KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR

K023356 · Card Guard Scientific Survival , Ltd. · DXQ · Jan 16, 2003 · Cardiovascular

Device Facts

• Record ID: K023356
• Device Name: KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Jan 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant

Device Story

KLOCK BP Monitor is a wrist-worn device for home health care; intended for adult self-use. Device utilizes oscillometric method to detect arterial blood movement in wrist; converts detected signals into digital systolic/diastolic blood pressure and pulse rate readings. Output displayed on device screen for user monitoring. Intended to assist users in tracking blood pressure trends at home; not for clinical diagnostic use in patients with circulatory disorders or pregnancy.

Clinical Evidence

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

Technological Characteristics

Wrist-worn oscillometric blood pressure monitor. Digital display. Operates via electronic sensing of arterial wall movement. Class II device (21 CFR 870.1120).

Indications for Use

Indicated for adult home use to monitor systolic/diastolic blood pressure and pulse rate. Contraindicated for pregnant individuals and those with circulatory conditions, including arrhythmia.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human figure with three arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2003

Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Regulatory Affairs, QA 2 Pekeris Street, P.O. Box 527 Rehovot 76100 Israel

Re: K023356

Trade Name: KLOCK BP Monitor Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: November 4, 2002 Received: November 6, 2002

Dear Mr. Gonorovsky:

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. Alex Gonorovsky

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 (OS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Келетим

ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Figure/0 description: The image shows the logo for Card Guard Scientific Survival LTD. The logo features the text "CARD GUARD" in bold, uppercase letters, with the trademark symbol next to the word "GUARD". Below the text is the phrase "Scientific Survival LTD." in a smaller font. To the right of the text is a stylized graphic resembling an electrocardiogram (ECG) waveform, with a sharp peak followed by a rounded curve and the letters "TM" indicating a trademark.

## Indications For Use KLOCK BP Monitor

023356

510(k) Number (if known):

The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use V

510(k) Numbe