CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK

K093389 · Computerized Screening, Inc. · DXN · Nov 17, 2009 · Cardiovascular

Device Facts

• Record ID: K093389
• Device Name: CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
• Applicant: Computerized Screening, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.

Device Story

Kiosk-based system for public use in retail/pharmacy settings; provides unsupervised measurement of blood pressure, pulse, and weight. User inserts arm into cuff mechanism; initiates measurement via push-button interface. Device utilizes oscillometric method to measure systolic/diastolic blood pressure and heart rate; includes weight measurement functionality. Emergency cuff deflation button provided. Output displayed on front-mounted screen for user review. Data intended for informational purposes; users advised to consult physician for diagnostic interpretation.

Clinical Evidence

Device subjected to clinical evaluation and bench testing. Meets AAMI/ANSI SP10:2002 standards for blood pressure measurement accuracy, as well as IEC 60601-1 (safety), IEC 60601-2-30 (particular safety requirements), and IEC 60601-1-2 (electromagnetic compatibility).

Technological Characteristics

Oscillometric blood pressure measurement via inflatable arm cuff. Push-button user interface for test initiation, weight measurement, and emergency deflation. Digital display for systolic/diastolic pressure, heart rate, and weight. Complies with AAMI/ANSI SP10:2002, IEC 60601-1, IEC 60601-2-30, and IEC 60601-1-2.

Indications for Use

Indicated for use by the general public for the measurement of blood pressure, pulse, and weight. Not intended as a diagnostic device.

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.

Predicate Devices

• PharmaSmart, Model PS-1000/PS-1500/PS-2000 (K063137)
• HealthGuard International, Lifeclinic 2400 (K040562)

Submission Summary (Full Text)

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# 510(k) Summary

(per 21 CFR 807.92)

I. Applicant NOV 1 7 2009

(093389 \$1/2

Computerized Screening, Inc. 9550 Gateway Drive Reno, NV 89521 USA

Contact:

Sam Kumar Vice President of Manufacturing Operations Tel: [phone] Fax: [phone] Email: [e-mail]

#### II. Device Name

Trade Name: CSI Model 5K Managed Health System Kiosk Common Name: Automated noninvasive blood pressure monitor Classification Name: Noninvasive blood pressure measurement system

Classification Number: 870.1130 Product Code: DXN Classification: Class II

#### III. Predicate Devices

K063137: PharmaSmart, Model PS-1000/PS-1500/PS-2000 K040562: HealthGuard International, Lifeclinic 2400

#### IV. Intended use of the Device

The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.

#### V. Description of the Device

The CSI Model 5K Managed Health System Kiosk provides an unsupervised means for measuring and tracking an individual's blood pressure (both systolic and diastolic) and pulse rate. The kiosk can typically be installed in retail establishments and drug stores and may or may not be part of the pharmacy.

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The device has push buttons for user interface. Such buttons include "Start" button to start the test after the user has inserted the arm into the cuff mechanism, a "Release" button to deflate the cuff mechanism in the event of an emergency, a "Weight" button to start the process of measuring the weight of the user. The output of the machine includes displays to indicate the blood pressure (systolic and diastolic), heart rate and weight.

To start the process, the user inserts her arm into the cuff and The machine then proceeds to inflate the cuff and pushes a button. measure the blood pressure using oscillometric method. Once measured, the blood pressure (both systolic and diastolic) and the heart rate are output to the display mounted on the front of the device.

#### VI. Technical Characteristics

The CSI Model 5K Managed Health System Kiosk measures systolic and diastolic arterial blood pressure using an inflatable cuff mechanism that is placed around the user's arm. The cuff is then inflated before it is gradually deflated through a series of controlled deflation steps (oscillometric method).

#### VI. Testing

CSI Model 5K Managed Health System Kiosk has been subjected to clinical evaluation and bench testing and meets the requirements of The device also meets the IEC 60601-1 AAMI/ANSI SP10:2002. standard for Medical Electrical Equipment - General requirements for safety and 60601-2-30 standard for Medical Electrical Equipment Part 2 Particular Requirements for Safety and 60601-1-2 General Requirements for Safety, Electromagnetic Compatibility,

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Computerized Screening, Inc. c/o Mr. Morten Christensen Staff Engineer, Reviewer Underwriters Laboratories, Inc. 455 E. Trimble Road, San Jose, CA 95131

NOV 1 7 2009

Re: K093389

Trade/Device Name: CSI Model 5K Managed Health System Kiosk Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 10, 2009 Received: October 30, 2009

Dear Mr. Christensen:

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 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. Morten Christensen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W. M. P.

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):

Device Name: _CSI Model 5K Managed Health System Kiosk

Indications for Use:

The CSI Model 5K Managed Health System Kiosk is intended for use by the general public to measure blood pressure, pulse and weight. It is not intended to be a diagnostic device; it only provides data on blood pressure, heart rate and weight and users are advised to consult a physician.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.S.A.

Division Sian-Off) Division of Cardiovascular Devices

5.10(k) Number K093282

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