The provided text is a 510(k) premarket notification letter from the FDA regarding the Zutron Medical ZUTR-10003 Endoscope Leak Tester. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The document states that "The device has passed internal testing and electrical safety testing requirements," and concludes that it is "substantially equivalent to the predicate device." However, no specific details about the methodology, sample sizes, or results of these tests are provided.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document only generally states that the device passed "internal testing."
Sample size used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable/provided. This device is an endoscope leak tester, not an AI-assisted diagnostic tool that would typically involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/provided in the context of an endoscope leak tester. Its function is to autonomously detect leaks.
The type of ground truth used: Not provided.
The sample size for the training set: Not applicable/provided. This device is not an AI/ML product where "training set" would apply in the usual sense.
How the ground truth for the training set was established: Not applicable/provided.

In summary, the provided FDA letter confirms the regulatory clearance for the Zutron Medical ZUTR-10003 Endoscope Leak Tester based on substantial equivalence, but it does not detail the specific performance studies, acceptance criteria, or experimental methodologies that would answer the requested questions. Its primary purpose is to inform of the FDA's decision regarding market clearance, not to be a scientific report of the device's performance characteristics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

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

Zutron Medical, LLC % Mr. Joseph Azary Senior Regulatory Affairs Consultant Orchid Design 80 Shelton Technology Center Shelton, CT. 06484

JUL 2 7 2015

Re: K093718 Trade/Device Name: Zutron Medical ZUTR-10003 Endoscope Leak Tester Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: I Product Code: FCY Dated (Date on orig SE ltr): November 9, 2009 Received (Date on orig SE ltr): December 9, 2009

Dear Mr. Azary,

This letter corrects our substantially equivalent letter of February 22, 2010.

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

{1}------------------------------------------------

Page 2 -

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 yours,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K 093718

Device Name: Zutron Medical ZUTR-10003 Endoscope Leak Tester

Indications For Use: The Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.

Contraindications: The device is not intended for use in patients.

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)

Page 1 of 1.

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness 093718 Zutron Medical Endoscope Leak Tester ZUTR-10003

November 9, 2009

Submitter:

Joseph Azary Orchid Design 80 Shelton Technology Center Shelton. CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com

FEB 2 2 2010

Manufacturer:

Zutron Medical 1911 Broadway Kansas City, MO 64108 Tel: (816) 472-4500 Contact: Jordan Hartong / VP of Operations Email: jordan.hartong@zutron.com

FDA Establishment Registration Number: 3005299806

Trade Name, Common Name, Classification:

Device Trade Name: Endoscope Leak Tester ZUTR-10003

Device Common or Usual Names: Endoscope Leak Tester

Classification: Class I, 21 CFR 876.1500

Predicate Device:

� Fujinon Leak Tester - Class 1 Exempt
� SRI Leak Tester - Class 1 Exempt
Telemed Systems Class 1 Exempt t

Description of the Device:

Endoscopes are complex devices that mix mechanical, illumination, optical and video elements, none of which react well to fluid. As a result, endoscope leak testing is a crucial part of proper scope cleaning and disinfection.

The Zutron Medical Endoscope Leak Tester is a leak testing device that detects damage to the interior or exterior of an endoscope.

Intended Use:

The Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.

{4}------------------------------------------------

Technological Characteristics:

Kog 3/8
By 2.02.

The Zutron Endoscope Leak Tester is substantially equivalent to the predicate devices. The device has passed internal testing and electrical safety testing requirements.

:. :

Conclusion:

We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate device.

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.