Confidant 2.0 is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. Confidant 2.0 is to be used only upon prescription of a licensed physician or other authorized healthcare provider.

Confidant 2.0 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 2.0 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.

Device Description

Confidant 2.0 is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Confidant 2.0 currently supports several models of glucose meters, non-invasive blood pressure cuffs and weight scales.

AI/ML Overview

The Confidant 2.0 device is a physiological transmitter and receiver that collects and transmits medical measurements to a healthcare provider and provides educational and motivational messages to the patient.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The provided text does not explicitly state specific, quantifiable acceptance criteria such as accuracy thresholds, sensitivity, or specificity. Instead, the evaluation focuses on "substantial equivalence" to a predicate device.

Acceptance Criteria	Reported Device Performance
Functional Equivalence to legally marketed predicate device (The Hermes System K050929)	Confidant 2.0 provides equivalent functionality to The Hermes System K050929.
Additional Device Support	Confidant 2.0 supports six models of off-the-shelf glucose meters (vs. 1 for predicate), two models of blood pressure cuffs (vs. 1 for predicate), and two models of weight scales (vs. 1 for predicate).
Battery Powered Data Converter	Confidant 2.0 uses a battery-powered serial to Bluetooth data converter (vs. AC powered for predicate).
Safety and Effectiveness	An extensive collection of tests was conducted and successfully completed, and Confidant Inc. concluded that the device presents no new concerns about safety and effectiveness. The FDA concurred with substantial equivalence.
Intended Use	The device's intended use, as stated, is to collect and transmit medical measurements and provide educational/motivational messages to out-of-hospital patients, upon prescription. It is not for emergency calls, real-time alarms, automated treatment decisions, or as a substitute for direct medical supervision. The device performed within this intended use.

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

The document mentions "usability and pilot studies" and "software unit, integration, system and load/performance testing," but it does not specify the sample size for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature).

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)

The document does not mention the use of experts to establish ground truth for a test set. This type of device (physiological transmitter and receiver) primarily focuses on data collection and transmission functionality, rather than diagnostic interpretation that would typically require expert ground truth.

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

Since the document does not describe a clinical study or a test set requiring interpretation, there is no mention of an adjudication method.

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

There is no indication of an MRMC comparative effectiveness study being conducted. The device is not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

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

The "stand-alone" performance of the Confidant 2.0 device itself was implicitly evaluated through "software unit, integration, system and load/performance testing." This testing would assess the device's functionality (data collection, transmission, message delivery) without direct human intervention in the core operational loop. However, the exact methodology and results are not detailed beyond "successfully completed."

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

Given the nature of the device, the "ground truth" for the functional and safety testing would likely involve:

Successful transmission and reception of data: Verifying that measurements are accurately collected from supported devices and transmitted to the database server.
Correct message delivery: Confirming that educational and motivational messages are delivered to the patient as intended based on configured parameters.
System stability and performance: Ensuring the device operates reliably under various conditions.

The document does not explicitly state "ground truth" based on expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic or prognostic devices.

8. The sample size for the training set

The document does not mention a training set or its sample size. The device functions as a data collection and transmission system, not a machine learning model that typically requires a distinct training set.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

Summary

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K062215
p1/3

OCT 16 2006

510(K) SUMMARY

In accordance with 21 CFR 807.92, the following information constitutes Confidant's summary for the Confidant 2.0 System.

SUBMITTER'S NAME:	Confidant Inc.
ADDRESS:	2530 Meridian Parkway, Suite 300
CONTACT PERSON:	Daniel R. Plonski
CONTACT PERSONTITLE	Director of Product Management
TELEPHONE NUMBER:	(919) 806-4323
FAX NUMBER:	(919) 806-4802
DATE OF SUBMISSION:	July 27, 2006

ldentification of device 1

Proprietary Name: Confidant 2.0 Common Name: Physiological Transmitter and Receiver Classification Status: Class II per regulations 870.2910 Product Codes: DRG

Equivalent devices N

Confidant Inc. believes that Confidant 2.0 is substantially equivalent to the following legally marketed device:

The Hermes System K050929 (DRG) .

3 Description of the device

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Confidant 2.0 messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Confidant 2.0 can send email to the patient's doctor and/or guardian if good habits are not maintained.

KO62215

トコピ3

4 Intended use

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5 Technological characteristics, comparison to predicate device.

Confidant 2.0 provides equivalent functionality as the following legally marketed device:

. The Hermes System K050929 (DRG)
Two technical characteristics differentiate The Confidant 2.0 from the predicate device:
1. Additional Support of Off The Shelf Measurement Devices -Confidant 2.0 supports six models of off the shelf glucose meters, two models of blood pressure cuffs and two models of weight scales. The predicate device provided support for one glucose meter, one blood pressure cuff and one weight scale.
1. Battery Powered Data Converter Confidant 2.0 uses a battery powered serial to Bluetooth data converter. The predicate device used an AC powered unit.

Discussion of functional and safety testing. 6

An extensive collection of tests has been conducted and successfully completed, including usability and pilot studies, software unit, integration, system and load/performance testing and document verification.

Conclusion 7

Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of Confidant Inc. that Confidant 2.0 is substantially equivalent to the previously cleared predicate device and presents no new concerns about safety and effectiveness.

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Image /page/3/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

OCT 16 2006

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

Re: K062215 Trade Name: Confidant 2.0 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitters and receivers Regulatory Class: Class II (two) Product Code: DRG Dated: September 15, 2006 Received: September 18, 2006

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 markcted 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 (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.

Blimmiman 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): K062215

Device Name: Confidant 2.0

Indications For Use: Confidant 2.0 is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and thought to their healthcare provider and to receive returned educational messages to pleasury better understand and manage their chronic condition. Confidant 2.0 is to be used only upon prescription of a licensed physician or other authorized healthcare provider.

Confidant 2.0 is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Bhimman

Division Sign-Off. Division of Cardiov 510/ki Nur

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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).