MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database. Monitoring devices that can interface to the MediCompass Connect include, but are not limited to:

Blood glucose monitor
Blood pressure cuffs I
Insulin pumps
Spirometers
. Scales

MediCompass Connect is designed for professional healthcare settings and home use.

Device Description

MediCompass Connect is a system that transmits data from personal monitoring devices using standard communication methods such as telephone lines or wireless, or transmits data by using a PC that has a connection to the Internet. MediCompass Connect transmits the data from a personal monitoring devices, such as a blood pressure cuff, to a remote general-purpose personal health management database.

Blood pressure cuffs .
. Blood glucose meters
Insulin pumps .
Spirometers .
. Scales

AI/ML Overview

This document is a 510(k) premarket notification for the MediCompass Connect device, which is a data transfer system for personal monitoring devices. It outlines the regulatory classification, a comparison to a predicate device, and the list of devices it is validated to work with. However, it does not contain the specific acceptance criteria or the results of a study that prove the device meets such criteria.

Therefore, I cannot populate the table or provide details for most of your questions based only on the provided text. The document is primarily a regulatory submission for substantial equivalence rather than a detailed performance study report.

Here's what I can infer and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not specified in this document. This document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance criteria related to accuracy or clinical effectiveness.
Reported Device Performance: Not provided. The document lists which devices MediCompass Connect is validated for use with, implying functional compatibility, but does not present data on its performance (e.g., data transfer success rate, speed, or accuracy of data transmission) against any set criteria.

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

Sample Size: Not specified.
Data Provenance: Not specified.

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

Not applicable as no specific test set or ground truth establishment relevant to device performance is described.

4. Adjudication method for the test set:

Not applicable.

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:

Not applicable. This device is a data transfer system, not an AI-powered diagnostic tool involving human readers.

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

Not explicitly stated. The "validation for use with" section (page 4) suggests functional testing for compatibility, but not a standalone performance study in the sense of an algorithm's diagnostic accuracy.

7. The type of ground truth used:

Not applicable as no specific ground truth for performance evaluation is mentioned. The ground truth for this type of device would likely be accurate data transfer, which would be verified through functional testing rather than expert-established ground truth.

8. The sample size for the training set:

Not applicable, as this device does not appear to involve machine learning or AI that would require a training set in the typical sense. It is a data transfer system.

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

Not applicable.

What information is provided regarding the device's assessment:

Predicate Device: Health Buddy® with BuddyLink (K040086) (Page 3).
Comparison: MediCompass Connect is stated to be "substantially equivalent" to the predicate device for general-purpose personal health management information communication (Page 4).
Validated Devices: A list of 27 personal monitoring devices (blood glucose monitors, blood pressure monitors, insulin pumps, spirometers) from various brands (Roche, Bayer, Abbott, LifeScan, Becton, Dickinson, and Company, HDI, A&D Medical, Omron Healthcare) that MediCompass Connect is validated to work with (Page 4). This indicates functional compatibility testing, but the details of this testing (e.g., how many tests per device, success rate, specific metrics) are not included in this summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2005

iMetrikus, Inc. c/o Mr. Curtis M. Egan Chief Operations Officer Certified Software Solutions, Inc. 5770 Armada Drive, Suite 100 Carlsbad, CA 92008

Re: K042768 MediCompass Connect Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: February 14,2005 Received: February 16,2005

Dear Mr. Egan;

This letter corrects our substantially equivalent letter of February 22, 2005, regarding the incorrect year cited for the date of your submission. Please see the above date for the correction.

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 (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 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. Curtis M. Egan

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 continue 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- _ . 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dmra R. Kochner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure 1. E-mail correspondance dated March 2,2005

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Indications for Use

510(k) Number (if known): K042768

Device Name: MediCompass Connect

Indications for Use:

Blood glucose monitor
Blood pressure cuffs I
Insulin pumps
Spirometers
. Scales

MediCompass Connect is designed for professional healthcare settings and home use.

Prescription Use (Per 21 CFR 801 109) OR

Over-the-counter U s e - X ____

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.L. Ammons

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042768

Page I of 1

01210

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K042768

FEB 2 2 2005

510(k) Summary

Date prepared:	September 29, 2004
Submitter/Owner:	iMetrikus, Inc.5770 Armada Drive, Suite 100Carlsbad, CA 92008
Contact person:	Dan Olivier16787 Bernardo Center Drive, Suite A-1San Diego, CA 92128
Phone number:	(858)675-8200
Fax number:	(858)675-8201
Proprietary name:	MediCompass Connect
Common name:	Data Transfer System
Classification:	Class II. 870.1130. Noninvasive blood pressure measurementsystem
Product Code:	DXN

Substantial equivalence claimed to:

Health Buddy® with BuddyLink 1. K040086 -

Description:

Blood pressure cuffs .
. Blood glucose meters
Insulin pumps .
Spirometers .
. Scales

{4}------------------------------------------------

K042768

Comparison of technological characteristics with predicate device:

MediCompass Connect is a system to transmit data that is substantially equivalent to the currently marketed Health Buddy with BuddyLink (K040086). Both systems are for the communication of general purpose personal health management information.

Devices validated for use with MediCompass Connect

Brand	Personal MonitoringDevices	Model
Roche	Blood glucose monitor	Accu-Chek® Advantage
Bayer	Blood glucose monitor	Ascensia Elite™ XL (model number3901G)
Abbott	Blood glucose monitor	TheraSense FreeStyle™ (A)**
LifeScan	Blood glucose monitor	One Touch® II®
LifeScan	Blood glucose monitor	One Touch® Profile®
LifeScan	Blood glucose monitor	One Touch® Ultra®
Becton, Dickinson,and Company	Blood glucose monitor	BD Logic™
Roche	Blood glucose monitor	Accu-Chek® Compact
Abbott	Blood glucose monitor	MediSense® Precision Xtra™
Abbott	Blood glucose monitor	MediSense® Precision Q-I-D®
Bayer	Blood glucose monitor	Ascencia® Breeze™
Roche	Blood glucose monitor	Accu-Chek® Complete
HDI (HomeDiagnostics, Inc.	Blood glucose monitor	Prestige IQ™
A&D Medical	Blood pressure monitor(arm cuff)	LifeSource™ UA-767PC
LifeScan	Blood glucose monitor	One Touch® SureStep®
Omron Healthcare	Blood pressure monitor(arm cuff)	HEM 705CP
Omron Healthcare	Blood pressure monitor(wrist cuff)	HEM 637
Becton, Dickinson,and Company	Blood glucose monitor	BD Paradigm Link™
LifeScan	Blood glucose monitor	InDuo®
Abbott	Blood glucose monitor	TheraSense FreeStyle™ (C)**
LifeScan	Blood glucose monitor	One Touch® Basic®
Roche	Blood glucose monitor	Accu-Chek® Active
Bayer	Blood glucose monitor	Glucometer Elite™ XL (model number3901B)
iMetrikus	Personal respiratorymonitor	AirWatch®
Roche	Insulin pump	Disetronic D-TRON™ plus
HDI	Blood glucose monitor	TrueTrack Smart System™
Bayer	Blood glucose monitor	Ascensia® DEX™

Typically referred to as the (A) model, the serial number of this TheraSense Freesty'e begins with A.

** Typically referred to as the (C) model, the serial number of this TheraSense Freestyle meter begins with C.

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).