressure measurements, biocompatibility, or sterilization validation).
The data provenance is not mentioned beyond the fact that testing was conducted to demonstrate compliance with standards like ISO 10993 and ISO 11137. It is implicitly prospective from the perspective of validating the new design and sterilization method, but no country of origin for specific test data is provided.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is a medical device (vascular clamp) and the evaluation is based on engineering and materials testing, not diagnostic performance requiring expert consensus on images or clinical data.
4. Adjudication Method for Test Set
Not applicable. This type of device verification does not typically involve adjudication by human experts in the way clinical studies for diagnostic tools do. Tests are objective and measurable (e.g., force, sterility).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a surgical instrument, not a diagnostic imaging tool or an AI-powered diagnostic aide. Therefore, an MRMC study is not relevant.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical surgical instrument, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through adherence to recognized international standards and objective physical measurements:
- Biocompatibility: Demonstrated by testing according to ISO 10993 and FDA guidance.
- Sterilization: Validated according to ISO 11137.
- Closing Pressures: Measured physical forces of the clamps.
8. Sample Size for Training Set
Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).