(302 days)
The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.
The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery. The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL): and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture size is 3-0, which is the size identified in the currently recognized United States Pharmacopoeia. The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35, USP 35 and USP35 . The Synthetic Absorbable Suture is provided EO sterilized as a single used device.
Acceptance Criteria and Device Performance Study for WEGO-PGCL Absorbable Surgical Monofilament Suture
The WEGO-PGCL Absorbable Surgical Monofilament Suture was evaluated for substantial equivalence to a predicate device (MoNo Q (PGCL), K100461) by demonstrating compliance with established performance standards for absorbable surgical sutures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Guideline) | Reported Device Performance (WEGO-PGCL) |
|---|---|---|
| Suture Physical Properties | USP 35 SUTURES - DIAMETER: Diameter within specified limits for suture size. | Complied with the diameter requirement listed in USP 35 Diameter. |
| USP 35 TENSILE STRENGTH: Tensile strength meets specified minimums for suture size. | Complied with the tensile requirement listed in USP 35 Tensile Strength. | |
| USP 35 SUTURES -- NEEDLE ATTACHMENT: Bond between suture and needle meets specified strength. | Met the requirements defined in USP 35 . | |
| USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE: Overall compliance with the monograph for absorbable sutures. | Complied with the USP monograph requirements for Absorbable Surgical Suture. | |
| Residual Strength and Absorption Rate (FDA Class II Special Controls Guidance Document: Surgical Sutures): Demonstrated appropriate biodegradability and strength retention. | Studies performed in accordance with FDA guidance, results indicated compliance. | |
| Packaging Integrity | ASTM F88-09 (Seal Strength of Flexible Barrier Materials): Packaging seal strength. | Test results demonstrated compliance. |
| ASTM F 1140-07 (Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications): Packaging resistance to internal pressure. | Test results demonstrated compliance. | |
| ASTM F1929-98(2004) (Detecting Seal Leaks in Porous Medical Package by Dye Penetration): Packaging seal integrity. | Test results demonstrated compliance. | |
| Sterilization | ISO 11135-1:2007 (Sterilization of health care products- Ethylene oxide): Requirements for EO sterilization. | Test results demonstrated compliance. |
| Biocompatibility | USP Bacterial Endotoxin Limit: Endotoxin levels within acceptable limits. | Test results demonstrated compliance. |
| ISO 10993-3:2003 (Genotoxicity, Carcinogenicity and Reproductive Toxicity): Evaluation for potential genotoxic, carcinogenic, or reproductive effects. | Complied with ISO 10993-3. | |
| ISO 10993-5:1999 (In vitro cytotoxicity): Evaluation for cytotoxic potential. | Complied with ISO 10993-5. | |
| ISO 10993-6:1994 (Local Effects after Implantation): Evaluation of local tissue reactions after implantation. | Complied with ISO 10993-6. | |
| ISO 10993-10:2002 (Irritation and delayed-type hypersensitivity): Evaluation for irritation and sensitization. | Complied with ISO 10993-10. | |
| ISO 10993-11:1993 (Systemic toxicity): Evaluation for systemic toxic effects. | Complied with ISO 10993-11. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for "test sets" in the context of individual tests. Instead, it refers to the performance of "non clinical tests" conducted to verify compliance with various established standards (USP, ASTM, ISO). The nature of these tests (e.g., tensile strength, diameter measurement, biocompatibility) implies that a sufficient number of samples were tested to meet the statistical requirements outlined in the respective standards.
Data Provenance: The document does not explicitly state the country of origin for the data generated from the non-clinical tests. However, the sponsor is Foosin Medical Supplies Inc., Ltd, located in Weihai, Shandong, China. The studies were non-clinical, meaning they were laboratory-based tests of the device's physical, chemical, and biological properties, not human subject data. Therefore, the data would be retrospective in the sense that it reflects the performance of manufactured batches, and its origin would be related to the manufacturing and testing facilities in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this submission. The "ground truth" for the non-clinical tests described is established by objective, standardized measurements and criteria defined in recognized international and national standards (USP, ASTM, ISO). These tests do not involve human expert interpretation or adjudication to establish a "ground truth" in the way that, for example, medical image analysis requires expert reads. The standards themselves dictate the acceptable ranges and methodologies.
4. Adjudication Method for the Test Set
This section is not applicable as the tests are objective, standardized measurements against predefined criteria. There is no mention of subjective interpretation of results requiring an adjudication process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without the assistance of an AI algorithm in diagnostic tasks, often with a focus on clinical endpoints or diagnostic accuracy. The current submission is for a medical device (surgical suture) and involves physical and biological property testing, not diagnostic imaging or clinical interpretation by multiple readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This section is not applicable. The device is a surgical suture, not an AI algorithm. Therefore, there is no "standalone algorithm" performance to report. The "device performance" refers to its inherent physical, chemical, and biological attributes as measured in laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests conducted is defined by the objective, quantitative criteria and methodologies specified in globally recognized standards and monographs. These include:
- USP (United States Pharmacopeia) Monographs: Specifically USP 35 (Diameter), USP 35 (Needle Attachment), USP 35 (Tensile Strength), and the general Monograph of Absorbable Surgical Suture. These documents define the precise methods and acceptable ranges for these physical properties.
- ASTM (American Society for Testing and Materials) Standards: Such as ASTM F88-09, ASTM F1140-07, and ASTM F1929-98(2004) for packaging integrity. These standards provide exact testing procedures and pass/fail criteria.
- ISO (International Organization for Standardization) Standards: Specifically SO 11135-1:2007 for sterilization and various parts of ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility. These standards specify how tests should be performed and what constitutes an acceptable biological response.
- FDA Class II Special Controls Guidance Document: Surgical Sutures: This document provides guidance on residual strength and absorption rate studies, outlining the expectations for acceptable performance.
Essentially, the ground truth is compliance with established, quantitative, and scientifically validated testing standards.
8. The Sample Size for the Training Set
This section is not applicable. This submission is for a medical device (surgical suture), not a machine learning model or AI algorithm. Therefore, there is no "training set" in the context of algorithm development. The testing conducted is to demonstrate product quality and compliance with established standards.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8; there is no training set for this device.
§ 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.