The IDEAL LIFE BP-MANAGER™ is a non-invasive blood pressure monitor intended for the measurement of systolic and diastolic blood pressure and heart rate (pulse rate) using the oscillometric technique.

The IDEAL LIFE BP-MANAGER™ should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BPMANAGER ™ should not be used on infants or children. The end user of this device should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. This device makes no interpretation, evaluation, medical judgeners or recommendations for treatment. Clinical judgment and experience are required for interpretation of information. This device is not intended as a substitute for reedical care.

The IDEAL LIFE POD™ is an optional accessory to the IDEAL LIFE BPMANAGER TM and is a transmitter that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting. The IDEAL LIFE POD™ is an optional accessory designed to ssist in the management of user information. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check or interpret information transmitted. This device is not intepded as a substitute for medical care.

Device Description

The IDEAL LIFE BP-MANAGER™ is a single unit software-controlled device with a blood pressure cuff, and operation is automatic. The IDEAL LIFE BP-MANAGFER™ can bc used alone without any other accessories. Blood pressure and heart rate results are displayed on the screen of the IDEAL LIFE BP-MANAGER™. Up to 70 blood pressure readings are stored in the blood pressure computer processor. The device is not intended for self-diagnosis of discase and it is expected that individuals using the IDEAL LIFE BP-MANAGER™ will consult with a physician for interpretation of results.

If an individual desires automated graphical presentation of their blood pressure and heart rate data, the IDEAL LIFE POD™ may be purchased separately and used with the IDEAL LIFE BP-MANAGER™ as an optional accessory. The IDEAL LIFE POD™ is not required for operation of the IDEAL LIFE BP-MANAGER™ . The IDEAL LIFE POD™ is a simple transmitter (i.e., a wireless router) that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting.

AI/ML Overview

The provided text describes the IDEAL LIFE BP-MANAGER™ and IDEAL LIFE POD™ devices. However, it does not contain specific acceptance criteria or detailed results from a study that definitively proves the device meets such criteria in a quantitative manner as requested in the input format.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that the performance testing was conducted "in accordance with the guidance document entitled 'Non-Invasive Blood Pressure (NIBP) Monitor Guidance' dated March 10, 1997." This guidance document would contain the actual acceptance criteria (e.g., accuracy ranges for blood pressure measurements).

However, the provided text does not explicitly list these acceptance criteria or the specific reported device performance values (e.g., mean difference and standard deviation of blood pressure readings compared to a reference standard). It only provides a general statement: "Results of these tests confirm the appropriate performance of both the IDEAL LIFE BP-MANAGER™ and the IDEAL LIFE POD™."

Therefore, a table cannot be fully constructed from the provided text.

2. Sample size used for the test set and the data provenance:

The document mentions "performance testing in human volunteers" but does not specify the sample size for this test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document states that performance testing included "performance testing in human volunteers." For a blood pressure monitor, the ground truth is typically established by trained medical professionals using a reference blood pressure measurement method (e.g., auscultation with a sphygmomanometer). However, the document does not specify the number of experts used or their qualifications.

4. Adjudication method for the test set:

The document does not mention any adjudication method for the test set.

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:

This device is a blood pressure monitor and a data transmitter, not an AI-powered diagnostic tool requiring human interpretation of images or complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.

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

The IDEAL LIFE BP-MANAGER™ is a standalone device for measuring blood pressure. The performance testing "in human volunteers" would inherently be a standalone performance evaluation of the algorithm's ability to measure blood pressure. However, the document does not explicitly label it as a "standalone" study in contrast to human-in-the-loop. The IDEAL LIFE POD™ is a data transmitter and doesn't have an "algorithm-only" performance in the sense of making medical judgments.

7. The type of ground truth used:

For the blood pressure measurements, the ground truth would typically be established by concurrent measurements using a validated reference method (e.g., auscultation by trained observers). While not explicitly stated as "ground truth," performance testing in human volunteers for a blood pressure monitor implies comparison against such a standard.

8. The sample size for the training set:

The document does not mention a training set or its sample size. Given the device's function as a blood pressure monitor, it's unlikely to have a "training set" in the context of machine learning. The device's calibration and algorithm development might have used a dataset, but it's not referred to as a "training set" in the provided text.

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

Since no training set is described, this information is not available.

In summary:

The provided document, a 510(k) summary, focuses on establishing substantial equivalence to predicate devices and generally stating that performance tests were conducted according to guidance. It lacks the specific quantitative details requested regarding acceptance criteria, sample sizes for testing, expert qualifications, or detailed study methodology. To obtain such information, one would typically need to refer to the full study reports that were submitted to the FDA, which are not included in this summary.

Summary

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IDEAL LIFE INC.

