(74 days)
Not Found
No
The description focuses on data collection, transmission, storage, and basic trending/alerting, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a physiological monitoring system that collects and transmits patient vital signs and other physiological data, providing supplemental information for patient care, rather than directly treating or mitigating a disease.
No.
The "Intended Use / Indications for Use" states that the system "collects, accumulates and transmits patient vital signs and other physiological data" and that "The results of these measurements are transmitted to a computer monitoring station in a clinical setting". The "Device Description" also emphasizes its role in gathering and transmitting data to caregivers for informational purposes ("provides supplemental information for the care of the patient"). While it measures physiological parameters, its primary function described is data collection and transmission for monitoring, not for primary diagnosis where it would interpret or classify findings to determine a disease state without clinician intervention.
No
The device description explicitly states that the system consists of hardware components including wireless radiofrequency transmitter adapters, a communication hub, and an internet server, in addition to the software for data transmission and presentation.
Based on the provided information, the Carematix™ Wellness System itself is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Carematix™ System Function: The Carematix™ system is a physiological monitoring system. Its primary function is to collect, accumulate, and transmit data from other monitoring devices (which may or may not be IVDs themselves, like the glucometer or coagulation measurement system). It doesn't perform the diagnostic test on the specimen itself.
- Role of the System: The system acts as a data aggregator and communication tool, facilitating the transfer of physiological data from the patient's home to the healthcare practitioner. The diagnostic interpretation is done by the healthcare practitioner based on the data provided by the connected devices.
Think of it this way: The Carematix™ system is like a secure messenger service for medical data. It doesn't perform the medical tests; it just reliably delivers the results of those tests (performed by other devices) to the doctor.
While the system uses data from devices that could be IVDs (like the glucometer for blood glucose), the Carematix™ system itself is focused on data transmission and management, not the in vitro diagnostic testing process.
N/A
Intended Use / Indications for Use
The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:
Non-invasive blood pressure measurement:
Pulse rate measurement;
Blood glucose level using a Glucometer;
Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter;
Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system:
Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;
Patient weight using a stand-on electronic scale
The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
Product codes
DRG
Device Description
The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient.
The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server:
- The radiofrequency transmitter adapter is connected, either wired directly or . to a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEVR/PEF.
- The communications hub, or receiving station, collects and stores data . transmitted from each of the radiofrequency transmitter adapters and transmits patient data to the internet server at specified intervals.
- The internet server receives the patient data from the home setting or remote location where it is made available to the caregiver to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside . the criteria set.
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
patient home use, caregivers at a clinical facility
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
Not Found
Summary of Performance Studies
The Carematix™ Wellness System was tested and passed all required electrical and mechanical testing. The Carematix™ Wellness System performance was tested with clinical data and the results met the acceptable criteria.
Key Metrics
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
510(k) Summary of Safety and Effectiveness
Carematix™ Wellness System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter
Carematix™, Inc. 120 S. Riverside Plaza, Suite 2100 Chicago, IL 60606
Contact Person
Sukhwant Khanuia, Ph. D. Chief Executive Officer Carematix™, Inc. 120 S. Riverside Plaza, Suite 2100 Chicago, IL 60606
JAN 1 1 2008
Phone: (312 627-9300 e-mail: skhanuja@carematix.com
Date Prepared:
October 23, 2007
Name of Device
Carematix™ Wellness System
Classification Names
Radiofrequency Physiological Signal Transmitters and Receivers
Device Classification
| Regulatory Class: | Class II |
|---|---|
| Product Code: | DRG |
| Classification Panel: | Cardiovascular Device Panel |
| Regulation Number: | 21 CFR 870.2910 |
Predicate Devices
K040966 Carematix™ Wellness System
Carematix™, Inc.
Description of Device
The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient.
The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server:
- The radiofrequency transmitter adapter is connected, either wired directly or . to a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEVR/PEF.
- The communications hub, or receiving station, collects and stores data . transmitted from each of the radiofrequency transmitter adapters and transmits patient data to the internet server at specified intervals.
1
- . The internet server receives the patient data from the home setting or remote location where it is made available to the caregiver to track, graph, trend, note Page 1 of 2
- variances, set alert criteria, and receive alerts when parameters are outside . the criteria set.
Indications For Use
The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:
Non-invasive blood pressure measurement:
Pulse rate measurement:
Blood qlucose level using a Glucometer:
Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter;
Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coaqulation measurement system:
Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;
Patient weight using a stand-on electronic scale
The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
Nonclinical Performance
The Carematix™ Wellness System was tested and passed all required electrical and mechanical testing.
Clinical Performance
The Carematix™ Wellness System performance was tested with clinical data and the results met the acceptable criteria.
Conclusion
The Carematix™ Wellness System is substantially equivalent to the following 510(k) cleared devices:
Carematix™ Wellness System cleared under K040966 on June 2, 2004
... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ? > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > >
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, composed of three curved lines, symbolizing health and well-being. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
JAN 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carematix Inc. c/o Sukhwant Khanuja, Ph.D. Chief Executive Officer 120 S. Riverside Plaza, Suite 2100 Chicago, IL 60606
Re: K073038
Trade/Device Name: Carematix™ Wellness System Model CWS-5000.1-B Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: December 11, 2007 Received: December 13, 2007
Dear Dr. Khanuja:
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.
3
Page 2 - Sukhwant Khanuja, Ph.D.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Bymmermafr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K073038 510(k) Number
Device Name: Carematix™ Wellness System
Indications for Use:
The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:
Non-invasive blood pressure measurement: Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system: Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale
The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
Prescription Use (per 21 CFR 801.109)
and/or Over-the-counter Use
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bymmoma
Division of Caraio 510fk) Number