HEMOSONIC 200HEMODYNAMIC MONITOR

{0}------------------------------------------------ K040802 ์ APR 2 8 2004 | 510(k) Summary | | |------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA | | Contact person: | William G. McLain<br>Manager, Regulatory Affairs<br>Phone: 610-378-0131, ext. 3323<br>Fax: 610-478-3188<br>Email: bill.mclain@arrowintl.com | | Date summary prepared: | March 26, 2004 | | Device trade name: | Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor. | | Device common name: | Sheath, Jacket or Sheath Jacket. | | Device classification<br>name: | FED; 21 CFR Part 876.1500; Sheath, for Endoscope | | Legally marketed<br>devices to which the<br>device is substantially<br>equivalent: | The predicate device is the jacket used in Arrow International, the<br>HemoSonic™ 200 Hemodynamic Monitor cleared under K031153. | | Description of the<br>device: | The probe jacket contains the acoustic gel into which the ultrasound<br>crystals are placed. It consists of a plug rod, tip cap, hub, body,<br>acoustic gel and tip. | | Intended use of the<br>device: | The probe jacket is an accessory to the HemoSonic™ 200<br>Hemodynamic Monitor. | | Technological<br>characteristics: | The proposed device has the same technological characteristics as<br>the predicate device(s). | | Performance tests: | Tests were performed to demonstrate substantial equivalence in the<br>following areas:<br>• tensile strength,<br>• acoustic properties,<br>• simulated insertion, and<br>• biocompatibility. | | Conclusions: | The results of the laboratory tests demonstrate that the device is as<br>safe and effective as the legally marketed predicate devices. | . {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an image of a stylized bird with three wing segments and a tail. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 8 2004 Arrow International, Inc. c/o Mr. William G. McLain Manager, Regulatory Affairs 2400 Bernville Road Reading, PA 19605 Re: K040802 HemoSonic™M 200 Hemodynamic Monitor Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: ' DPN Dated: March 26, 2004 Received: March 29, 2004 Dear Mr. McLain: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. William G. McLain Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Sincerely yours, Donna R. Vicinel A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ¥ 04 0 80 2 Device Name: HemoSonic™ 200 Hemodynamic Monitor Indications For Use: The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability. Prescription Use _X AND/OR Over-The-Counter Use . . . . . . . . (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dona R. La due (Division Sign-Off) Division of Cardiovascular Devices **510(k) Number** k040802