(261 days)
The CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
The synthetic non-absorbable surgical sutures CARDIOFLON® and CARDIOXYL® are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOFLON® braids are coated with a polymer of tetrafluorethylene (PTFE) and CARDIOXYL® braids are coated with polysiloxane. CARDIOFLON® and CARDIOXYL® sutures are green dyed (D&C green nº6 CI 61565) and white (undyed). Some packs are composed of green and white II is to facilitate location during use. CARDIOFLON® and CARDIOXYL® sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for nonabsorbable surgical sutures.
The provided text describes a 510(k) summary for the CARDIOFLON® and CARDIOXYL® sutures. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria. Therefore, most of the requested information (related to a clinical study, sample sizes, ground truth establishment, expert involvement, and MRMC studies) is not applicable to this type of regulatory submission.
However, I can extract the relevant information from the document regarding acceptance criteria and performance as pertaining to the regulatory submission for substantial equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| USP (United States Pharmacopoeia) requirements for nonabsorbable surgical sutures | Complies with USP Monographs for non-absorbable surgical sutures |
| EP (European Pharmacopoeia) requirements for nonabsorbable surgical sutures | Complies with EP Monographs for non-absorbable surgical sutures |
| Biocompatibility | Polyester material is commonly used in surgical applications and has been proven to be biocompatible. |
Study that proves the device meets the acceptance criteria:
The document states that "Non-clinical laboratory testing was performed demonstrating that the devices complied with the USP Monographs and with the EP Monographs for non-absorbable surgical sutures." This implies that a series of in-vitro and/or bench tests were conducted to verify the physical, chemical, and mechanical properties of the sutures against the established standards.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. As this is non-clinical laboratory testing against pharmacopoeial monographs, specific sample sizes for clinical testing are not relevant here. The pharmacopoeias themselves would define the sample sizes for the specific tests required.
- Data provenance: Not specified, but implied to be from internal lab testing conducted by Peters Surgical, likely in France (country of origin of the company). This would be retrospective in the sense that the testing was performed to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for clinical studies (e.g., expert consensus on medical images) is not relevant for demonstrating compliance with pharmacopoeial monographs. The "ground truth" here is the established specifications and methods within the USP and EP.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies involving multiple reviewers. The testing against USP/EP monographs is objective.
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. This is a medical device submission for surgical sutures, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device submission for surgical sutures, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance data mentioned is the specifications and testing methodologies detailed within the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) Monographs for nonabsorbable surgical sutures.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of this type of regulatory submission for a physical medical device.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.