(99 days)
042273
No
The description focuses on data collection and transmission, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is described as a remote patient monitoring system that collects and transmits historical medical information. It is not intended to provide automated treatment decisions or directly treat a patient.
No.
The device is described as an accessory device that collects and transmits historical patient information to healthcare providers. It is not stated to perform any diagnostic analysis or interpretation of the data itself. Its function is data transfer, supporting, but not performing, diagnosis.
No
The device description explicitly states that the "CP appliance contains software" and "The CP appliance with device connectivity retrieves data from a specific medical device and transmits to a remote healthcare provider". This indicates the presence of a physical appliance (hardware) that houses the software and facilitates connectivity, making it a hardware and software system, not software-only.
Based on the provided information, the Care Pal (Model no. CPW-10X) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Care Pal's Function: The Care Pal's intended use and description clearly state that it is a remote patient monitoring system that collects and transmits historical medical information from external medical devices (blood glucose meter, blood pressure, weight scale) to healthcare professionals. It does not directly analyze or process biological specimens from the patient.
- No Specimen Analysis: The device description explicitly states it is "not used directly on the patient" and acts as a communication link between compatible external devices and the healthcare facility.
Therefore, the Care Pal falls under the category of a medical device, specifically a remote patient monitoring system accessory, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Care Pal (Model no. CPW-10X) is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.
Product codes
DRG, CGA, DXN, FRI
Device Description
The Care Pal ("CP") remote patient monitoring system is for use in non-clinical settings as an accessory device to collect and transmit historical patient information to healthcare providers. It is intended to be used in combination with a variety of external devices. The CP remote patient monitoring system serves as the remote communication link between compatible external devices and the compatible healthcare facility at another location. The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgment.
The CP appliance contains software that can be activated to function with specific medical devices (including blood glucose meter, blood pressure and weight scale). The CP appliance with device connectivity retrieves data from a specific medical device and transmits to a remote healthcare provider using standard digital communication technologies. The CP appliance is not used directly on the patient, and poses no significant risk to the patient or other people within the patient's home.
Care Pal provides interfaces to the following connecting peripheral devices and back end server as well a. BT
Selected device (Brand/Model): weight scale, A&D/UC-321PBT
- b. USB
Selected device (Brand/Model): glucose meter, Johnson & Johnson LifeScan / OneTouch Ultra II (K053529)
c. RS-232 (Serial Port) Selected device (Brand/Model): blood pressure meter, A&D UA-787PC (K012013)
d. Internet (Ethernet/wireless) connection to backend server
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
non-clinical settings
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
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 requirements.
Key Metrics
Not Found
Predicate Device(s)
Health Buddy® with Device Connectivity (042273)
Reference Device(s)
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
AUG 2 1 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | digiO2 International Co., Ltd. |
|---|---|
| Address: | 4F-13, No. 79, Sec. 1, Hsin Tai Wu Rd., Hsi-Chih, Taipei Hsien |
| 221, Taiwan | |
| Phone: | +886-2-2698-5593 |
| Fax: | +886-2-2698-1274 |
| Contact: | Mr. Casper Chen / Title: President |
-
- Device Name : Trade Name:
Care Pal
- Device Name : Trade Name:
Model no.: CPW-10X
Common Name: Classification name
Data Management System; Accessory to Medical Device Refer to table
| Regulation
Number | Classification
Name | Product
Code | Device
Class |
|----------------------|--------------------------------------------------------|-----------------|-----------------|
| 870.2910 | Physiological Signal
Transmitters and
Receivers | DRG | II |
| 862.1345 | Glucose Test System | CGA | II |
| 870.1130 | Noninvasive Blood
Pressure
Measurement
System | DXN | II |
| 880.2700 | Patient Weight Scale | FRI | I |
4. Predicate Device:
· Health Buddy® with Device Connectivity (042273) marketed by HEALTH HERO NETWORK, INC..
-
- Intended Use:
Care Pal (Model no. CPW-10X) is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
- Intended Use:
Product : Care Pal (Model no. CPW-10X) Section 4 - 510(k) Summary
REV. [B]
1
The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.
6. Device Description:
The Care Pal ("CP") remote patient monitoring system is for use in non-clinical settings as an accessory device to collect and transmit historical patient information to healthcare providers. It is intended to be used in combination with a variety of external devices. The CP remote patient monitoring system serves as the remote communication link between compatible external devices and the compatible healthcare facility at another location. The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgment.
The CP appliance contains software that can be activated to function with specific medical devices (including blood glucose meter, blood pressure and weight scale). The CP appliance with device connectivity retrieves data from a specific medical device and transmits to a remote healthcare provider using standard digital communication technologies. The CP appliance is not used directly on the patient, and poses no significant risk to the patient or other people within the patient's home.
Care Pal provides interfaces to the following connecting peripheral devices and back end server as well a. BT
Selected device (Brand/Model): weight scale, A&D/UC-321PBT
- b. USB
Selected device (Brand/Model): glucose meter, Johnson & Johnson LifeScan / OneTouch Ultra II (K053529)
c. RS-232 (Serial Port) Selected device (Brand/Model): blood pressure meter, A&D UA-787PC (K012013)
d. Internet (Ethernet/wireless) connection to backend server
Product : Care Pal (Model no. CPW-10X) Section 4 - 510(k) Summary
Page 2 of 3
REV. 【B】
2
7. Performance Summary:
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 requirements.
1091430 83/3
8. Conclusions:
The Care Pal (Model no. CPW-10X) has the same intended use and similar technological characteristics as the Health Buddy® with Device Connectivity (042273) marketed by HEALTH HERO NETWORK, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The Care Pal (Model no. CPW-10X) is substantially equivalent to the predicate devices.
Product : Care Pal (Model no. CPW-10X) Section 4 - 510(k) Summary
REV. [B]
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Digio2 International Co., Ltd. c/o Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 N. Boldt Drive Flagstaff, AZ 86001
AUG 21 2009
Re: K091430
Trade/Device Name: Care Pal, Model No. CPW-10X Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (Two) Product Code: DRG Dated: July 10, 2009 Received: July 15, 2009
Dear Ms. Reich:
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.
4
Page 2 - Ms. Jennifer Reich
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,
[signature]
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):
Device Name: Care Pal (Model no. CPW-10X) digi02 International Co., Ltd.
Indications For Use:
Care Pal (Model no. CPW-10X) is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Httllfke for BZuckerman
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 09/1430
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