PFLEIDERER'S INTRATYMPANIC CATHETER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Exmoor Plastics. On the left side of the logo is a drawing of a deer head with large antlers. To the right of the deer head is the company name, with "Exmoor" on top of "Plastics." Our Ref: K974008 1974008 Image /page/0/Picture/3 description: The image contains two logos. The logo on the left is a circular logo with the text "QUALITY ASSURED FIRM ISO 9001" surrounding the letters "SGS" with a checkmark below. The logo on the right has a crown on top of a checkmark with the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES" below. MAY | 3 1998 Your Ref: | Contact: Margaret Blackmore | | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 14 April 1998 | | | SUMMARY OF SAFETY & EFFECTIVENESS | | | Trade Name: | Pfleiderer's Intratympanic Catheter | | Common Name: | Intratympanic Catheter | | Classification Name: | Catheter Eustachian, General and Plastic Surgery | | Predicate Devices: | Portex Remote Injection Catheter | | Description of Device: | This single use device consists of a silicone rubber catheter, 21cm in length, with a spring loaded Luer lock at one end and a soft rubber flange, to retain the device in the middle ear, at the other. | | Intended Use: | For use as a closed system for the repeated, safe delivery of therapeutic agents into the middle ear, to facilitate the control of disabling vertigo arising from active unilateral Meniere's Disease. | | Comparison with Predicate Devices: | The Portex Remote Injection Catheter is constructed of nylon tubing, with a Luer connector at one end and a Luer lock mount at the other similar.<br><br>The Exmoor Intratympanic Catheter is constructed of silicone tubing with a silicone bevelled flange at one end and a one-way Luer valve at the other.<br><br>The function is the same, in that they both deliver medication. The fit is similar, except that a silicone flange replaces the lock mount, making it possible for the doctor or patient to perform a relatively, pain-free, self-administration of his/her medication. | MB/PAS/K974008 Exmoor Plastics Ltd., Lisieux Way, Taunton, TA1 2LB, U.K. Co. Reg. No: 2075762 (Eng) {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is depicted in a simple, black-and-white design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 3 1998 Margaret Blackmore Regulatory Affairs Exmoor Plastics, Ltd. Lisieux Way Taunton, TA1 2LB U.K. Re: K974008 Pfleiderer's Intratympanic Catheter Dated: April 14, 1998 Received: April 17, 1998 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD Dear Ms. Blackmore: 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 (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 Fecteral 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/cdrl/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}------------------------------------------------ ## RAM/19/A/1 (1) B = Device Listing Number: A875609 510(k) Number (if known):___974008 Device Name: Pfleiderer's Intratympanic Catheter Indications for Use: Incapacitating unilateral Menière's Disease (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <table style="border: none;"><tr><td></td></tr><tr><td>(Division Sign-Off)</td></tr><tr><td>Division of Reproductive, Abdominal, ENT,</td></tr><tr><td>and Radiological Devices</td></tr></table> | | (Division Sign-Off) | Division of Reproductive, Abdominal, ENT, | and Radiological Devices | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------|-------------------------------------------|--------------------------| | | | | | | | | (Division Sign-Off) | | | | | | | Division of Reproductive, Abdominal, ENT, | | | | | | | and Radiological Devices | | | | | | | 510(k) Number | K974008 | | | | | | Prescription Use | <div> <span style="font-size: 2em;">✓</span> </div> | OR | Over-The-Counter Use _ | |----------------------|-----------------------------------------------------|----|------------------------| | (Per 21 CFR 801.109) | | | |