ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD by ETHICON ENDO-SURGERY, INC.

The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.

The ENDOPATH ETS-Flex-45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex 45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.

Device Description

These instruments are all mechanical surgical stapling devices. The ENDOPATH Linear Cutter models are sterile single use instruments that deliver staples while simultaneously dividing tissue between rows. The ENDOPATH No-Knife Staplers are sterile single use instruments that deliver staples, but do not cut. These instruments may be used in either open or Endoscopic procedures, depending upon the design. Some instruments are Reloadable and, if so, they may be reloaded with various reloads (i.e., vascular/thin, standard, thick) depending on the thickness of tissue that is to be transected or resected.

AI/ML Overview

The provided text is a 510(k) summary for the ENDOPATH® Endocutter Gray Cartridge, a surgical stapling device. This document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the way envisioned by your request for a medical device AI.

The document mainly focuses on the device's intended use, classification, and substantial equivalence to a predicate device. While it mentions "Bench testing and pre-clinical laboratory evaluations were performed to demonstrate that the device will perform as intended," it does not provide any specifics about these tests, methodologies, acceptance criteria, or results.

Therefore, I cannot provide the requested information in the format of your table and detailed points, as the necessary data is absent from the provided text.

The document does not describe the acceptance criteria and a study that proves the device meets those criteria.

Here's why and what information is missing:

No Acceptance Criteria: The document does not list any specific performance metrics (e.g., accuracy, sensitivity, specificity, false positive rate) or associated thresholds that the device must meet to be considered acceptable.
No Study Details: While "Bench testing and pre-clinical laboratory evaluations" are mentioned, no details are provided about:
- The specific tests conducted.
- The results of these tests.
- The methodologies used.
- The sample sizes.
- The ground truth establishment.
- Any involvement of experts.
- Any comparison with human performance or a "gold standard."

Summary of missing information based on your requested points:

Table of acceptance criteria and reported device performance: Not available. No acceptance criteria or specific performance data is reported.
Sample size used for the test set and data provenance: Not available. No details on test sets or data provenance are provided.
Number of experts used to establish the ground truth for the test set and qualifications: Not available. No mention of experts or ground truth establishment.
Adjudication method for the test set: Not available.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not available. The device is a mechanical stapling device, not an AI or imaging device that would typically undergo MRMC studies with human readers.
Standalone performance (algorithm only without human-in-the-loop performance): Not available. The device is a mechanical surgical instrument, not an AI algorithm.
Type of ground truth used: Not available.
Sample size for the training set: Not applicable/Not available. This is a mechanical device, not an AI model that would have a training set.
How the ground truth for the training set was established: Not applicable/Not available.

In essence, the provided text is a regulatory filing for a physical medical device (surgical stapler) and not a scientific study report about an AI-powered diagnostic or predictive tool. Therefore, it does not contain the kind of performance data and study details you're looking for, which are typically associated with the validation of AI/ML-enabled medical devices.

Summary

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Image /page/0/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 body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

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

Ethicon Endo-Surgery, Inc. Ms. Georgia C. Abernathy, MBA, RAC Senior Regulatory Affairs Associate 4545 Creek Road Cincinnati, OH 45242

K033269 Re:

Trade/Device Name: ENDOPATH® Endocutter Gray Cartridge Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW, GDW Dated (Date on orig SE ltr): October 8, 2003 Received (Date on orig SE ltr): October 16, 2003

Dear Ms. Abernathy,

This letter corrects our substantially equivalent letter of December 10, 2003.

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.

·JUL 2 7 2015

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

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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 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. . Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K033269

Device Name: ENDOPATH® Endocutter Gray Cartridge

Indications For Use:

The ENDOPATH ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

f. Mark N. Millen

rision of General, Restorative ad Neurological Devices

Page 1 of __ 1___

Number K033269

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6333269

510(k) Summary of Safety and Effectiveness Information

Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242

Georgia C. Abernathy, MBA, RAC Contact Senior Regulatory Affairs Associate Telephone: (513) 337-3179 (513) 337-1444 Fax: Email: gabernat@eesus.jnj.com

October 8, 2003 Date Prepared

Trade Name: ENDOPATH® Endocutter Gray Cartridge Device Name Classification Name: Endoscope and Accessories, Implantable Staples
Predicate Device ENDOPATH® Linear Cutters and Staplers

These instruments are all mechanical surgical stapling devices. The Device Description ENDOPATH Linear Cutter models are sterile single use instruments that deliver staples while simultaneously dividing tissue between rows. The ENDOPATH No-Knife Staplers are sterile single use instruments that deliver staples, but do not cut. These instruments may be used in either open or Endoscopic procedures, depending upon the design. Some instruments are Reloadable and, if so, they may be reloaded with various reloads (i.e., vascular/thin, standard, thick) depending on the thickness of tissue that is to be transected or resected.

Indications for Use

This is an addition of a gray cartridge reload to this Technological Characteristics product line. The Gray Cartridge is for use on thin tissue such as mesentery and vessels and has a nominal closed staple height of 0.85mm.

Performance Data Bench testing and pre-clinical laboratory evaluations were performed to demonstrate that the device will perform as intended.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.