(196 days)
Coated VICRYL Plus Antibacterial Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
The Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. It is coated with a mixture composed of equal parts of Polyglactin 370 (65%PLA/35%PGA, a copolymer of glycolide and L-lactide) and calcium stearate. A small amount of an antibacterial agent, Irgacare MP** (triclosan), has been added to the suture coating. Irgacare** MP is the tradename given by CIBA Specialty Chemicals Corp. for their high purity material that meets U.S.P. specifications for triclosan. Coated VICR YL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a multifilament suture and is available dyed and undyed. It meets U.S.P. requirements, except for diameter, as described in the U.S.P. Monograph for synthetic absorbable surgical suture. The dyed version of the device is available with an approved color additive (D&C Violet No.2). The product is available in U.S.P. sizes 5-0 through 2 in a variety of lengths, with or without needles, and on LIGAPAK* dispensing reels.
The subject device is identical to the predicate device (K032420) in all aspects, including design, materials, sterilization and packaging. The only difference between the proposed and the predicate devices lies in the some labeling statements.
The provided document describes a 510(k) summary for a surgical suture, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance (like effect size of AI assistance, MRMC studies, training set size, etc.) are not applicable and cannot be found in the provided text.
The document focuses on demonstrating substantial equivalence of a new version of a surgical suture (Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture) to a previously cleared predicate device (K032420). The argument for acceptance is based on the new device being "identical to the predicate device... in all aspects, including design, materials, sterilization and packaging" with only minor labeling differences.
Here's the information that can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria here are based on substantial equivalence to the predicate device. The performance data is deemed "not necessary" because of this identical nature.
| Acceptance Criterion (Based on Predicate Device Equivalence) | Reported Device Performance (Proposed Device) |
|---|---|
| 510(k) Number: K032420 | K132580 (New device identifier) |
| Product Code: GAM | Same |
| Regulation: 21 CFR § 878.4493 | Same |
| Absorbable: Yes | Yes |
| Characteristics: Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture | Same |
| Intended use: Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular, and neurological tissues. Should not be used where extended approximation of tissue under stress is required. Should not be used in patients with known allergic reactions to Irgacare MP**. | Same (with labeling modifications) |
| How supplied: Sterile, Multifilament strand (braided), Available in a variety of lengths, with or without needles, and on LIGAPAK* dispensing reels. The devices are available in one, two or three dozen boxes. | Same |
| Color: Undyed or Dyed Suture Strands | Same |
| Material Composition: Composed of a copolymer made from 90% glycolide and 10% L-lactide. Coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and Calcium Stearate. | Same |
| Breaking Strength Retention profile: Approximate percent breaking strength remaining (%BSR) 14 Days -75%, 21 Days -50%, 28 Days -25%. | Same |
| Absorption profile: Absorption is essentially complete between 56 and 70 days. | Same |
| USP requirements: Meets USP Monograph -except for diameter. | Same |
| Sterilization: Sterilized by Ethylene Oxide | Same |
| Packaging: Foil packaging | Same |
| Antibacterial agent: The suture contains Irgacare MP** (triclosan), a broad-spectrum antibacterial agent, at no more than 472ug/m. | Same |
| Labeling Comparison: Modifications in ACTION section regarding meta-analyses of clinical trials referencing benefits of triclosan-coated sutures. | Modified labeling (see original document for full text) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a substantial equivalence submission for a physical medical device (suture), not an AI/ML device requiring a test set for performance evaluation in the typical sense. Performance data for the device was not deemed necessary due to its identical nature to the predicate. The labeling modifications refer to pre-existing meta-analyses of randomized clinical trials, but details on sample size or provenance of those studies are not provided in this 510(k) summary.
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)
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the suture itself, "ground truth" is established by adherence to physical specifications, material composition, and performance characteristics (like breaking strength and absorption profile) that match the predicate device and meet USP requirements. For the labeling changes related to antibacterial efficacy and reduction of surgical site infections, the ground truth is derived from previous "zone of inhibition studies" and "animal studies," and referenced "prospectively planned meta-analyses of randomized clinical trials."
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.