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.

Summary

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Surgical Devices, a global business unit of Tyco Healthcare Group, LP (d/b/a Covidien)

5. 510(K) SUMMARY:

510(k) Summary of Safcty and Effectiveness:

SUBMITTER:	Surgical Devices, a global business unit ofTyco Healthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473
CONTACT PERSON:	Robert ZottProgram Director, Regulatory AffairsPhone: (203) 492-6013Fax: (203) 492-5029
DATE PREPARED:	September 21, 2007
TRADE/PROPRIETARY NAME:	To Be Determined
COMMON/USUAL NAME:	Convenience Kit
CLASSIFICATION NAME:	Convenience Kit
PREDICATE DEVICE(S):	K883018: Endo Clip* 5mm Clip Applier
	K914753: Roticulator Endo Dissect* 5mm,Endo Grasp* 5mm, & Endo Mini-Shears* 5mm
	K920599: AcuClip* Right Angle Clip Applier
	K922123: Endo Catch* Gold
	K951589: Roticulator Endo Sciz* 5mmHook Scissors
	K981941: Dexide* 5mm Threaded Trocar
	K012539: VersaStep* Plus 12mm Trocar
	All predicate devices manufactured bySurgical Devices, a global business ofTyco Healthcare Group LP (d/b/a/ Covidien)

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072414

Surgical Devices, a global business unit of Tyco Healthcare Group, LP (d/b/a Covidien)

DEVICE DESCRIPTION:	Convenience kit of laparoscopic instruments.
INTENDED USE:	"Single-Incision Laparoscopic Surgery and otheradvanced laparoscopic procedures."
TECHNOLOGICALCHARACTERISTICS:	The convenience kit contains variousconfigurations of tools for the performance oflaparoscopic procedures. These tools providelaparoscopic access, tissue dissection andmanipulation, hemostasis, and specimen collection.
MATERIALS:	Unchanged from predicate devices.
PERFORMANCE DATA:	Relevant clinical literature has been cited insupport of the intended use of this convenience kit.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2008

Covidien % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K072814

Trade/Device Name: Convenience Kit for "Single-Incision Laparoscopic Surgery and and other advanced laparoscopic procedures." Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 20, 2008 Received: March 21, 2008

Dear Mr. Zott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Robert Zott

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millikan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment l

Indications for Use

510(k) Number (if known):	K072814
Device Name:	Convenience Kit for "Single-Incision Laparoscopic Surgeryand other advanced laparoscopic procedures."
Indications for Use:	For Single-Incision Laparoscopic Surgery and otheradvanced laparoscopic procedures.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for MXM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K072814

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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.