PR3 ULTRASOUND SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human profiles or a bird-like shape, which is the department's official emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 0 2000 Carroll L. Turner, Ph.D. President Carolina Medical 157 Industrial Drive King, North Carolina 27021-0307 Re: K993978 Trade Name: PR3 Ultrasound System Regulatory Class: II 21CFR892.1560/Procode: 90 TYO 21CFR892.1570/Procode: 90 ITX Dated: November 18, 1999 Received: November 24, 1999 Dear Dr. Turner: We have reviewed your Section 510/k) notification of intent to market the device 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. This determination of substantial equivalence applies to the following transducers intended for use with the PR3 Ultrasound System, as described in your premarket notification: Transducer Model Number 6.5 R11 Endocavity Probe 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 Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the investigational device {1}------------------------------------------------ Page -2- Dr. Turner been marketed for these uses in interce prior to May 28, 1976, or reclassified into class 1 (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use. This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your 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 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) 594-4591. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". If you have any questions regarding the content of this letter, please contact Paul M. Gammell, Ph.D. at (301) 594-1212. Sincerely yours, David A. Syverson Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {2}------------------------------------------------ Appendix F ## Ultrasound System PR3 Diagnostic Ultrasound Indications for Use Form い K993978 Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------| | Clinical Application | A | B | M | PWD | CWO | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | N | N | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: PLEASE OO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PA Concurrence of CDRH, Office of Device Eyaltuation (ODE) David C. Tyson (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) F-3 Page 4.3-2 {3}------------------------------------------------ Appendix F ## Probe: Endocavity 6.5R11 Diagnostic Ultrasound Indications for Use Form ・・ K993978 ## Fill out one form for each ultrasound system and each transducer. Intenced Use: Ciagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intracoerative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | N | N | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: (PLEASE DO NOT WRITE BELOW THIS UNE - CONTINUE ON ANOTHER PAGE IS Concurrence of CDRH, Office of Device Exaluation (ODE) David A. Seymore (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) F-3 Page 4.3-2