(49 days)
No
The description focuses on data collection, transmission, and basic monitoring/alerting features. There is no mention of AI or ML algorithms being used for analysis, interpretation, or prediction.
No.
The system is described as a "physiological monitoring system" for collecting, accumulating, and transmitting patient vital signs and other physiological data for remote monitoring by healthcare practitioners. It is not intended to treat or prevent a disease or condition, which is a characteristic of a therapeutic device.
No
The device is described as a "physiological monitoring system" intended for collecting, accumulating, and transmitting patient vital signs and other physiological data. While it monitors various health parameters, its primary function is data collection and transmission for a healthcare practitioner to review, rather than providing a diagnosis itself. It facilitates monitoring, which can inform a diagnosis, but does not perform diagnostic functions like interpreting symptoms or signs to determine the nature of a disease.
No
The device description explicitly lists several hardware components (Blood pressure unit, Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, etc.) that are part of the system, indicating it is not software-only.
Based on the provided text, the Carematix Wellness System is not an In Vitro Diagnostic (IVD) 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 Wellness System collects and transmits physiological data from the patient's body (blood pressure, pulse rate, temperature, weight, etc.) using various monitoring devices. While it uses data from devices that might involve in vitro measurements (like a glucometer or coagulation measurement system), the Carematix system itself is primarily a data collection and transmission system for in vivo physiological parameters.
- Intended Use: The intended use describes the system as a "physiological monitoring system" that collects and transmits "patient vital signs and other physiological data." This aligns with monitoring in vivo functions, not analyzing in vitro specimens.
Therefore, the Carematix Wellness System falls under the category of a physiological monitoring system, not an IVD.
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;
- Blood glucose level using a Glucometer;
- Patient weight using a stand-on electronic scale.
- Pulse rate measurement;
- 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;
- Body temperature measurement using a digital thermometer;
- Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;
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 (comma separated list FDA assigned to the subject device)
DXN, DRG
Device Description
The Carematix Wellness System (CWS) provides easy monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send reminders and receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, Coagulation Measurement System adaptors, Digital Thermometer adaptors, Peak Flow Meter adaptors.
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 users and Health care provider / Home; clinic
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)
The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices. Testing to demonstrate substantial equivalence for this product similarly to the predicates relies on:
- Testing to meet the product requirements and functional specifications
- Verification that the physiologic data received by the patient monitors are stored properly; and
- Verification that the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K023749, K993169, K011779, K010029, K030419, K031840
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 2 2004
EXHIBIT 2 - 510(k) Summary of Safety and Effectiveness
Carematix, Inc. 2 N. LaSalle Street, Suite 1904 Chicago, IL 60602 Ph: 312-332-2444 Fax: 312-332-0100
April 05, 2004 Contact: Dr. Sukhwant Khanuja, Director
l. Identification of the Device:
Proprietary-Trade Name: Carematix Wellness System Classification Names: DXN: System, Measurement, Blood-Pressure, Non-Invasive DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency Common/Usual Name: Telemedicine system
-
- Equivalent legally marketed devices: This product is similar in function to the M3810a Philips Telemonitoring System, K023749 and Hewlett Packard Company Model 3810A, K993169; AvidCare Series 100 Telemanagement System, K011779; AvidCare Corporation Home Health Monitoring System, K010029; Viterion 100 Telehealth Monitor, K030419; Carematix Wellness System, K031840. The Carematix Wellness System only uses sensor devices already cleared with 510(k) approvals; OR provides adaptors for biometric measurement devices having existing 510(k) approvals. The Stand-on patient scale is exempt from pre-market notification as per 880.2700. Please refer to Exhibit 4: System Description for specific details on the sensor devices used with the Carematix Wellness Systems.
-
- Indications for Use (intended 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) and pulse rate using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio
1
(INR) measurement using an in-home coagulation measurement system; Body temperature measurement using a digital thermometry device or 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 Device: Federal law (US) restricts this device to sale by or on the order of a physician.
- Description of the Device: The Carematix Wellness System (CWS) provides easy 5. monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send reminders and receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, Coagulation Measurement System adaptors, Digital Thermometer adaptors, Peak Flow Meter adaptors.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices.
