UFIT TEN-10

K122443 · Biosign Technologies, Inc. · DXN · Nov 20, 2012 · Cardiovascular

Device Facts

• Record ID: K122443
• Device Name: UFIT TEN-10
• Applicant: Biosign Technologies, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services is a non-invasive blood pressure measurement system intended to measure the systolic and diastolic blood pressure and pulse rate. It is intended for patient use at home and by healthcare professionals in their respective practice. The device is intended for use by adults 18 years or older. The cuff is to be used for wrist sizes from 13.5 cm to 23 cm (5.3 in to 9.1 in).

Device Story

Non-invasive wrist-worn blood pressure monitor; uses inflatable cuff and oscillometric pressure sensor technology. Device lacks onboard display; requires USB connection to PC and support software to function. Readings transmitted via internet to cloud servers for analysis; results returned to user via cloud interface for progress monitoring. Used by patients at home or healthcare professionals in practice. Enables remote data tracking and clinical monitoring of blood pressure trends.

Clinical Evidence

No clinical data provided. Device performance validated through bench testing against ANSI/AAMI SP10:2002, IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Oscillometric measurement principle; pressure sensor technology. USB-connected peripheral; requires external PC and cloud-based software for operation. Cuff size 13.5-23 cm. Compliant with ANSI/AAMI SP10:2002, IEC 60601-1, and FCC Part 15 Subpart B.

Indications for Use

Indicated for adults 18+ years with wrist circumference 13.5-23 cm for non-invasive measurement of systolic/diastolic blood pressure and pulse rate. Intended for home and clinical use.

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

• iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock (K102939)
• Hosman USB Blood Pressure Monitor Model HM-100 (K103046)

Submission Summary (Full Text)

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K122443 pg 1 of 4

NOV 2 0 2012

# 510(k) Summary

# Submitter Information

Biosign Technologies, Inc. 100 Allstate Parkway, Suite 801 Markham ON L3R 6H3

| Contact Person: | Allison Scott, RAC |
|-----------------|-----------------------|
| | 317-569-9500 x106 |
| | [e-mail] |

Date:

August 10, 2012

Trade Name:

With Computer Controls and Web Services

UFIT® TEN-10 Automated Wrist Blood Pressure Monitor

Common Name: Noninvasive blood pressure measurement system

Classification Name(s): System, measurement, blood-pressure, non-invasive

Classification Number: 870.1130

## Predicate Device(s)

| 510(k) Number | Device Name | Submitter Name |
|---------------|------------------------------------------------------------------------|----------------------|
| K102939 | iHealth BP3 Fully Automatic Arm Cuff<br>Electronic Blood Pressure Dock | Andon Health Co |
| K103046 | Hosman USB Blood Pressure Monitor<br>Model HM-100 | Hosman International |

Biosign Technologies, Inc.

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K12 2443
PG 2084

510(k) Summary UFIT* TEN-10 Biosign Technologies, Inc.

## Device Description

UFIT® TEN-10 "Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services" is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-23cm.

UFIT® TEN-10 "Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services" is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric method and pressure sensor technology. It calculates the systolic and diastolic blood pressure. UFIT® TEN-10 "Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services" achieves its function by connecting the device to a Personal Computer via USB connection. Furthermore the device does not contain an LCD or other display components, so it is necessary for the device to connect to a Personal Computer containing a support software to constitute a complete blood pressure measurement system.

When a reading is taken by the device through the software, it is sent through the Internet to servers that perform the analysis of the reading and the result is returned through the Internet to the end user - all by means of Cloud Computing. This provides secure accounts for the users to submit their data so that they can monitor their results and progress.

#### Intended Use(s)

The UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services is a non-invasive blood pressure measurement system intended to measure the systolic and diastolic blood pressure and pulse rate. It is intended for patient use at home and by healthcare professionals in their respective practice.

The device is intended for use by adults 18 years or older. The cuff is to be used for wrist sizes from 13.5 cm to 23 cm (5.3 in to 9.1 in).

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K122443 pg 30p4

510(k) Summary UFFT TEN-10 Biosign Technologies, Inc.

#### Technological Characteristics

The UFIT® TEN-10 and the Hosman HM-100 have the same indications for use statement, are both used on the wrist, are connected to and powered by the USB port of a PC. The UFIT® TEN-10 and the iHealth BP3 are both intended for home and health professional use. The UFIT® TEN-10, Hosman HM-100, and iHealth BP3 all have an external display of either a PC (UFIT® TEN-10 and Hosman) or an Apple device (iHealth) and the blood pressure monitor depends on that external device to function, in that the blood pressure monitor has no function unless it is connected to the external device. Therefore, the UFIT® TEN-10 is substantially equivalent to the Hosman HM-100 and iHealth BP3.

#### Non-Clinical Performance Data

Non-clinical Tests have been done as follows:

Compliance to IEC 60601-1-2 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (Second Edition. 2001)

In the configuration tested, the EUT (UFIT® TEN-10) complied with the requirements of: EN 60601-1-2:2001, ICES-001 Issue 4 June 2006 and FCC 47 CFR Part 15, Subpart B - Verification

Following IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995), a representative sample of the UFIT® TEN-10 system was subjected to the test requirements of IEC 60601-1:1988, CAN/CSA C22.2 No.601.1-M90 and UL 60601-1:2003 which were conducted and witnessed at Global Advantage by CSA Certifier Mr. Peter Wong with satisfactory results.

The UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services meets all safety and performance requirements of ANSI/AAMI SP10:2002 as an automated sphygmomanometer

. . . . . . . . . . . . . . . . . . . .

## Clinical Performançe Data

AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.

AAMI / ANSI SP10:2002/A1:2003, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

AAMI / ANSI SP10:2002/A2:2006, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

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K122443
pg 4 of 4

510(k) Summary UFIT* TEN-10 Biosign Technologies, Inc.

UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services tests in accordance with ANSI/AAMI SP10, and the device meets all applicable requirements of the standard.

## Non-Clinical and Clinical Performance Data Conclusions

The conclusions drawn from the tests demonstrate that UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services conforms to the standards listed above, with regards to safety, effectiveness, and performance. Substantial Equivalence is met with our predicate devices, as they too conform to these standards with regards to safety, effectiveness, and performance.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

**NOV** 20 2012

Biosign Technologies, Inc c/o Allison Scott Anson Group, LLC (USA) 9001 Wesleyan Road, suite 200 Indianapolis, IN 46268

Re: K122443

Trade Name: UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Control and Web Services Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN Dated: October 19, 2012 Received: October 26, 2012

Dear Ms. Scott:

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. Iisting 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

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Page 2 - Ms. Allison Scott

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.

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/ucm 1 15809.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,

Owen P Faris -S

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: Pending

Device Name: UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services –

Indications For Use:

The UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services is a non-invasive blood pressure measurement system intended to measure the systolic and diastolic blood pressure and pulse rate. It is intended for patient use at home and by healthcare professionals in their respective practice.

The device is intended for use by adults 18 years or older. The cuff is to be used for wrist sizes from 13.5 cm to 23 cm (5.3 in to 9.1 in).

> AND/OR Over-The-Counter Use _ Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

Owen P. Faris -S
2012.11.20
11:23:06 -05'00'

Biosign Technologies, Inc.

UFIT® TEN-10 510(K)

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