(82 days)
None
Not Found
No
The summary describes a simple leak testing device with no mention of AI, ML, image processing, or data analysis that would typically indicate the use of such technologies.
No
The device is a leak tester for endoscopes, designed to detect damage, not to treat a condition or disease in a patient.
No
The device is described as a "leak testing device that detects damage to the interior or exterior of an endoscope." It's used to test the physical integrity of medical equipment, not to diagnose a medical condition in a patient.
No
The device description explicitly states it is a "leak testing device," implying a physical piece of equipment used to perform the test, not just software.
Based on the provided information, the Zutron Medical ZUTR-1003 Endoscope Leak Tester is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "detect interior and exterior leaks in endoscopes." This is a function related to the maintenance and integrity of a medical device (an endoscope), not the diagnosis of a disease or condition in a patient using samples from the human body.
- Device Description: The description reinforces this by stating it "detects damage to the interior or exterior of an endoscope."
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Measuring analytes or biomarkers
The device is clearly designed for testing the functionality and integrity of an endoscope, which is a medical device used on patients, but the leak tester itself does not perform a diagnostic test on a patient or their samples.
N/A
Intended Use / Indications for Use
The Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.
Product codes
FCY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Zutron Endoscope Leak Tester is substantially equivalent to the predicate devices. The device has passed internal testing and electrical safety testing requirements.
Key Metrics
Not Found
Predicate Device(s)
Fujinon Leak Tester, SRI Leak Tester, Telemed Systems Class 1 Exempt
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.