The A-PULSE CASPro/CASPal Monitors are intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic systolic pressure (CASP) and other waveform indices.

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 stratification and management of patients with elevated cardiovascular risk.

The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine 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 CASPro/CASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.

The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a nonvolatile memory to store and recall measurements.

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

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

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

Device Description

HealthSTATS A-PULSE CASPro/CASPal Monitors are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.

The CASPro/CASPal Monitors are comprised of four main elements:

Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546]).
. Wrist sensor module based on the technology of the BPro® monitor device [listed device K060315].
Software algorithm for radial arterial blood pressure measurement . and calculation of CASP based on the A-PULSE PC Software [listed device K072593].
A-PULSE CASPro®, A-PULSE CASPal® main processing unit. .

Two functionally equivalent monitors are offered in this 510(k), the A-PULSE CASPro Monitor and the A-PULSE CASPal Monitor:

. The CASPro Monitor device is equipped with a full featured color TFT LCD panel to display blood pressure readings and radial arterial pulse waveforms. The device also has a real time calendar clock for time-stamped stored readings.
The A-PULSE CASPal Monitor device is equipped with a simplified . monochrome LCD panel to provide numeric blood pressure readings and a pulse bar to display radial arterial pulsations.

The operation sequence of both A-PULSE CASPro and CASPal Monitors is the same and both devices use identical hardware and software alqorithms to measure and report conventional systolic and diastolic blood pressure readings (BP), Central Aortic Systolic Pressure (CASP), and pulse rate (PR).

AI/ML Overview

The provided text describes the HealthSTATS A-PULSE CASPro/CASPal Monitors, which are non-invasive blood pressure monitors designed to measure conventional oscillometric blood pressure, Central Aortic Systolic Pressure (CASP), and other indices based on arterial tonometry.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the A-PULSE CASPro/CASPal Monitors were "clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP). Test results demonstrate CASP measurements that are consistent with the predicate devices within the stated accuracy claims." However, the specific numerical acceptance criteria for CASP accuracy or other measurements (e.g., conventional blood pressure, pulse rate) are not detailed in the provided text. Therefore, a complete table cannot be constructed with specific numerical acceptance criteria.

Metric	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Central Aortic Systolic Pressure (CASP) Measurement Accuracy	Consistent with predicate devices.	Consistent with predicate devices within stated accuracy claims.
Conventional Oscillometric Blood Pressure Measurement Accuracy	(Assumed to be consistent with predicate devices and standards for BP monitors, but not explicitly stated or detailed.)	(Implied to meet relevant standards, as the oscillometric module is identical to a listed predicate device.)
Pulse Rate Measurement Accuracy	(Assumed to be consistent with predicate devices, but not explicitly stated or detailed.)	(Implied to meet relevant standards.)

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

The document states that the A-PULSE CASPro/CASPal Monitors were "clinically tested," but does not specify the sample size used for the test set.

The data provenance (country of origin, retrospective or prospective) is not mentioned in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number of experts used to establish ground truth or their qualifications. The clinical testing was performed "in comparison with listed devices" for CASP measurement, suggesting that the predicate devices' measurements were used as a reference, rather than independent expert ground truth establishment.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. The testing was a comparison against predicate devices.

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

A multi-reader multi-case (MRCM) comparative effectiveness study was not explicitly mentioned or described. The testing focused on the device's measurements relative to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed. The device, an "A-PULSE CASPro/CASPal Monitor," is described as a "standalone noninvasive blood pressure monitor" that uses "software algorithm for radial arterial blood pressure measurement and calculation of CASP." The clinical tests evaluate the accuracy of these measurements directly against predicate devices, indicating a standalone performance assessment.

7. Type of Ground Truth Used:

The ground truth for the clinical tests was established by comparison with measurements obtained from predicate devices. The text states, "The A-PULSE CASPro/CASPal Monitors were clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP)." This implies that the measurements from the predicate devices served as the reference standard.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. The focus is on the clinical testing against predicate devices. It is possible that the software algorithms used in the device were developed using internal data that is not disclosed in this summary, or that the algorithms are based on established methods from the predicate devices without requiring a separate "training set" in the context of this submission.

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

Since no training set information is provided, the method for establishing its ground truth is not mentioned.

