(456 days)
Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.
Biotex Non-Absorbable PTFE Suture is comprised of a single-arm, non-absorbable monofilament suture and the stainless-steel surgical needle connected to the suture. It is composed of 100% high-density PTFE provided uncoated, undyed and sterile for one-time use only.
The Biotex Non-Absorbable PTFE Suture was evaluated for substantial equivalence to a predicate device through mechanical, physical, and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical/Physical | Diameter | Conforms to USP monograph for non-absorbable sutures | Conformed to USP monograph |
| Tensile Strength | Conforms to USP monograph for non-absorbable sutures | Conformed to USP monograph | |
| Needle Adhesion | Conforms to USP monograph for non-absorbable sutures | Conformed to USP monograph | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Met acceptance criteria | All acceptance criteria were met |
| Sensitization (ISO 10993-10) | Met acceptance criteria | All acceptance criteria were met | |
| Intracutaneous Reactivity (ISO 10993-10) | Met acceptance criteria | All acceptance criteria were met | |
| Acute Systemic Toxicity (ISO 10993-11) | Met acceptance criteria | All acceptance criteria were met | |
| Genotoxicity (ISO 10993-3) | Met acceptance criteria | All acceptance criteria were met | |
| Implantation (ISO 10993-6) | Met acceptance criteria | All acceptance criteria were met | |
| Sterilization | Pyrogen Testing | Met acceptance criteria | All acceptance criteria were met |
| EO Sterilization Residuals | Met acceptance criteria | All acceptance criteria were met | |
| Stability | Shelf-Life | Met acceptance criteria | All acceptance criteria were met |
2. Sample Size and Data Provenance
The document does not specify the exact sample sizes used for each test. The studies were performed in accordance with FDA's Class II Special Controls Guidance Document for Surgical Sutures and ISO 10993-1. These are likely prospective evaluations conducted in a laboratory setting, with data provenance typically from the device manufacturer's testing facilities.
3. Number of Experts and Qualifications
Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The ground truth for this device is based on standardized physical, mechanical, and biological testing, not expert interpretation of medical images.
4. Adjudication Method
Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The assessment relies on objective measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe system.
6. Standalone Performance Study
Yes, standalone (algorithm only) performance was done. The performance of the Biotex Non-Absorbable PTFE Suture was assessed independently against established standards such as the USP monograph for non-absorbable sutures and ISO 10993-1 for biocompatibility.
7. Type of Ground Truth Used
The ground truth used for performance evaluation was based on:
- Established Standards: USP monograph for non-absorbable surgical sutures (for mechanical and physical properties).
- International Standards: ISO 10993-1 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" (for biocompatibility).
- Internal Specifications: Derived from the above standards, for tests like pyrogenicity, EO residuals, and shelf-life.
8. Sample Size for the Training Set
Not applicable. This is a medical device, not an AI/CADe system that requires a "training set." Performance is evaluated against pre-defined, objective criteria.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for physical medical devices of this nature. The ground truth for the performance evaluation relies on established scientific and regulatory standards.
§ 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.