HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE

K131788 · Healthstats International Pte. , Ltd. · DXN · Mar 4, 2014 · Cardiovascular

Device Facts

• Record ID: K131788
• Device Name: HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE
• Applicant: Healthstats International Pte. , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The A-PULSE CASPal+ Monitor is a compact standalone monitor that combines two methods of blood pressure measurement: - Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and . - Radial arterial pulse acquisition via a wrist-mounted tonometer sensor. The A-PULSE CASPal+ Monitor first measures systolic and diastolic blood pressure and pulse rate using the oscillometric method, and then acquires the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively. The MC3100+ monitor measures systolic and diastolic blood pressure and pulse rate via the oscillometric method via a brachial cuff at the upper arm. The monitors have a non-volatile memory to store and recall measurements, and the ability to transfer measurement data via Bluetooth wireless communications to other suitably equipped electronic devices, such as a PC with HealthSTATS.my-BP PC software. my-BP PC software is used in conjunction with the HealthSTATS A-PULSE CASPal+ and MC3100+ Monitors to store and display blood pressure data obtained from the monitors. The A-PULSE CASPal+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPal+, have a palpable radial pulse. Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPal+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.

Device Story

A-PULSE CASPal+ and MC3100+ are non-invasive blood pressure monitors. CASPal+ uses brachial cuff (oscillometric) and wrist-mounted tonometer sensor (radial arterial pulse) to derive Central Aortic Systolic Pressure (CASP). MC3100+ uses only brachial cuff. Both devices feature Bluetooth for data transfer to my-BP PC software for storage and display. Operated by healthcare personnel in clinical settings. Output provides systolic/diastolic BP, pulse rate, and CASP (CASPal+ only) to assist in cardiovascular disease management and hypertension assessment. Benefits include non-invasive CASP estimation and digital data management.

Clinical Evidence

No new clinical data submitted. Clinical testing performed on the predicate A-PULSE CASPal device was determined to be applicable to the subject devices, as they are functionally and physically identical regarding measurement technology.

Technological Characteristics

Monitors utilize oscillometric brachial cuff and radial arterial tonometry (CASPal+). Bluetooth wireless connectivity. Embedded processing unit. Biocompatible materials for skin contact. Tested for electrical safety, EMC, environmental, and mechanical strength. Software-based data management via my-BP PC application.

Indications for Use

Indicated for patients 18 years and older requiring blood pressure and pulse rate monitoring. CASPal+ model requires a palpable radial pulse. Used by qualified healthcare personnel as an aid to diagnosis and treatment.

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

• HealthSTATS A-PULSE CASPal (K101002)
• A&D Medical UA767BT Blood pressure monitor (K040371)
• Omron Health Management Software (K061822)

Reference Devices

• BPCalibrator (K041546)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

- . HealthSTATS International Pte. Ltd. (a) Submitted bv: 6 New Industrial Road #04-01/02/03 Singapore 536199
Phone: [phone] Fax: [phone]

E-mail: [e-mail]

- Contact Person: Position/Title:
Dr. Choon Meng TING Chairman/CEO

May 31, 2013 Date of Preparation:

Trade Name:

HealthSTATS A-PULSE CASPal®+and MC3100TM+ Monitors and my-BP™ BP Management Application Software

74 DXN, 21 CFR § 870.1130

- Common/Classification Name: System, Measurement, Blood-pressure, Non-invasive
Product Code:

Class:

Class II

- (3) Predicate Device(s):
- HealthSTATS A-PULSE CASPal® , HealthSTATS K101002 International Pte Ltd.
- K040371 A&D Medical UA767BT Blood pressure monitor, A&D Engineering, Inc.
- Omron Health Management Software (accessory PC K061822 software to Omron HEM-780, Omron Healthcare Ltd.

Reason for Submission: New Device

- Description of Device: (4)
The HealthSTATS A-PULSE CASPal® and MC3100™ are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2)

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Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.

The CASPal®+ Monitor is comprised of four main elements:

- System embedded processing unit. �
- Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546], also cleared iin CASPal device K101002).
- . Wrist sensor module for acquistion of central aortic systolic pressure (CASP) via radial arterial tonometry at the wrist [cleared accessory and method K101002].
- Bluetooth® wireless communications module. .

The MC3100™* is a reduced feature set of the CASPal®* which only offers the oscillometric blood pressure measurement and not the CASP measurement, but is otherwise identical. my-BP™ PC software may be used with either device to store and display blood pressure and pulse rate measurements on a suitably equipped computer.

### Intended use: (5)

The A-PULSE CASPal® and MC3100™* Monitors are intended to measure systolic and diastolic blood pressure and pulse rate via the oscillometric method with cuff. The A-PULSE CASPal® utilizes a wrist sensor to obtain the radial pulse waveform to derive central aortic systolic pressure (CASP) and other waveform indices. Both monitors utilize Bluetooth wireless technology to transfer measurements to HealthSTATS my-BP™ PC Software or other suitable devices.

Cardiovascular disease remains among the leading causes of death worldwide. Hypertension assessment is one of the primary factors in the evaluation of cardiovascular disease. Assessment of CASP may improve the management of patients with elevated cardiovascular risk.

## Indications for Use:

The A-PULSE CASPal+ Monitor is a compact standalone monitor that combines two methods of blood pressure measurement:

- · Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and
- . Radial arterial pulse acquisition via a wrist-mounted tonometer sensor.

