EXMOOR SUCTION CLEARANCE KIT

{0}------------------------------------------------ K990366 Image /page/0/Picture/1 description: The image shows a dark background with some text. The text at the top appears to say "Attachment 1". The text at the bottom appears to say "DMR/LAL". The text is white and is in a sans-serif font. Image /page/0/Picture/2 description: The image contains two logos. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top and "ISO 9001" in the center. Below the text is a check mark and the letters "SGS". The logo on the right has a crown at the top and a V-shaped symbol below it. Underneath the V-shaped symbol is the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES". Image /page/0/Picture/3 description: The image shows the logo for Exmoor Plastics. The logo includes a drawing of a deer head with antlers, and the text "Exmoor Plastics" is written to the right of the deer head. Above the deer head, there is a handwritten date of 3/5/99. Your Ref: MB/PAS Contact: Margaret Blackmore Our Ref: 28 January 1999 Date: Reference: DMR/1/1/64 ## SUMMARY OF SAFETY AND EFFECTIVENESS | Trade Name: | Exmoor Suction Clearance Kit | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Ear Suction Clearance Kit | | Classification Name: | Surgical Instrument Kit, Disposable 79 KDD | | Predicate Devices: | Richards Ear Examkit, Exmoor Tympanocentesis Kit<br>(510K 973587), Exmoor Myringotomy Kit (510K<br>980828) | | Description of Device: | Comprehensive, single use, sterile procedure pack<br>comprising: 18 swg fine end<br>14 swg suction tube<br>Cotton wool mop<br>Wax curette | | Intended Use: | This device is intended to clean the external ear<br>canal and tympanum. | | Comparison with Predicate<br>Devices: | The component parts of this kit are present in both<br>the Exmoor Tympanocentesis Kit (510K 973587)<br>and the Exmoor Myringotomy Kit (510K 980828).<br>The Richards Ear Examkit is manufactured from<br>very similar stainless steel and plastic, the main<br>difference being the inclusion of aural specula in the<br>Richards kit. Exmoor considered these | outpatients departments. unnecessary, as they are standard equipment in {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 5 1999 Margaret Blackmore Regulatory Affairs Exmoor Plastic Ltd. Lisieux Way, Taunton, TA12LB,U.K.-United Kingdom Re: K990366 Exmoor Suction Clearance Kit Regulatory Class: II/21 CFR 874.4420 Product Code: 77 LRC Dated: January 29, 1999 Received: February 5, 1999 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 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. However, you are responsible to determine that the medical devices you use as components in the kit have 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 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 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. . {2}------------------------------------------------ ## Page 2 -- Margaret Blackmore 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/dsma/dsmamain.html". be the country of the county of the a proved for are and super . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sincerely yours, M David W. Seymon 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 idiological Heal {3}------------------------------------------------ 510(k) Number (if known): 190364 EXMOOR SUCTION CLEARANCE KIT Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications for Use: : 【 The need to clear and clean the external ear canal. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Third G. Seegm (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K990366 Prescription Use √ (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)