(56 days)
Modified USSC* POLYSORB* Sutures are indicated for use in soft tissue approximation or ligation and opthalmic surgery, but not in cardiovascular or neural tissue.
Modified USSC* POLYSORB* sutures are composed of LACTOMER* glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.
This K970863 submission for the Modified USSC* POLYSORB* Suture is a premarket notification for a Class II medical device. The information provided heavily focuses on the material composition, intended use, and conformance to general standards rather than a detailed clinical study demonstrating specific performance metrics against acceptance criteria. Therefore, several requested elements cannot be fully addressed from the given text.
Here's the breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength: Meets USP Synthetic Absorbable Suture Monograph requirements. | The device "Meets the requirements of U.S.P. Synthetic Absorbable Suture Monograph for tensile strength." |
| Needle Attachment: Meets USP Synthetic Absorbable Suture Monograph requirements. | The device "Meets the requirements of U.S.P. Synthetic Absorbable Suture Monograph for needle attachment." |
| Diameter: Meets USP Synthetic Absorbable Suture Monograph requirements. | The device "Meets the requirements of U.S.P. Synthetic Absorbable Suture Monograph for diameter." |
| Biocompatibility/Safety Profile: (Implicitly assumed to be met through material composition and predicate device equivalence) | The device is composed of "LACTOMER* glycolide/lactide copolymer," a synthetic polyester. The predicate devices (USSC* Braided Synthetic Absorbable Suture K961997 and USSC* POLYSORB* Sutures K963253) indicate prior clearance for similar materials and intended use. |
| Intended Use: Indicated for soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. | The device "are indicated for use in soft tissue approximation or ligation and opthalmic surgery, but not in cardiovascular or neural tissue." This is a statement of the intended use, which the device is designed to meet. |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated. The submission refers to meeting USP Monograph requirements, which are standardized tests performed on a representative sample of the device. However, the specific sample size, country of origin, or whether the data was retrospective or prospective (clinical trial data) is not detailed in this summary. USP monographs typically outline the methodology and sample sizes for testing physical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on the physical and material properties of a surgical suture, not on diagnostic accuracy requiring expert interpretation of images or clinical data. The "ground truth" here is defined by objective, measurable physical properties as outlined by the USP Monograph.
4. Adjudication method for the test set:
- Not applicable. See point 3. The assessment relies on standardized laboratory testing protocols, not on human adjudication of subjective interpretations.
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 an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used:
- Standardized Physical Properties/Laboratory Measurements. The "ground truth" for this device is defined by the objective, quantifiable requirements outlined in the U.S.P. (United States Pharmacopeia) Synthetic Absorbable Suture Monograph for characteristics such as tensile strength, needle attachment, and diameter.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device (suture), not a machine learning algorithm that requires 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.