MEDIVISION CYSTOSCOPE

K982620 · Medivision Scope Service Center, Inc. · FAJ · Sep 30, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982620
• Device Name: MEDIVISION CYSTOSCOPE
• Applicant: Medivision Scope Service Center, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. This device is marketed as a reusable device; methods for cleaning, disinfecting, and sterilization are included in latter sections of this submission under Section 5, STERILIZATION INFORMATION .

Device Story

MediVision Cystoscopes (Models MV400, MV415, MV430, MV470) are reusable endoscopic devices used for visualization of the lower urinary tract. Operated by clinicians in a clinical setting, the device allows for diagnostic and therapeutic interventions when used with compatible accessories. The device functions as a traditional cystoscope, providing optical access to the urinary tract to assist in clinical decision-making and patient treatment.

Clinical Evidence

No clinical data provided; bench testing and sterilization validation were utilized to support the submission.

Technological Characteristics

Reusable cystoscope; rigid or flexible form factor (implied by model series); intended for lower urinary tract visualization; requires manual cleaning, disinfection, and sterilization per provided protocols.

Indications for Use

Indicated for examination of the lower urinary tract and performance of diagnostic and therapeutic procedures using accessories in patients requiring cystoscopy.

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

SEP 3 0 1998

Mr. Wayne B. Sterner MediVision Scope Service Center, Inc. 1440 South State College Blvd. Suite ID Anaheim, CA 92806

Re: K982620

MediVision Cystoscopes, Models MV400, MV415, MV430 and MV470 Dated: July 27, 1998 Received: July 27, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FAJ

Dear Mr. Sterner:

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 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 Ouality System Regulation (OS) 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 submission does not affect any obligation you might have under sections 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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/dsmaldsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

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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510(k) Number (if known): K982620
Device Name: METO, VISION Cystoscope

Indications For Use:

## MEDIVISION CYSTOSCOPE MV400/MV415/MV430/MV470

INDICATIONS for USE

Indications for use for the MediVision Cystoscope are as follows:

MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. This device is marketed as a reusable device; methods for cleaning, disinfecting, and sterilization are included in latter sections of this submission under Section 5, STERILIZATION INFORMATION .

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harish A. Seymore
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 982620 510(k) Number .

Prescription Use_ (Per 21 CFR 801. 109) SEP-28-1998 05:54

OR

Over-The-Counter Use_

301 594 2339

(Optional Format 1-2-96)

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