(16 days)
Polypropylene suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
The Polypropylene Surgical Suture and Quill™ Polypropylene Tissue-Closure Devices are sterile, synthetic Knotless nonabsorbable surgical suturing devices that are intended for use in the closure of soft tissue. They are comprised of high molecular weight, isotactic polypropylene, undyed, or dyed with Phthalocyaninato (2-) Copper. The proposed blue modification is a change in supplier of the polypropylene resin raw material. The devices are supplied either single or doublearmed with various needle types, and are available in USP diameter Sizes 2 through 11-0, as applicable.
The Quill™ Polypropylene devices are designed with either small opposing bi-directional or uni-directional barbs along the long axis of the suture monofilament. The uni-directional products contain a welded primary loop and secondary loop design at the distal end, opposite the attached needle.
The provided text describes the performance tests conducted for the Polypropylene Surgical Suture and Quill™ Polypropylene Knotless Tissue-Closure Devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the devices conform to the USP (United States Pharmacopeia) monograph for nonabsorbable sutures regarding diameter and tensile strength.
| Acceptance Criteria (from USP Monograph for Nonabsorbable Sutures) | Reported Device Performance (from Non-clinical Laboratory Testing) |
|---|---|
| Conformity to specified diameter requirements | Devices conform to specified diameter requirements |
| Conformity to specified tensile strength requirements | Devices conform to specified tensile strength requirements |
| Chemical equivalency to predicate devices | Chemical characterization and biological risk assessment demonstrates chemical equivalency |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for the non-clinical laboratory performance testing. It only mentions that "Non-clinical laboratory performance testing was conducted." The data provenance is implied to be retrospective as it involves testing of manufactured devices to confirm adherence to existing standards and comparison to predicate devices, rather than a prospective study to generate new clinical data. The country of origin for the data is not explicitly stated but is implied to be in the USA given the FDA context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the ground truth for these non-clinical performance tests is established by adherence to a standardized monograph (USP) and direct physical/chemical testing, not by expert interpretation or consensus.
4. Adjudication Method for the Test Set:
This information is not applicable for non-clinical laboratory performance testing. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical laboratory performance study, not a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical surgical suture, not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical performance tests is based on established industry standards and physical/chemical properties, specifically:
- The USP (United States Pharmacopeia) monograph for nonabsorbable sutures for diameter and tensile strength.
- Chemical characterization and biological risk assessment to evaluate chemical equivalency.
8. The Sample Size for the Training Set:
This information is not applicable as the study described is a non-clinical performance test for a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above (no training set for a physical medical 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.