(165 days)
The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.
The DemeTECH polypropylene sutures are inert, non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polylefin. The suture is pigmented to enhance visibility.
This 510(k) summary (K043330) is for a medical device called "DemeTECH Polypropylene Surgical Sutures." It demonstrates substantial equivalence to a predicate device, the Pronova Non-Absorbable Suture (K001625), rather than providing a study proving a device meets specific performance criteria.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information from the provided text.
Here's a breakdown of the acceptance criteria and related information based only on the provided text, acknowledging that a full clinical study with the listed criteria is not present in this document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a 510(k) submission like this are primarily about demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria Category (implied by 510(k)) | Predicate Device Performance (Pronova, K001625) (as described in the 510(k)) | DemeTECH Device Performance (K043330) (as described in the 510(k)) |
|---|---|---|
| Intended Use | General soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. | General soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. |
| Material Composition | Isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin). | Isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin). |
| Non-Absorbable | Yes | Yes |
| Sterility | Sterile | Sterile |
| Pigmentation | Pigmented and Clear (for predicate) | Pigmented Blue (for DemeTECH) |
| Size Range (USP) | 10-0 to 8-0 and 6-0 to 2 | 10-0 to 8-0 and 6-0 to 2 |
| Thread Diameter (USP sizes) | 10-0 to 8-0 and 6-0 to 2 | 10-0 to 8-0 and 6-0 to 2 |
| Metric Sizes in mm | 0 - .350 to .399mm (likely a typo, suggesting a range) | 0.2 to 0.4 and 0.7 to 5.0 |
| Packaging | Cartons of 12, 24 and 36 | Cartons of 12, 24 and 36 |
| Thread Length | Variety of Lengths | 45 -100 cm |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Application | Single Use Only | Single Use Only |
Study Proving Device Meets Acceptance Criteria:
The provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a predicate device. It does not present a detailed study proving the device meets specific performance criteria in the way a clinical trial or a standalone diagnostic study would. Instead, the "study" is the comparison made to the predicate device to satisfy the FDA's requirements for substantial equivalence.
The regulatory review process itself, based on the information provided in the 510(k) submission, served as the "proof" that the device meets the acceptance criteria for a 510(k) clearance. The FDA's letter (K043330, May 16, 2005) confirms that the device was determined to be "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a clinical "test set" with a specific sample size in the context of typical device performance studies (e.g., patient data). The "test" is a comparison to the predicate device's specifications and performance.
- Data Provenance: Not applicable. The data is primarily comparative information from existing device specifications and regulatory submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This document does not involve experts establishing ground truth for a test set of data. The "ground truth" for a 510(k) comparison is the known, cleared specifications and performance of the chosen predicate device.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" in the context of a 510(k) comparison as there would be for a multi-reader study. The FDA reviews the provided data against the predicate device's known characteristics and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an MRMC study. It is a 510(k) submission for a surgical suture.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical suture, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established specifications, performance, and regulatory clearance of the predicate device (Pronova Non-Absorbable Suture - Ethicon K001625). The applicant (DemeTECH) asserts that their device is substantially equivalent to this predicate.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not an AI/ML device.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.