DUAL NEEDLE SUTURE PASSER SYSTEM

• K Number: K082518
• Device Name: DUAL NEEDLE SUTURE PASSER SYSTEM
• Manufacturer: CAYENNE MEDICAL, INC.
• Date Cleared: 2009-01-16 ( 136 days)
• Product Code: GAT
• Regulation Number: 878.5000
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K063778 , K041894 , K023388 , K062307 , K072322
• Predicate For: N/A

Intended Use

The Dual Needle Suture Passer System is intended for approximation of soft tissue in procedures such as meniscal repair

Device Description

The Dual Needle Suture Passer System is a sterile hand-held, manually operated single procedure suture placement system for soft tissue approximation procedures.

AI/ML Overview

The provided text describes the 510(k) summary for the Dual Needle Suture Passer System. The study conducted to demonstrate equivalence is a mechanical test rather than a clinical study involving human or animal subjects that would typically have the detailed information requested.

Here's the information extracted and filled in to the best of what's available in the text:

Device: Dual Needle Suture Passer System

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Suture knot pull-out strength significantly higher than a predicate device	Suture knot pull-out strength is significantly higher than that of a predicate device.
Meet knot pull-out strength requirements in animal tissue	The proposed device was tested in animal tissue and meets the knot pull-out strength requirements.
Meet USP requirements for non-absorbable sutures	The proposed device meets USP requirements for non-absorbable sutures.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document implies a test set was used for mechanical testing of suture knot pull-out force in "animal tissue." No specific number of samples or animal subjects is provided.
   • Data provenance: "animal tissue" is mentioned, not a specific country. The study appears to be a laboratory/benchtop test rather than a clinical study. It is a retrospective comparison against a predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This was a mechanical engineering/biomedical performance test, not a study requiring expert consensus for ground truth.

3. Adjudication method for the test set:

   • Not applicable, as there was no expert review or human assessment of ground truth. The acceptance criteria were based on quantitative mechanical measurements.

4. 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:

   • No, an MRMC study was not done. This device is a surgical instrument, not an AI diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a surgical instrument, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for this study was defined by established mechanical engineering standards (e.g., USP requirements) and direct comparison to a predicate device's performance through quantitative mechanical testing (suture knot pull-out force).

7. The sample size for the training set:

   • Not applicable. This was a mechanical performance study, not a machine learning study involving training data.

8. How the ground truth for the training set was established:

   • Not applicable. This was a mechanical performance study, not a machine learning study involving training data.

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.