(158 days)
The VITALITEC INTERNATIONAL, INC. Hemostatic Clip is designed for the intended use of figure occlusion of vessels and prevent any slippage once applica. The clip masters is required or radiographic marking is necessary. Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The clip can be left in vivo without sequela as it is biologically inert.
The clips are composed exclusively of titanium and are supplied sterile in various sizes (mini-micro, micro, small/medium, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and International Organization Standard , ISO 5832-2-93 "Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium".
Acceptance Criteria and Device Performance Study for Titanium Hemostatic Clip
This document describes the acceptance criteria for the Vitalitec International, Inc. Titanium Hemostatic Clip and the supporting data demonstrating its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Reference |
|---|---|---|
| Material Composition | ||
| Meet ASTM F-67 95, Grade I Titanium standards | Device composed of ASTM F-67 95, Grade I Titanium | Data Summary (Page 1) |
| Meet ISO 5832-2-93, Grade I Titanium standards | Device composed of ISO 5832-2-93, Grade I Titanium | Data Summary (Page 1) |
| Biologically Inert | Device clips are biologically inert; can be left in vivo without sequela | Indications For Use (Page 3) |
| Intended Use & Functionality | ||
| Effective for ligation of blood vessels | Hemostatic clip effectively ligates blood vessels | Data Summary (Page 1) |
| Ensures complete occlusion of vessels | Clip designed to ensure complete occlusion of vessels | Indications For Use (Page 3) |
| Prevents slippage once applied | Clip designed to prevent slippage once applied | Indications For Use (Page 3) |
| Wide acceptance of method for hemostatic control | Millions of clips applied yearly since 1963, attesting to wide acceptance | Safety and Efficacy Information (Page 1) |
| Manufacturing Standards | ||
| Manufactured according to cGMP's | Device manufactured according to cGMP's | Data Summary (Page 1) |
| Manufactured according to AAMI and ASTM requirements | Device manufactured according to AAMI and ASTM requirements | Data Summary (Page 1) |
| Manufactured according to applicable Harmonized Standards ISO 9002/EN 46002 | Device manufactured according to applicable Harmonized Standards ISO 9002/EN 46002 | Data Summary (Page 1) |
| Sterility | Supplied sterile | Clips are supplied sterile |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe specific device performance testing with a "test set" in the traditional sense of a clinical trial or algorithm validation. Instead, the safety and efficacy information relies on:
- Data Provenance: The primary basis for safety and efficacy is stated as "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control." This suggests a reliance on a retrospective analysis of widespread clinical use and long-term historical data for titanium hemostatic clips in general, rather than a prospective study on the specific Vitalitec device.
- Sample Size: No specific sample size or cohort is mentioned for a dedicated "test set" for this particular device. The "millions of clips" reference implies a very large, real-world population of patients who have received titanium hemostatic clips, though this is not a controlled sample.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since evidence is based on widespread historical use rather than a specific test set requiring ground truth establishment by experts, this information is not applicable in the context of the provided document. The "ground truth" seems to be established through the long-standing clinical acceptance and observation of outcomes over decades of use by numerous medical professionals.
4. Adjudication Method for the Test Set
As there is no described test set requiring expert adjudication for specific cases, this information is not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a physical medical device (titanium hemostatic clip), not an AI algorithm or imaging device that would typically involve 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 is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the safety and efficacy of the Titanium Hemostatic Clip is based on:
- Long-term Clinical Outcomes Data: The statement "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control" indicates reliance on decades of real-world clinical experience and observed patient outcomes for titanium hemostatic clips.
- Expert Consensus/Clinical Acceptance: The "wide acceptance" by the medical community of this method of hemostasis serves as a form of ground truth based on collective expert experience and consensus.
- Material Standards Compliance: Ground truth for material composition is established by compliance with recognized international standards (ASTM F-67 95, ISO 5832-2-93).
- Predicate Device Equivalence: The safety and efficacy are also heavily supported by the "substantial equivalence" claim to predicate devices, which implies that the safety and performance characteristics are well-established for similar products already on the market.
8. The Sample Size for the Training Set
This product is a physical medical device. There is no concept of a "training set" as would be used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.