The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges has application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses and can be used with staple line or tissue buttressing materials.

Device Description

The Ethicon Endo-Surgery Linear Cutter is a sterile, single patient use instrument used in open surgical procedures. The instrument delivers six staggered rows of staples, three on either side of the cut line. The instrument is shipped without a cartridge loaded into the instrument. The cartridge must be loaded as a separate step prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired. Each Ethicon Endo-Surgery Selectable Cartridge contains six staggered rows of staples and an integrated knife located in the safety housing. The selectable staple height feature provides the ability to use one cartridge for compressed tissue with thicknesses of 1.5mm, 1.8mm or 2.0mm. The staple retaining cap on the cartridge protects the staples during shipping and transportation.

AI/ML Overview

The provided text describes the Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges, including its indications for use, technological characteristics, and a brief mention of performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the document states:
"Performance Data Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the new devices will perform as intended."

This is a very high-level statement and does not provide the granular details required for your table or the specific sections of your request.

Therefore, I can only provide a partial answer based on the available information.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document	"Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the new devices will perform as intended."

Explanation: The document does not explicitly state specific acceptance criteria (e.g., minimum staple retention force, burst pressure, or specific success rates). It only broadly mentions that testing was done to ensure the device "perform[s] as intended."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample size for test set: Not specified.
Data provenance: "preclinical laboratory evaluation in an animal model" - This implies prospective data collection, but the country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. The study mentioned is a "preclinical laboratory evaluation in an animal model," which typically involves researchers and veterinarians, but their number and qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

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:

This is not a software device that involves "readers" or "AI." It is a surgical stapling device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.

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

This is not a software algorithm; it is a physical surgical device. Therefore, a standalone algorithm-only performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given it was "preclinical laboratory evaluation in an animal model," the ground truth would likely be based on direct observations, measurements (e.g., staple line integrity, tissue integrity, healing), and potentially histology/pathology of the animal tissue, but this is not explicitly detailed.

8. The sample size for the training set:

This is not a machine learning/AI device, so there is no "training set" in the conventional sense. The "bench testing" and "animal model" are for validation and verification of the device's mechanical and biological performance.

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

As above, there is no "training set."

In summary, the provided document focuses on the regulatory submission (510(k) Summary) and clearance of a surgical stapler. While it confirms performance testing was conducted, it lacks the detailed scientific study parameters and results typically found in a dedicated research paper or detailed technical report.

Summary

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SEP 1 6 2009

K092577 Page 1/2

510(k) Summary

Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969

Contact Abhilasha Mukherjee, RAC Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3623 Fax: AMukher5@its.jnj.com Email:

Date Prepared August 19, 2009

Device Name Trade Name: Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges Common or Usual Name: Cutter/Stapler and Cartridges Classification Name: Staple, Implantable

Predicate Device Proximate Linear Cutter with Safety Lock-Out and Cartridges (cleared under K020779) .

Device Description The Ethicon Endo-Surgery Linear Cutter is a sterile, single patient use instrument used in open surgical procedures. The instrument delivers six staggered rows of staples, three on either side of the cut line. The instrument is shipped without a cartridge loaded into the instrument. The cartridge must be loaded as a separate step prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.

Each Ethicon Endo-Surgery Selectable Cartridge contains six staggered rows of staples and an integrated knife located in the safety housing. The selectable staple height feature provides the ability to use one cartridge for compressed tissue with thicknesses of 1.5mm, 1.8mm or 2.0mm. The staple retaining cap on the cartridge protects the staples during shipping and transportation: -------------------------------------------------------------------------------------------------------------------

Indications for Use The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges has application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses and can be used with staple line or tissue buttressing materials.

.. . . . . . . .

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K09577 page 2/2

Technological Characteristics The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridge incorporates a new selectable staple height feature, which enables the surgeon to use one cartridge for compressed tissue with thicknesses of 1.5mm, 1.8mm or 2.0mm. This ability eliminates the need for multiple cartridges (a blue cartridge for compressed tissue with a thickness of 1.5mm, a gold cartridge for compressed tissue with a thickness of 1.8mm and a green cartridge for compressed tissue with a thickness of 2.0mm), which is required when using the predicate device. The cartridge contains six staggered rows of staples with an integrated knife located in the safety housing.

Performance Data Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the new devices will perform as intended.

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

NOV 18 2009

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Ms. Abhilasha Mukherjee, RAC 4545 Creek Road Cincinnati. Ohio 45242

Re: K092577

Trade Name: Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Product Code: GDW, GAG Dated: August 19, 2009 Received: August 21, 2009

Dear Ms. Mukherjee:

This letter corrects our substantially equivalent letter dated September 15, 2009

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. Ilisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Abhilasha Mukherjee, RAC

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Soubane Buelm
les

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

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges

Indications for Use:

The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges has application in The Ethicon Endo-Surgery Lifeai Cattler and Selectuble Ory for transection, resection, and the creation of anastomoses and can be used with staple for tissue buttressing materials.

Prescription Use X (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)

Harbare AniemD

vision Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092577 Page 1 of 1

(Posted November 13, 2003)

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.