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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ANSI/AAMI SP10:2002)	Reported Device Performance (UFIT® TEN-10)
All applicable safety and performance requirements for an automated sphygmomanometer (as defined by ANSI/AAMI SP10:2002, and its amendments A1:2003 and A2:2006)	The UFIT® TEN-10 complies with and meets all applicable requirements of the standards.
Compliance to IEC 60601-1-2 (Electromagnetic Compatibility)	Complied with EN 60601-1-2:2001, ICES-001 Issue 4 June 2006, and FCC 47 CFR Part 15, Subpart B - Verification.
Compliance to IEC 60601-1 (General Requirements for Safety)	Successfully subjected to the test requirements of IEC 60601-1:1988, CAN/CSA C22.2 No.601.1-M90 and UL 60601-1:2003.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the number of subjects (sample size) used for the clinical tests that demonstrated compliance with ANSI/AAMI SP10. It only mentions that "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."
Data Provenance: Not explicitly stated. The document doesn't provide information on the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts used to establish ground truth or their qualifications. The clinical performance data references compliance with the ANSI/AAMI SP10 standard, which implies a standardized method for validation, usually involving a comparison to a reference standard (like a mercury sphygmomanometer) performed by trained observers. However, the details of these observers or their specific roles in establishing "ground truth" are not provided.

4. Adjudication Method:

Not explicitly stated. The document refers to compliance with ANSI/AAMI SP10, which outlines specific methodologies for validating blood pressure devices. These methodologies often involve simultaneous measurements by multiple observers (adjudication). However, the specific adjudication method (e.g., 2+1, 3+1) is not detailed in this summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance (Algorithm only without Human-in-the-loop performance):

Yes. The entire testing described in the "Non-Clinical Performance Data" and "Clinical Performance Data" sections, specifically compliance with ANSI/AAMI SP10, refers to the standalone performance of the UFIT® TEN-10 device in measuring blood pressure and pulse rate. The software merely processes and displays the data, and the web services provide storage and analysis, but the core measurement is performed by the device itself.

7. Type of Ground Truth Used:

Compliance with a recognized standard: The ground truth for validating the device's accuracy would have been established through a comparison to a referencestandard according to ANSI/AAMI SP10 protocols. This typically involves simultaneous measurements against a highly accurate, calibrated reference device (e.g., mercurysphygmomanometer) performed by trained observers.

8. Sample Size for the Training Set:

The document does not provide a sample size for a training set. This is because the device is a medical measurement device, not an AI/machine learning model that typically requires a separate training set. The performance is validated through clinical testing against a standard, not by training an algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm. The "ground truth" for the device's performance evaluation was established by adherence to the methodologies outlined in the ANSI/AAMI SP10:2002 standard and its amendments, as described in point 7.

Summary

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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
	ascott@ansongroup.com

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 CuffElectronic Blood Pressure Dock	Andon Health Co
K103046	Hosman USB Blood Pressure MonitorModel HM-100	Hosman International

Biosign Technologies, Inc.

Page 19 of 1236

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K12 2443
PG 2084

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

Device Description

Intended Use(s)

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 (800) 638-2041 or (301) 796-7100 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 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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Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).