(129 days)
For safe and reliable soft tissue approximation, wound closure and ligation.
General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.
AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle are Non-Pyrogenic devices used for safe and reliable soft tissue approximation, wound closure, and ligation. American Sutures are made of Silk, Nylon, Polypropylene, and Polyester materials. Sterile, Single Use, Non Absorbable. With or without Needles attached.
The provided document describes a 510(k) premarket notification for "AMERICAN SUTURE™ Non Absorbable Surgical Sutures with/without Needles." This is a medical device clearance, not an AI/ML device, and therefore the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size, etc.) is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, intended use, and performance testing against recognized standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Predicate Device Performance | AMERICAN SUTURE™ Performance |
|---|---|---|
| Physical/Mechanical Properties (USP 30) | ||
| Diameter :2007 | Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. | Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. |
| Tensile Strength :2007 | Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. | Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. |
| Needle Attachment :2007 | Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. | Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. |
| Suture Length Requirement | Meets or exceeds performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. | Meets or exceeds the performance requirements for Non-Absorbable surgical sutures as defined in the Official monograph of the United States Pharmacopeia. |
| Biocompatibility (AAMI / ANSI / ISO 10993) | Not explicitly stated for predicate in comparison table, but general statement of equivalent safety. | Tested to AAMI / ANSI / ISO 10993-5:1999 (In Vitro Cytotoxicity) and ISO 10993-10:2002 (Irritation and Delayed-Type Hypersensitivity). (Testing performed to verify biocompatibility.) |
| Sterilization ETO Validation (AAMI / ANSI / ISO 11135-1:1994) | Not explicitly stated for predicate. | Tested to AAMI / ANSI / ISO 11135-1:1994 (Validation and routine control of ETO Sterilization). |
| Sterilization Gamma Validation (AAMI / ANSI / ISO 11137-1:2000) | Not explicitly stated for predicate. | Tested to AAMI / ANSI / ISO 11137-1:2000 (Validation and routine control of GAMMA Sterilization). |
| Mexican Norms for Biocompatibility (FEUM) | Not explicitly stated for predicate. | Tested to FEUM-MGA-DM-3171 (Intracutaneous Irritation Test), FEUM-MGA-DM-3083 (Systemic Injection Test), FEUM-MGA-DM-3081 (Implantation Test). |
| Mexican Norms for Medical Sutures (NOM) | Not explicitly stated for predicate. | Tested to NOM-067-SSA-1993 for Medical Sutures, NOM-B-1-70 (Analysis Methods for Steels and Smelting - Needles), NOM-B-119-78 (Determination of Rockwell Hardness for Metals - Needles), NOM-BB-46-76 (Determination of Corrosion Resistance for Hypodermic Needles). |
Study Proving Acceptance Criteria Met:
The acceptance criteria are met through a series of "performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility," by testing the AMERICAN SUTURE™ against several FDA Recognized Standards and Mexican Norms. The application states that "The American Sutures™ Surgical sutures intended to be introduced have been tested in compliance with the following test methods," followed by a list of standards. The overall study approach is one of verification against established performance standards for surgical sutures.
Regarding the AI/ML specific questions (2-9):
- Sample size used for the test set and the data provenance: N/A (not an AI/ML device)
- Number of experts used to establish the ground truth... and qualifications: N/A (not an AI/ML device)
- Adjudication method: N/A (not an AI/ML device)
- If a multi reader multi case (MRMC) comparative effectiveness study was done...: N/A (not an AI/ML device)
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (not an AI/ML device)
- The type of ground truth used: N/A (not an AI/ML device). For this physical device, the "ground truth" is defined by the requirements and specifications set forth in recognized standards (e.g., USP monographs, ISO 10993) for mechanical properties, biocompatibility, and sterility.
- The sample size for the training set: N/A (not an AI/ML device)
- How the ground truth for the training set was established: N/A (not an AI/ML device)
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.