BLIP MODEL BP-700WF

K123020 · Carematix, Inc. · DXN · Nov 28, 2012 · Cardiovascular

Device Facts

• Record ID: K123020
• Device Name: BLIP MODEL BP-700WF
• Applicant: Carematix, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 28, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type. The device can transmit the readings through wireless communication for record archiving and review.

Device Story

BP-700WF is an automated, non-invasive oscillometric blood pressure monitor for home use. Device measures systolic/diastolic blood pressure and pulse rate via an upper arm cuff (9-13 inch circumference). Operation involves inflation/deflation of cuff around the arm; internal sensors detect pressure oscillations to calculate BP and pulse. Readings are displayed on the device and transmitted via wireless communication to external systems for record archiving and clinical review. Intended for patient self-use to monitor cardiovascular health; data allows patients and healthcare providers to track blood pressure trends over time.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to predicate technology.

Technological Characteristics

Non-invasive oscillometric blood pressure monitor. Upper arm cuff (9-13 inch circumference). Wireless communication module for data transmission. Powered by internal battery/power source. Class II device (Product Codes: DXN, DRG).

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in adults over age 18. For home use. Cuff circumference limited to 9-13 inches.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NOV 2 8 2012

Carematix Inc. c/o Mr. Sukhwant Khanuja 209 W. Jackson Blvd, Suite 800 Chicago, IL 60606

Re: K123020

Trade/Device Name: Blip model bp-700wf Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN, DRG Dated: October 31, 2012 Received: November 1, 2012

## Dear Mr. Khanuja:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Sukhwant Khanuja

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/Resourcesfor You/Industry/default.htm.

> Sincerely yours r

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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Special 510(k) Notification

Indications for Use

510(k) Number_ K123020

Device Name: BP-700WF

## Indications for Use:

BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type.

The device can transmit the readings through wireless communication for record archiving and review.

Prescription Use (21 CFR 801 Subpart D) and/or

Over-the-counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

vision Sign-Off) Mision Sign-Om)
vision of Cardiovascular Devices

510(k) Number K123020

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Carematix Inc.