RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)

{0}------------------------------------------------ # MAY 1 8 1998 Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108 ### 510 (k) Summary of 2 #### Submitter Name, Address, and Date of Submission. 1. Mr. James R. Whitney Group Requlatory Affairs Associate Willy Rüsch AG Group Tall Pines Park Jaffrey, New Hampshire 03452 (603) 532-7706 Telephone: (603) 532-8211 Facsimile: Same as above. Contact: - Name of the Device, Common, Proprietary (if known), and 2. Classification. Classification Name: Tube, Gastrointestinal and Accessories Common Name: Blakemore Tube Proprietary Name: Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile ### Identification of the legally marketed device to which the 3. submitter claims equivalence. The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is substantially equivalent to the Rüsch Ultra Blakemore Tube - 4 Lumen, sterile - K832672. #### 4 . Description of the Device. The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile consists of a radiopaque (BaSO2) soft red rubber tube which is rounded and sealed at the distal end and belled out to form a funnel at the proximal end. Four elongated eyes are cut in the tube between the distal end and the cuffs. Two SILKOLATEX™ cuffs are inflated via separate color identified {1}------------------------------------------------ funnels using any Luer syringe; pilot balloons are provided to indicate cuff inflation. A fourth lumen is provided for suctioning of saliva from just above the esophageal cuff. #### Intended Use of the Device. 5. The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is a single use, sterile, naso-gastric double balloon tube that can be passed nasally or orally into the stomach suitable for use in the management of bleeding esophageal varices. #### 6. Summary of Technological Characteristics. The Rusch Blakemore Tube - 4 Lumen (Minnesota Type), sterile, is manufactured of the same materials and by the same processes as the Rüsch Blakemore Tube - 3 Lumen, non sterile. The new 4 Lumen tube will have an additional lumen for suctioning saliva from just above the esophageal cuff and will be available sterile. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health. The letters "USA" are also visible above the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Re: K973892 Rusch Blakemore Tube - 4 Lumen (Minnesota Type) Dated: February 17, 1998 Received: February 18, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dear Mr. Whitney: MAY 1 8 1998 Mr. James R. Whitney RUSCH® International Tall Pines Park Jaffrey, NH 03452 Group Regulatory Affairs Associate 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 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 (OS) 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. this response to vour premarket notification submission does not affect any obligation you might have under sections 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 programs on the programs 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/odrb/dsmaldsmamain.html". Sincerely yours Lillian Yin, Ph.D. Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): __ K 973892_ Device Name: Indications for Use: . . The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is a single use, sterile, naso-gastric double balloon tube that can be passed nasally into the stomach suitable for use in the management of bleeding esophageal varices. ## PLEASE DO NOT WRITE BELOW THIS LINE (CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert R. Satting (Division Sign-Off Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number Prescription Use (Per 21 CFR 801.109) な OR Over-The-Counter Use