(86 days)
MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
MONOCRYL* Plus Antibacterial (poliglecaprone 25) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broadspectrum antibacterial agent, at no more than 2360 ug/m.
The provided text describes a 510(k) premarket notification for a medical device, MONOCRYL* Plus Antibacterial Suture. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies as might be described in a PMA (Premarket Approval) application.
Therefore, many of the requested details, such as specific acceptance criteria for numerical performance metrics, sample sizes for test sets to establish ground truth, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or not explicitly provided in this type of submission document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices. This means the new device must be as safe and effective as a legally marketed device and share similar technological characteristics and indications for use.
- Specifically, for performance, the device had to conform to the USP Monograph for absorbable surgical sutures (except for diameter) and perform as intended and claimed in in-vivo/in-vitro testing.
- Reported Device Performance:
- "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures."
- "Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed."
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K960653, K964072, K032420) in terms of safety, effectiveness, technological characteristics, and intended use. | Concluded by FDA to be substantially equivalent based on the provided information. |
| Conformity to USP Monograph for absorbable surgical sutures (except for diameter). | Non-clinical laboratory testing performed, demonstrating conformity. |
| Performance as intended and claimed in in-vivo/in-vitro testing. | In-vivo/in-vitro testing provided, showing performance as intended and claimed. |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The document mentions "non-clinical laboratory testing" and "in-vivo/in-vitro testing" but does not provide specific sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or included in a 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission doesn't involve subjective interpretations or diagnoses that would require expert-established ground truth in the way clinical diagnostic devices do. The testing described (USP monograph compliance, in-vivo/in-vitro performance) relies on objective measurement standards.
4. Adjudication method for the test set
- Not applicable. As there's no expert-established ground truth in this context, no adjudication method would be used.
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 device is a surgical suture, not a diagnostic imaging device or an AI-powered system that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (suture) and does not involve algorithms or AI.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on objective, standardized measurements against the USP Monograph for absorbable surgical sutures and general biological/mechanical performance evaluations (in-vivo/in-vitro testing) to ensure it performs as intended and claimed. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the manner of diagnostic devices.
8. The sample size for the training set
- Not applicable. The device is a physical suture, not a software algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
§ 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.