HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System with BProSOft CASP® PC software is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements:
. BPro wrist-mounted tonometric monitor (listed device K060315),
. BProSoft CASP report management software, a PC-based computer program (new/added measurement function).
. BPCalibrator MC3000 oscillometric blood pressure monitor [listed device, K051546] for calibration of BPro monitors.

Once the BPro is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours. Arterial pulse waveforms obtained over the 24 hour period are used by the BProSoft CASP PC software to calculate central aortic systolic pressure (CASP).

AI/ML Overview

This document describes the HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System with BProSOft CASP® PC software.

Here's an analysis of the provided text to answer your questions:

Acceptance Criteria and Device Performance

The document states that the BProSOft CASP PC Software's accuracy was confirmed against a predicate device. However, it does not provide a specific table of acceptance criteria with quantitative performance metrics (e.g., mean difference, standard deviation of difference) for CASP measurement. It only states that the "Test results confirm the accuracy of the BProSOft CASP measurement consistent with the predicate device measurements within the stated accuracy claims."

Without specific numerical acceptance criteria, a direct comparison table cannot be provided. The general acceptance criterion implied is equivalence in accuracy to the predicate device for CASP measurement.

Study Information

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: Not explicitly stated. The document mentions "clinically studied" but does not give the number of participants.
Data Provenance: Not explicitly stated. The document indicates the submission is from Singapore but does not specify where the clinical study data originated. It does not mention if the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Number of experts: Not explicitly stated.
Qualifications of experts: Not explicitly stated. The ground truth (predicate device measurements) is established by another device rather than human experts for the CASP comparison study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not explicitly stated. The study compares the BPro with a predicate device, implying the predicate device's measurements serve as the reference.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly mentioned. This device measures physiological parameters and calculates CASP, rather than providing interpretations that human readers would then review. The focus is on the accuracy of the device's measurements relative to a predicate device, not on improving human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, the clinical study for the BProSOft CASP PC Software appears to be a standalone performance study. It compares the CASP measurements generated by the software (algorithm) with those from a predicate device. The BPro system itself is stated to be "intended only for measurement, recording, and display. It makes no diagnosis," further supporting a standalone assessment of its output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Ground Truth: The ground truth for the CASP measurement comparison was the measurements from a listed predicate device. The document states, "BProSOft CASP PC Software has been clinically studied with the BPro monitor in comparison to a listed predicate device for the derivation of central aortic systolic pressure (CASP)."

8. The sample size for the training set:

Training Set Sample Size: Not explicitly stated. The document mentions the software "calculates central aortic systolic pressure (CASP)" but does not detail any machine learning or AI training process, nor any specific training datasets.

9. How the ground truth for the training set was established:

Training Set Ground Truth Establishment: Not explicitly stated. Given the description, it's unclear if a traditional "training set" in the machine learning sense was used for the CASP calculation algorithm. If it was, the method for establishing ground truth for such a set is not provided. The focus is on the validation of the calculation against a predicate.

Summary

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MAR 1 1 2014

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

(a) Submitted by: HealthSTATS International Pte. Ltd. 6 New Industrial Road #04-01/02 Singapore 536199 Phone: +65-6858 3248 Fax: +65-6858 0148 E-mail: cmting@healthstats.com.sg Contact Person: Dr. Choon Meng TING, M.D. Position/Title: President/CEO Date of Preparation: June 20, 2013 HealthSTATS BPro® Ambulatory Blood Trade Name: Pressure Monitoring System with BProSOft CASP® PC software Common/Classification Name: System, Measurement, Blood-pressure, Central, Non-invasive Product Code: 74 DXN, 21 CFR & 870.1130 Class: Class II
- (3) Predicate Device(s):

K060315	BPro Ambulatory Blood Pressure Monitoring with BProSOftapplication software
K072593	A-PULSE CASP PC application software -- Central AorticSystolic System
K110603	Mobil-O-Graph 24h PWA with Hypertension ManagementSoftware Client Server (HMS-CS 4.3)

Reason for Submission: New Device

(4) Description of Device:

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. BPro wrist-mounted tonometric monitor (listed device K060315),
. BProSoft CASP report management software, a PC-based computer program (new/added measurement function).
. BPCalibrator MC3000 oscillometric blood pressure monitor [listed device, K051546] for calibration of BPro monitors.

