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510(k) Data Aggregation
(315 days)
Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.
This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.
The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:
- Intended use
- Material
- Design
- Performance (Diameter, Needle attachment, and Tensile strength)
- Sterilization method
- Biocompatibility evaluation
The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.
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(90 days)
The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.
The U-CLIP™ Device is a self-closing clip for dura mater and prosthetic material approximation or attachment applications. The U-CLIP™ consists of a self-closing Nitinol clip connected to surgical needles via flexible members. The U-CLIP™ includes a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol.
The provided document is a 510(k) summary for the U-CLIP™ Device, specifically focusing on its use in neurosurgical procedures. It establishes substantial equivalence to previously cleared U-CLIP™ devices and non-absorbable sutures for dura approximation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (U-CLIP™ K062057, K053252, K013664, Ethicon PRONOVA Suture K001625, Surgilon/Polyamide Suture K981582) for dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures. | "In vivo testing confirmed that the U-CLIP Device is comparable to the predicate, standard non-absorbable suture, for dura approximation application." The device design, fabrication, packaging, specifications, and fundamental scientific technology are stated to be identical to previously cleared U-CLIP™ devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific in vivo tests. The document refers generally to "in vivo testing."
- Data Provenance: Not specified (e.g., country of origin). The study is described as "in vivo testing," implying a pre-clinical study rather than human clinical data. It is a retrospective notification of previous testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study does not involve expert readers establishing ground truth for image interpretation or similar diagnostic tasks. It's an in vivo comparability study for a surgical device.
4. Adjudication Method for the Test Set
Not applicable. The study does not involve expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes an "in vivo testing" comparing the device to a predicate, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study in the form of "in vivo testing" was done to confirm comparability of the U-CLIP™ Device to the predicate non-absorbable suture for dura approximation. This assesses the device's performance directly without human intervention in its function.
7. Type of Ground Truth Used
The ground truth used was the performance of the predicate device (standard non-absorbable suture) in dura approximation applications, as established through "in vivo testing." The study aimed to demonstrate comparability to this established performance.
8. Sample Size for the Training Set
Not applicable. This device is a surgical clip, and the study described is an in vivo comparability test, not an AI/algorithm-based system requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device/study type.
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