The MediCompass® Connect serves as an interface or a gateway between personal monitoring devices and a general-purpose personal health management database. The MediCompass Connect collects physiologic measurements and retrospectively monitors vital signs from defined personal monitoring devices and transmits the data to a central database server, using standard communication technologies. MediCompass Connect is designed for professional, personal and home use.

MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.

Device Description

MediCompass® Connect is a telehealth gateway to upload biometric data from personal health monitoring devices, including glucose monitors, insulin pumps, blood pressure monitors, digital spirometers, pulse oximeter, PT/INR meter, activity monitor/pedometer, and weight scales. The system conveniently transfers data via a standard phone line or Internet-enabled personal computer using the MetrikLink® connectivity hub, or connection directly to mobile devices via wireless technology.

After connectivity is activated by a health care professional, patients can connect their monitoring device to MediCompass Connect using MetrikLink, adapters or compatible cables provided for their specific medical device and model. The data captured from the personal monitoring medical devices is transferred securely to the MediCompass database or other secure online database, then to the health care provider's remote general purpose health management database.

MediCompass Connect does not provide diagnosis of any disease or medical condition, nor is it intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

MediCompass Connect is not intended for emergency use or for transmission or indication of any real-time alarms or time critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

AI/ML Overview

The provided text describes the MediCompass® Connect, a telehealth gateway. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

The document mainly focuses on:

Regulatory information: Device classification, predicate devices, and FDA substantial equivalence determination.
Device description: How it functions as an interface to transfer biometric data.
Indications for Use: The intended purpose of the device.
Performance Testing (High-level): A brief statement saying "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of MediCompass Connect... The results of all performance testing were acceptable and demonstrated performance as intended."

Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth, and expert involvement for a specific study proving device performance cannot be extracted from this document.

Here's how to address each point based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
(Not specified in the document)	"The results of all performance testing were acceptable and demonstrated performance as intended."
Functionality as a data transfer gateway	Demonstrated in performance testing.
Reliability of data transfer	Demonstrated in performance testing.
Connectivity with listed personal monitoring devices	Demonstrated in performance testing (implied by "support the connection of additional personal medical devices").
Secure data transfer to database	Implied by device description ("data captured... is transferred securely to the MediCompass database").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document does not describe a study involving expert-established ground truth for diagnostic or clinical performance. The device is a data transfer gateway, not a diagnostic tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable; no clinical study or diagnostic performance evaluation described.

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

No MRMC study was done. This device is not an AI diagnostic tool and does not involve human readers for interpretation.

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

A "standalone" performance testing for the device's function as a data gateway was done, as stated: "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of MediCompass Connect... The results of all performance testing were acceptable and demonstrated performance as intended." However, no quantitative standalone performance metrics (e.g., accuracy of data transfer, speed, error rate) are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically used in diagnostic or AI studies is not directly applicable here. The device's function is data transfer. Its "ground truth" would likely involve successful transfer of data identical to the source, without corruption or loss. The text does not detail how this "ground truth" for data integrity was established during testing.

8. The sample size for the training set

Not applicable. This device is a hardware/software system for data transfer, not an AI model that requires a "training set" in the machine learning sense.

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

Not applicable. (See #8)

Summary

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Attachment 6 510(k) Summary

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Michael Acosta iMetrikus, Inc. 2141 Landings Drive Mountain View, CA 94043 650.396.1200 (phone) 650.396.1155 (fax)

NAME OF DEVICE

MediCompass® Connect Trade Name: Common Name: Data Transfer and Management System Classification Names: Physiological Signal Transmitter and Receiver

RegulationNumber	ProductCode	Classification Name	DeviceClass
870.2910	DRG	Physiological Signal Transmittersand Receivers	II

PREDICATE DEVICES

. MediCompass Connect (iMetrikus, Inc): #K042768
CareMatix Wellness System (CareMatix, Inc.): #K073038, K040966 t
. Confidant 2.6, (Confidant, Inc): #K083331
Health Buddy Appliance (Health Hero Network): (#K080091, #K070543, #K063612, � #K060843, #K050567, #K042273, K040086, #K993128)

DEVICE DESCRIPTION

510(K) #K091021 MediCompass® Connect

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INDICATION FOR USE STATEMENT

MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.

SUBSTANTIAL EQUIVALENCE COMPARISON

This submission represents a modification to the existing MediCompass Connect software to support the connection of additional personal medical devices. It is substantially equivalent to the cleared MediCompass Connect (iMetrikus, Inc) in #K042768. The device is also substantially equivalent to Confidant 2.6, Health Buddy Appliance, and to the CareMatix Wellness System, all of which use connections between the personal health monitoring device and management database.

PERFORMANCE TESTING

Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of MediCompass Connect when connected to personal monitoring medical devices using the associated communications methods. The results of all performance testing were acceptable and demonstrated performance as intended.

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CONCLUSION

MediCompass Connect is substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food, Drug and Cosmetic Act. The modified device has the same fundamental scientific technology and intended use as the predicate devices. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate devices.

510(K) #K091021 MediCompass® Connect

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 2009

iMetrikus , Inc. c/o Mr. Michael Acosta Vice President, Quality Assurance and Regulatory Affairs 2141 Landings Drive Mountain View, CA 94043

K091021 Re:

MediCompass® Connect Regulation Number: 21 CFR 870. 2910 Regulation Name: Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: June 03, 2009 Received: June 04, 2009

Dear Mr. Acosta:

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 - Mr. Michael Acosta

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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iMetrikus, Inc

Attachment 5 Indications for Use

. # K091021 510(k) Number:

Device Name:

MediCompass® Connect

Indications for Use:

MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.

Prescription Use_XX (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 807 Subpart C) K091021

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
	7/15/09

Page 1 of 1

510(K) #K091021MediCompass ® Connect 510(k) Number	Division of Cardiovascular DevicesK091021
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Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).