(47 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.
Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
The provided text describes a 510(k) submission for Hem-o-lok® Ligating Clips, asserting substantial equivalence to predicate devices rather than presenting novel performance criteria that would necessitate a new clinical study with specific acceptance criteria, human experts, and ground truth establishment methods for device performance beyond basic safety and mechanical integrity.
Here's an analysis based on the provided document:
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Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The proposed Hem-o-lok® Ligating Clips have the same technology and functional characteristics as the predicate systems." and "A comparison of the technological characteristics of the proposed Hem-o-lok® Ligating Clips and the predicates has been performed. The results of this comparison demonstrate that the Hem-o-lok® Ligating Clips are equivalent to the marketed predicate devices."
Therefore, the primary acceptance criterion for this 510(k) submission is Substantial Equivalence to the predicate devices (K062914 and K030311). The "reported device performance" is that it is equivalent in technological and functional characteristics to these cleared predicates.
Acceptance Criterion Reported Device Performance Substantial Equivalence to Predicate Devices (K062914 & K030311) in technology and functional characteristics Demonstrated equivalence to predicate devices. Modifications (MR Safe claims, cleaning/sterilization instructions, three-clip configuration, packaging changes) do not introduce new safety/effectiveness issues. Compliance with ISO 10993-1 All patient contacting materials are in compliance. Compliance with ISO 11607-1:2006 Testing conducted to support changes to packaging materials. Validation of Cleaning and Sterilization Processes Performed for reusable clip appliers and removers. -
Sample size used for the test set and the data provenance:
The submission focuses on non-clinical performance testing for packaging and cleaning/sterilization validation. There is no mention of a "test set" in the context of clinical performance or diagnostic accuracy that would involve patient data. The provenance of any materials testing or validation data is not specified (e.g., country of origin, retrospective/prospective), as it's typically laboratory-based engineering and materials testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This 510(k) is about demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics, not a clinical study requiring expert ground truth for diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no "test set" in the context of a clinical performance study with human readers or image analysis.
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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 is not an AI/CAD device. It is a ligating clip.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical performance. For the non-clinical tests mentioned:
- Packaging: Adherence to ISO 11607-1:2006 standards.
- Cleaning/Sterilization: Successful validation against pre-defined microbiological and cleanliness acceptance criteria as per recognized standards (not explicitly named beyond "validation").
- Biocompatibility: Compliance with ISO 10993-1.
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The sample size for the training set:
Not applicable. The device is a ligating clip, not a machine learning model.
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How the ground truth for the training set was established:
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.