(132 days)
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
The proposed device, WEGO-PTFE, is monofilament, synthetic, non-absorbable surgical suture composed of 100% polytetrafluoroethylene without any additives. The molecular formula is (C-F2)n. WEGO-PTFE is undyed and uncoated.
The proposed device is composed of suture and needle.
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes.
WEGO-PTFE complies with the requirements of the European Pharmacopoeia for Sterile Non-Absorbable Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
This document describes the premarket notification for the WEGO-PTFE surgical suture, asserting its substantial equivalence to a predicate device. It includes information on non-clinical testing performed to establish this equivalence, but no clinical study was conducted. Therefore, the device does not have acceptance criteria based on clinical performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a premarket notification for a surgical suture claiming substantial equivalence to a predicate device, the "acceptance criteria" are based on compliance with recognized standards and biocompatibility, rather than clinical performance metrics. The "reported device performance" refers to the results of non-clinical tests demonstrating this compliance.
| Acceptance Criteria (Compliance with Standard) | Reported Device Performance (WEGO-PTFE Test Results) |
|---|---|
| USP 39-NF 34:2016 Nonabsorbable Surgical Suture | Complies with the requirements |
| USP 39-NF 34:2016 Sutures Diameter | Complies with the requirements |
| USP 39-NF 34:2016 Sutures Needle Attachment | Complies with the requirements |
| USP 39-NF 34:2016 Tensile Strength | Complies with the requirements |
| ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity | Conforms to the requirements |
| ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | Conforms to the requirements |
| ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | Conforms to the requirements |
| ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Conforms to the requirements |
| ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | Conforms to the requirements |
| USP Bacterial Endotoxins Limit | Complies with the requirements |
| ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials | Complies with the requirements |
| ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages | Complies with the requirements |
| ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration | Complies with the requirements |
| ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | Conforms to the requirements |
| ISO 11737-2:2009, Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Complies with the requirements |
| Shelf life stability (Product performance and Package integrity) | Supported by test reports for three years, two years, one year, and six months |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each of the non-clinical tests. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly stated in terms of country of origin, but the submitting company is "Foosin Medical Supplies Inc., Ltd." located in Weihai, Shandong, China. The studies are non-clinical, likely laboratory-based, and therefore not categorized as retrospective or prospective in the human study sense.
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)
This information is not applicable. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., USP, ISO, ASTM), not by expert consensus on clinical cases. The tests themselves are designed to measure against predefined physical and biological parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical study or expert-based evaluation of a test set for performance was conducted. The tests are laboratory procedures with defined pass/fail criteria based on standards.
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
No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." This device is a surgical suture, not an AI-assisted diagnostic tool, so such a study would not be relevant.
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 or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced standards (e.g., USP for tensile strength and diameter, ISO for biocompatibility categories). These standards provide quantifiable criteria that the device must meet.
8. The sample size for the training set
This information is not applicable. There is no training set mentioned or implied as this is a physical medical device and not an AI/machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.