(65 days)
The Dunamis Force DFX Tensile Tape Sutures are indicated for use in approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries".
The Dunamis Force DFX Tensile Tape Sutures are sterile single use sutures used in approximation and/or ligation of soft tissues, including use in allograft tissue for orthopaedic surgeries. Force DFX Tensile Tape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force DFX Tensile Tape suture is flat in shape and differs from USP requirements (not USP). It is available in 1.5mm, 2mm, tape width sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE). Force DFX Tensile Tape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.
This document describes a 510(k) premarket notification for the "Dunamis Force DFX Tensile Tape Sutures". It compares the new device to a legally marketed predicate device, the "Teleflex Force Fiber OrthoTape Polyethylene Non-Absorbable Surgical Sutures (K150438)".
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets in this document. Instead, the document claims that the Dunamis device's performance is "identical to the Teleflex device characteristics" and meets "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture." The reported performance for the Dunamis device is that it meets these requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suture Average Width (equivalent to predicate and USP #2) | Meets requirements (identical to predicate) |
| Suture Average Height (equivalent to predicate and USP #2) | Meets requirements (identical to predicate) |
| Suture Length (equivalent to predicate) | Meets requirements (identical to predicate) |
| Knot-Pull Tensile Strength (meets USP #2 requirements) | Meets USP tensile strength requirements for USP size #2 suture |
| Needle Attachment Strength (meets USP #2 requirements) | Meets USP needle attachment requirements for USP size #2 suture |
| Sterility (maintains sterility) | Sterility test performed, implied to meet criteria for sterile product |
| Biocompatibility (equivalent to predicate) | Risk profile identical to predicate, no changes related to biocompatibility |
| Physical/performance characteristics (equivalent to predicate) | Identical to predicate characteristics |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that "Dunamis LLc. has established a contract manufactured product specifications that has been accepted by Teleflex Medical which documents and secures the product configuration and required test methods to assure the device is equivalent in performance and to all the elements of Teleflex 510k K150438." This suggests that the testing likely followed the same or similar protocols as the predicate device, but specific details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device submission focused on physical and mechanical properties, not diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device submission focused on physical and mechanical properties.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support systems where human interpretation is a key factor. This submission concerns the physical properties and performance of a surgical suture.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device submission for a physical surgical suture, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be established by:
- USP (United States Pharmacopeia) standards: Specifically, "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture."
- Predicate device characteristics: The Dunamis device claims to have "identical" characteristics and "risk profile identical" to the Teleflex Force Fiber OrthoTape (K150438). This implies that the performance established for the predicate device serves as the benchmark.
8. The Sample Size for the Training Set
Not applicable. This is a medical device submission for a physical surgical suture, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.