(46 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 is available in 6-0, 5-0, 4-0, 2-0, 0 and 1, which are the sizes 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the WEGO-PGCL Absorbable Surgical Monofilament Suture:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reference/Requirement | Reported Device Performance |
|---|---|---|
| Suture Diameter | USP 35 SUTURES - DIAMETER (USP Monograph of Absorbable Surgical Suture) | The suture diameters of the proposed device comply with the diameter requirement listed in USP 35 Diameter. |
| Needle Attachment Strength | USP 35 SUTURES – NEEDLE ATTACHMENT (USP Monograph of Absorbable Surgical Suture) | The bond between suture and needle of the applicant device meets the requirements defined in USP 35 . |
| Tensile Strength | USP 35 TENSILE STRENGTH (USP Monograph of Absorbable Surgical Suture) | The tensile strengths of the proposed device comply with the tensile requirement listed in USP 35 Tensile Strength. |
| Absorbable Surgical Suture Monograph | USP Monograph of Absorbable Surgical Suture | The performance of this absorbable sutures complies with United States Pharmacopoeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35, USP 35 and USP35 . |
| Residual Strength & Absorption Rate | FDA's Class II Special Controls Guidance Document: Surgical Sutures | Demonstrated and evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures. (Specific values or ranges for these are not provided in the document, only that they were demonstrated and evaluated for compliance with the guidance). |
| Biocompatibility (against predicate device) | ISO 10993-3, ISO 10093-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 Standard | Comply with ISO 10993-3, ISO 10093-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 Standard. (This is a comparison to the predicate, implying the predicate met these and the new device also complies). |
| sterility | N/A (Standard practice for surgical devices) | EO sterilized as a single-used device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
- Sample Size: The document does not specify the exact sample sizes used for each non-clinical test (diameter, tensile strength, needle attachment, residual strength, absorption rate, biocompatibility). It only indicates that "tests were conducted."
- Data Provenance: The document does not specify the country of origin of the data. Since the manufacturer is "Foosin Medical Supplies Inc., Ltd" located in China, it's highly probable the non-clinical tests were conducted in China. The data is retrospective in the sense that these are pre-market tests performed on the device to demonstrate performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided for this type of device and study. The "ground truth" for a surgical suture's physical properties (diameter, strength, etc.) is established by comparing its performance against a universally accepted standard (e.g., United States Pharmacopoeia - USP) using validated laboratory equipment and methodologies, not by expert consensus in the typical sense for diagnostic or prognostic devices. Experts may design the tests and interpret the results, but they don't establish the ground truth through subjective assessment in this context.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for studies involving human interpretation (e.g., diagnostic image reading) where there's subjectivity and potential disagreement among reviewers. For physical device testing against objective standards, the results are typically quantitative and directly measured, not subject to human adjudication for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers (e.g., radiologists) use the device to interpret cases. The WEGO-PGCL Absorbable Surgical Monofilament Suture is a physical medical device (suture) used in surgical procedures, not a diagnostic tool requiring human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This concept is not applicable to this device. A "standalone" performance study refers to the performance of an algorithm or AI model without human intervention, typically in diagnostic or analytical applications. This device is a physical surgical product. Its performance is evaluated through physical and material tests, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is established by objective, predefined standards and methodologies outlined in recognized pharmacopeias (United States Pharmacopoeia - USP) and international standards (ISO 10993 series). These standards define the acceptable range or minimum/maximum values for properties like diameter, tensile strength, and biocompatibility. The device's test results are then compared directly to these established benchmarks.
- Expert Consensus: Not used for objective physical properties.
- Pathology: Not used in this context.
- Outcomes Data: Not used for establishing the direct physical properties in these non-clinical tests, though clinical outcomes from predicate devices would inform the safety profile.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. A "training set" is relevant for machine learning or AI algorithms. This submission is for a physical medical device (a surgical suture), not an AI-driven device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided, as there is no "training set" for this physical medical 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.