(32 days)
The EXPANDED BODY suture is indicated for use in soft-tissue approximation and/or ligation in rotator cuff repair procedures.
The EXPANDED BODY suture is a braided, nonabsorbable, sterile, surgical suture composed of Poly(ethylene terapthalate) intended for use in rotator cuff soft-tissue repair procedures. This device is prepared from fibers of high molecular weight, fong-chain, linear polyesters having recurrent aromatic rings as an integral component.
The EXPANDED BODY suture is identical to currently marketed polyester sutures within this device class with the exception of the following:
- a new labeled indication for use stating specific use in rotator cuff soft tissue repair procedures, and
- a new design which incorporates an expanded midsection equidistant from both ends of the suture possessing a larger outer diameter (two to four times) than the standard USP size.
The outer diameter of the expanded midsection thus has a cross-sectional area equal to or greater than the cross-sectional area of the needle or drill used to create the hole in the tissue. This ensures that the expanded midsection firmly engages the hole created by the drill or needle in the tissue.
Acceptance Criteria and Device Performance Study for EXPANDED BODY Suture
This document describes the acceptance criteria and the study conducted to demonstrate that the EXPANDED BODY Suture meets these criteria, as detailed in the provided 510(k) Premarket Notification.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets USP Monograph for Nonabsorbable Surgical Suture requirements (except diameter) | USP Compliance Testing: |
| 1) Suture Needle Attachment Testing (USP #871): Results confirm the USP #5 EXPANDED BODY suture exceeds applicable requirements. | |
| 2) Suture Tensile (Knot Pull) Test (USP #881): Results confirm the USP #5 EXPANDED BODY suture exceeds applicable requirements. | |
| Equivalent to predicate device in simulated pull-out strength | Comparative Testing with TI•CRON: The EXPANDED BODY suture performs equivalent to the TI•CRON suture in simulated pull-out strength using Last-a-Foam Polyurethane Foam as a bone material surrogate. |
| Materials are biocompatible/established | Materials: Constructed of Poly(ethylene terephthalate), D&C Blue #6, D&C Green #6 (colors), and 420C Stainless Steel (needles). These materials are similarly used in predicate devices and are well-established. FDA has also approved the color additives for polyester sutures. |
| Sterilization method is appropriate | Sterilization: Gamma sterilization is used, which is identical to predicate devices. |
| Packaging is appropriate | Packaging: Method of manufacture and device packaging are identical to predicate devices. |
| Indication for use is supported by literature/device design | Indication for Use (Soft-tissue approximation and/or ligation in rotator cuff repair procedures): Although a new labeled indication, medical literature documents the widespread use of nonabsorbable polyester suture devices for soft-tissue repair of the shoulder, including rotator cuff repair. The expanded midsection design improves engagement and distributes force more evenly, which supports the rationale for this specific application. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For USP Compliance Testing (USP #871 and #881): A representative USP #5 EXPANDED BODY suture was used.
- For Comparative Testing (pull-out strength): A representative USP #5 EXPANDED BODY design configuration was used, compared against a USP #5 TI•CRON nonabsorbable, polyester suture.
- Data Provenance: The studies were conducted by MedicineLodge, Inc. and are described as internal testing to verify conformance and comparative performance. This indicates a prospective nature, with data generated specifically for this submission. The country of origin of the data is not explicitly stated but can be inferred as the United States, given the manufacturer's location and FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This submission does not rely on expert consensus or human interpretation for its performance evaluation. The "ground truth" for the test set is based on established, quantitative engineering and material standards, specifically the United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Suture and direct comparative physical testing against a predicate device. Therefore, no human experts were explicitly used to establish a subjective "ground truth" for the performance tests described.
4. Adjudication Method
Not applicable. The tests performed are objective, quantitative physical tests comparing against specified standards (USP) or direct comparison in a simulated environment, not clinical studies requiring adjudication of outcomes or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A MRMC comparative effectiveness study was not performed. This device is a surgical suture, and its performance is evaluated through biomechanical and material property testing, not through human interpretation of images or clinical data where MRMC studies would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device under review. The EXPANDED BODY Suture is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here. All performance testing described is for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" used for testing the EXPANDED BODY Suture is based on:
- Established Industry Standards: Specifically, the United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Suture for tests like suture needle attachment and tensile strength.
- Comparative Performance to a Predicate Device: For pull-out strength, the "ground truth" for comparison was the performance of a legally marketed predicate device (TI•CRON) under identical simulated conditions.
- Material Science and Biocompatibility Data: The material composition (poly(ethylene terephthalate), color additives, stainless steel) is accepted as "ground truth" based on prior FDA approvals and established biocompatibility for predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device. The concepts of "training set" and "validation set" are relevant to machine learning or AI algorithm development, which is not applicable here. The device's design and manufacturing processes are based on established engineering principles and material science, not statistical training from a data set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for a physical medical device of this nature.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.