(329 days)
PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.
The provided text describes the submission of a 510(k) premarket notification for a new surgical suture device named PREMIO®. The purpose of this submission is to demonstrate that PREMIO® is substantially equivalent to a legally marketed predicate device, PRONOVA™. The document focuses on comparing the new device to the predicate device, particularly regarding their technological characteristics and intended use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to USP Monographs for non-absorbable surgical sutures | "Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs..." |
| Conformance to EP Monographs for non-absorbable surgical sutures | "...and with the EP Monographs for non-absorbable surgical sutures." |
| Biocompatibility of raw materials | "The raw material used for both medical devices [PREMIO® and PRONOVA™] is commonly used in surgical applications and has been proven to be biocompatible." |
| Intended Use | "PREMIO® has the same intended use as the predicate device PRONOVA™: general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery and in neurological surgery." |
| Technological Characteristics | "Our new device PREMIO® has similar technological characteristics as the predicate device PRONOVA™. Like currently marketed PRONOVA™ suture, PREMIO® is a sterile monofilament synthetic non-absorbable surgical suture..." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that non-clinical laboratory testing was performed. However, it does not specify the sample size used for this testing. The data provenance is also not detailed beyond mentioning "non-clinical laboratory testing." It does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be based on laboratory testing against established pharmacopoeia standards (USP and EP) rather than expert review of cases or outcomes.
4. Adjudication Method for the Test Set
Since there is no mention of experts or a test set requiring adjudication in the context of human review, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. The submission focuses on demonstrating substantial equivalence through technological and performance comparisons against established standards and a predicate device, not on assessing human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the device being described. PREMIO® is a physical surgical suture, not a software algorithm or AI-powered system designed for standalone performance or human-in-the-loop assistance.
7. Type of Ground Truth Used
The ground truth used for evaluating PREMIO® appears to be the established standards and specifications outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. The biocompatibility of the raw material is also cited as "proven," likely referring to existing literature or prior regulatory approvals for the material.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this submission. PREMIO® is a physical medical device, not a machine learning model that requires a training set. The evaluation is based on laboratory testing and comparison to a predicate device and monograph standards.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 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.