SHAH PERMAVENT

{0}------------------------------------------------ K974007 Image /page/0/Picture/2 description: The image contains two logos. The logo on the left is a seal that says "Quality Assured Firm ISO 9001." The logo on the right has a crown on top of a check mark inside of a square. There is some illegible text below the check mark. Image /page/0/Picture/3 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 the top line and "Plastics" on the bottom line. The text is in a bold, sans-serif font. * ﺃﺷﺨﺎ ﻧﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ Your Ref: Our Ref: MB/PAS/A.8756100 Contact: Margaret Blackmore 14 October 1997 ## 510K Pre-Market Notification Summary Trade Name: Common Name: Classification Name: Predicate Devices: Description of Device: Intended Use: Comparison with Predicate Devices: Shah Permavent Permavent Tympanostomy Tube Richards Shah Perma-vent Tube, Cat. No. 24-0012 54-0002 24-0026 Richards Per-Lee Drain Tube, Cat. No. 24-0026 Xomed-Treace Per-Lee Vent Tube, Cat. No. 10-25025 A middle ear ventilation tube, fabricated in silicone rubber and featuring a single, circular, bevelled flange. The device is intended to ventilate the middle ear cleft. The Richards Shah Permavent Ventilation Tube has very similar form, except for the mesh a reinforcement of the flange. Its fit and function are exactly similar. The Richards, Per-Lee drain tube has an exactly similar fit and function. The form is very similar but is larger overall. The Xomed-Treace, Per-Lee vent tube is exactly similar in all respects to the Richards version. noor Plastics Ltd., Lisieux Way, Taunton, TA1 2LB, U.K. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal features the words "OF HEALTH & HUMAN SERVICES - USA" arranged in a semi-circle around a stylized eagle-like symbol. The symbol consists of three curved lines that resemble the wings of a bird, with a wavy line below them. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Re: Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC I 2 1997 Margaret Blackmore Regulatory Affairs Exmoor Plastics Ltd. Lisieux Way Tauton, TA1 2LB, U.K. 1974007 K973273 Exmoor Shah Permavent Tympanostomy Tube Dated: October 14, 1997 Received: October 21, 1997 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD Dear Ms. Blackmore: We have reviewed your Section 5100k) 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, which 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Pederal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 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 predication 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 vite diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions 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. 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 {2}------------------------------------------------ A STATE STATE FOR FORMATION FOR 510(k) Number (if known): كاك14 6974 ك Device Name:_ SHAH PERMAVENT Indications for Use: In the treatment of: - otitis media with effusion (glue ear) 1. - eustachian tube dysfunction 2. - other condition requiring ventilation of the middle 3. ear cleft, e.g. retraction pockets in the tympanic membrane, adhesive otitis media, where long-term ventilation is indicated. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David le. Seymm Division Sign-Off) sion of Reproductive, Abdominal 510(k) Number R911807 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)/