CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G by ETHICON ENDO-SURGERY, LLC

The CONTOUR™ Curved Cutter Stapler and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.

Device Description

The CONTOUR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and creates a 40 mm curved transection. The device is designed with a feature which 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 five times, for a maximum of six firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on each side, an anvil, a cutting washer, a retaining pin, and a staple retainer. Reload cartridges are available in two sizes: a blue cartridge for compressed tissue with a thickness of 1.5mm, and a green cartridge for compressed tissue with a thickness of 2.0mm.

AI/ML Overview

This document is a 510(k) summary for the CONTOUR™ Curved Cutter Stapler and Reloads. It does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices in the US. This pathway does not typically require detailed performance studies against specific acceptance criteria to be submitted as part of the 510(k) summary for review by the public. Instead, it relies on the device being similar enough to a previously cleared device.

Therefore, I cannot provide values for the following:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and data provenance
Number of experts and their qualifications for ground truth
Adjudication method for the test set
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
Whether a standalone performance study was done
The type of ground truth used
Sample size for the training set
How ground truth for the training set was established

Key takeaway from the document:

The CONTOUR™ Curved Cutter Stapler is deemed "substantially equivalent" to predicate devices K040038 (Curved Cutter Stapler) and K061156 (ENDOPATH® Linear Cutters and Staplers) based on:

Identical technological characteristics to the K040038 Curved Cutter Stapler predicate device.
Same intended use as the ENDOPATH® Linear Cutters and Staplers.

This implies that the performance of the CONTOUR™ device is considered comparable to these existing, legally marketed devices, rather than being demonstrated against novel acceptance criteria in this specific submission. Performance data, if generated, would typically be internal to the manufacturer and not explicitly stated in a 510(k) summary unless it's a novel device requiring such proof for substantial equivalence.

Summary

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K062869

EB 26 200;

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510(k) Summary

Company Ethicon Endo-Surgery, LLC Angora Industrial Park, Building G Caguas, Puerto Rico 00725
Contact Dennis Hahn Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Phone: (513) 337-3134 FAX: (513) 337-1444 Email: dhahn1@eesus.ini.com

Date Prepared February 21, 2006

Trade Name: CONTOUR™ Curved Cutter Stapler and Reloads Device Name Common or Usual Name: Cutter/Stapler and Reloads Classification Name: Staple, Implantable
Predicate Devices K040038 Curved Cutter Stapler K061156 - ENDOPATH® Linear Cutters and Staplers

Device Description: The CONTOUR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and creates a 40 mm curved transection. The device is designed with a feature which 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 five times, for a maximum of six firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on each side, an anvil, a cutting washer, a retaining pin, and a staple retainer. Reload cartridges are available in two sizes: a blue cartridge for compressed tissue with a thickness of 1.5mm, and a green cartridge for compressed tissue with a thickness of 2.0mm.

Indications for Use: The CONTOUR™ Curved Cutter Stapler and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.

Technological Characteristics: The CONTOUR™ Curved Cutter Stapler is identical to the Curved Cutter Stapler predicate device with respect to technological characteristics. The CONTOUR™ Curved Cutter Stapler has the same intended use as the ENDOPATH® Linear Cutters and Staplers.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, U.S.A."

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon Endo-Surgery, LLC % Mr. Dennis Hahn, RAC Director, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242

2 8 8 8 2007

Re: K062869

Trade/Device Name: CONTOUR"" Curved Cutter Stapler and Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: January 29, 2007 Received: January 31, 2007

Dear Mr. Hahn:

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 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 sct 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.

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Page 2 - Mr. Dennis Hahn, RAC

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" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R. Ogden

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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Indications for Use

510(k) Number (if known): K062869

Device Name: CONTOUR™ Curved Cutter Stapler and Reloads

Indications for Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	for MXM
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(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number	K062869	Page 1 of 1
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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.