HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES

K081159 · Harvard Medical Devices , Ltd. · DXN · Aug 8, 2008 · Cardiovascular

Device Facts

• Record ID: K081159
• Device Name: HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
• Applicant: Harvard Medical Devices , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Kinetik BPM1 Series is for use at home and is a non-invasive blood pressurement system intended to measure the diastolic and systelle blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

Device Story

Non-invasive blood pressure monitor for home use; measures systolic/diastolic blood pressure and pulse rate. Operates via inflatable cuff wrapped around upper arm. Device processes pressure oscillations to determine hemodynamic parameters. Output displayed on integrated screen for patient review. Intended for adult population; supports self-monitoring of blood pressure.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Non-invasive blood pressure measurement system; inflatable cuff mechanism; electronic display; intended for home use; Class II device (Product Code DXN).

Indications for Use

Indicated for adult individuals for home use to measure diastolic and systolic blood pressure and pulse rate via non-invasive upper arm cuff.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2008

Harvard Medical Devices LTd. c/o Mr. Paul Aylett General Manager 1310 Floor, Railway Plaza 39 Chatham Road South Tsimshatsui, Kowloon Hong Kong

Re: K081159

Trade/Device Name: Kinetik BPM1 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 29, 2008 Received: August 1, 2008

Dear Mr. Paul Aylett:

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.

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Page 2 - Mr. Paul Aylett

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

K081159

Kinetik BPM1 Series Device Name:

Kinetik BPM1 Series is for use at home and is a non-Indications For Use: invasive blood pressurement system intended to measure the diastolic and systelle blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use YES (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED)

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