(72 days)
NYLON is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
NYLON is a nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6. NYLON meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered coated or uncoated, undyed and dyed with an appropriate FDA listed color additive, D&C Blue No. 2. (21CFR74.3102) or Logwood extract, C.I. Natural Black 1. (21CFR74.1410). NYLON will be offered with or without standard needles attached.
Acceptance Criteria and Device Performance Study for NYLON Surgical Suture
This analysis focuses on the acceptance criteria and the study performed for the T.CAD International NYLON surgical suture, as presented in the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by USP Standards) | Reported Device Performance (NYLON) |
|---|---|
| Suture Diameter meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Suture Length meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Knot Pull Tensile Strength meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Needle Attachment Strength meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Material composition: Long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6 | Composed of long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6. |
| Sterilization Method | Gamma Irradiation (Acceptable and comparable to predicate) |
| Biocompatibility and safety | Implied by meeting USP and substantial equivalence to predicate, which are already deemed safe. |
| Predicate Device Comparability (Functional Equivalence) | Functions identically to predicate devices (DERMALON®, Ethilon®) in intended use and characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the non-clinical testing. The provenance of the data is not specified beyond being "non-clinical testing" conducted to prove conformance to U.S.P. standards. It is implied the testing was performed by or for T.CAD International. The nature of the testing (physical properties and functionality) suggests it was retrospective in the sense that the suture material was already manufactured and then tested.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the number or qualifications of experts used to establish ground truth for the test set. The ground truth for the non-clinical tests appears to be the United States Pharmacopeia (U.S.P.) standards themselves.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The testing was against pre-defined U.S.P. standards, implying a pass/fail outcome based on direct measurement compared to the standard, rather than subjective expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There was no MRMC comparative effectiveness study performed. Surgical sutures are not typically evaluated using MRMC studies, as their effectiveness is primarily gauged by their physical and biological performance rather than interpretative tasks. Clinical testing was explicitly stated as "Not available at the present time."
6. Standalone Performance Study (Algorithm Only)
This question is not applicable as the device is a physical surgical suture, not an algorithm or software. Therefore, there was no "algorithm only" performance study.
7. Type of Ground Truth Used
The primary ground truth used for the device's acceptance was United States Pharmacopeia (U.S.P.) Standards. This represents established regulatory and performance benchmarks for surgical sutures. The comparison to predicate devices also implies a ground truth established by the long-standing safe and effective use of those predicate devices.
8. Sample Size for the Training Set
This question is not applicable. Surgical sutures, being physical devices, do not typically involve "training sets" in the context of machine learning or algorithms. The manufacturing process is controlled to produce sutures that consistently meet specifications.
9. How Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8. The production of surgical sutures relies on established manufacturing processes and quality control to ensure consistency, rather than a "training set" with established ground truth in the AI sense.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.