POC ENT ENDOSCOPE - SINUSCOPE

{0}------------------------------------------------ Section 7 K483123 #### 2 2 1998 510(k) SUMMARY ## SUBMITTERS INFORMATION Name and Address Precision Optics Corporation 22 E. Broadway Gardner, MA 01440 Telephone 978.630.1800 Contact Person James A. Reilly, Quality Assurance Manager Date of Summary 26 June 1998 ## DEVICE NAME Proprietary Name: Common Name: Classification Name: ENT Endoscope - Sinuscope Sinuscope Sinuscope ## PREDICATE DEVICE IDENTIFICATION Predicate devices referenced include Precision Optics Corporation's endoscopes (Laparoscope and Arthroscope). ### SUBSTANTIAL EQUIVALENCE Precision Optics Corporation's ENT Endoscope is substantially equivalent to cited predicate Endoscope devices since the basic features, design, and primary functions are the same. Any minor differences in design and dimensions between the Precision Optics Corporation's ENT Endoscope - Sinuscope and the predicate devices raise no new issues of safety and effectiveness as these differences have no effect on the safety, performance and function of the ENT Endoscopes. This device will be identical with respect to external materials, construction, and fundamental operational principles to Precision Optics Corporation's current line of cleared Laparoscopes (K914084) and Arthroscopes (K945684) except for variations of tube diameter and insertion length. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is black and appears to be printed on a white background. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 5 1998 James A. Reilly Manager, Quality Assurance Precision Optics Corporation 22 East Broadway Gardner, MA 01240 Re: K983123 POC ENT Endoscope - Sinuscope Dated: June 30, 1998 Received: July 1, 1998 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB Dear Mr. Reilly: 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 II (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 (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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmaldsmamain.html". Sincerely yours, Kilian Yin Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE Intended Use: Precision Optics Corporation's ENT Endoscopes - Sinuscopes are indicated for use to Precision Optics Corporation 3 22 x 22.3 x 22.3 x 25.5 x 12.0 x 11.0 mination and visualization of these regions. Vinit C. Sejpm (Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices Provision of Reproductive, and Radiological Devices 510(k) Number . 4983123 **Prescription Use** (Per 21 CFR 801.109)