CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES

• K Number: K072814
• Device Name: CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
• Manufacturer: COVIDIEN
• Date Cleared: 2008-04-16 ( 198 days)
• Product Code: KDD , GEI
• Regulation Number: 878.4800
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K883018 , K914753 , K920599 , K922123 , K951589 , K981941 , K012539

Intended Use

For Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.

Device Description

Convenience kit of laparoscopic instruments. The convenience kit contains various configurations of tools for the performance of laparoscopic procedures. These tools provide laparoscopic access, tissue dissection and manipulation, hemostasis, and specimen collection.

AI/ML Overview

This is a medical device 510(k) premarket notification for a Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain specific acceptance criteria or quantitative performance data for the "Convenience Kit" device. It is a 510(k) premarket notification for a medical device focusing on demonstrating substantial equivalence to predicate devices, not on proving performance against specific acceptance criteria.

The "PERFORMANCE DATA" section states: "Relevant clinical literature has been cited in support of the intended use of this convenience kit." This indicates the reliance on existing literature for the individual components rather than a new study for the kit itself.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. The document does not describe a new performance study with a test set.
• Data Provenance: Not applicable. The document refers to "Relevant clinical literature" for its individual components, but does not specify the origin or type (retrospective/prospective) of this literature in detail for the kit as a whole.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no mention of a test set with ground truth established by experts.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is a kit of laparoscopic instruments, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This is a physical medical device kit, not an algorithm.

7. The type of ground truth used:

• Not applicable. No new ground truth for a study is mentioned. As this is a substantial equivalence submission, the "truth" is based on the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. (See #8)

Summary of what the document does provide:

• Device: Convenience Kit of laparoscopic instruments.
• Intended Use: "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."
• Predicate Devices: Several previously cleared (K883018, K914753, K920599, K922123, K951589, K981941, K012539) individual laparoscopic instruments, all from the same manufacturer.
• Basis for Clearance: Substantial equivalence to these predicate devices, meaning the FDA determined the new device is as safe and effective as existing legally marketed devices.
• Performance Data Mentioned: "Relevant clinical literature has been cited in support of the intended use of this convenience kit." This implies that the safety and effectiveness of the individual components within the kit are established through existing literature and the clearance of the predicate devices. There is no new study described for the kit as a whole to meet new acceptance criteria.

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.