(76 days)
Not Found
No
The description focuses on data collection, transmission, and the delivery of pre-set educational/motivational messages based on parameters set by the healthcare provider. There is no mention of the device learning from data or making decisions based on complex algorithms that would indicate AI/ML.
No
Explanation: Confidant 2.0 is described as a device that collects and transmits medical measurements and sends educational/motivational messages. It explicitly states it is "not intended to provide automated treatment decisions" or be "a substitute for professional healthcare judgment," indicating it does not directly provide therapy.
No
The device collects and transmits medical measurements to healthcare providers and provides educational/motivational messages. It is explicitly stated that it is "not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment." This indicates it does not independently diagnose. All diagnoses are to be performed by a healthcare professional.
No
The device description explicitly states that Confidant 2.0 is an "accessory device that collects data from a range of supported measurement devices" such as glucose meters, blood pressure cuffs, and weight scales. While it uses software for data transmission and message delivery, it relies on external hardware devices for data collection, making it not solely a software device.
Based on the provided information, Confidant 2.0 is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description of Confidant 2.0 clearly state that it collects and transmits measurements from external devices (glucose meters, blood pressure cuffs, weight scales). It does not analyze biological specimens.
- Confidant 2.0 acts as a data collection and transmission hub. It facilitates the transfer of data from measurement devices to healthcare providers and sends back educational/motivational messages. It does not perform any diagnostic testing itself.
The device's function is focused on remote patient monitoring and communication, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / 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 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.
Product codes
DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
out-of-hospital patients, licensed physician or other authorized healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 PERSON | |
| TITLE | 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
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.
1
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
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.
2
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: -
- 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.
-
- 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.
3
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.
4
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
5
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.
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.
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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