MAR 1 4 2006 IDEAL LIFE BP-MANAGER™ 510(k) IDEAL LIFE POD™ 510(k)

SUMMARY OF SAFETY AND EFFECTIVENESS

GENERAL INFORMATION l

1.1 Submitter and Owner of the 510(k)

Jason Goldberg IDEAL LIFE INC. 110 Eglinton Avenue West Suite 303 Toronto, Ontario Canada M4R 1A3

1.2 Official Correspondent

Diane Mandell, Ph.D., RAC THE WEINBERG GROUP INC. 1220 19th Street N.W., Suite 300 Washington, D.C. 20036 Telephone: 202.730.4130 Facsmile: 202.833.7057 Electronic mail: dima@weinnberggroup.com

1.3 Date of Preparation

February 6, 2006

2 NAME OF THE DEVICES

Trade/Proprietary Names 2.1

IDEAL LIFE BP-MANAGER™, Model BPM 0001; IDEAL LIFE POD™, Model ILP 0001

2.2 Common/Usual Names

Noninvasive Blood Pressure Measurement System: Radiofrequency Physiological Signal Transmitter and Receiver

2.3 Classification Information

Classification Name: System, Measurement, Blood-Pressure, Noninvasive Classification Regulation:21 CFR §870.1130 Class: I I Product Code: DXN Panel: Circulatory System Devices

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IDEAL LIFE INC.

Classification Name:	Transmitters and Receivers, Physiological Signal,Radiofrequency
Classification Regulation:	21 CFR §870.2910
Class:	II
Product Code:	DRG
Panel:	Circulatory System Devices

3 PREDICATE DEVICES

1. Omron Automatic Blood Pressure Monitor with Intellisense™, Model HEM-773AC (K021682),
1. IN TOUCH® Diabetes Management Software System, K984527; and
1. Carematix Wellness System, K031840.

4 DESCRIPTION OF THE DEVICES

v. INDICATIONS FOR USE AND INTENDED USE

The IDEAL LIFE BP-MANAGER™ should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BP-MANAGER™ should not be used on infants or children. The end user of this device should not have common arrhythmias, such as atrial or ventrie ular ance or mis cats or atrial fibrillation. This device makes no interpretation, evaluation, medical judgments or

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KOLOSC4 13/3

recommendations for treatment. Clinical judgment and experience are required for interpretation of information. This device is not intended as a substitute for medical care. The IDEAL LIFE POD™ is an optional accessory to the IDEAL LIFE BP-MANAGER™ and is a transmitter that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting.

The IDEAL LIFE POD™ is an optional accessory designed to assist in the management of user information. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check or interpret information transmitted. This device is not intended as a substitute for medical care.

6 SUBSTANTIAL EQUIVALENCE

The IDEAL LIFE BP-MANAGER™ (Model No. BPM 0001) is substantially equivalent to the K021682, Omron Automatic Blood Pressure Monitor with Intellisense™, Model HEM-773AC. These devices have similar intended uses and technology comparisons.

The IDEAL LIFE POD™ (Model No. ILP 0001) is substantially equivalent to two predicate devices: K984527, IN TOUCH® Diabetes Management Software System (similar in intended use); and K031840, Carematix Wellness System (similar in technological comparison). Any differences between these devices and the IDEAL I.IFLi devices do not affect safety and effectiveness of the IDEAL LIFE devices, as demonstrated through bench and clinical testing of the IDEAL LIFE devices.

7 PERFORMANCE TESTING

This 510(k) provided performance testing data in accordance with the guidance document entitled "Non-Invasive Blood Pressure (NIBP) Monitor Guidance" dated March 10, 1997. These performance data included electromagnetic compatibility, electrical testing, performance testing in human volunteers, as well as other performance tests. Results of these tests confirm the appropriate performance of both the IDEAL LIFE BP-MANAGER™ and the IDEAL LIFE POD™, and the substantial equivalence of these devices to the predicates.

8 CONCLUSIONS

This 510(k) submission demonstrates that the IDEAL LIFE BP-MANAGER™ and the IDEAL LIFE POD™ are substantially equivalent to the three predicate devices.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

MAR 1 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ideal Life, Inc. c/o Diane Mandell, Ph.D., RAC The Weinberg Group, Inc. 1220 19th Street N. W., Suite 300 Washington, DC 20036

Re: K060504

Trade Name: IDEAL LIFE BP-MANAGER™, Model BPM 0001 and IDEAL LIFE POD™, Model ILP 0001 Regulation Number: 21 CFR 870.1130 and 21 CFR 870.2910 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN and DRG Dated: February 06, 2006 Received: February 27, 2006

Dear Dr. Mandell:

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.

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Page 2 - Diane Mandell, Ph.D., RAC

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); 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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours.

Blyminman 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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K060504

Attachment 1b

Page 1 of 1

510(k) Number (if known): K060504
Device Name: IDEAL LIFE BP-MANAGERT™ and IDEAL LIFE PODTM

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atymauma
(Division Sign-Off)

Prescription Use
(Per 21CFR801.109)

()[ર

Over-the-Counter Use - X

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).