MEDICOMPASS CONNECT

K042768 · Imetrikus, Inc. · DXN · Feb 22, 2005 · Cardiovascular

Device Facts

• Record ID: K042768
• Device Name: MEDICOMPASS CONNECT
• Applicant: Imetrikus, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Insulin pumps Spirometers Scales MediCompass Connect is designed for professional healthcare settings and home use.

Device Story

MediCompass Connect acts as a data transmission gateway; it collects health data from personal monitoring devices (blood glucose meters, blood pressure cuffs, insulin pumps, spirometers, scales). The system transmits this data to a remote general-purpose personal health management database via telephone lines, wireless connections, or an internet-connected PC. Used in professional healthcare settings and home environments; operated by patients or healthcare providers. The device facilitates remote monitoring by enabling the transfer of patient-generated health data to a centralized database, allowing providers to review patient information for clinical decision-making and health management.

Clinical Evidence

No clinical data provided. The submission relies on the substantial equivalence of the data transmission functionality to the predicate device.

Technological Characteristics

Data transmission system; interfaces with various third-party personal monitoring devices via standard communication methods (telephone, wireless, internet-connected PC). Acts as a gateway for data relay to a remote database. No specific materials, energy sources, or software algorithm classes are detailed beyond its function as a communication interface.

Indications for Use

Indicated for use as a data gateway between personal monitoring devices (e.g., blood glucose monitors, blood pressure cuffs, insulin pumps, spirometers, scales) and a personal health management database. Intended for professional healthcare settings and home use.

Regulatory Classification

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.

Predicate Devices

• Health Buddy with BuddyLink (K040086)

Submission Summary (Full Text)

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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 [phone] or [phone] 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:

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.

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)

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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

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K042768

# FEB 2 2 2005

# 510(k) Summary

| Date prepared: | September 29, 2004 |
|-------------------|------------------------------------------------------------------------------|
| Submitter/Owner: | iMetrikus, Inc.<br>5770 Armada Drive, Suite 100<br>Carlsbad, CA 92008 |
| Contact person: | Dan Olivier<br>16787 Bernardo Center Drive, Suite A-1<br>San Diego, CA 92128 |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Proprietary name: | MediCompass Connect |
| Common name: | Data Transfer System |
| Classification: | Class II. 870.1130. Noninvasive blood pressure measurement<br>system |
| Product Code: | DXN |

### Substantial equivalence claimed to:

Health Buddy® with BuddyLink 1. K040086 -

#### 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

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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 Monitoring<br>Devices | Model |
|-----------------------------------|----------------------------------------|----------------------------------------------|
| Roche | Blood glucose monitor | Accu-Chek® Advantage |
| Bayer | Blood glucose monitor | Ascensia Elite™ XL (model number<br>3901G) |
| 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,<br>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 (Home<br>Diagnostics, Inc. | Blood glucose monitor | Prestige IQ™ |
| A&D Medical | Blood pressure monitor<br>(arm cuff) | LifeSource™ UA-767PC |
| LifeScan | Blood glucose monitor | One Touch® SureStep® |
| Omron Healthcare | Blood pressure monitor<br>(arm cuff) | HEM 705CP |
| Omron Healthcare | Blood pressure monitor<br>(wrist cuff) | HEM 637 |
| Becton, Dickinson,<br>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 number<br>3901B) |
| iMetrikus | Personal respiratory<br>monitor | 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.