CARE PAL, MODEL CPW-10X

K091430 · Digio2 International Co., Ltd. · DRG · Aug 21, 2009 · Cardiovascular

Device Facts

• Record ID: K091430
• Device Name: CARE PAL, MODEL CPW-10X
• Applicant: Digio2 International Co., Ltd.
• Product Code: DRG · Cardiovascular
• Decision Date: Aug 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

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. The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.

Device Story

Care Pal (CPW-10X) is a remote patient monitoring appliance used in non-clinical settings to bridge patient-side medical devices and remote healthcare facilities. It acts as a communication hub, retrieving data from peripheral devices—including blood glucose meters (via USB), blood pressure monitors (via RS-232), and weight scales (via Bluetooth)—and transmitting this information to a backend server via Ethernet or wireless internet. The device is not used directly on the patient. Healthcare providers access the transmitted historical data to support patient management. The system does not provide automated treatment decisions or replace professional clinical judgment.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1 and IEC 60601-1-2 standards for safety and electromagnetic compatibility.

Technological Characteristics

Remote patient monitoring appliance; interfaces via Bluetooth, USB, and RS-232; connectivity via Ethernet/wireless to backend server. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for use in non-clinical settings to collect and transmit historical medical data to healthcare professionals for patient management support. Not for automated treatment decisions or as a substitute for professional clinical judgment.

Regulatory Classification

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.

Predicate Devices

• Health Buddy® with Device Connectivity (042273)

Reference Devices

• OneTouch Ultra II (K053529)
• A&D UA-787PC (K012013)

Submission Summary (Full Text)

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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<br>221, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Mr. Casper Chen / Title: President |

- 2. Device Name : Trade Name:
Care Pal

Model no.: CPW-10X

Common Name: Classification name

Data Management System; Accessory to Medical Device Refer to table

| Regulation<br>Number | Classification<br>Name | Product<br>Code | Device<br>Class |
|----------------------|--------------------------------------------------------|-----------------|-----------------|
| 870.2910 | Physiological Signal<br>Transmitters and<br>Receivers | DRG | II |
| 862.1345 | Glucose Test System | CGA | II |
| 870.1130 | Noninvasive Blood<br>Pressure<br>Measurement<br>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..

- 5. 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.

Product : Care Pal (Model no. CPW-10X) Section 4 - 510(k) Summary

REV. [B]

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The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.

K091430

# 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】

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## 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]

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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.

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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 [phone]. 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 [phone] or [phone] 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

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K091430

# 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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