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 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

AI/ML Overview

The provided text describes the 510(k) summary for the "Care Pal" device (Model no. CPW-10X). However, it does not contain specific acceptance criteria for device performance or a detailed study demonstrating how the device meets those criteria in the way typically expected for an AI/ML medical device submission (e.g., accuracy, sensitivity, specificity studies).

Instead, this document focuses on substantial equivalence to a predicate device based on intended use, technological characteristics, and conformance to safety and EMC standards.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily references general performance summaries related to operating specifications, safety, and EMC requirements.
It states that the device conforms to applicable standards, including IEC 60601-1 and IEC 60601-1-2 requirements. These are general safety and electromagnetic compatibility standards for medical electrical equipment.
It also states that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." However, specific acceptance criteria for this bench testing (e.g., data transfer accuracy percentage, successful connection rate) and the detailed results are not provided in this summary.

Without the actual study report, it's impossible to create a precise table. Based on the summary, a conceptual table would look like this:

Acceptance Criterion (Implied)	Reported Device Performance
Conformance to IEC 60601-1	Conforms
Conformance to IEC 60601-1-2	Conforms
No new safety/effectiveness questions compared to predicate via bench testing	Bench testing indicated no new safety or effectiveness concerns.
Functionality with specified peripheral devices (weight scale, glucose meter, blood pressure meter) and backend server for data retrieval and transmission.	Care Pal provides interfaces to selected devices (A&D/UC-321PBT, Johnson & Johnson LifeScan / OneTouch Ultra II, A&D UA-787PC) and backend server. Specific performance details (e.g., data accuracy for transmission) are not specified in this summary.

Missing Information (Crucial for an AI/ML device, but this isn't one):

Specific quantitative performance metrics like accuracy, sensitivity, specificity, or F1-score.
Thresholds for passing these metrics.

2. Sample size used for the test set and the data provenance:

Not applicable / Not specified. This device is a data management/transmission system, not an AI/ML algorithm that predicts or diagnoses based on a test dataset. The "bench testing" mentioned would focus on the device's ability to connect and transmit data reliably, not on a "test set" of patient data for diagnostic evaluation.
The document mentions "historical medical information" being transmitted, but this refers to the type of data the device handles, not a dataset used for performance evaluation of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not specified. As a data transmission device, ground truth for diagnostic or prognostic purposes is not established by experts for its functional evaluation. The "ground truth" for this device would likely be the accurate transfer of data from the peripheral device to the server, which would be verified through technical means rather than expert clinical review.

4. Adjudication method for the test set:

Not applicable / Not specified. No clinical test set requiring expert adjudication is described in this summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI algorithm designed to assist human readers or perform diagnostic tasks. It's a data transmission system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm, but a hardware and software system for data collection and transmission. Its "standalone" performance would relate to its ability to perform its transmission function independently, which would be covered under bench testing and EMC/safety compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not specified in detail. For this type of device, ground truth would relate to the successful and accurate transmission of data. For instance, if a glucose meter reads "120 mg/dL," the ground truth for the Care Pal's performance would be that "120 mg/dL" is accurately received by the remote server. This is typically verified through technical validation, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

In summary:

The provided document describes a "Care Pal" device which is a data management/transmission system, not an AI/ML diagnostic or therapeutic device. Therefore, it does not contain the types of performance data (e.g., accuracy, sensitivity, specificity, expert ground truth, sample sizes for training/test sets) that are typically associated with AI/ML device approval. The "study" mentioned is "bench testing" and compliance with general safety and EMC standards, aimed at demonstrating substantial equivalence to a predicate device rather than statistical performance on a clinical dataset.

Summary

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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 Hsien221, Taiwan
Phone:	+886-2-2698-5593
Fax:	+886-2-2698-1274
Contact:	Mr. Casper Chen / Title: President

1. Device Name : Trade Name:
  Care Pal

Model no.: CPW-10X

Common Name: Classification name

Data Management System; Accessory to Medical Device Refer to table

RegulationNumber	ClassificationName	ProductCode	DeviceClass
870.2910	Physiological SignalTransmitters andReceivers	DRG	II
862.1345	Glucose Test System	CGA	II
870.1130	Noninvasive BloodPressureMeasurementSystem	DXN	II
880.2700	Patient Weight Scale	FRI	I

4. Predicate Device:

· Health Buddy® with Device Connectivity (042273) marketed by HEALTH HERO NETWORK, INC..

1. 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]

{1}------------------------------------------------

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:

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 (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

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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:

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

Page 1 of 1

Regulation Number and Section

§ 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).