VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS by ETHICON ENDO-SURGERY, INC.

The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Device Description

The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of a reusable circular stapler handle and disposable reloads (containing the anvil, knife, washer, and staples) in three sizes (25.5, 28.5, and 32.5 mm).

AI/ML Overview

The provided text describes performance testing for a medical device called the "ValuTrus™ Reusable Circular Stapler and Disposable Reloads." However, it does not contain the detailed quantitative acceptance criteria and device performance results that would typically be presented in a table for an AI/CADe system. The information is more general, stating that criteria were "met" for bench and animal testing.

Therefore, I cannot fully complete a table with specific numerical acceptance criteria and reported device performance. I will extract and organize the available information as best as possible, and highlight what is missing.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Bench Testing	Not specified quantitatively. Implies performance of disposable reload and reusable handle after 200 simulated uses.	"Test results demonstrated the bench testing acceptance criteria were met."
Animal (Tissue) Testing	Leak pressure for an anastomotic stoma created in porcine colon.	"Testing results demonstrated that staple lines created by the circular stapler device met the leak pressure acceptance criteria."

Missing Information: The specific numerical thresholds or qualitative attributes for "bench testing acceptance criteria" and "leak pressure acceptance criteria" are not provided in the document.

Study Details for Device Performance

The provided text focuses on the performance of a mechanical surgical stapler, not an AI/CADe system for image analysis. Therefore, many of the requested points related to AI/CADe studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I will address the relevant points based on the information provided for this mechanical device:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Bench Testing: The sample size for bench testing is not explicitly stated. The testing was conducted to demonstrate performance after "200 simulated uses."
- Animal (Tissue) Testing: The sample size (number of animals or anastomoses) for animal testing is not specified. The data provenance is "porcine colon" (animal testing). It is implicitly prospective in nature as it's part of a device clearance application.
- Country of Origin: Not specified.
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):
- Not applicable. This relates to human interpretation of data, which is not described for this mechanical device's performance studies. Ground truth here refers to physical measurements and observations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to discrepancies among human evaluators, which is not described for this mechanical device's performance studies.
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:
- Not applicable. This type of study applies to image-based diagnostic systems with human interpretation, not a surgical stapler.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm described for this device. Its "performance" is based on mechanical function and physical outcomes (e.g., staple line integrity).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Testing: The ground truth would be direct physical measurements and observations of the device's mechanical function (e.g., staple formation, cutting ability, durability after simulated uses), as defined by engineering specifications.
- Animal (Tissue) Testing: The ground truth was "leak pressure" of the anastomotic stoma, which is an objective physiological measurement.
The sample size for the training set:
- Not applicable. This device is a mechanical stapler, not an AI/machine learning system that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model is involved.

Summary

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K111195 page 1/2

510(k) Premarket Notification (Traditional) for ValuTrus™ Reusable Circular Stapler and Disposable Reloads

AUG - 3 2011

510(k) Summary

Ethicon Endo-Surgery, LLC Company: 475 Calle C Guaynabo, PR 00969
Contact: Dennis Hahn, RAC Director, Regulatory Strategic Initiatives Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3134 (513) 337-2134 Fax: Email: dhahn l @its.jnj.com

Date Prepared: April 27, 2011

Device Name: ValuTrus™ Reusable Circular Stapler and Disposable Reloads Common or Usual Name: Circular Stapler Classification Name: Staple, Implantable

Predicate Device: PROXIMATE® ILS Curved and Straight Intraluminal Staplers (cleared under K983536 cleared on December 18, 1998)

Device Description: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of a reusable circular stapler handle and disposable reloads (containing the anvil, knife, washer, and staples) in three sizes (25.5, 28.5, and 32.5 mm).

Indications for Use: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-toside anastomoses.

Contraindications for use:

Do not use where the combined tissue thickness is less than 1.0 mm or greater than 2.5 . mm or where the internal diameter of the structure is less than 25.5 mm. If the instrument is used on tissue less than 1.0 mm or greater than 2.5 mm in thickness, an inadequate anastomosis could be formed resulting in leakage, inadequate hemostasis or improper healing.

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Technological Characteristics: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of two components: the reusable handle and disposable reloads. The handle can be used for 200 applications. An adjustable knob on the handle adjusts the device for use on compressed tissue from 1.0 to 2.5 mm. The sterile reloads, which are designed for a single use, are made up of an anvil head and two staggered rows of staples. The reloads are available in three sizes: 25.5 mm, 28.5 mm, and 32.5 mm.

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 anasotomic stoma created in porcine colon. Testing results demonstrated that staple lines created by the circular stapler device met the leak pressure acceptance criteria.

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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 or bird-like figure 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 bird-like figure.

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

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

AUG - 3 2011

Re: K111195

Trade/Device Name: ValuTrus™ Reusable Circular Stapler and Disposable Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 15, 2011 Received: July 18, 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 syste:ns (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/MedicalDevices/Safety/ReportaProblem/default.hun 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.

Sincerely vours.

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): K111195

Device Name: ValuTrus™ Reusable Circular Stapler and Disposable Reloads

Indications for Use: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-toside anastomoses.

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)

Page 1 of 1

Daniel Krenek MEM

Division Sig Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111195

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.