PIESOMETER, MODEL MK-1

K041169 · Canamet Canadian Natl Medical Technologies, Inc. · DXN · Aug 24, 2004 · Cardiovascular

Device Facts

• Record ID: K041169
• Device Name: PIESOMETER, MODEL MK-1
• Applicant: Canamet Canadian Natl Medical Technologies, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician. Patient diagnosis is not to be performed solely based on the results of this device.

Device Story

Piesometer MK-1 is a non-invasive automated blood pressure monitor for ambulatory use. Device utilizes electronic pressure cuff with three acoustic sensors: two sensors on biceps detect Korotkoff sounds; one sensor on triceps detects interference signals. System employs adaptive interference cancellation signal processing to filter out noise and vibration, enabling readings in high-noise environments. Device records systolic, diastolic, and heart rate data over 48-hour periods or single measurements. Used in hospitals, clinics, or home settings by physicians, staff, or trained patients. Output displayed on 32-character LCD; data stored for review. Healthcare providers use output to assess cardiac health; device intended for preliminary data collection in non-time critical applications. Patient diagnosis must not rely solely on device results.

Clinical Evidence

Bench and clinical testing performed. Results indicate device is as safe and effective as predicate devices. No specific quantitative clinical metrics (e.g., sensitivity, specificity) provided in summary.

Technological Characteristics

Auscultatory blood pressure measurement system using Korotkoff sound technique. Features three acoustic sensors (microphones) for adaptive interference cancellation. Powered by rechargeable Lithium-Ion battery. Includes 32-character LCD display. Memory capacity for 60 records. Form factor: 13.4 cm x 9.5 cm x 4.4 cm. Weight: 850 grams.

Indications for Use

Indicated for ambulatory patients requiring cardiac health assessment via blood pressure and heart rate monitoring. Suitable for use in clinical settings or home care by trained patients. Not for sole diagnostic use.

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

• Spacelabs ABP (Ambulatory Blood Pressure) (K031479, K941167, K904318, K855127)
• SunTech Accutracker DX (K913844)

Submission Summary (Full Text)

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K04/169

S1/2

AUG 2 4 2004

# EXHIBIT 2 510(k) Summary

# CANAMET CANADIAN NATIONAL MEDICAL TECHNOLOGIES INC. 1120 Finch Ave West, Suite 201 Toronto ON M3J-3H7 Phone [phone] Ext 333 Fax: [phone] Email: [e-mail] Contact: STERGIOS STERGIOPOULOS Date: July 31, 2004

- Identification of the device 1. Proprietary-Trade Name: PIESOMETER MK-1 Classification Names: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, Common/Usual Name: Non-invasive automated blood pressure meter.
#### 2. Equivalent legally marketed devices

This product is similar in function and design to the Spacelabs ABP (Ambulatory Blood Pressure), K031479, K941167, K904318, K855127 and, SunTech Accutracker DX, K913844.

#### Indications for Use (intended use) 3.

The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician. Patient diagnosis is not to be performed solely based on the results of this device.

#### 4. Description of the Device

The Model PIESOMETER MK-1 Digital Blood Pressure Monitor measures systolic and diastolic blood pressure and heart rate using adaptive interference cancellation (signal processing) technologies. The system employs three acoustic sensors (i.e. microphones) in the electronic pressure cuff. During a blood pressurement, two acoustic sensors are placed in the traditional location on the patient's biceps. This set of sensors, operating much like a conventional stethoscope, senses the Korotkoff sounds. Unique to the PIESOMETER MK-1 is a second set of a sensor placed in the triceps area. This sensor serves to detect any interference signals that would normally compromise the reading. This allows reading to be taken even in noise and vibration intensive environment. This technology functions by identifying signals lying within the audio frequency and filtering out the interference signal. The CANAMET PIESOMETER is protected by U.S. Patent 6,520,918.

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## Safety and Effectiveness, comparison to predicate device 5.

The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices.

| Designation | Spacelabs ABP (Ambulatory<br>Blood Pressure), K031479,<br>K941167, K904318, K855127 | SunTech<br>Accutracker DX,<br>K913844. | PIESOMETER MK-1 |
|------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Operating<br>Principle | Auscultatory Technology<br>Korotkoff sound technique. | Auscultatory<br>Technology<br>Korotkoff sound<br>technique, Motion<br>Tolerant | Auscultatory<br>Technology<br>Korotkoff sound<br>technique, Motion<br>Tolerant |
| Display | 4-digit, 7-segment LCD;<br>systolic, diastolic and<br>heart rate information | 32 Character LCD | 32 Character LCD |
| Recording Time | Up to 48 hours | Up to 48 Hours | Up to 48 Hours |
| Power supply | 4 AA alkaline disposable<br>or rechargeable NiCad<br>batteries | Four 1.5 (AA) alkaline<br>batteries | Rechargeable Lithium-<br>Ion battery (Not user<br>replaceable)<br>rechargeable with<br>supplied charger. |
| External<br>dimensions | 1.1"x4.5"x3.4" (2.8 cm<br>x11.4 cm x8.6 cm)<br>Model 90217:<br>0.97"x3.94"x2.77" (2.5 cm<br>x10.0 cm x7.0 cm) | 3.25"W x 5"L x 1.30"D<br>(8.25cm x 12.7cm x<br>3.3cm) | 5.28" x 3.74" x 1.73"<br>(13.4 cm X 9.5cm X<br>4.4cm) |
| Memory | Not specified | Over 250 samples of<br>systolic, diastolic, and<br>heart rate. | 60 records of systolic,<br>diastolic, and heart rate |
| Weight | 12.2 oz. (347 g) (with<br>batteries)Model 90217: 9<br>oz. (255 g) (with<br>batteries) | 12.6oz. (357.2 grams) | 850 grams |
| Accessories | Not specified | Multiple cuff sizes | Multiple cuff sizes |

## Comparison matrix - new ys. Predicate device 6

### 7. Conclusion

After analyzing both bench and clinical testing data, it is the conclusion of Canamet that that the "PIESOMETER MK-1" Automated Blood Pressure Monitor is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

p (_/%

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

Canamet Canadian National Medical Technologies, Inc. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K041169

> Trade Name: Piesometer, Model MK-1 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 09, 2004 Received: August 10, 2004

Dear Mr. Kamm:

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 such 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 statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Daniel Kamm, P.E.

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 contact the Office 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden for
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):________________K041169

Device Name: PIESOMETER MK-1

The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician.

Patient diagnosis is not to be performed solely based on the results of this device.

Prescription Use X (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)

Neil H. Golen

for BOZ

| (Division Sign-Off) Division of Cardiovascular Devices | |
|--------------------------------------------------------|---------|
| 510(k) Number | K041169 |

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