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 Description

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.

AI/ML Overview

The provided text describes the PIESOMETER MK-1, a non-invasive automated blood pressure meter, and its FDA 510(k) summary for substantial equivalence. However, it does not contain explicit acceptance criteria or a detailed study description with specific performance metrics and statistical analyses to prove the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices (Spacelabs ABP and SunTech Accutracker DX) based on design and functional similarity. It broadly states that "The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices," but does not provide the results of these tests in a quantifiable manner or against predefined acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from the provided text. I will indicate where information is missing.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Blood Pressure Measurement Accuracy: Specific accuracy standards (e.g., ISO 81060-2 or AAMI standards) for systolic and diastolic blood pressure measurements.	Not explicitly stated. The document asserts "safe and effective as the predicate devices" based on bench and user/clinical testing, but does not provide specific accuracy metrics (e.g., mean difference, standard deviation) or comparisons to a reference method (e.g., mercury sphygmomanometer).	This is a critical missing piece of information for evaluating device performance against established standards.
Heart Rate Measurement Accuracy: Specific accuracy standards for heart rate measurements.	Not explicitly stated. Similar to blood pressure, the document claims "safe and effective," but no quantitative heart rate accuracy data is provided.	Quantitative data for heart rate accuracy is not present.
Reliability/Repeatability: Criteria for consistent measurements over time or across different users.	Not explicitly stated.	No information provided.
Safety: Criteria related to electrical safety, biocompatibility (for cuff materials), and absence of adverse events.	Not explicitly stated, but implied. The 510(k) submission process itself inherently addresses safety and effectiveness. The conclusion states "safe and effective."	General statement of safety and effectiveness, but no specific criteria or data.
Performance in Noise/Vibration: Performance metrics (e.g., accuracy, success rate) in challenging environments.	The device description highlights its "adaptive interference cancellation (signal processing) technologies" and ability to take readings "even in noise and vibration intensive environment." No quantitative performance data for this aspect is provided.	A key feature of the device, but its performance under these conditions is not quantified against any criteria.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "bench and user/clinical testing" but does not provide details on the number of subjects or cases included in these tests.
- Data Provenance: Not specified. It is unclear if the data was collected retrospectively or prospectively, or the country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not specified. The document does not describe the methodology for establishing ground truth for any clinical testing that might have been performed.
Adjudication method for the test set:
- Adjudication Method: Not specified. There is no information about how discrepancies or variations in "ground truth" measurements (if any were used) were resolved.
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, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The general claim of "safe and effective as the predicate devices" for the PIESOMETER MK-1 implies a standalone performance evaluation of the device's ability to measure blood pressure and heart rate. However, specific performance metrics are not provided. The device is an automated blood pressure meter, so its primary function is standalone measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated. For blood pressure devices, the typical ground truth involves comparison to a validated reference method, such as a mercury sphygmomanometer or an oscillometric device that has been independently validated, often with readings taken by trained clinicians. This detail is missing.
The sample size for the training set:
- Sample Size for Training Set: Not specified. The document details the device's technology ("adaptive interference cancellation (signal processing) technologies") but does not provide information about a "training set" in the context of machine learning or AI. It's possible that the "signal processing" algorithms were developed using internal data, but no specifics are given.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not specified. Given the lack of information on a "training set" and its methodology, how ground truth for such a set was established is also not present in the document.

Summary

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K04/169

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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 (416) 916-0469 Ext 333 Fax: (416)-916-0313 Email: Stergios@canamet.com 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.

4. Description of the Device

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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 (AmbulatoryBlood Pressure), K031479,K941167, K904318, K855127	SunTechAccutracker DX,K913844.	PIESOMETER MK-1
OperatingPrinciple	Auscultatory TechnologyKorotkoff sound technique.	AuscultatoryTechnologyKorotkoff soundtechnique, MotionTolerant	AuscultatoryTechnologyKorotkoff soundtechnique, MotionTolerant
Display	4-digit, 7-segment LCD;systolic, diastolic andheart 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 disposableor rechargeable NiCadbatteries	Four 1.5 (AA) alkalinebatteries	Rechargeable Lithium-Ion battery (Not userreplaceable)rechargeable withsupplied charger.
Externaldimensions	1.1"x4.5"x3.4" (2.8 cmx11.4 cm x8.6 cm)Model 90217:0.97"x3.94"x2.77" (2.5 cmx10.0 cm x7.0 cm)	3.25"W x 5"L x 1.30"D(8.25cm x 12.7cm x3.3cm)	5.28" x 3.74" x 1.73"(13.4 cm X 9.5cm X4.4cm)
Memory	Not specified	Over 250 samples ofsystolic, diastolic, andheart rate.	60 records of systolic,diastolic, and heart rate
Weight	12.2 oz. (347 g) (withbatteries)Model 90217: 9oz. (255 g) (withbatteries)	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.

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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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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

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

Page 1 of 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).