(30 days)
Biopsy valves are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The EndoChoice biopsy valve can be manufactured with a choice of two types – regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary for a medical device (EndoChoice Biopsy Valves) which focuses on demonstrating substantial equivalence to a predicate device.
Here's why the requested information cannot be extracted from this document:
- No performance standards: The text explicitly states, "No performance standards exist for this device." This implies there are no pre-defined quantitative acceptance criteria that the device needs to meet through a specific performance study.
- Substantial Equivalence: The entire submission is based on showing "substantial equivalence" of the EndoChoice Biopsy Valve to a predicate device (US Endoscopy - Bioshield - ERCP Biopsy Valve). This means the focus is on comparing technological characteristics and overall performance to an already legally marketed device, rather than proving performance against new, independent acceptance criteria.
- Lack of detailed study data: The document mentions "Performance Data" but does not elaborate on any specific study, its design, sample size, ground truth, or statistical analysis. It only concludes that based on technological characteristics and overall performance, the device is substantially equivalent, and differences are minor without new safety or effectiveness issues.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided 510(k) summary.
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JUL 28 2011
K////821
page 1 of 2
This 510(k) summary of safety and effectiveness information is being submitted in
accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name andAddress: | EndoChoice, Inc.11810 Wills Rd, Suite 100Alpharetta, GA 30009 |
|---|---|
| Contact Person: | Theron GoberQuality and Regulatory Manager |
| Phone Number: | 678-534-6021 |
| Fax Number: | 770-410-9008 |
| EstablishmentRegistration Number: | 300759133 |
| Date Prepared: | June 22, 2011 |
| Device Trade Name(s): | EndoChoice Biopsy Valves: |
| Device Common Name: | Biopsy Valves |
| Classification Name: | OCX - Endoscope and accessories |
| Predicate Device(s): | US Endoscopy - Bioshield - ERCP Biopsy Valve |
| General DeviceDescription: | The EndoChoice biopsy valve can be manufactured with achoice of two types – regular disposable biopsy valve andirrigating biopsy valve. Each of these types can be orderedfor Olympus, Fujinon, and Pentax gastrointestinalendoscopes. |
| Intended Use: | Biopsy valves are intended to provide access for endoscopicdevice passage and exchange, helps maintain sufflation,minimizes leakage of biomaterial from the biopsy portthroughout the endoscopic procedure, and provides accessfor irrigation. |
| TechnologicalCharacteristics: | From a clinical perspective and comparing designspecifications, the EndoChoice biopsy valves and thepredicate devices are substantially equivalent. Based on thtechnological characteristics and overall performance of thedevices, EndoChoice, Inc. believes that no significant |
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K111821
page 2 of 2
differences exist between the proposed biopsy valve and the predicate device.
No performance standards exist for this device. Performance Data:
Based on the technological characteristics and overall Conclusion: performance of the devices, EndoChoice, Inc. believes that the biopsy valve and the predicate device selected are substantially equivalent and that any differences between the devices are minor which do not raise new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Theron Gober RA/QA Manager EndoChoice, Inc. 11810 Wills Road, Suite 100 ALPHARETTA GA 30009
JUL 2 8 2011
Re: K111821
Trade/Device Name: Biopsy Valve Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: July 19, 2011 Received: July 20, 2011
Dear Mr. Gober:
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 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 of medical device-related
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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 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.
Sincerely yours,
Herbert Kenion MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Proprietary to EndoChoice, Inc.
INDICATIONS FOR USE
| 510(k) Number (if known): | K1111821 |
|---|---|
| --------------------------- | ---------- |
Device Name: Biopsy Valve
Indications for Use
1 .
Biopsy valves are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Helen Glenn
sion Sian oductive. Gastro-Rena al, and
§ 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.