The IDEAL LIFE Pod™ receives data wirelessly from IDEAL LIFE devices to transmit over the Internet or common telephone lines from the user's home. The Pod is an optional accessory to IDEAL LIFE devices, including the GlucoManager™, the BP-Manager™ and/or the Body Manager™. The Pod is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.

The IDEAL LIFE Pod makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.

Device Description

The IDEAL LIFE Pod is a simple, user-friendly wireless modem accessory that wirelessly receives data from IDEAL LIFE devices and transmits the data to the IDEAL LIFE website. The IDEAL LIFE database is updated securely with the user's information, which is available for review via secure Internet access. Using the Pod, an individual can more easily view and track their blood pressure, blood glucose, and/or body weight information.

AI/ML Overview

The provided text describes a 510(k) submission for the IDEAL LIFE Pod™ Model ILP 0001, which is an accessory designed to wirelessly transmit data from other IDEAL LIFE devices (like GlucoManager™, BP-Manager™, and Body Manager™) to a website for review.

Crucially, this submission does not include a study with acceptance criteria and a detailed description of device performance in a clinical or analytical setting. The IDEAL LIFE Pod is a data transmission device, not a diagnostic or therapeutic device that directly measures physiological parameters. Its function is to transmit data, and the provided document focuses on demonstrating substantial equivalence to predicate devices based on software, hardware, and user experience, rather than performance against a specific clinical metric.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample size for test set, expert involvement, adjudication method, MCMC study, standalone performance, type of ground truth, training set details) cannot be extracted from the given text because such information is not present or relevant to the device's function as described.

The document states:

"Differences with the new Pod have been demonstrated not to affect safety or effectiveness of the device, using software design controls, V&V testing, and user testing of the device."
"Hardware, software, and the manufacturing processes are the same as the predicate Pod. Software controls and validation and verification testing have demonstrated that the software changes do not affect device performance."
"Since the Pod is a wireless device, the radiofrequency interference and emissions have been tested and the Pod complies with appropriate FCC Standards."
"User testing and historical experience with the Pod have demonstrated that the Pod can be used in the intended setting."

This indicates that the "study" was primarily focused on software validation and verification (V&V), hardware testing (specifically RF interference and emissions), and user testing/historical experience to confirm that the updated version of the Pod maintains its intended function and safety without introducing new risks compared to its predicate. There is no mention of performance metrics like accuracy, sensitivity, or specificity, which would typically be associated with diagnostic devices.

Summary of available information:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of clinical or analytical performance metrics. The implied criteria revolve around maintaining software and hardware functionality, compliance with FCC standards, and user-friendliness, equivalent to the predicate device.
- Reported Device Performance: The text states, "Software controls and validation and verification testing have demonstrated that the software changes do not affect device performance." Also, "radiofrequency interference and emissions have been tested and the Pod complies with appropriate FCC Standards." And "User testing and historical experience with the Pod have demonstrated that the Pod can be used in the intended setting." No quantitative performance metrics (e.g., accuracy, reliability of data transmission rate, error rates) are provided.
Sample size used for the test set and the data provenance: Not mentioned. The testing described (software V&V, FCC compliance, user testing) does not detail sample sizes. Data provenance is not specified beyond "user testing and historical experience."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned. The device transmits data rather than making a diagnosis or measurement that would require expert ground truth.
Adjudication method for the test set: Not applicable or mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This type of study is for diagnostic devices where human readers interpret results.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is an "algorithm only" in the sense that its function is data transmission. The "testing" mentioned is its standalone functionality and compliance, but not in the context of diagnostic performance.
The type of ground truth used: Not applicable. The device's function doesn't involve generating data that requires a ground truth in a clinical sense. The "ground truth" for its operation would be successful data transmission and proper function.
The sample size for the training set: Not applicable or mentioned, as this is not a machine learning-based diagnostic device.
How the ground truth for the training set was established: Not applicable.

In conclusion, the 510(k) summary for the IDEAL LIFE Pod™ ILP 0001 details its function as a data transmission accessory and demonstrates its substantial equivalence to predicate devices through software/hardware validation, FCC compliance, and user testing. It does not provide information related to clinical or diagnostic performance studies with specific acceptance criteria or detailed results, as those are not within the scope of this device's intended use.

Summary

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Konoss38

510(k) Summary

JUL - 3 2008

IDEAL LIFE Pod™ ILP 0001

Name of Device:	IDEAL LIFE Pod™ Model ILP 0001
Common Name:	Over the Counter Blood Glucose Test System
Classification Name:	21 CFR 862.1345, Class II
Product Code:	NBW
Classification Panel:	Clinical Chemistry Devices Panel
Sponsor:	IDEAL LIFE INC.
	110 Eglinton Ave., West, Ste. 303
	Toronto, M4R 1A3
	Ontario, CANADA
Contact:	Jason M. Goldberg
Tele:	416.489.1494, Ext 200
Fax:	416.489.3009
Date Prepared:	February 15, 2008

A. LEGALLY MARKETED PREDICATE DEVICES

K984527, In Touch Diabetes Management Software, Lifescan, Inc. K060504, IDEAL LIFE Pod, IDEAL LIFE INC.

B. DEVICE DESCRIPTION

C. INTENDED USE

The IDEAL LIFE Pod™ reccives data wirelessly from IDEAL LIFE devices to transmit over the Internet or common telephone lines from the user's home. The Pod is an optional accessory of IDEAL LIFE devices, including the GlucoManager™, the BP-Manager™ and/or the Body Manager™. The Pod is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.

The IDEAL LIFE Pod makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.

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510(k) Summary IDEAL LIFE Pod™ ILP 0001

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The IDEAL LIFE Pod Model ILP 0001, Version 2, is substantially equivalent to the Intended Use of the In Touch Diabetes Management Software (K984527) and both the Intended Use and technology of the IDEAL LIFE Pod Model ILP 0001, Version 1 (K060504). Differences with the new Pod have been demonstrated not to affect safety or effectiveness of the device, using software design controls, V&V testing, and user testing of the device. The decision algorithm brings us to a determination of Substantial Equivalence, as defined in the Federal Food, Drug, and Cosmetic Act.

E. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the IDEAL LIFE Pod Model ILP 0001 and the predicate Pod are extremely similar, having the same software and hardware design and controls and basic functionality.

F. TESTING

Hardware, software, and the manufacturing processes are the same as the predicate Pod. Software controls and validation and verification testing have demonstrated that the software changes do not affect device performance. Since the Pod is a wireless device, the radiofrequency interference and emissions have been tested and the Pod complies with appropriate FCC Standards. User testing and historical experience with the Pod have demonstrated that the Pod can be used in the intended setting.

G. CONCLUSIONS

IDEAL LIFE INC. has demonstrated through its comparison of characteristics with the predicate devices and software and hardware testing, that the ILP Model 0001, Version 2 is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion around the eagle. The eagle is facing left, and the text is in all capital letters.

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

JUL - 8 2008

Ideal Life, Inc. c/o Mandell Horwitz Consultants LLC Diane Horwitz, Ph.D., Regulatory Affairs Consultant 2995 Steven Martin Drive Fairfax, VA 22031

Re: K080538 Trade/Device Name: IDEAL LIFE Pod™, Model ILP 001 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: June 30, 2008 Received: June 30, 2008

Dear Dr. Horwitz:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M.Coopers, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K080538

Device Name: IDEAL LIFE Pod™, Model ILP 0001

Indication For Use:

The IDEAL LIFE Pod makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol Benson
Division Side Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080538

Page 1 of 2

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.