MEDIFIX INC.

K992483 · Medifix, Inc. · FAJ · Aug 30, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992483
• Device Name: MEDIFIX INC.
• Applicant: Medifix, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Aug 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Operative and Diagnostic Cystoscopy for visual imaging and light transmission.

Device Story

Medifix Cystoscope is a medical endoscope used for visual imaging and light transmission during operative and diagnostic cystoscopy procedures. The device is operated by a physician in a clinical setting. It functions as a passive optical instrument, utilizing lens systems to transmit images and light to the clinician. The device is designed to provide visualization of the urinary tract to assist in clinical decision-making and diagnosis. It is manufactured using standard industry materials, including glues and epoxies common to endoscope production.

Clinical Evidence

Bench testing only. Prototypes underwent extensive mechanical and thermic stress testing to ensure safe and long-term use. No clinical data provided.

Technological Characteristics

Optical cystoscope utilizing lens-based imaging and light transmission. Materials include industry-standard glues and epoxies. Mechanical design consistent with traditional endoscope construction. No electronic or software components described.

Indications for Use

Indicated for patients requiring operative or diagnostic cystoscopy for visual imaging and light transmission.

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.

Predicate Devices

• R.Wolf Cystoscopes (pre-1976)

Submission Summary (Full Text)

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AUG 30 1999

Page 1 of 1

1992483

# 510(k) Statement (Section 807.93)

Application: Cystoscopes

### A. Summary of Safety and Effectiveness

We compared our Cystoscope prototypes in detail to much older equipment, manufactured by R.Wolf and other Manufacturers and we conclude that our Cystoscopes are as safe and effective as all other devices earlier and currently on the market. Our designs, lens-systems, materials, glues and epoxies are commonly used by the endoscope industry.

## B. Parts of finding Substantial Equivalence

We compared our manufacturing drawings with corresponding devices from R.Wolf. We found substantial equivalence in all significant details.

## C. Descriptive Information

We intend to manufacture our Cystoscopes under strict GMP Guidelines: From incoming material registration and testing to detailed manufacturing instructions and device master and history filing including complaint reporting.

## D. Performance Testing

Our Prototypes underwent extensive mechanical and thermic stress testing to asure safe and long term use.

## E. Adverse Health Effects

We are not able to determine any adverse health effects compared to the already marketed devices and can not imagine any possibility of this kind.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Mr. George Albulescu President Medifix, Inc. 8727 Narragansett Morton Grove, Ilinois 60053-0000 Re: K992483 Medifix Inc. Cystoscopes Dated: July 23, 1999. Received: July 26, 1999 Regulatory Class: II 21 CFR §876.1500/Procode: 78 FAJ

Dear Mr. Abulescu:

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 (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 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 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 requlatory 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 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), piease 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/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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510(k) Number (if Known): K992483

Page 1 of 1

Device Name: Cystoscope / MEDIFIX Inc.

Indications for Use:

Operative and Diagnostic Cystoscopy for visual imaging and light transmission.

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.1091

Øver-The-Counter Use (Optional Format 1-2-96)

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

OR