(86 days)
The Edwards Lifesciences LifeStitch Suturing Device is used for the approximation of soft tissue.
The Edwards LifeStitch Suturing Device is a sterile, single use only device that uses aspiration and mechanically activated surgical needles to approximate and place interrupted sutures into soft tissue. The LifeStitch suturing device has a handle/housing attached to a 30F (10 mm) barrel that is approximately 23 cm in length. Attached to the distal tip of the barrel is a needle holder that contains four stainless steel needles with pre-attached 4-0 nonabsorbable, monofilament polybutester surgical suture. Sterile tubing is provided for connection between the device and a vacuum source. The LifeStitch Suturing Device is provided in a kit that also contains an optional-use knot pusher/cutter for lowering hand-tied suture knots and cutting suture tails.
The Edwards LifeStitch Suturing Device (K013990) received 510(k) clearance based on substantial equivalence to predicate devices, rather than explicit acceptance criteria with specific performance metrics. Therefore, detailed acceptance criteria and a study demonstrating adherence using quantitative performance measures are not provided in the document.
The "Functional/Safety Testing" section states: "The LifeStitch Suturing Device has successfully completed design verification testing." However, the document does not elaborate on the specific tests conducted, their acceptance criteria, or the reported performance.
Here's an attempt to answer the questions based on the provided document, acknowledging the limitations due to the nature of a 510(k) summary focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Inferred from "Functional/Safety Testing") |
|---|---|
| Comparable design to predicate devices | Demonstrated through comparative analysis |
| Comparable intended use to predicate devices | Demonstrated through comparative analysis |
| Comparable materials to predicate devices | Demonstrated through comparative analysis |
| Comparable principle of operation to predicate devices | Demonstrated through comparative analysis |
| Safe for intended use (verified through design testing) | Successfully completed design verification testing |
| Effective for intended use (verified through design testing) | Successfully completed design verification testing |
Limitations: The document does not provide specific numerical or qualitative acceptance criteria (e.g., tensile strength, knot security, tissue approximation efficacy metrics) or the measured performance values.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide details about a specific "test set" in the context of a clinical performance study with human subjects or a large-scale evaluation set for an algorithm. The "Functional/Safety Testing" likely refers to bench testing and potentially animal studies, but no sample sizes or data provenance (country, retrospective/prospective) are mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The clearance is based on substantial equivalence to existing devices and design verification testing, not on an "AI algorithm" or a "test set" requiring expert ground truth in the way a diagnostic AI would.
However, the regulatory review process itself involves experts at the FDA.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic devices, especially those incorporating AI, to assess the impact of the device on human reader performance. The LifeStitch Suturing Device is a surgical instrument.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study in the context of an algorithm's performance was not done. The LifeStitch Suturing Device is a physical medical device for suturing, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the device's substantial equivalence and safety/effectiveness is established through:
- Comparison to predicate devices: The established safety and effectiveness of the existing predicate devices (Auto Suture ENDO STITCH, Sew-Right SR•5, Novafil™ suture material) serve as a de facto "ground truth" for the new device's comparable attributes.
- Design verification testing: This would involve engineering specifications, material testing, functional testing (e.g., ability to place sutures, tension, knot security), and potentially biocompatibility tests to ensure the device meets predefined performance and safety criteria.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
§ 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.