(42 days)
MONOCRYL suture, dyed is intended for use in general soft tissue approximation and/or ligation.
MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
MONOCRYL suture, dyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. MONOCRYL suture is dyed violet using D&C Violet No. 2.
This document describes a medical device submission (K960653) for a MONOCRYL (poliglecaprone 25) suture, dyed. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device.
It's important to note that this submission is for a surgical suture, not an AI/ML powered device. Therefore, the questions regarding AI/ML-specific criteria (such as AI assistance, training/test sets, ground truth establishment, expert qualifications, etc.) are not applicable to this document. The "device" in this context refers to the physical surgical suture.
Here's the information as it applies to the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same Intended Use as Predicate Device | "MONOCRYL suture, dyed has the same intended use as predicate device MONOCRYL suture, dyed." (Intended for use in general soft tissue approximation and/or ligation) |
| Same Technological Characteristics as Predicate Device | "The modified device has the same technological characteristics as the predicate device. There is no change in chemistry, material or composition." |
| Acceptable Breaking Strength Retention (BSR) Profile | "When compared to the predicate device, dyed MONOCRYL suture, MONOCRYL suture, dyed has an increased breaking strength retention (BSR) profile." |
| Biocompatibility | "Biocompatibility and clinical was deemed unnecessary to support this labeling change." (Implies previous biocompatibility for the predicate, and no new biocompatibility issues are expected with this change.) |
2. Sample sized 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 physical suture, and the "test set" for performance evaluation would refer to the materials and conditions used for testing the suture's physical properties. The document states "Nonclinical laboratory testing was performed to determine breaking strength retention." It does not specify sample size, country of origin, or whether it was retrospective/prospective.
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. As this is not an AI/ML device, the concept of "experts to establish ground truth" (as it relates to image interpretation or diagnosis) is not relevant. The performance (breaking strength retention) is determined through laboratory measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used to resolve discrepancies among human readers or expert opinions in diagnostic tasks, which is not relevant here.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical/Physical Measurement Data: The ground truth for the performance claim (breaking strength retention) is derived from nonclinical laboratory testing that measures the physical properties of the suture.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML device, this question is not relevant.
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MAR 28 1996
MAR 2 8 1996
.
SECTION 7
K960653 (P.1002)
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary ofSafety and Effectiveness | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug and Cosmetic Act,respecting safety and effectiveness is summarized below. Forthe convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summariesand 510(k) Statements..." (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requestingit from the Agency. |
|---|---|
| NEW DEVICE NAME: MONOCRYL (poliglecaprone 25) suturedyed | |
| PREDICATE DEVICE NAME: Predicate device MONOCRYL(poliglecaprone 25) suture, dyed | |
| 510(k) SUMMARY | |
| Device Description | MONOCRYL suture, dyed is a monofilament syntheticabsorbable surgical suture prepared from a copolymer ofglycolide and epsilon-caprolactone. MONOCRYL suture is dyedviolet using D&C Violet No. 2. |
| Intended Use | MONOCRYL suture, dyed is intended for use in general softtissue approximation and/or ligation. |
| MONOCRYL suture, dyed has the same intended use aspredicate device MONOCRYL suture, dyed. | |
| Continued on next page |
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K460653 (12-23-23)
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued Indications Statement MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. The modified device has the same technological characteristics as Technological Characteristics the predicate device. There is no change in chemistry, material or composition. When compared to the predicate device, dyed MONOCRYL suture, MONOCRYL suture, dyed has an increased breaking strength retention (BSR) profile. Performance Data Nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and clinical was deemed unnecessary to support this labeling change. Conclusions Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act. Contact John D. Paulson, Ph.D. Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
February 14, 1996
MONOCRYL (Poliglecaprone 25) Suture, Dyed ETHICON, Inc.
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.