ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES

K993103 · Richard Wolf Medical Instruments Corp. · GCM · Dec 10, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993103
• Device Name: ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GCM · Gastroenterology, Urology
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The endoscopes serve to visualize the inside of the patient via natural or surgically generated access.

Device Story

Rigid endoscopes (10mm diameter; 0°, 30°, 50° models) provide visualization of internal body cavities via natural or surgical access. Operated by trained physicians in clinical/surgical settings. Device connects to external light sources, flexible light cables, video/reflex cameras, and objective lenses. Used in conjunction with endoscopic accessories (trocar sleeves, forceps, electrodes) to facilitate diagnostic or therapeutic procedures. Provides optical visualization to assist clinical decision-making and procedural guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscope, 10mm diameter. Optical visualization system. Compatible with external light sources, cameras, and endoscopic accessories. Non-powered optical device.

Indications for Use

Indicated for examination, diagnosis, and/or therapy by trained and qualified personnel in medical disciplines including surgery, urology, gynecology, and ENT. No specific contraindications known; physician to determine appropriateness based on patient condition.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JUL 2 7 2015

RICHARD WOLF Medical Instruments Corporation Mr. Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, IL 60061

Re: K993103

Trade/Device Name: Rigid Endoscopes, 10mm diameter, Models 8934.431, 0°, 8934.432, 30°, and 8934.433, 50° Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCM, GCJ Dated (Date on orig SE ltr): September 10, 1999 Received (Date on orig SE ltr): September 16, 1999

Dear Mr. Casarsa,

This letter corrects our substantially equivalent letter of December 10, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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found in the Code of Federal 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 that FDA has made a determination 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K993103 |
|---------------------------|---------|
|---------------------------|---------|

Endoscopes Device Name:_

#### Intended Use:

The endoscopes serve to visualize the inside of the patient via natural or surgically generated access.

### Indications and Application:

For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as surgery, urology, gynecology, and ENT.

## Contraindications:

Contraindications directly related to the product are currently unknown.

The attending physician must determine if the intended application is appropriate based on the general condition of the patient.

For further instructions, please refer to the current technical literature.

#### Combinations:

The endoscopes are used in connection with light sources and flexible light cables, video cameras, or reflex cameras and objective lenses, as well as accessories for endoscopic use, e.g. trocar sleeves, forceps, electrodes.

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

in

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Dey 510(k) Number

Prescription Use
Per 21 CFR 801.109

Over-The Counter.

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