The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42 cm).

The BPCalibrator™ MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it.

Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

Device Description

The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate at home or in clinical settings.

A cuff is applied to the upper arm before measurement. When a measurement is initiated, the cuff is inflated to a pressure higher than the systolic pressure and then deflated. Pressure pulses measured from the cuff during deflation are used to calculate blood pressure and pulse rate using the oscillometric method.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was clinically tested in accordance with AAMI-SP10: 1992, Electronic or Automated Sphygmomanometers, and that the "requirements of the standard were met." While the specific numerical acceptance criteria from AAMI-SP10:1992 are not explicitly detailed in the provided text, the standard generally sets forth requirements for accuracy in blood pressure measurements.

Therefore, the table can be structured as follows, with the understanding that "Met AAMI-SP10: 1992 requirements" implies compliance with the standard's accuracy and performance thresholds.

Feature/Metric	Acceptance Criteria (Implicit from AAMI-SP10:1992)	Reported Device Performance
Blood Pressure Accuracy	Conformance to AAMI-SP10: 1992 standard for electronic or automated sphygmomanometers. (Typically includes mean difference and standard deviation of differences when compared to a reference method).	Met the requirements of AAMI-SP10: 1992.

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

The document does not explicitly state the sample size used for the clinical test set. It only mentions that "The BPCalibrator™ MC3000/MC3100 was clinically tested in accordance with AAMI-SP10: 1992, Electronic or Automated Sphygmomanometers."

Sample Size for Test Set: Not explicitly stated in the provided text. AAMI-SP10: 1992 typically recommends a minimum of 85 subjects for clinical validation.
Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). Clinical testing conforming to AAMI-SP10 is usually prospective.

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

The document does not provide details on the number of experts used or their qualifications for establishing ground truth. AAMI-SP10: 1992 typically requires simultaneous auscultatory measurements by trained observers (often two) as the reference standard (ground truth).

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. In AAMI-SP10: 1992, if two observers are used for ground truth, their readings are averaged or a consensus is reached if there are significant discrepancies, but a formal adjudication process beyond that is not typically described as a standalone method.

Adjudication Method: Not explicitly stated.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

MRMC Study: No.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The entire premise of the clinical testing section is to validate the device itself (the BPCalibrator™ MC3000/MC3100) as a standalone blood pressure monitor, without human intervention in the measurement process other than placing the cuff and initiating the reading. The device calculates blood pressure and pulse rate using its internal oscillometric algorithm.

Standalone Study: Yes.

7. The Type of Ground Truth Used

The ground truth used for the clinical testing would have been expert consensus (auscultation). AAMI-SP10: 1992 requires comparison of the automated device's readings against simultaneously obtained auscultatory measurements performed by trained observers using a mercury sphygmomanometer as the reference standard.

Type of Ground Truth: Expert consensus (auscultatory measurements).

8. The Sample Size for the Training Set

The document does not mention or imply a "training set" in the context of machine learning or AI. This is a traditional medical device (oscillometric blood pressure monitor), not a device that uses AI algorithms requiring a distinct training phase. The device's algorithm for calculating blood pressure from oscillometric pulses is fixed and pre-programmed, not "trained" in the AI sense.

Sample Size for Training Set: Not applicable/not mentioned, as this is not an AI/ML device in the context of typical "training sets."

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

As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided information.

How Ground Truth for Training Set was Established: Not applicable.

Summary

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

(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. Ting Choon Meng, M.D.
	Position/Title:	President/CEO
	Date of Preparation:	June 6, 2005
(2)	Trade Name:	MC3000/MC3100 Oscillometric BloodPressure Monitor
	Common/Classification Name:	System, Measurement, Blood-pressureNon-invasive
	Product Code:	74 DXN, 21 CFR § 870.1130
	Class:	Class II
(3)	Predicate Device(s):
	K982481	UA-767PC Digital Blood Pressure Monitor, A & D Medical
	Reason for Submission:	New Device

Description of Device: (4)

The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate at home or in clinical settings.

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(5) Intended use:

Blood pressure is measured in millimeters of mercury (mmHg) and is Brood procession this application by two values: systolic pressure and diastolic pressure. The systolic pressure represents the pressure in the diaolono processes when the heart contracts (pumps), while the diastolic pressure is the pressure when the heart relaxes and blood fills the heart.

Blood pressure fluctuates throughout the day. Specific ranges are associated with normal, hyper- and hypotension. Blood pressure may be associated by persons in order to be better informed of their condition and to assist their doctor in assessing and specifying a treatment.

Indications for Use:

The BPCalibrator™ MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it.

Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

Technological Characteristics: (6)

BPCalibrator™ MC3000/MC3100 oscillometric blood pressure The monitors embody similar technological characteristics as the predicate device. An embedded microcontroller operates an air pump for cuff inflation and an electric valve to control cuff deflation. A pressure transducer measures the pressure signals from the cuff and the blood pressure is calculated by the oscillometric method. The devices are battery operated and utilize an LCD for display of the measurements. The MC3000 and predicate device are capable of serial communication via an RS-232 port. The MC3100 has a historical memory capable of calculating the previous 20 measurements.

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

The BPCalibrator™ MC3000/MC3100 devices were tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, shock and vibration, and environment (temperature and humidity). The devices passed the tests.

Accessory devices (NIBP cuffs) were evaluated for conformance with labeling and biocompatibility requirements. The cuffs met the requirements.

System level tests including measurement accuracy and stability, and inflation and deflation safety were performed to applicable standards for non invasive blood pressure devices. The requirements of the standards were met.

The BPCalibrator™ MC3000/MC3100 embedded software was verified to requirements and validated to meet intended use. Risk and failure mode analysis was performed and residual risks were determined to be acceptable.

Clinical Tests Submitted: (2)

The BPCalibrator™ MC3000/MC3100 was clinically tested in accordance with AAMI-SP10: 1992, Electronic or Automated Sphygmomanometers. The requirements of the standard were met.

Conclusions from Tests: (3)

As described in (b)(1) and (b)(2) above, all of the testing demonstrates that the BPCalibrator™ MC3000/MC3100 oscillometric blood pressure monitors are as safe and effective as, and function in a manner equivalent to the predicate device, the UA-767PC Digital Blood Pressure Monitor.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2005

HealthSTATS International Pte. Ltd. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K051546

Trade Name: BPCalibrator MC3000/MC3100 Oscillometric Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 10, 2005 Received: June 13, 2005

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreating to trg. Any enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in occordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, mains 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may be subject to back additions, 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. Robert Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r Rase be advisou that I Dr visuan that your device complies with other requirements of the Act that I Dr mas Interes and regulations administered by other Federal agencies. You must or any I caetar bakated and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Far 607); accems (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. product thanklou control po begin marketing your device as described in your Section 510(k) This letter will and my a the FDA finding of substantial equivalence of your device to a legally premarket notificated. " a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blummenhofer

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):

HealthSTATS BPCalibrator MC3000/MC3100 Oscillometric Blood Pressure Device Name: Monitor

Indications for use:

The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and-pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42 cm).

The BPCalibrator™ MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it.

Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX (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)

Blummino

(Division Sign-Off) Division of Cardlovascular Deyices o l ú(k) Number

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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).