BPCALIBRATOR MC3000/MC3100

K051546 · Healthstats International Pte. , Ltd. · DXN · Jun 24, 2005 · Cardiovascular

Device Facts

• Record ID: K051546
• Device Name: BPCALIBRATOR MC3000/MC3100
• Applicant: Healthstats International Pte. , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

Oscillometric blood pressure monitor for home or clinical use. Input: pressure pulses from upper arm cuff during deflation. Operation: embedded microcontroller controls air pump/valve; pressure transducer captures signals; oscillometric method calculates systolic/diastolic pressure and pulse rate. Output: digital display of measurements; MC3000 includes RS-232 serial port for data transmission; MC3100 includes historical memory for 20 readings. Healthcare providers use output as aid to diagnosis and treatment. Benefits: provides patients/clinicians with blood pressure data to inform treatment decisions.

Clinical Evidence

Clinical testing performed in accordance with AAMI-SP10:1992 (Electronic or Automated Sphygmomanometers). The device met all requirements of the standard. No specific sensitivity/specificity metrics provided.

Technological Characteristics

Oscillometric blood pressure monitor. Components: embedded microcontroller, air pump, electric valve, pressure transducer, LCD display. Power: battery operated. Connectivity: RS-232 serial port (MC3000). Memory: 20-reading historical storage (MC3100). Biocompatible NIBP cuffs. Standards: AAMI-SP10:1992.

Indications for Use

Indicated for patients 18 years and older for measurement of systolic/diastolic blood pressure and pulse rate. Contraindicated for patients with common arrhythmias (atrial/ventricular premature beats, atrial fibrillation). Arm circumference: 21-42 cm.

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

• UA-767PC Digital Blood Pressure Monitor (K982481)

Submission Summary (Full Text)

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

| (a) | (1) | Submitted by: | HealthSTATS International Pte. Ltd.<br>6 New Industrial Road #04-01/02<br>Hoe Huat Industrial Building<br>Singapore 536199 |
|-----|-----|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | | | Phone: [phone]<br>Fax: [phone] |
| | | | E-mail: [e-mail] |
| | | Contact Person: | Dr. Ting Choon Meng, M.D. |
| | | Position/Title: | President/CEO |
| | | Date of Preparation: | June 6, 2005 |
| | (2) | Trade Name: | MC3000/MC3100 Oscillometric Blood<br>Pressure Monitor |
| | | Common/Classification Name: | System, Measurement, Blood-pressure<br>Non-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.

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.

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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/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.

#### 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 [phone]. 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 [phone] or [phone] 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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