(260 days)
Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.
Silk Non-Absorbable Surgical Sutures are composed of the organic protein fibroin which is derived from the domesticated species Bombyx mori (B.mori) of the family Bombycidae. Silk sutures are braided or twisted and available in white or dyed (black or blue). Braided sutures (except for size 8/0) are coated with silicone. Silk sutures are also available in various lengths, diameters and quantities with or without surgical needles. SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time. The proposed Silk suture needle will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the silk strand which is then cured and cut to length.
The provided text describes a 510(k) submission for a Silk Non-Absorbable Surgical Suture with UV-10 adhesive, focusing on the substantial equivalence to a previously cleared device. The key change is an automated needle-end stiffening process compared to a manual one.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility (tested per ANSI/AAMI 10993 and USP guidelines) | Passed all specified tests: Cytotoxicity, Hemolysis, Sensitization, Acute Systemic Toxicity, Irritation, Intracutaneous. | Indicates the material and design are safe for biological contact. |
| Material Composition (Organic protein fibroin derived from Bombyx mori) | Composed of organic protein fibroin from Bombyx mori. | Confirms the fundamental material is unchanged and consistent with predicate. |
| Sterility | Stated to be sterile sutures. | Implies the sterilization process meets standards. |
| Indications for Use (General soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neural tissue) | Same indications for use as the predicate device. | Confirms the intended medical applications remain unchanged. |
| Physical Characteristics (Lengths, diameters, quantities, colors, availability with/without needles) | Available in the same various lengths, diameters, quantities, colors and sizes, with and without surgical needles. | Confirms physical attributes are consistent with predicate. |
| Packaging (Identical Tyvek/Mylar packaging) | Packaged in identical Tyvek/Mylar packaging. | Confirms packaging remains consistent. |
| Tensile Strength Loss (in-vivo degradation) | "Progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time." | This is a known characteristic of silk sutures and is consistent with the predicate. It's not an "acceptance criterion" in the sense of a target value, but rather a descriptive characteristic. The acceptance is likely that this behavior is comparable to the predicate. |
| Performance of automated needle end stiffening process (Implicit: should not negatively impact device performance compared to manual process) | Not explicitly detailed but implied by the "substantially equivalent" claim and the lack of specific performance testing beyond biocompatibility. | The biocompatibility testing likely serves as the primary evidence that the change in manufacturing process for the needle-end stiffening does not introduce new risks or alter fundamental material properties. There is no mention of comparative mechanical testing (e.g., knot strength, needle attachment strength) as an explicit acceptance criterion or reported performance. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a typical clinical study or a performance study with a defined sample size for the evaluation of the automated needle-end stiffening process. The primary evidence presented is biocompatibility testing.
- Sample size: Not explicitly stated for biocompatibility tests. It's usually a small number of samples required to demonstrate biological compatibility according to standards.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, biocompatibility testing is typically conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device submission primarily relies on biocompatibility testing and demonstrating substantial equivalence to a predicate device. There is no "ground truth" derived from expert review of cases in the way that might apply to a diagnostic imaging AI algorithm. The "ground truth" for biocompatibility is established by adherence to recognized standards (ANSI/AAMI 10993 and USP guidelines) and passing the specified tests.
4. Adjudication method for the test set
Not applicable. There is no "test set" that requires adjudication (e.g., clinical cases reviewed by experts).
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 surgical suture, not a diagnostic device with an AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical suture, not a diagnostic device with an AI component.
7. The type of ground truth used
For the safety assessment, the "ground truth" is based on:
- Biological standards: Adherence to ANSI/AAMI 10993 and USP guidelines for biocompatibility.
- Predicate device characteristics: The known safety and performance profile of the legally marketed predicate Silk Non-Absorbable Surgical Suture (K930590). The new device is considered "substantially equivalent" if it shares the same safety and effectiveness profile.
8. The sample size for the training set
Not applicable. This is a physical medical device (suture), not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device (suture), not a machine learning model.
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.