(57 days)
angioLOCK® Non-Absorbable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
AngioLOCK ligating clips are permanent implant, non-absorbable, sterile single use, surgical clips made of implantable grade polymer and are available in multiple sizes.
ligating clips are non-absorbable, non-active implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.
angioLOCK® open and Laparoscopic Ligation Clip Appliers are for use as delivery devices for angioLOCK® Non-Absorbable Polymer Ligation Clips. Other ligation clips cannot be used with these appliers. angioLOCK® Laparoscopic Polymer Ligation Clip Appliers are designed for use with specific size cannulas.
This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the angioLOCK Polymer Ligating Clip. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.
Therefore, the information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, training set sample size, and ground truth establishment for the training set cannot be extracted from the provided text because these elements are typically associated with performance studies against established criteria, which are not detailed in this regulatory submission for substantial equivalence.
The document does provide information about the device's comparison to a predicate device, which is a different type of assessment.
Here's an analysis of the information that is available:
1. A table of acceptance criteria and the reported device performance:
- This information is not present in the document. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria in a dedicated study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not present. The document describes qualitative and dimensional comparisons to a predicate device, but not a study involving a "test set" in the context of performance metrics.
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 information is not present. Ground truth establishment for a test set is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not present. Adjudication methods are not discussed.
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:
- This information is not present. This device is a polymer ligating clip, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not present. This device is a physical surgical clip, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not present. The concept of "ground truth" in the context of performance evaluation against clinical outcomes is not applicable or discussed for this type of device and submission.
8. The sample size for the training set:
- This information is not present. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- This information is not present. This device does not involve a "training set" or its ground truth establishment.
Information that is extractable regarding the comparison to a predicate device (instead of a performance study):
The document details a substantial equivalence analysis between the angioLOCK Polymer Ligating Clip and the predicate device, Teleflex Medical Hem-o-lok Ligating Clips (510k - K030311).
Summary of Performance Data (as presented for substantial equivalence):
The document states that "AngioLOCK ligating clips are made of an implantable grade of polyacetal polymer with same dimensions and same material characteristics as the predicate Teleflex Medical Hem-o-lok ligating clips."
The following analyses (not performance studies against acceptance criteria) were performed to demonstrate substantial equivalence:
- i. Dimensional comparison: angioLOCK clip to predicate clip dimensional comparison was completed at an open and closed state within an applier, resulting in "having the same function as Hem-o-lok when clips are applied and closed."
- ii. Material comparison: "Both biocompatibility and polymer material comparisons prove that the molded and sterilized material used for the angioLOCK clip is as safe and the same as the material used in Hem-o-lok."
- iii. Qualitative closure testing: "angioLOCK clip closure testing proved that the clips latch/lock, are secure in the applier, and release from applier's jaws equivalent to Hem-o-lok."
- iv. Qualitative dimensional/geometry comparisons: "dimensional/geometry comparisons using precise overlays prove that angioLOCK and Hem-o-lok clips are the same size."
- v. Mechanism of action comparison: "Mechanism of action is the same between angioLOCK and Hem-o-lok; cartridge and clip design allows for an applier to easily load a clip, haptic feedback occurs when the clip bosses locate in the applier grooves, and clips are then removed for use. When the clip is closing the upper and lower curved legs with inner teeth pivots in from a hinged section and haptic feedback occurs as clips are latched closed."
The document concludes with a "Statement of Substantial Equivalence: The angioLOCK® Ligating Clips are substantially equivalent to their predicate device... based upon similarities in intended use, design, principles of operation and performance specifications."
§ 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.