The Reusable Linear Stapler and Disposable Reload has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
The Reusable Linear Stapler and Disposable Reload has application throughout the alimentary tract and in thoracic surgery for transection of internal tissues.

Device Description

The Reusable Linear Stapler and Disposable Reload is a surgical stapling device used throughout the alimentary tract an in thoracic surgery for transection and resection of internal tissues. The device delivers two staggered rows of titanium alloy staples in a 40 mm staple line to approximate internal tissues. Staple height is adjustable to compensate for tissue thicknesses from 1.5 mm to 2.5 mm. The device consists of two components: the Reusable Linear Stapler Handle (ADLH) and the disposable Linear Stapler Rcload (ADL40R).
The Reusable Linear Stapler and Disposable Reload consists of two components: the reusable handle and the disposable reload. The handle can be used for 200 applications. The reload, which is designed for a single use, is made up of two staggered rows of staples with a length of 40 mm. The staple height can be adjusted to accommodate a compressed tissue thickness of 1.5 mm to 2.5 mm. A spent reload indicator warns when the reload must be discarded.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Reusable Linear Stapler and Disposable Reload, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Bench Testing: Performance of the disposable reload and reusable handle after 200 simulated uses.	"Test results demonstrated the bench testing acceptance criteria were met."
Animal (tissue) Testing: Leak pressure tolerance of an anastomotic stoma created in porcine colon.	"Testing results demonstrated that staple lines created by the linear stapler device met the leak pressure acceptance criteria."

No further specifics on the exact quantitative acceptance criteria (e.g., specific pressure thresholds, performance metrics for bench testing) are provided in the text.

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size for Test Set: Not explicitly stated. For bench testing, it mentions "after 200 simulated uses" for the reusable handle, implying the handle was tested through 200 cycles, but the number of disposable reloads tested is not specified. For animal testing, it mentions "porcine colon" but does not give the number of animals or anastomotic stomas.
Data Provenance: Not explicitly stated. However, animal testing was conducted on "porcine colon," indicating animal data. The text doesn't specify the country of origin for the data, nor whether it was retrospective or prospective. Given the nature of a 510(k) submission, it would almost certainly be prospective testing conducted for regulatory purposes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not provided in the given text. For a stapling device, ground truth is typically based on objective measurements and observations rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading), which is not explicitly the case for this type of device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers evaluating cases and is common for diagnostic imaging AI. The Reusable Linear Stapler is a surgical device, and its performance is evaluated through bench and animal testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is a physical surgical stapler, not an AI algorithm. Its performance is inherently "standalone" in the sense that it operates as designed without requiring human-in-the-loop assistance for its mechanical function.

7. The Type of Ground Truth Used:

Bench Testing: The ground truth for bench testing would be defined by engineering specifications and performance metrics for the device's mechanical operation (e.g., staple formation, firing force, integrity after repeated uses). These are objective measurements.
Animal (Tissue) Testing: The ground truth for animal testing would be based on objective physiological measurements, specifically the "leak pressure acceptance criteria" for the anastomotic stoma. This indicates a measurable outcome related to the biological function and integrity of the staple line.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a mechanical surgical stapler, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

Summary

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510(k) Summary

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

FEB 1 0 201

KI10049

Contact: Dennis Hahn, RAC Director, Regulatory Strategic Initiatives Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3134 Fax: --(513) 337-2134 Email: dhahn1@its.jnj.com

Date Prepared: January 6, 2011

Device Name: Reusable Linear Stapler and Disposable Reload Common or Usual Name: Linear Stapler and Reload Classification Name: Staple, Implantable

PROXIMATE® Reloadable Linear Stapler and Reload Predicate Device: (cleared under K020779)

Device Description: The Reusable Linear Stapler and Disposable Reload is a surgical stapling device used throughout the alimentary tract an in thoracic surgery for transection and resection of internal tissues. The device delivers two staggered rows of titanium alloy staples in a 40 mm staple line to approximate internal tissues. Staple height is adjustable to compensate for tissue thicknesses from 1.5 mm to 2.5 mm. The device consists of two components: the Reusable Linear Stapler Handle (ADLH) and the disposable Linear Stapler Rcload (ADL40R).

Indications for Use: The Reusable Linear Stapler and Disposable Reload has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues

Contraindications:

Do not use on the heart, aorta, coronary, carotid or pulmonary arteries or veins, the . superior or inferior vena cava, common internal or external iliac arteries or veins, or the brachiocephalic trunk.
Do not use the ADLH (and corresponding reload ADL40R) on tissue with a thickness . that requires an instrument setting of less than 1.5 mm or greater than 2.5 mm.
Do not use the instruments on ischemic or necrotic tissue. .
Do not use the instruments on solid organs, such as liver or spleen, where attempted . compression would be destructive.
Do not use when surgical stapling is contraindicated. .

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Technological Characteristics: The Reusable Linear Stapler and Disposable Reload consists of two components: the reusable handle and the disposable reload. The handle can be used for 200 applications. The reload, which is designed for a single use, is made up of two staggered rows of staples with a length of 40 mm. The staple height can be adjusted to accommodate a compressed tissue thickness of 1.5 mm to 2.5 mm. A spent reload indicator warns when the reload must be discarded.

Performance Data: Bench testing was conducted to demonstrate and verify the performance of the disposable reload and the reusable handle after 200 simulated uses. Test results demonstrated the bench testing acceptance criteria were met.

Animal (tissue) testing was conducted to evaluate the pressure tolerance of an anastomotic stoma created in porcine colon. Testing results demonstrated that staple lines created by the linear stapler device met the leak pressure acceptance criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

FEB 10 : .

Re: K110049

Trade/Device Name: Reusable Linear Stapler and Reload Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: January 6, 2011 Received: January 7, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Dennis Hahn. RAC

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 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 Pan 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Aty B. Kh
for

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): K11004-9

Device Name: Reusable Linear Stapler and Reload

Indications for Use:

The Reusable Linear Stapler and Disposable Reload has application throughout the alimentary tract and in thoracic surgery for transection of internal tissues.

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)

Daniel Krane for MKM
Division Sign-Off

Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K110049

Confidential

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.