The A-PULSE CASPal+ Monitor first measures systolic and diastolic blood pressure and pulse rate using the oscillometric method, and then acquires the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.

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The MC3100+ monitor measures systolic and diastolic blood pressure and pulse rate via the oscillometric method via a brachial cuff at the upper arm.

The monitors have a non-volatile memory to store and recall measurements, and the ability to transfer measurement data via Bluetooth wireless communications to other suitably equipped electronic devices, such as a PC with HealthSTATS my-BP PC software.

my-BP PC software is used in conjunction with the HealthSTATS A-PULSE CASPal+ and MC3100+ Monitors to store and display blood pressure data obtained from the monitors.

The A-PULSE CASPal+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPal+, have a palpable radial pulse.

Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPal+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

### Technological Characteristics: (6)

Two monitors are offered in this 510(k), the A-PULSE CASPal®* Monitor and the MC3100™*:

- The A-PULSE CASPal®+ Monitor measures and displays blood . pressure readings with a pulse bar to display radial arterial pulsations. The device measures both oscillometric blood pressure via a brachial cuff and Central Aortic Systolic Pressure (CASP) via a wrist-mounted tonometer sensor. The A-PULSE CASPal®+ is substantially identical to the predicate A-PULSE CASPal monitor except that the CASPal®+ is capable of Bluetooth® wireless data transmission of measurements.
- . The MC3100™+ Monitor offers a reduced feature set of the CASPal®+ and measures only oscillometric blood pressure via a brachial cuff. The MC3100™+ also is capable of Bluetooth® wireless data transmission.

Mv-BP™ PC Software is a software application which, when loaded on a computer suitably equipped with Bluetooth® functionality, is able to acquire measurement data from CASPal® and MC3100 ™* for subsequent storage and display.

#### Non-Clinical Tests Submitted: (1) (b)

The A-PULSE CASPal®/MC3100™* Monitors have been tested to meet applicable standards for medical device electrical safety, electromagnetic

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compatibility, environmental (temperature and humidity), and mechanical strength (shock and vibration).

Materials utilized in skin contact surfaces are in accessories cleared for the same intended use. The materials met biocompatibility requirements.

The embedded software of the A-PULSE CASPar® /MC3100™* Monitors has been verified to requirements and validated to meet intended use. HealthSTATS mv-BP™ PC Software has been verified to meet specified requirements for the storage and display of retrospective vital blood pressure and pulse rate data.

System level risk, hazard, and failure mode analysis has been performed on both hardware and software, and residual risks were determined to be acceptable.

### Clinical Tests Submitted: (2)

Clinical testing performed on the cleared predicate A-PULSE CASPal device, which is functionally and physically identical to the A-PULSE CASPal® device except for the addition of the Bluetooth® wireless data transmission, was determined to be applicable to the CASPal®* and MC3100 ** monitors. Therefore no new clinical data was submitted.

### (3) Conclusions from Tests:

As described in (b)(1) and (b)(2) above, the testing demonstrates that the A-PULSE CASPal® /MC3100 ** Monitors and my-BP™ PC Software are as safe and effective as, and function in a manner equivalent to the referenced predicate devices.

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Public Health Service

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

Image /page/4/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

March 4, 2014

Healthstats International Pte. Ltd. Stephen Gorski S65 W35739 Piper Road Eagle, WI 53119 US

Re: K131788

> Trade/Device Name: Trade/Device Name: HealthSTATS A-PULSE CASPal®+ and MC3100 TM+ Monitors and my-BPTM BP management application software

Regulation Number: 21 CFR 870.1130 Regulation Name: System, Management, Blood-Pressure, Non-Invasive Regulatory Class: Class II Product Code: DXN Dated: January 22, 2014 Received: January 27, 2014

Dear Stephen Gorski:

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 connolo provisions of the reling, 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 If your device 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.

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 statues 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); the recordinations, more 801); medical device reporting of medical device-related adverse labeling (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems

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Page 2 - Stephen Gorski

(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 contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

FDA

for Bram D. Zuckerman, Ph.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):

HealthSTATS A-PULSE CASPal®+ and MC3100™+ Monitors and Device Name: my-BPTM BP Management Application Software

Indications for use:

The A-PULSE CASPal+ Monitor is a compact standalone monitor that combines two methods of blood pressure measurement:

- Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and .
- Radial arterial pulse acquisition via a wrist-mounted tonometer sensor.

The A-PULSE CASPal+ Monitor first measures systolic and diastolic blood pressure and pulse rate using the oscillometric method, and then acquires the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.

The MC3100+ monitor measures systolic and diastolic blood pressure and pulse rate via the oscillometric method via a brachial cuff at the upper arm.

The monitors have a non-volatile memory to store and recall measurements, and the ability to transfer measurement data via Bluetooth wireless communications to other suitably equipped electronic devices, such as a PC with HealthSTATS.my-BP PC software.

my-BP PC software is used in conjunction with the HealthSTATS A-PULSE CASPal+ and MC3100+ Monitors to store and display blood pressure data obtained from the monitors.

The A-PULSE CASPal+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPal+, have a palpable radial pulse.

Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPal+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.

Prescription Use × (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (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)

Date:
2014:03.04
15:57:04 -05'00'
for Bram Zuckerman

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