-
- Substantial Equivalence Chart
| Feature | Avid Care
K011779 and
K010029 | Philips
K023749 | Viterion
K030419 | Carematix
K031840 | Carematix
Modified
System |
|-----------------------|-----------------------------------------------------------------------------------------------|--------------------|---------------------|----------------------|---------------------------------|
| Indications of
Use | Enables
healthcare
providers to
manage chronic
conditions of
patients remotely | Same | Same | Same | Same |
| Intended use | Telemedicine
System | Same | Same | Same | Same |
| Intended
Users | Home users and
Health care
provider | Same | Same | Same | Same |
| Site of Use | Home; clinic | Same | Same | Same | Same |
| Data | Avid Care | Philips | Viterion | Carematix | Carematix |
2
| Collection | Proprietary
software | Proprietary
Software | Proprietary
software | Proprietary
software | Proprietary
software |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Data
Collection
Software
Functionality | Transmit data
from Sensor
devices to Central
database | Transmit
data from
Sensor
devices to
Central
database | Transmit data
from Sensor
devices to
Central
database | Transmit
data from
Sensor
devices to
Central
database | Transmit data
from Sensor
devices to
Central
database |
| Communicati
on method of
hub with
central server | Via modem over
telephone line | Same | Same | Same | Same |
| Types of
sensors which
can be
interfaced
(wired or
wirelessly) to
receiver hub | • Blood
Pressure
• Weight
• Glucose
levels
• Oxygen
Saturation
• PT/INR
• FEV/PEF | • Blood
Pressure
• Weight
• Glucose
levels
• ECG | • Blood
Pressure
• Weight
• Glucose
levels
• Oxygen
Saturation
• Temperature
• FEV/PEF | • Blood
Pressure
• Weight
• Glucose
levels | • Blood
Pressure
• Weight
• Glucose
levels
• Oxygen
Saturation
• PT/INR
• Temperature
• FEV/PEF |
| Implemen-
tation-
method of
collecting
data from
sensors | Modify off-the
shelf sensors with
previous 510(k)
clearance by adding
communications
interface. Basic
sensors unchanged. | Same | Same | Same | Same |
| Sensor
Software | Sensor
software
unchanged | Sensor
software
unchanged | Sensor
software
unchanged | Sensor
software
unchanged | Sensor
software
unchanged |
| Connectivity | Wired to hub | Wired or
Wireless to
hub | Wired to hub | Wireless to
hub | Wireless to
hub |
| Communi-
cation method
of hub with
devices | Wired - over
serial port | Wireless RF
protocol | Wired - over
serial port | Wireless
RF protocol | Wireless RF
protocol |
| Communicati
ons protocol | Serial protocol | Proprietary
protocol | Serial
protocol | Proprietary
protocol | Proprietary
protocol |
| Communicati
on frequency | Wired | 915MHz
FCC assigned
channel | Wired | 915 MHz
FCC assigned
channel | 915 MHz
FCC assigned
channel |
| Power Source | Wall power plug
for hub (120
VAC/50-60~) and
batteries in devices | Same | Same | Same | Same |
| Display | On devices and
hub, and monitors
connected to
central server | On devices
and hub, and
monitors
connected to
central server | On devices
and hub, and
monitors
connected to
central server | On devices,
and monitors
connected to
central server | On devices,
and monitors
connected to
central server |
3
TC-0966
8. Non-clinical Testing
Similar to the predicate device Viterion 100 (K030419) which further refers to Panasonic Telehomecare system (K004050), the Carematix Wellness System utilizes patient sensors that have already received 510(k) clearance. The testing to demonstrate substantial equivalence for this product similarly to the predicates relies on:
- . Testing to meet the product requirements and functional specifications
- Verification that the physiologic data received by the patient monitors are stored . properly; and
- . Verification that the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the data.
9. Conclusion
After analyzing bench, electrical safety, FCC, and user testing data, it is the conclusion of Carematix, Inc. that the Carematix Wellness System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices. The modification to the Carematix Wellness System approved under K031840 submitted for approval in this application does not alter the fundamental scientific technology of the sensor devices.
4
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.
UN = 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carematix, Inc. c/o Sukhwant Khanuja, Ph. D. CEO 2 N Lasalle St., Suite 1805 Chicago, IL 60602
Re: K040966
Trade Name: Carematix Wellness System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: April 12, 2004 Received: April 14, 2004
Dear Dr. Khanuja:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimeres processified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Costiere rece (110.) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, mereleve, include requirements for annual registration, listing of general controls provision 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 If your device 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.
5
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 deviee complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I 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 OF I ratt 0077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic reral in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in the low you to begin marketing your device as described in your Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. The 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 in you t the Office of Compliance at (301) 594-4648. 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 other Economic International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nél R.P. Ogden
B.Zucker, M.D., S.C.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
j) Indications for Use
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; .
- Blood glucose level using a Glucometer; .
- Patient weight using a stand-on electronic scale .
- Pulse rate measurement; .
- 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;
- Body temperature measurement using a digital thermometer; .
- Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements . using an electronic peak flow meter;
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 Device.
Federal law (US) restricts this device to sale by or on the order of a physician.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Cardiovascular Devices | |
| 510(k) Number | K040966 |
Prescription Use X OR Over the Counter Use ______
(Per 21 CFR 801.109)
3