OAC (OPTICAL ASPIRATING CURETTE)

{0}------------------------------------------------ K980096 Pi92 1 1898 MAY ## 510(k) Summary Imagyn Medical Technologies , Inc. Optical Aspirating Curette (OAC) General Information on Submitter: I. > Imagyn Medical Technologies, Inc. Name: 5 Civic Plaza, Suite 100 Address: Newport Beach, CA 92660 (714) 362-2500 Phone: (714) 362-2520 Fax: Ronald H. Bergeson Name of Contact Person: January 8, 1998 Date Summary Prepared: General Information on Device II. > Name: Optical Aspirating Curette Classification Name: Obstetric-gynecologic general manual instrument, uterine curette (curette portion of device), 21 C.F.R. § 884.1175 Hysteroscope and accessories (hysteroscope portion of device), 21 C.F.R. §884.1690 III. Predicate Devices: The flexible fiberoptic hysteroscope component is similar to the MicroSpan Hysteroscope (510(k) No. K961688). The disposable curette component is similar to the Milex "Tis-U-Trap" Uterine Suction Curette, Milex, (510(k) No. K760264); and the Pipelle "Endometrial Suction Curette", (510(k) No. K881456). Description of the Device: IV. Imagyn's Optical Aspirating Curette consists of a disposable aspirating curette intended to remove tissue from the uterus and from the mucosal lining of the uterus by scraping and aspirating. The curette has a multi-lumen design that accommodates the introduction of Imagyn's reusable fiberoptic hysteroscope, which allows for visualization of the uterine cavity during the curettage procedure. V. Intended Use: The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation. VI. Technological Characteristics of Device Compared to Predicate Device: Optical Aspirating Curette (OAC) Imagyn Medical Technologies, Inc. 01/07/98 {1}------------------------------------------------ The OAC uses the same type of curette as the Milex “Tis-U-Trap” curette device, and the same type hysteroscope as the Imagyn “MicroSpan” Hysteroscope device. Optical Aspirating Curette (OAC) Imagyn Medical Technologies, Inc. 01/08/98 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a black and white logo. The logo appears to be a stylized representation of an eagle or bird, with three distinct, curved lines forming the head and wings. The logo is partially obscured on the left side, with some text visible, possibly indicating the name of an organization or department. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY --1688 Mr. Ronald H. Bergeson Corporate Director, Regulatory Affairs IMAGYN Medical Technologies, Inc. 27651 La Paz Road Laguna Niguel, CA 92677 Re: K980096 Optical Aspirating Curette Dated: March 13, 1998 Received: March 16, 1998 Regulatory Class: II 21 CFR §884.4530/Procode: 85 HCY 21 CFR \$884.1690/Procode: 85 HIH Dear Mr. Bergeson: 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 probibitions 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 equivalient 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/cdrh/dsmaddsmam.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 {3}------------------------------------------------ ## INDICATION FOR USE FORM | | | Page | 1 | of | 1 | |----------------------------|----------------------------|------|---|----|---| | 510 (k) Number (if known): | K980096 | | | | | | Device Name: | Optical Aspirating Curette | | | | | Indications for Use: : 《 The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert R. Sattler/ (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K980096 Prescription Use (Per 21 CFR 801.1091 OR Over-The-Counter Use (Optional Format 1-2-96) Optical Aspirating Curette (OAC) Imagyn Medical Technologies, Inc. 01/08/98