(42 days)
The RAM® COR-SUTURE® QUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials.
The COR-SUTURE® OUICK LOAD® surgical suture is indicated for use in the approximation of soft tissue and prosthetic materials.
LSI SOLUTIONS® offers both the RAM® COR-SUTURE® QUICK LOAD® surgical suture, which is a non-absorbable polytetrafluoroethylene (PTFE)-coated, braided polyester surgical suture, and the COR-SUTURE® QUICK LOAD® surgical suture, which is available as either a PTFE-coated, braided polyester surgical suture or a monofilament, uncoated polypropylene surgical suture. The RAM® COR-SUTURE® QUICK LOAD® surgical suture is also supplied with an optional pre-attached PTFE pledget that is used to aid in suture buttressing and to mechanically secure and support the suture in fragile tissue, increasing the suture holding strength. A short length of modified surgical stainless-steel tubing, called a "needle cap", is attached to each end of the suture for both the RAM® COR-SUTURE® QUICK LOAD® surgical suture and the COR-SUTURE® QUICK LOAD® surgical suture. Relative to the COR-SUTURE® QUICK LOAD® device, the RAM® COR-SUTURE® QUICK LOAD® device additionally includes a needle cap holder to secure the optional pledget and needle caps in the suture tray. Both the RAM® COR-SUTURE® QUICK LOAD® surgical suture and the COR-SUTURE® QUICK LOAD® surgical suture also include a detachable clear suture tube to keep the suture from tangling. The needle caps are removed from the sutures and discarded once suturing is completed as they are not intended for implantation in the patient; only the suture and pledget are implantable of components.
Both devices are packaged for single patient use and are provided sterile by means of a validated ethylene oxide (EO) cycle. The polyester RAM® COR-SUTURE® QUICK LOAD® surgical suture is offered undyed (white), dyed green with the FDA approved colorant D&C Green No. 6. or striped green/white; all of which are offered with a surgical suture diameter of USP size 2-0 and a length of 38 inches. The polyester COR-SUTURE® QUICK LOAD® surgical suture is available undyed (white) or dyed green with the FDA approved colorant D&C Green No. 6 and will be offered with a surgical suture diameter of USP size 2-0 and a length of 38 inches. The polypropylene COR-SUTURE® QUICK LOAD® surgical suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 3-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RAM® COR-SUTURE® QUICK LOAD® and COR-SUTURE® QUICK LOAD® surgical sutures, with needle caps removed, contains implantable components which are considered MR safe. The implantable polyester and polypropylene sutures and PTFE pledget material are non-metallic and non-conducting materials and therefore, considered MR safe.
This document describes the RAM® COR-SUTURE® QUICK LOAD® and COR-SUTURE® QUICK LOAD® surgical sutures. It concerns a 510(k) premarket notification for these devices, asserting their substantial equivalence to a predicate device.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from USP Monograph for Non-Absorbable Sutures) | Reported Device Performance (RAM® COR-SUTURE® QUICK LOAD® and COR-SUTURE® QUICK LOAD® Surgical Sutures) |
|---|---|
| Conformance to USP Monograph for Non-Absorbable Sutures (specifically Physical Tests) | The subject RAM® COR-SUTURE® QUICK LOAD® and COR-SUTURE® QUICK LOAD® surgical sutures continue to conform to these requirements. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size used for the benchtop testing test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the testing was conducted as recommended by the FDA Guidance for Industry, Class II Special Control Guidance Document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The device is a surgical suture, and "ground truth" as typically used in AI/medical imaging studies (e.g., expert consensus on diagnoses) is not relevant for this type of device and its performance testing. The performance is assessed against established physical standards and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which is not the case for the physical and biocompatibility testing of a surgical suture.
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:
This information is not applicable. This is a medical device (surgical suture) and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the benchtop testing, the "ground truth" or standard for performance is the United States Pharmacopeia (USP), Monograph for Non-Absorbable Sutures, specifically sections from the USP General Chapter on Physical Tests.
For biocompatibility testing, the standards are ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process and the FDA Guidance for Industry, Use of International Standard ISO 10993-1.
8. The sample size for the training set:
This information is not applicable. There is no concept of a "training set" for physical and biocompatibility testing of a surgical suture.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of device testing.
§ 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.