(39 days)
The RD® QUICK LOAD® suture is intended for use in general soft tissue approximation and/or ligation.
LSI SOLUTIONS® RD® QUICK LOAD® SUTURE is a non-absorbable surgical suture available as monofilament polypropylene suture (diameter of USP size 2-0) and polytetrafluoroethylene (PTFE)-coated, braided polyester suture (diameter of USP sizes 0 and 2-0). A short length of surgical stainless-steel tubing, called a "needle cap," is attached to one end of the suture. The needle cap is removed from the suture after suturing is completed and not meant for implantation into the patient. The RD® QUICK LOAD® SUTURE includes a detachable clear suture tube to keep the suture from tangling. The RD® QUICK LOAD® SUTURE is packaged for single patient use and is provided sterile by means of a validated ethylene oxide (EO) cycle. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 2-0 and in a length of 53 inches. The polyester suture is offered dyed green with the FDA approved colorant D&C Green No. 6 and is offered in a surgical suture diameter of USP size of 0 and 2-0 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 RD® QUICK LOAD® SUTURE products, with needle caps removed, contain implantable components which are considered MR (magnetic resonance) safe. The implantable polyester and polypropylene suture materials are non-metallic and nonconducting materials and therefore, considered MR safe.
This document does not describe a study involving an AI/Medical Device that requires the establishment of ground truth, expert consensus, or multi-reader multi-case studies. Instead, it is a 510(k) premarket notification for a surgical suture, the RD QUICK LOAD SUTURE, asserting its substantial equivalence to a previously cleared predicate device.
The acceptance criteria and proof of substantial equivalence for this suture device are based on non-clinical performance testing and biocompatibility assessment, not on clinical performance studies involving a test set, expert consensus, or multi-reader studies as one would expect for an AI/Medical Device.
Here's why and what information is provided:
1. Acceptance Criteria and Device Performance (for a Suture)
The acceptance criteria for the RD QUICK LOAD SUTURE are based on established standards for surgical sutures. The performance of the device is evaluated against these standards.
| Acceptance Criteria (for Suture) | Reported Device Performance (Summary) |
|---|---|
| Conformance to USP 42-NF37:2019 Monograph for Non-Absorbable Sutures (Physical Tests) | The RD® QUICK LOAD® SUTURE continues to conform to these requirements and test methods. |
| Biocompatibility in accordance with ISO 10993-1:2009(R)2013 | All appropriate biological endpoints for consideration per ISO 10993-1 were assessed with passing results. |
2. Sample Size and Data Provenance for Testing:
- Data provenance: The document states "Biocompatibility results from Teleflex® Medical OEM were leveraged." This implies testing was conducted by the raw material supplier.
- The specific sample sizes for the USP and biocompatibility testing are not explicitly stated in this document. These would typically be defined by the relevant standards and internal test protocols. The nature of this 510(k) summary means highly detailed test parameters are usually omitted, with the FDA reviewing the full test reports.
- The tests are non-clinical (benchtop and lab-based biocompatibility), not clinical.
3. Number of Experts/Qualifications (Not Applicable for Suture Evaluation):
This information is not relevant to the evaluation of a surgical suture's substantial equivalence based on physical and biocompatibility properties. There are no "experts" establishing ground truth in the context of image interpretation or diagnosis.
4. Adjudication Method (Not Applicable):
Not applicable for a medical device cleared through substantial equivalence based on physical and biological testing.
5. MRMC Comparative Effectiveness Study (Not Applicable):
- No MRMC study was done. This is a surgical suture, not a diagnostic AI device. There are no "human readers" to improve with AI assistance. Clinical studies were deemed unnecessary.
6. Standalone Performance (Not Applicable as AI):
This is not an AI/algorithm. Its performance is its tensile strength, knot security, and biocompatibility, which are tested through benchtop methods defined by USP standards.
7. Type of Ground Truth (for Suture Properties, not a Diagnostic):
- The "ground truth" for the suture's performance is established by validated physical test methods (USP standards) and biocompatibility testing against ISO standards.
- For the claim of substantial equivalence, the "ground truth" is also the performance of the predicate device, against which the new device is compared.
8. Sample Size for Training Set (Not Applicable - No AI/Machine Learning):
This device does not involve a "training set" in the context of AI or machine learning. It is a manufactured physical good.
9. How Ground Truth for Training Set was Established (Not Applicable):
Not applicable, as there's no training set for an AI model.
In summary, this FDA clearance document is for a traditional medical device (surgical suture) demonstrating chemical and physical equivalence to a predicate device, not an AI-powered diagnostic tool. Therefore, many of the requested criteria, which are standard for AI/ML device evaluations, are not applicable here.
§ 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.