(121 days)
Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6. The subject device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached.
This document (K231183) is a 510(k) Premarket Notification for a Non-absorbable Surgical Polyester Suture. It seeks to demonstrate substantial equivalence to a predicate device (K172149). The information provided focuses on the physical and biological compatibility of the suture, rather than the performance of a software or AI-driven medical device in a diagnostic context. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated by compliance with various ISO, USP, and ASTM standards. The "acceptance criteria" are implied by these standards, meaning the device must "Pass" or "Comply" with the requirements of each standard.
| Test Category | Specific Test / Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical Performance | USP Sutures - Diameter | Comply with USP | Comply with USP |
| USP Sutures - Needle Attachment | Comply with USP | Comply with USP | |
| USP Tensile Strength | Comply with USP | Comply with USP | |
| Length (of suture) | Not less than 95.0% of the length stated on the label | Met the criteria (stated in Analysis 3) | |
| Packaging & Sterility | ASTM F88/F88M-15 Seal Strength of Flexible Barrier Materials | Comply with ASTM F88/F88M-15 | Comply with ASTM F88/F88M-15 |
| ASTM F1929-15 Detecting Seal Leaks by Dye Penetration | Comply with ASTM F1929-15 | Comply with ASTM F1929-15 | |
| USP Bacterial Endotoxins Test | Comply with USP | Comply with USP | |
| ISO 10993-7:2008 Ethylene oxide sterilization residuals | Acceptable Residual Levels | (Not explicitly stated Pass/Fail, but implied by compliance with ISO 10993-1) | |
| Biocompatibility | ISO 10993-5 Cytotoxicity | Pass | Pass |
| ISO 10993-10 Sensitization | Pass | Pass | |
| ISO 10993-10 Intracutaneous Reactivity | Pass | Pass | |
| ISO 10993-11 Acute systemic toxicity | Pass | Pass | |
| USP Pyrogen Test | Pass | Pass (also stated as Comply to USP) | |
| ISO 10993-11 Subacute Systemic Toxicity | Pass | Pass | |
| ISO 10993-3 Bacterial Reverse Mutation | Pass | Pass | |
| ISO 10993-3 Chromosome Aberration | Pass | Pass | |
| ISO 10993-3 Gene Mutation | Pass | Pass | |
| ISO 10993-6 Implantation | Pass | Pass | |
| ASTM F756-17 Hemolysis | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For non-clinical tests like those listed (USP, ASTM, ISO standards), specific sample sizes and testing methodologies are defined within the respective standards. The document only states that the tests were "conducted" and "complies" or "passed." The data provenance (country of origin, retrospective/prospective) is also not specified, as these are lab-based tests rather than patient studies.
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)
Not Applicable. This document describes the testing of a physical medical device (suture) against established performance and biocompatibility standards. "Ground truth" in the context of expert consensus, typical for diagnostic software or AI, is not relevant here. The "ground truth" for physical device performance is defined by the objective measurement criteria within the specified international and national standards (e.g., USP monographs for suture diameter, tensile strength).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As described above, this is not a study involving human interpretation of diagnostic data that would require an adjudication method.
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
Not Applicable. An MRMC study is relevant for diagnostic software performance, particularly AI-driven tools. This submission is for a physical surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or more accurately, the reference standard) for this device is based on established objective measurements and criteria defined by validated international and national standards (e.g., USP Monographs for physical properties, ISO 10993 series for biocompatibility). These standards specify methodologies and acceptance limits that the device must meet.
8. The sample size for the training set
Not Applicable. This is not an AI or machine learning device that requires a training set. The device is a physical product.
9. How the ground truth for the training set was established
Not Applicable. As this device does not use a training set, no ground truth needs to be established for it.
§ 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.