(72 days)
Not Found
No
The description focuses on data collection, transmission, and basic data presentation (tracking, graphing, variance noting, alerts based on set criteria). There is no mention of algorithms that learn from data or perform complex analysis beyond simple thresholding for alerts.
No
The device is described as a "physiological monitoring system" intended to collect, accumulate, and transmit patient vital signs and other physiological data for monitoring purposes, not for direct treatment or therapy.
No
The device is a physiological monitoring system that collects and transmits patient vital signs and other physiological data. It provides supplemental information for patient care, but it does not independently diagnose conditions.
No
The device description explicitly states that the system consists of hardware components: wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server.
Based on the provided information, the Carematix™ Wellness System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Carematix™ Function: The Carematix™ system collects physiological data from the patient in vivo (within the body or directly from the body surface). It uses existing monitoring devices (like blood pressure cuffs, pulse oximeters, glucometers, etc.) to gather this data and then transmits it.
- Data Sources: While it collects data from devices that might perform in vitro measurements (like a glucometer or PT/INR system), the Carematix™ system itself is not performing the in vitro test. It's acting as a data collection and transmission system for various physiological parameters.
- Intended Use: The intended use describes monitoring physiological parameters and transmitting them to a healthcare practitioner. This aligns with remote patient monitoring, not in vitro diagnostics.
The system acts as a hub and communication channel for various monitoring devices, some of which could be IVDs (like the glucometer or PT/INR system), but the Carematix™ system itself is not performing the diagnostic test on a specimen.
N/A
Intended Use / Indications for Use
The Carematix TM 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. 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 FEV/PEFR.
- The communications hub, or receiving station, collects and stores data transmitted from each of the radiofrequency transmitter adapters or wired device and transmits patient data to the internet server via PSTN. LAN. cellular, wireless etc.
- 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, note variances, set alert criteria, and receive notifications 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
Home use, healthcare practitioner, clinical setting.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation tests were conducted for the Carematix Wellness System in accordance with Good Manufacturing Practices and the results met acceptable criteria. The Carematix™ Wellness System also conforms to requirements of IEC 60601-1 and we consider it safe and effective.
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
510(k) Summary
Carematix™ Wellness System
MAY - 5 2010
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. 209 W Jackson Blvd, Suite 800 Chicago, IL 60606
Contact Person
Sukhwant Khanuja, Ph. D. Chief Executive Officer Carematix™, Inc. 209 W Jackson Blvd, Suite 800 Chicago, IL 60606 Phone: (312) 627-9300 e-mail: skhanuja@carematix.com
Date Prepared:
February 15, 2010
NAME OF DEVICE
Carematix™ Wellness System
CLASSIFICATION NAMES
Radiofrequency Physiological Signal Transmitters and Receivers
DEVICE CLASSIFICATION
Regulatory Class: Product Code: Classification Panel: Regulation Number:
Class II DRG Cardiovascular Device Panel 21 CFR 870.2910
PREDICATE DEVICES
K040966; K073038- 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 FEV/PEFR.
- � The communications hub, or receiving station, collects and stores data transmitted from each of the radiofrequency transmitter adapters or wired device and transmits patient data to the internet server via PSTN. LAN. cellular, wireless etc.
- 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, note
1
Special 510(k) Notification- Response for additional Information
variances, set alert criteria, and receive notifications 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 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.
PERFORMANCE TESTING
Verification and Validation tests were conducted for the Carematix Wellness System in accordance with Good Manufacturing Practices and the results met acceptable criteria. The Carematix™ Wellness System also conforms to requirements of IEC 60601-1 and we consider it safe and
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, and Carematix™ Wellness System cleared under K073038 on Jan 11, 2008.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - GSA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - GSA" arranged around the circumference. Inside the circle is a stylized image of an abstract human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create a sense of movement and openness.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Carematix, Inc c/o Sukhwant Khanuja, PhD CEO 209 W Jackson Blvd, Suite 800 Chicago, IL 60606
MAY - 5 2010
Re: K100508
Trade/Device Name: Carematix Wellness System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: April 1, 2010 Received: April 5, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Dr. Khanuja
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
W.W. Watt
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
510(k) Number K100508
Device Name: CarematixTM 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. 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.
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)
ivision of Cardiovascular Devices
510(k) Number K100508