PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA

K051565 · Proton Healthcare , Ltd. · DXN · Sep 12, 2005 · Cardiovascular

Device Facts

• Record ID: K051565
• Device Name: PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA
• Applicant: Proton Healthcare , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

All five models automatically measures human's Systolic, Diastolic blood pressure and pulse rate by using the oscillometric method. The measurement results are displayed in one LCD Panel. The intended use of Models PH168A, PH168E and PH168W is for age 16 and above. The intended use for the Models PHC888JA and PH888HA is for adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6").

Device Story

Digital blood pressure monitors (Models PH168A, PH168E, PH168W, PHC888JA, PH888HA) utilize oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Device inputs include pressure oscillations detected via cuff; internal processor calculates blood pressure values; output displayed on integrated LCD panel. Intended for over-the-counter use by patients for self-monitoring. Provides non-invasive hemodynamic data to assist users in tracking blood pressure trends.

Clinical Evidence

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

Technological Characteristics

Noninvasive oscillometric blood pressure measurement system. Digital display (LCD). Battery-powered. Models PHC888JA and PH888HA include specific cuff size constraints (24-32cm).

Indications for Use

Indicated for automatic measurement of systolic/diastolic blood pressure and pulse rate in humans. Models PH168A, PH168E, and PH168W indicated for individuals age 16 and older. Models PHC888JA and PH888HA indicated for adult patients with arm circumference 24-32cm.

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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SEP 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Proton Health Care Ltd. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight Inc. 13 Red Fox Lane Littleton, CO 80127

## Re: K051565

No1200
Trade Name: Proton Digital Blood Pressure Monitor Models PH168A, PH168W, ade Name: Trees and Proton Blood Pressure Monitor Model PHC888JA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 31, 2005 Received: September 1, 2005

Dear Mr. Walls:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, DNIg, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allo Cosmetic Act (Act) that do not require app to the general controls provisions of the Act. The I ou may, merciole, market the act include requirements for annual registration, listing of general controls provision 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 If your device is crassified (see above) this. Existing major regulations affecting your device can thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Coursements concerning your device in the Federal Register.

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Page 2 - Mr. Kevin Walls, RAC

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 [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 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,

Bismimar for

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): Kul S-15-6 ك

Device Names:

- 1. Proton Digital Blood Pressure Monitor, Model PH168A
- Proton Digital Blood Pressure Monitor, Model PH168E 2.
- Proton Digital Blood Pressure Monitor, Model PH168W က
- 4. Proton Blood Pressure Monitor, Model PHC888JA
- Proton Digital Blood Pressure Monitor, Model PH888HA 5.

Indications for Use:

All five models automatically measures human's Systolic, Diastolic blood pressure and All five models adtomatically measures haman's Cyclers, and out in one LCD Panel.

The intended use of Models PH168A, PH168E and PH168W is for age 16 and above.

The intended use for the Models PHC888JA and PH888HA is for adult patients whose The Interioed ass for the ween 24-32cm (approx. 8.7" to 12.6").

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Over-The-Counter Use _ × Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Hemmer

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

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