CONFIDANT 2.5

K072698 · Confidant, Inc. · DRG · Nov 16, 2007 · Cardiovascular

Device Facts

• Record ID: K072698
• Device Name: CONFIDANT 2.5
• Applicant: Confidant, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health. Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.5 does not provide diagnosis of any disease or medical condition. Confidant 2.5 is not 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. Confidant 2.5 is not intended for emergency calls 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. Confidant 2.5 is intended for over-the-counter use.

Device Story

Accessory system collecting physiologic data (glucose, blood pressure, weight) from home-monitoring devices; transmits data via wireless technology to central database server. Server software processes current and historic patient data to select and send automated feedback messages to patient's cell phone. Used by patients in home setting; OTC. Provides objective observations and motivational information to assist patient health management. Does not provide diagnosis, real-time alarms, or treatment decisions; requires professional healthcare oversight.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including electrical safety, EMC testing of the Confidant Connector, and software testing of the Confidant Collector and Server components, alongside device compatibility testing with supported home-monitoring hardware.

Technological Characteristics

System comprises Confidant Connector (hardware), Confidant Collector, and Confidant Server software. Utilizes standard wireless technologies for data transmission. Operates as an accessory to home-monitoring devices (glucose meters, BP cuffs, scales).

Indications for Use

Indicated for out-of-hospital patients for retrospective collection and recording of physiologic measurements (blood glucose, blood pressure, weight) from home monitoring devices to receive objective observations and motivational feedback via cell phone. Not for emergency use, real-time alarms, diagnosis, or automated treatment decisions.

Regulatory Classification

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.

Predicate Devices

• Confidant 2.0 (K062215)
• Honeywell HomMed Genesis OTC Monitor System (K061087)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for DC Confidant. The logo consists of two curved shapes resembling the letters 'D' and 'C'. To the right of the curved shapes, the word "CONFIDANT" is written in capital letters. The font appears to be a serif font.

# 510(K) SUMMARY

K072698

In accordance with 21 CFR 807.92, the following information constitutes Confidant's summary for the Confidant 2.5 System.

SUBMITTER'S NAME: ADDRESS: CONTACT PERSON: CONTACT PERSON TITLE: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION:

Confidant International, LLC 2530 Meridian Parkway, Suite 300 Daniel R. Plonski Director of Product Management [phone] [phone] September 20, 2007

## Identification of device 1

Proprietary Name: Confidant 2.5 Common Name: Physiological Transmitter and Receiver Classification Status: Class II per regulations 870.2910 Product Codes: DRG

## 2 Equivalent devices

Confidant Inc. believes that Confidant 2.5 is substantially equivalent to the following legally marketed devices:

Confidant 2.0 Honeywell HomMed Genesis K062215 OTC Monitor System K061087 Confidant Inc. Honeywell HomMed, LLC

## Description of the device 3

Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.5 currently supports several models of glucose meters, noninvasive blood pressure cuffs and weight scales.

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# 4 Intended use

Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.

Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.5 does not provide diagnosis of any disease or medical condition.

Confidant 2.5 is not 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.

Confidant 2.5 is not intended for emergency calls 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.

Confidant 2.5 is intended for over-the-counter use.

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2530 Meridian Parkway, Ste 300 Durham, NC 27713 (W) 919.806.4620 (F) 919.806.4802

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## Technological characteristics, comparison to predicate 5 device.

Confidant 2.5 utilizes the same technology as one or both of the predicate devices (Confidant 2.0, K062215 and/or Honeywell HomMed Genesis OTC Monitor System, K061087) including:

- The same supported monitoring devices �
- The same operating features .
- The same fundamental technology .

### Discussion of functional and safety testing. 6

Testing of Confidant 2.5 included electrical safety and EMC testing of the Confidant Connector component; software testing of the Confidant Collector and Confidant Server components; and low-level, device compatibility testing with each of the supported monitoring devices. The test results demonstrate that Confidant 2.5 is in compliance with the applied standards and that it performed within its specifications and functional requirements.

#### Conclusion 7

Based on the comparison of intended use, supported monitoring devices, operational features and technology and the results of electrical safety. EMC, device compatibility and performance testing, it is our conclusion that Confidant 2.5 is as safe, as effective and performs as well as the legally marketed predicate devices.

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, which is the symbol of the HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

Confidant International, LLC c/o Mr. Daniel R. Plonski Director of Product Management 2530 Meridian Parkway, Suite 300 Durham, NC 27713

Re: K072698

Device Name: Confidant 2.5 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: September 20, 2007 Received: September 24, 2007

Dear Mr. Plonski:

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. Daniel R. Plonski

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 [phone]. 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.gov/cdrh/industry/support/index.html.

Sincerely yours,

B.Jemimson 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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# Indications for Use

510(k) Number (if known): K072698

Device Name: Confidant 2.5

Indications For Use: Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.

Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.

Confidant 2.5 does not provide diagnosis of any disease or medical condition.

Confidant 2.5 is not 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.

Confidant 2.5 is not intended for emergency calls or for transmission of any real-time alarms or timecritical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.

Confidant 2.5 is intended for over-the-counter use.

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima

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