(27 days)
V-Loc™ Nonabsorbable Wound Closure Device is indicated for soft tissue approximation.
The V-Loc™ Nonabsorbable Wound Closure Device is a polybutester suture prepared from a copolymer of butylene terephthalate and polytetramethlyene ether glycol. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc™ Nonabsorbable Wound Closure Device will be offered both Undyed (clear) and Dyed with [Phthalocyaninato(2-)] copper (21 CFR 74.3045) at a level not exceeding 0.5% by weight of the suture in sizes USP (EP) 3-0 (Metric 3), 2-0 (Metric 3.5), 0 (Metric 4) and 1 (Metric 4.5). They will be supplied in pre-cut lengths affixed to various needle types.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:
Device: V-Loc™ Nonabsorbable Wound Closure Device
K Number: K103052
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Needle Attachment meets USP/EP specification | Meets USP/EP specification. |
| Diameter (non-barbed suture) Maximum Overage | Meets USP/EP specification as stated in the Instructions for Use. |
| Tensile Strength (T=0 straight pull evaluation) | Pass |
| Barb Holding Strength (T=0 simulated barb holding of felt medium) | Pass |
| Product safety and efficacy in porcine model (burst pressure) | No statistical differences in burst pressure between the barbed control (V-Loc™ 180 Absorbable) and test device (V-Loc™ Nonabsorbable). |
Note: The document explicitly states "No statistical differences" in burst pressure, indicating that the new device performed equivalently to the predicate device in this critical in-vivo measure, which serves as the acceptance criterion for efficacy and safety in this context.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing (In-vitro): Not explicitly stated numbers for each test (needle attachment, diameter, tensile strength, barb holding strength). The document states these tests were conducted, implying sufficient samples were used to demonstrate compliance.
- Sample Size for In-vivo Performance Evaluation (Porcine Model): Not explicitly stated, but the study was a "Chronic 21 day study."
- Data Provenance: The bench tests are laboratory-based. The in-vivo study was conducted using a porcine model, which is an animal model. The country of origin of the data is not specified, but the submission is to the U.S. FDA by an American company (Covidien). The studies appear to be prospective as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device is a medical suture, and the "ground truth" for its performance is established through objective physical measurements (tensile strength, diameter, etc.) and direct biological/biomechanical outcomes (burst pressure in a porcine model), not through expert interpretation of images or clinical assessments.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the assessment criteria are objective physical and biomechanical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images. The V-Loc™ device is a surgical suture, and its assessment focuses on physical and biological performance rather than human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a sense, the entire evaluation is "standalone" because the device performance is measured directly (e.g., tensile strength, burst pressure) without human interpretation being part of the primary outcome measure. There is no algorithm, as this is a physical medical device.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth is based on established USP/EP specifications for medical sutures and direct physical measurement outcomes (pass/fail for tensile strength, barb holding strength).
- In-vivo Study: The ground truth is based on direct biomechanical outcomes (burst pressure measurements) in a porcine model, comparing the test device to a predicate device. This is a form of direct performance measurement in a biological system.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this 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.