(116 days)
Not Found
No
The summary describes a system for collecting and transmitting basic physiological measurements (blood pressure, blood glucose, weight) for remote monitoring. There is no mention of any analytical or predictive capabilities that would typically involve AI/ML. The focus is on data collection, transmission, storage, and basic visualization/alerting.
No.
The device's intended use is for measurement and monitoring of patient wellness parameters, not for direct treatment or therapy. It transmits data to a clinical setting for caregiver review.
Yes
The "Intended Use / Indications for Use" section states the device is for "Non-invasive blood pressure measurement; Measurement of blood glucose; Patient weight using a stand-on electronic scale." These are all measurements taken to assess a patient's health status, which falls under the definition of diagnostics.
No
The device description explicitly mentions hardware components like "Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors" and a "hub (receiving station)". While software is a key part of the system for data transmission and monitoring, it is not a software-only device.
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 (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This is typically done in vitro (in a lab setting, outside the body).
- Carematix Wellness System Function: The description clearly states the system performs:
- Non-invasive blood pressure measurement (done on the body).
- Measurement of blood glucose (while it uses a blood glucose meter, the system itself is focused on transmitting and monitoring the results of this measurement, not performing the in vitro analysis of the blood sample).
- Patient weight using a stand-on electronic scale (done on the body).
- Focus on Monitoring and Transmission: The primary function described is the transmission and monitoring of these physiological measurements from the patient's home to a clinical setting.
The system is designed for monitoring physiological parameters in vivo (on the body) and transmitting that data, rather than performing laboratory analysis of biological specimens.
N/A
Intended Use / Indications for Use
The Carematix Wellness System is intended for patient home use for the following: Non-invasive blood pressure measurement; measurement of blood glucose, 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.
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
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.
Not Found
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
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
June 13, 2003 Contact: Mr. Sukhwant Khanuja, Director
-
- 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
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- 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. The Carematix Wellness System only uses sensor devices already cleared with 510(k) clearance: OR provides external adaptors for Blood glucose monitors having existing 510(k) clearances. The Stand-on patient scale is exempt from pre-market notification as per 880.2700.
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- Indications for Use (intended use): The Carematix Wellness System is intended for patient home use for the following: Non-invasive blood pressure measurement; measurement of blood glucose, 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 4. 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 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.
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- 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.
1
| Feature | Avid Care K011779 | Philips K023749 | Carematix |
|---|---|---|---|
| Indications of | |||
| Use | Enables healthcare providers to | ||
| manage chronic conditions of | |||
| patients remotely | Same | Same | |
| Intended use | Telemedicine System | Same | Same |
| Intended Users | Home users and Health care | ||
| provider | Same | Same | |
| Site of Use | Home; clinic | Same | Same |
| Software | Patient Database | Same | Same |
| Types of | |||
| Sensors | Blood Pressure | ||
| Weight | |||
| Glucose levels | |||
| Oxygen Saturation | |||
| PT/INR | |||
| FEV/PEF | Blood Pressure | ||
| Weight | |||
| Glucose levels | |||
| ECG | Blood Pressure | ||
| Weight | |||
| Glucose levels | |||
| Power Source | Wall power plug for health | ||
| monitor (hub) and Standard | |||
| batteries in devices | Same | Same | |
| Communication | |||
| method with | |||
| devices | Wired - over serial port | Wireless RF protocol | Wireless RF protocol |
| Communication | |||
| method with | |||
| central server | Via modem over telephone line | Same | Same |
| Display | On devices, and monitors | ||
| connected to central server | Same | Same |
6. Substantial Equivalence Chart
7. 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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Carematrix, Inc. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K031840
Trade Name: Carematrix Wellness System Regulation Number: 21 CFR 870.1130 and 870.2910 Regulation Name: Noninvasive Blood Pressure Measurement System and Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXN and DRG Dated: September 17, 2003 Received: September 22, 2003
Dear Mr. Kamm:
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 - Mr. Daniel Kamm, P.E.
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Через Мар
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K031840
j) Indications for Use
510(k) Number K031840
Device Name: Carematix Wellness System
Indications for Use: The Carematix Wellness System is intended for patient home use for the following:
Non-invasive blood pressure measurement; Measurement of blood glucose; 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031840
Prescription Use X OR Over the Counter Use
(Per 21 CFR 801.109)