CONTOUR TRANSTAR CURVED CUTTER STAPLER SET by ETHICON ENDO-SURGERY, INC.

The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

Device Description

The CONTOUR® TRANSTAR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers three staggered rows of titanium staples, with a knife between the first and second row of staples, and creates a 30 mm curved transection. The device is designed with a feature that prevents closing if a used reload or no reload is in the instrument. Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger. The instrument may be reloaded seven times, for a maximum of eight firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on the patient side, one staggered row of staples on the specimen side, an anvil, a cutting washer, a retaining pin, a knife guide pin, and a staple retainer. Additional reload cartridges will be available in one size: a green cartridge for compressed tissue with a thickness of 2.0mm.

The CONTOUR® TRANSTAR™ Curved Cutter Stapler is packaged sterile as a single patient use device with two accessories, a Circular Anal Dilator with Obturator and an Access Suture Anoscope. This set is commonly referred to by the product code STR5G.

AI/ML Overview

The provided text describes a 510(k) summary for the CONTOUR® TRANSTAR™ Curved Cutter Stapler Set. It outlines the device description, indications for use, and a general statement about performance data. However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets specific criteria.

The relevant section {1} states: "Performance Data. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device."

This statement is very broad and does not provide the detailed information requested in the prompt. Therefore, most of the questions cannot be answered from the provided text.

Here's a breakdown of what can be answered and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document

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

Sample Size (Test Set): Not specified. The document only mentions "Bench testing and preclinical laboratory evaluations."
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

Not applicable/Not specified. The document does not describe the establishment of a "ground truth" using human experts for the conducted "bench testing and preclinical laboratory evaluations."

4. Adjudication method for the test set:

Not applicable/Not specified.

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

Not applicable. This device is a surgical stapler, not an AI-powered diagnostic device, and thus an MRMC study with human readers comparing AI assistance is not relevant or described.

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

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used:

Not explicitly stated for the "bench testing and preclinical laboratory evaluations." For mechanical devices, "ground truth" would typically refer to engineering specifications, physical measurements, and histological analysis in preclinical studies. The document mentions these evaluations aimed to "demonstrate that the new device will perform as intended," implying performance against design specifications and intended function.

8. The sample size for the training set:

Not applicable. This is a hardware device, not a machine learning algorithm requiring a "training set."

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

Not applicable. This is a hardware device.

In summary: The provided 510(k) summary is for a medical device (surgical stapler) and predates widespread AI/ML software submissions. It focuses on demonstrating substantial equivalence to a predicate device through general performance testing (bench and preclinical) and a literature review, rather than the rigorous statistical study details often required for AI/ML devices outlined in your prompt. The document does not contain the detailed study information regarding acceptance criteria, sample sizes, expert involvement, or specific performance metrics that you requested.

Summary

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K053631/1/2

JAN 3 0 2006

510(k) Summary

Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242
Contact Wendy L. Turner, RAC Group Manager, Regulatory Affairs Telephone: (513) 337-8807 Fax: (513) 337-2807 Email: wturner@eesus.jnj.com

Date Prepared December 28 , 2005

Trade Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set Device Name Common or Usual Name: Curved Cutter Stapler Classification Name: Staple, Implantable [21 CFR 878.4750 (GDW)]

Predicate Devices PROXIMATE® (currently marketed as CONTOUR®) 40mm Curved Cutter Stapler and Reloads PROXIMATE® HCS Hemorrhoidal Circular Stapler Set

Device Description The CONTOUR® TRANSTAR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers three staggered rows of titanium staples, with a knife between the first and second row of staples, and creates a 30 mm curved transection. The device is designed with a feature that prevents closing if a used reload or no reload is in the instrument. Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger. The instrument may be reloaded seven times, for a maximum of eight firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on the patient side, one staggered row of staples on the specimen side, an anvil, a cutting washer, a retaining pin, a knife guide pin, and a staple retainer. Additional reload cartridges will be available in one size: a green cartridge for compressed tissue with a thickness of 2.0mm.

Indications for Use The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

Technological Characteristics The CONTOUR® TRANSTAR™ Curved Cutter Stapler is similar to the design of the predicate device, the PROXIMATE® (or CONTOUR®) 40mm Curved Cutter Stapler. The new device is different from the predicate device in that it produces a 30mm curved staple line.

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K053631²/₂

Performance Data. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle and profiles are black, and they are surrounded by a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written along the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2006

Ms. Wendy L. Turner, RAC Group Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K053631

Trade/Device Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: December 28, 2005 Received: December 29, 2005

Dear Ms. Turner:

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 docs 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 comply with 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 - Ms. Turner

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 Section 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barclay Brechin

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

Enclosure

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K05363j

Indications for Use

510(k) Number (if known):

Device Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Labare Buchar

Division of General, Restorative. and Neurological Devices

(Posted November 13, 2003)

KUS 363 510(k) Number_

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.