DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, bold line drawing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JAN 1 0 2002 Mr. Robert Duffy Director of Product Development Pulse Metric, Inc. 11777 Sorrento Valley Road San Diego, CA 92121 Re: K013478 Trade Name: DynaPulse 5200A Pathway Blood Pressure Monitor System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system. Regulatory Class: II (two) Product Code: DXN Dated: December 23, 2001 Received: January 2, 2002 Dear Mr. Duffy: 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. {1}------------------------------------------------ Page 2 - Mr. Robert Duffy 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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, Dak Tille Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DynaPulse 5200A Pathway Non-Invasive Blood Pressure Monitor - K013478 - response 12/23/01 ## Indications for Use Statement ## (U)ST-bod and Drug Administration Center for Devices and Radio Celler line 510(k) Number: K013478 Device Name: DynaPulse 5200A Pathway Non-Invasive Blood Pressure Monitor Indications for Use: The DynaPulse 5200A Pathway is indicated for trained medical professionals to operate on patients at clinical settings to collect and measure blood pressure and pulse rate information. In addition, the DynaPulse DPS200A Pathway is indicated for patients at home who are capable and willing to selfadministrate this device upon prescription of their healthcare provider. The DP5200A monitor must be connected to an IBM PC-compatible computer that is concurrently running DP5200A Pathway PC Software. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered. | Concurrence Of CDRH, Office of Device Evaluation (ODE) | |--------------------------------------------------------| |--------------------------------------------------------| | Prescription Use レ | | |----------------------|--| | (Per 21 CFR 801.109) | | OR Over-The-Counter-Use (Optional Format 1-2-96) ാവാടിനെ വ് 510(k) Number story Devicer Pulse Metric Confidential Page 3