(160 days)
"DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.
Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".
This document describes the Demetech Non-Absorbable Stainless Steel Surgical Suture (DemeSTEEL) and its equivalency to predicate devices, primarily through non-clinical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document leverages the United States Pharmacopeia (USP) standards as its primary acceptance criteria. The device is reported to meet or exceed these standards.
| Acceptance Criteria (USP Standard) | Reported Device Performance (DemeSTEEL) |
|---|---|
| Performance requirements for "Non-Absorbable Surgical Suture" (Official Monograph of USP) | Meets or exceeds performance requirements |
| Performance requirements for "Diameter", Section (USP) | Meets performance requirements |
| Performance requirements for "Tensile Strength" (USP) | Meets or exceeds performance requirements |
| Performance requirements for "Needle Attachment" (USP) | Meets or exceeds performance requirements |
| Performance requirements for "Suture Length Requirement" (95% of stated label length) (USP) | Meets performance requirements |
| Performance requirements for Sterility (USP and ISO-11137) | Meets performance requirements |
| Requirements of ASTM F138-13a -- Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS S31673 | Meets requirements |
| Classification requirements in 21CFR section 878.4495, Identification A stainless steel suture | Meets classification requirements |
| Biocompatibility: Cytotoxicity, Acute Toxicity, Skin Sensitization, Mutagenicity, Carcinogenicity and Reproductive Toxicity | Performed on 316L stainless steel sutures and considered acceptable due to material's established history |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test. It generally states that "Non-clinical testing was conducted on the device to prove conformance to the requirements of USP standards." The data provenance is laboratory testing conducted by Demetech, likely in the US, given the company's address and the FDA submission. The data is prospective, generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a medical device submission primarily based on objective physical and chemical testing against established standards (USP, ASTM). There were no experts involved in establishing a "ground truth" in the way it is typically understood for interpretative tasks (e.g., medical image analysis). The "ground truth" here is adherence to specified material and performance parameters.
4. Adjudication Method for the Test Set:
Not applicable. No adjudications were performed as this primarily involves objective measurements of physical and chemical properties against predefined 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:
Not applicable. This is a submission for a surgical suture, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device (suture), not an algorithm or software.
7. The Type of Ground Truth Used:
The "ground truth" used is defined by:
- Established Industry Standards: United States Pharmacopeia (USP) for non-absorbable surgical sutures, including specific sections for diameter, tensile strength, needle attachment, suture length, and sterility.
- Material Specifications: ASTM Standard F138 Grade 2 for 316L stainless steel.
- Biocompatibility Standards: Implicitly, common standards for biocompatibility testing for implantable devices, with the 316L material having an "established history of use."
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, there is no "training set." The performance of the suture is assessed against predefined, universally accepted physical and chemical standards.
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.