(36 days)
Hem-o-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
The Weck Hem-o-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. The clips are intended for use in procedures involving ligation of vessels or tissue structures.
The Hem-o-Lok® clips are made from a non-absorbable acetyl polymer and are available in various sizes. Surgeons select the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
The document provided does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on metrics like accuracy, sensitivity, or specificity. This 510(k) summary (K063914) for the Hem-o-Lok® Ligating Clip primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document does not specify quantitative acceptance criteria or performance metrics such as accuracy, sensitivity, or specificity for the device. The basis for clearance is substantial equivalence to predicate devices, implying that its performance is considered comparable.
2. Sample size used for the test set and the data provenance:
Not applicable. No new performance study or test set is described in this 510(k) summary. The submission relies on the established safety and effectiveness of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment is described for a new study.
4. Adjudication method for the test set:
Not applicable.
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. This device is a passive implantable clip and not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
Not applicable. The clearance is based on substantial equivalence, implying that the established safety and effectiveness of the predicate devices serve as the "ground truth" for the current device's acceptability.
8. The sample size for the training set:
Not applicable. No new training set is described for this submission.
9. How the ground truth for the training set was established:
Not applicable.
Summary of Device and Regulatory Action:
- Device Name: Hem-o-Lok® Ligating Clip
- Device Description: Manually applied hemostatic clip made from non-absorbable acetyl polymer, available in various sizes.
- Intended Use: For use in procedures involving ligation of vessels or tissue structures.
- Regulatory Basis: Substantial equivalence to predicate devices (K982941, K993157, K003337, K030311, and K021808). The FDA determined that the device is substantially equivalent to legally marketed predicate devices. This means that direct, new performance studies with specific acceptance criteria are not typically required for this type of submission when substantial equivalence can be demonstrated.
§ 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.