(25 days)
The USGI ShapeLock Endoscopic Guide is intented to be used with an endoscopes and removal of The USGI ShapeLock chooscopy, change of endoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
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I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "USGI ShapeLock™ Endoscopic Guide." It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt. The letter merely states that the device has been found substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot extract the information needed to answer your request from this document.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Lou Mooney Vice President of Clinical, Regulatory and Quality USGI Medical 1140 Calle Cordillera SAN CLEMENTE CA 92673 FEB 2 3 2005
RE: K050253
Trade/Device Name: USGI ShapeLock™ Endoscopic Guide Regulation Number: 21 CFR § 876.1500 Regulation Name: Endoscopes and/or Accessories Regulatory Class: II Product Code: 78 KOG Dated: February 1, 2005 Received: February 3, 2005
Dear Ms. Mooney:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the endobare) to regary comment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de necs that have boon formation of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, mains of the Act include requirements for annual registration, listing of general controlo provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is valuational controls. Existing major regulations affecting your device can be it may of Subject to adentifical 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 I Rass oc advised that I DT issum that your device complies with other requirements of the Act that I Dri has Inado a assud regulations administered by other Federal agencies. You must of any I ederal statures and reguirements, including, but not limited to: registration and listing Comply with an the Hec oreq (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), lebems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of the (<< sions 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) I his letter will anow you to begin mancing your cover convalence of your device to a legally premarket notification: "The I DA Inding of basican - "Saosanna" - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Pat 801), please If you desire specific advice for your device of our laceming on 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 Also, please note the regulation entitled, "The stime" 807.97). You may outler general missational and Consumer Assistance at its toll-free number (800) DWISION of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
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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Indications for Use
510(k) Number (if known):
$\Ko50^{2.53}$
USGI ShapeLock Endoscopic Guide Device Name:
Indications For Use:
The USGI ShapeLock Endoscopic Guide is intented to be used with an endoscopes and removal of The USGI ShapeLock chooscopy, change of endoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
Prescription Use __
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
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.