Summary

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JUN - 8 2010

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Page 1 of 4

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

(a) (1) Submitted by:	HealthSTATS International Pte. Ltd.6 New Industrial Road #04-01/02Hoe Huat Industrial BuildingSingapore 536199
	Phone: +65-6858 3248Fax: +65-6858 0148
	E-mail: cmting@healthstats.com.sg
Contact Person:	Dr. Choon Meng TING
Position/Title:	Chairman/CEO
Date of Preparation:	August 1, 2009
Trade Name:	HealthSTATS A-PULSE CASPro/CASPalMonitors
Common/Classification Name:	System, Measurement, Blood-pressure,Non-invasive
Product Code:	74 DXN, 21 CFR § 870.1130
Class:	Class II

(3) Predicate Device(s):

K072593	HealthSTATS A-Pulse® Arterial Pulse Waveform AnalysisSystem, HealthSTATS International Pte Ltd
K060315	HealthSTATS BPro® Ambulatory Blood Pressure MonitoringSystem, HealthSTATS International Pte Ltd
K051546	HealthSTATS BPCalibrator MC300/MC3100 Blood PressureMonitor, HealthSTATS International Pte Ltd
K012487	SphygmoCor Pulse Waveform Analysis System, AtCorMedical Pty Ltd

Reason for Submission:	New Device
------------------------	------------

(4) Description of Device:HealthSTATS A-PULSE CASPro/CASPal Monitors 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 CASPro/CASPal Monitors are comprised of four main elements:

Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546]).
. Wrist sensor module based on the technology of the BPro® monitor device [listed device K060315].
Software algorithm for radial arterial blood pressure measurement . and calculation of CASP based on the A-PULSE PC Software [listed device K072593].
A-PULSE CASPro®, A-PULSE CASPal® main processing unit. .
(5) Intended use:

Indications for Use:

The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine 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.

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Page 3 of 4

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

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

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

(6) Technological Characteristics: .

Two functionally equivalent monitors are offered in this 510(k), the A-PULSE CASPro Monitor and the A-PULSE CASPal Monitor:

. The CASPro Monitor device is equipped with a full featured color TFT LCD panel to display blood pressure readings and radial arterial pulse waveforms. The device also has a real time calendar clock for time-stamped stored readings.
The A-PULSE CASPal Monitor device is equipped with a simplified . monochrome LCD panel to provide numeric blood pressure readings and a pulse bar to display radial arterial pulsations.

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

The A-PULSE CASPro/CASPal Monitor has been tested to meet applicable standards for medical device electrical safety, electromagnetic compatibility, shock and vibration, and environment (temperature and humidity), as well as specific compliance requirements for blood pressure monitors.

Materials utilized in skin contact surfaces were reviewed for conformance with biocompatibility requirements. The materials met the requirements.

The embedded software of the A-PULSE CASPro/CASPal Monitors has been verified to requirements and validated to meet intended use. System level risk, hazard, and failure mode analysis has been performed and residual risks were determined to be acceptable.

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(2) Clinical Tests Submitted:

The A-PULSE CASPro/CASPal Monitors were clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP). Test results demonstrate CASP measurements that are consistent with the predicate devices within the stated accuracy claims.

(3) Conclusions from Tests:

As described in (b)(1) and (b)(2) above, the testing demonstrates that the A-PULSE CASPro/CASPal Monitors are as safe and effective as, and function in a manner equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, abstract style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN - 8 2010

HealthSTATS International Pte., Ltd., c/o Mr. Stephen Gorski Imagenix. Inc. S65 W35739 Piper Road Eagle, WI 53119

Re: K101002

Trade/Device Name: A-PULSE CASPro® and A-PULSE CASPal® Monitors Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 5, 2010 Received: April 12, 2010

Dear Mr. 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 manufacturing 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 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. Stephan Gorski

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/CDRH0ffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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):	K 10/0022
---------------------------	-----------

Device Name: HealthSTATS A-PULSE CASPro/CASPal Monitors

Indications for use:

The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine 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. .

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

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

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)	X
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)

(Division Sign-Off)
Division of Cardiovascular Devices	Page 1 of 1
510(k) Number	K10002

4-1 ·

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).