(5) Intended use:

Blood pressure is measured in millimeters of mercury (mmHg) and is typically represented by two values: systolic pressure and diastolic pressure. The systolic pressure represents the pressure in the blood vessels when the heart contracts (pumps), while the diastolic pressure is the pressure when the heart relaxes and blood fills the heart. The calculation of central aortic systolic pressure (CASP) which is determined from arterial pulse waveform analysis can provide additional useful information on the condition of the heart.

Blood pressure fluctuates throughout the day. Specific ranges are associated with normal, hyper- and hypotension. Ambulatory blood pressure measurement devices provide useful 24 hour blood pressure profiles This submission includes the addition of ambulatory central aortic systolic pressure measurement. Evaluation of blood pressure profiles can assist with diagnosis of specific cardiovascular conditions.

Indications for Use:

The BPro® system is a noninvasive ambulatory central blood pressure monitoring system based on tonometry at the radial artery of the wrist. The system consists of a BPro® wrist-mounted tonometric monitor, and a BPCalibrator MC3000™ oscillometric blood pressure monitor for calibration, and BProSOft CASP® Software, a PC-based computer program.

Before each measurement session, the wrist-mounted tonometric device is calibrated using the oscillometric monitor. Once calibrated, the BPro wrist device is capable of recording and displaying up to 96 measurements of systolic and diastolic blood pressure, pulse rate, and radial pulse waveform over a 24-hour period. The central aortic systolic pressure (CASP) is calculated utilizing the recorded radial pulse waveform and BProSOft CASP® PC software.

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BProSOft CASP® PC software is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to 24-hour period.

The BPro system is intended for use on patients who are eighteen (18) vears and older and who have a palpable radial pulse.

The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.

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:

The BPro Ambulatory Blood Pressure Monitoring System combines two established measurement methods used by the referenced predicate devices:

. BPro ambulatory blood pressure monitoring at the wrist using arterial tonometry
. Arterial pulse waveform analysis to determine the CASP.

The BPro monitor is applied to the wrist with a pressure transducer placed over the radial artery. The monitor has a size and weight similar to a sports type wrist watch.

An embedded microcontroller supervises the actions of the monitor including scheduled measurements, status reporting, and serial data communications with the host PC.

The BProSOft CASP® PC software utilizes arterial pulse waveform analysis to calculate ambulatory central aortic systolic pressure (CASP), which is in addition to the cleared blood pressure parameters of the BPro Ambulatory Blood Pressure Monitoring System.

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

The BPro monitor device meets applicable standards for medical device electrical safety, electromagnetic compatibility, shock and vibration, and environment (temperature and humidity).

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

The BProSOft CASP PC software was verified to requirements and validated to meet intended use. System level risk, hazard, and failure

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mode analysis was performed and residual risks were determined to be acceptable.

(2) Clinical Tests Submitted:

The BPro Ambulatory Blood Pressure Monitoring System has been previously clinically validated and cleared for the measurement of ambulatory systolic and diastolic pressure and pulse rate measurements.

The BProSOft CASP PC Software is an upgraded PC Software application that adds the CASP measurement function. BProSOft CASP PC Software has been clinically studied with the BPro monitor in comparison to a listed predicate device for the derivation of central aortic systolic pressure (CASP). Test results confirm the accuracy of the BProSOft CASP measurement consistent with the predicate device measurements within the stated accuracy claims.

(3) Conclusions from Tests:

As described in (b)(1) and (b)(2) above, the testing demonstrates that the HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System with BProSOft CASP® PC software is as safe and effective as, and functions in a manner equivalent to the 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 20993-002

March 11, 2014

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

Re: K131916

Trade/Device Names: HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System with BProSOft CASP® PC Software Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: January 29, 2014 Received: January 31, 2014

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. 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. Stephen 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/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/ReportalProblem/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

forBram 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): K131916

HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System Device Name: with BProSOft CASP® PC software

Indications for use:

The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.

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) Conci 2014.03.11 00 -04'00' for Bram Zuckerman

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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).