COOK TEST TUBE HEATER

{0}------------------------------------------------ #### K983609 9 · 510(K) SUMMARY Submitted By: Brenda Davis Regulatory Affairs COOK OB/GYN™ 1100 West Morgan Street Spencer. Indiana, 47460. October 13, 1998 # Names of Device: COOK Test Tube Heater Trade Name: Common/Usual Name: IVF Test Tube Heater Assisted reproduction accessory - Collection tube Proposed Classification Name: warmer 21 CFR §884.6120 Predicate Device: 63 FR 48428. September 10, 1998 # Device Description: The COOK Test Tube Heater is an electronically controlled heating unit that holds collection test tubes and their contents during oocyte recovery. The unit is designed to accept up to six Falcon® 2001 Series 10 mL test tubes. ## Intended Use: The COOK Test Tube Heater is intended to be used to maintain the temperature of egg (oocvte) collection tubes at or near body temperature. ## Substantial Equivalence: The COOK Test Tube Heater is comparable with respect to intended use to the FDA published predicate device description and meets the requirements for 510(k) substantial equivalence. ## Discussion of Tests and Test Results: The COOK Test Tube Heater was subjected to testing to assure satisfactory operating performance. The COOK Test Tube Heater passed the requirements of all tests. # Conclusions Drawn from Tests: This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description. 7 {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract shapes that resemble human figures or birds in flight. The shapes are arranged in a diagonal line, with the top shape being the largest and the bottom shape being the smallest. DEC I 6 1998 Ms. Brenda Davis Regulatory Affairs Cook Ob/Gyn® 1100 West Morgan Street Spencer, IN 47460 Dear Ms. Davis: Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Re: K983609 Cook Test Tube Heater Dated: October 13, 1998 Received: October 14, 1998 Regulatory Class: II 21 CFR 884.6120/Procode: 85 MQG We have reviewed vour 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 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 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/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 {2}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________ COOK Test Tube Heater Indications For Use: The COOK Test Tube Heater is intended to be used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. The unit is designed to accept up to six Falcon® 2001 Series 10 mL test tubes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Segeen (Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological D 510(k) Number Prescription Use_ V (Per 21 CFR 801.109) Over-The-Counter Use___ (Optional Format 1-2-96)