LAPAROSCOPIC GASTROSTOMY KIT

{0}------------------------------------------------ ### APPENDIX VII | JAN 12 1998 | 510(k) SUMMARY | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------| | 510(k) NUMBER: | PENDING | | SUBMITTED BY: | Applied Medical Resources Corporation<br>26051 Merit Circle, Unit #103<br>Laguna Hills, California 92653<br>(714) 582-6120 EXT. 310 | | CONTACT PERSON: | Howard V. Rowe | | DATE OF PREPARATION: | October 3, 1997 | | NAME OF DEVICE: | Applied Medical Laparoscopic Gastrostomy Kit | | CLASSIFICATION NAME: | Gastrointestinal Tube and Accessories | | TRADE NAME: | Not determined at this time | ## SUMMARY STATEMENT: The Applied Medical Laparoscopic Gastrostomy Kit is indicated for use as a means of percutaneously inserting a feeding tube into the stomach through the abdominal wall. The Laparoscopic Gastrostomy Kit is disposable and designed to be used under laparoscopic visualization. The Kit includes (1 each): - Electrosurgical Obturator / Stylet . - . 26F Silicone Feeding Tube All testing demonstrates that the Applied Medical Laparoscopic Gastrostomy Kit is equivalent to the predicate devices and introduces no new safety and effectiveness issues when used as indicated. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 2 1998 Howard V. Rowe -----------Director of Regulatory Affairs Applied Medical Resources 26051 Merit Circle, #104 Laguna Hills, California 92653 Re: K973891 AMR Laparoscopic Gastrotomy Kit Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT 21 CFR 878.4400/procode: 78 GCT Dated: October 3, 1997 Received: October 14, 1997 Dear Mr. Rowe: 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions 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 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, 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 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. {2}------------------------------------------------ #### Page - 2 - Mr. Howard V. Rowe 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 the 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/dsmamain.html". Sincerely yours, Robert R. Suttingl 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}------------------------------------------------ K973891 #### APPENDIX IX # INDICATIONS FOR USE Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluations (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850 Applied Medical Resources is providing this separate cover page for the Applied Medical Laparoscopic Gastrostomy Kit "Indication for Use" as required. 510(k) Number: Not Assigned Applied Medical Laparoscopic Gastrostomy Kit. Device Name: The Laparoscopic Gastrostomy Kit is indicated for use as a means of Indications for Use: percutaneously inserting a feeding tube into the stomach through the abdominal wall. The Laparoscopic Gastrostomy Kit is disposable and designed to be used under laparoscopic visualization. | <strong>Labels</strong> | <strong>Values</strong> | |-------------------------|------------------------------| | Signature: | | | Title: | Director, Regulatory Affairs | | Date: | 10991 | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |--------------------------------------------------------------------|---------|--------------------------| | Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use | | (Division Sign-Off) | | (Optional Format 1-2-96) | | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | | 510(k) Number | K973891 | 75 |