(48 days)
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and is intended for dermatological use only.
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot.
This document is a 510(k) Pre-market Notification for a medical device, specifically absorbable polydioxanone surgical sutures. The purpose of this document is to demonstrate that the new device, "Secret Line up / i-Thread," is substantially equivalent to existing legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
The document implicitly uses the performance of the predicate devices as its acceptance criteria and demonstrates that the subject device meets or is similar to these criteria through various tests. Explicit numerical acceptance criteria are not presented in a direct table with reported performance. However, the "Substantially Equivalent (SE) Comparison Chart" (page 6) serves this purpose by comparing various attributes of the subject device to the predicate device. All "SE" remarks indicate that the device meets the implied acceptance criteria.
Key performance tests and their outcomes (reported device performance):
| Category | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Subject Device) | Remark/Outcome |
|---|---|---|---|
| Product Code | NEW | NEW | SE |
| Regulation Number | 21 CFR 878.4840 | 21 CFR 878.4840 | SE |
| Class | II | II | SE |
| Sterilization method | E.O. sterilization (SAL: 1.0×10-6) | E.O. sterilization (SAL: 1.0×10-6) | SE |
| Stability time | 2 years | 2 years | SE |
| Suture material | Polydioxanone | Polydioxanone | SE |
| Configuration | PDO Suture and Needle (pre-loaded, hollow needle, not swaged) | PDO Suture and Needle (pre-loaded, hollow needle, not swaged) | SE |
| Suture Color | Dyed suture (violet) | Dyed suture (violet) | SE |
| Suture type | Cog (barb) type | Cog (barb) type | SE |
| Barb angle | 2 - 45 degrees (Predicate) | 50 - 80 degrees | Justified by barb holding performance test |
| Suture composition | Polydioxanone, Dyed with D&C Violet No.2 | Polydioxanone, Dyed with D&C Violet No.2 | SE |
| Needle Material | Stainless steel | Stainless steel | SE |
| Absorbable / Non-Absorbable | Absorbable | Absorbable | SE |
| Braided / Monofilament | Monofilament | Monofilament | SE |
| Barb Type | Bi-directional | Bi-directional | SE |
| Biocompatible | Yes | Yes | SE |
| Material of components that come into patient contact | Needle: Stainless steel; Suture: Polydioxanone | Needle: Stainless steel; Suture: Polydioxanone | SE |
| Anatomical Location | Soft tissue (Skin, Dermal or Sub-dermal tissue) | Soft tissue (Skin, Dermal or Sub-dermal tissue) | SE |
| Intended population | Adults population | Adults, but inappropriate for elderly population | SE |
| Performance Test conducted | Suture (Length, Diameter, Tensile strength, Barb-Holding, Needle attachment strength); Needle (Length, Outer diameter, Bending(elasticity), Flexural strength, Pulling out) | Same tests conducted | SE |
| Performance (Animal Testing) | In Vivo Biodegradation in Sprague-Dawley Rat - Barb Holding forces, Absorption and Residual Tensile Strength over time | In Vivo testing in Sprague-Dawley Rat - Absorption, Barb Holding force and Tensile Strength over time | SE |
| Performance testing result | Pass | Pass | SE |
| Single use | Yes | Yes | SE |
Differences noted and justified:
- Suture Size (USP): Predicate: 4-0, 3-0, 2-0, 0. Subject: 2-0, 2, 0. (Similar - predicate has more sizes but subject still equivalent).
- Suture Length: Predicate: 90, 110, and 150 mm. Subject: 150, 160 mm. (Similar - predicate has various lengths but subject still equivalent).
- Barb Angle: Predicate: 2 - 45 degrees. Subject: 50 - 80 degrees. (Justified by barb holding performance test).
The overall conclusion states: "Despite the differences, the test results submitted in this 510k show that the subject device is substantially equivalent to In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device." (Page 7)
2. Sample size used for the test set and the data provenance:
The document references several performance tests, but it does not explicitly state the sample sizes used for each test. The tests include:
-
Bench Tests (Non-clinical):
- Suture measurements (Length, Diameter, Hub)
- Bending test
- Barb Holding strength
- Flexural test
- Pulling out (or) Extraction Test
- USP standards: Sutures Diameter (), Sutures Needle Attachment (), Sutures Tensile Strength ().
- ASTM F1874-98 9 bending test.
-
Biocompatibility Tests (in vitro and in vivo):
- ISO 10993 series tests for various aspects (cytotoxicity, hemolysis, systemic toxicity, irritation, sensitization, local effects after implantation, genotoxicity).
- Ethylene Oxide Sterilization Results (ISO 10993-7, ISO 11135).
-
Animal Study (In Vivo):
- Biodegradability evaluation in Sprague-Dawley Rats.
- Comparing "absorption", "Tensile strength test" and "Barb holding strength test" over time.
Data Provenance: The document does not explicitly state the country of origin of the data. The studies and tests appear to be retrospective, conducted in support of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided within the document. The document describes laboratory and animal studies, not studies involving human experts establishing ground truth for a diagnostic interpretation.
4. Adjudication method for the test set:
This information is not applicable as the studies described are laboratory, animal, and biocompatibility tests, not studies requiring expert adjudication of results like image interpretation.
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:
This information is not applicable as the device is a surgical suture, not an AI-powered diagnostic device, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable as the device is a surgical suture, not an algorithm.
7. The type of ground truth used:
For the performance and biocompatibility studies, the "ground truth" is established by adherence to recognized international and FDA standards, and comparison to the performance of legally marketed predicate devices.
- Bench Test Ground Truth: Defined by the specifications and performance characteristics of the predicate device, as well as established industry standards (USP, ASTM). The goal is to show the subject device performs similarly or within acceptable limits.
- Biocompatibility Ground Truth: Defined by the requirements of the ISO 10993 series of standards, which assess the biological safety of medical devices.
- Animal Study Ground Truth: The observed biological response in the Sprague-Dawley Rat model (absorption, tensile strength, barb holding strength) is compared against the expected performance based on the predicate device and established knowledge of polydioxanone sutures.
8. The sample size for the training set:
This information is not applicable as the device is a surgical suture, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.