AED CYSTOSCOPE

K993689 · National Advanced Endoscopy Devices, Inc. · FAJ · Dec 15, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993689
• Device Name: AED CYSTOSCOPE
• Applicant: National Advanced Endoscopy Devices, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Dec 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This device is used to provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure. The AED line of rigid Cystoscopes is indicated to provide illumination and visualization in: - Diagnostic cystoscopy procedures.

Device Story

AED Cystoscope is a rigid endoscope designed for diagnostic cystoscopy. Device provides illumination and visualization of bladder and urethra interiors. Operated by physicians in clinical settings to facilitate visual inspection without surgical intervention. Device functions as a passive optical instrument; transmits light to the target site and returns visual information to the clinician. Benefits include non-surgical assessment of urinary tract anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid cystoscope; optical illumination and visualization system. Device is a non-powered or light-source-coupled mechanical instrument. No software or electronic algorithms.

Indications for Use

Indicated for patients requiring diagnostic cystoscopy procedures for illumination and visualization of the interior of the bladder and urethra.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1999

Ms. Gayle M. Butler Compliance Office National Advanced Endoscopy Devices, Inc. 10801 National Boulevard, Suite 603 Los Angeles, CA 90064

Re: K993689 AED Cystoscope Dated: October 26, 1999 Received: November 1, 1999 Requiatory Class: Il 21 CFR §876.1500/Procode: 78 FAJ

Dear Ms. Butler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance al [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also. please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT G

Page _ 1_ of _1_

510(k) Number (if known): _ x 99 3689 Device Name: AED Cystoscope

Indications for Use:

This device is used to provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure.

The instructions enclosed with the device state (see Attachment B):

## INDICATIONS FOR USE:

The AED line of rigid Cystoscopes is indicated to provide illumination and visualization in:

- Diagnostic cystoscopy procedures. .
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDHR, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.

Over-The-Counter Use _ (Optional Format)

G-1