(11 days)
The USGI ShapeLock Endoscopic Guide is intended to be used with an endoscope to to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "USGI ShapeLock Endoscopic Guide," indicating that the device has been found substantially equivalent to a legally marketed predicate device.
The letter mentions:
- Trade/Device Name: USGI ShapeLock™ Endoscopic Guide
- Regulation Number: 21 CFR §876.1500 (Endoscope and accessories)
- Regulation Name: Endoscope and accessories
- Regulatory Class: II
- Indications For Use: To be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the given text.
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Image /page/0/Picture/2 description: The image shows a black and white logo. The logo features a stylized bird in flight, with three lines representing its wings. To the left of the bird, there is text arranged in a circular pattern, but the text is not legible due to the image quality.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
JUL 26 2005
Ms. Mary Lou Mooney Vice President of Clinical, Regulatory and Quality USGI Medical, Inc. 1140 Calle Cordillera SAN CLEMENTE CA 92673
Re: K051919
Trade/Device Name: USGI ShapeLock™ Endoscopic Guide Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: July 14, 2005 Received: July 15, 2005
Dear Ms. Mooney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have and have determined the device is substantially equivalent (for the indications for use stated in above and hel 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 May 20, 1910, and classince with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassition in accordal of a premarket approval application (PMA). You may, therefore, market the do not require 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket It your de results of subject to such additional controls. Existing major regulations affecting your Apployal), it thay be sayse to battle develations, 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 I roase of advisor that i Dr i on 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 I carates and regulations as association and listing (21 CFR Part 807); labeling ACC STEQuirements, moduling, but novements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you don't office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K051919
Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: USGI ShapeLock Endoscopic Guide
Indications For Use:
The USGI ShapeLock Endoscopic Guide is intended to be used with an endoscope to to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
Prescription Use L (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)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K051919
Page 1 of
§ 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.