The CareStation CS126S is intended to be used upon prescription of an authorized healthcare provider by patients to provide two-way video, audio, and data communications including patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site.

The information includes heart, lung, and bowel sounds, blood oxygen saturation, pulse rate, blood pressure, temperature, blood glucose, weight, and breath peak flow measurements. The information is collected upon the request and direction of the health care provider.

The device does not send any real-time alarms. The device is a diagnostic aid. Clinical judgment and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Device Description

The CareStation 126S Videophone system is a standalone videophone system that is equipped with the capability to transmit and receive data from a variety of external vital signs and medical measurement devices. The CareStation 126S also includes an integrated electronic digital stethoscope that provides for both local and remote auscultation functions and an optional accessory plug-in pulse oximetry sensor unit.

Typically, the CareStation is deployed in a patient's home and another CareStation is installed in a healthcare provider or caregiver's office. Each is connected to a standard telephone network connection and the two systems communicate with each other through internal modems and transmit real-time video, audio, and data between them. The realtime video and audio communications allow the patient and caregiver to view and speak with each other.

Using a supplied stethoscope transducer attached to the patient's system, heart, breath, and bowel sounds may be transmitted to the caregiver's system where they may be listened to using a set of stethoscope earphones that are supplied with the system.

With existing legally marketed vital signs measurement devices attached to the patient's system, the caregiver may monitor the patient's blood pressure, pulse rate, temperature, weight, blood oxygen saturation, blood glucose level, breath peak flow, and transmit this data to the caregiver's system. Vital signs measurement devices used with the CareStation system are FDA approved devices and are used for the same purposes for which they received 510(K) approval or are devices that are exempt under applicable 21 CFR sections. The data may be captured, displayed, and/or saved on a computer using one or more of a variety of software packages including CareStation for Windows™. The CareStation may be configured for use with one to three external devices

AI/ML Overview

This document describes the CareStation 126S Videophone, a tele homecare system. The acceptance criteria and the study proving it meets these criteria are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional Performance (Integrated Digital Stethoscope)	Performance exceeds that of the predicate device (CareTone II Telephonic Stethoscope (#K963678)).	Performance testing of the integrated digital stethoscope functions was performed to show that the performance exceeds and thus meets substantial equivalency of the predicate device.
Functional Performance (External Vital Signs Devices)	Operate equivalently when used with the CareStation as when operated as independent devices.	Testing was performed with each vital signs measurement device to show that they operate equivalently when used with the CareStation as when operated as independent devices.
Safety	Compliance with applicable safety standards.	The CareStation has been subjected to performance testing to applicable safety standards. All specifications were met.
Mechanical	Compliance with applicable mechanical standards.	The CareStation has been subjected to performance testing to applicable mechanical standards. All specifications were met.
Electrical	Compliance with applicable electrical standards.	The CareStation has been subjected to performance testing to applicable electrical standards. All specifications were met.
Electromagnetic Compatibility (EMC)	Compliance with applicable EMC standards.	The CareStation has been subjected to performance testing to applicable EMC standards. All specifications were met.
Environmental	Compliance with applicable environmental standards.	The CareStation has been subjected to performance testing to applicable environmental standards. All specifications were met.

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

The document does not specify the exact sample size for the test set used in the functional performance testing of the integrated digital stethoscope or the external vital signs devices.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the functional performance tests. Given the nature of performance testing against predicate devices, "ground truth" would likely be the established performance characteristics of the predicate devices or calibrated measurement standards.

4. Adjudication method for the test set:

The document does not specify any adjudication method.

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:

No MRMC comparative effectiveness study was done. This device is a tele homecare system, not an AI-assisted diagnostic tool for image interpretation by clinicians.

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

The testing described is essentially for standalone device performance, as it focuses on the functional operation of the CareStation's integrated stethoscope and its ability to work with external vital signs devices. There is no mention of a human-in-the-loop component in the validation process for the device's functional equivalence compared to predicate devices.

7. The type of ground truth used:

For the integrated digital stethoscope, the ground truth was the established performance characteristics of the predicate device (CareTone II Telephonic Stethoscope). The study aimed to show the CareStation's stethoscope performance "exceeds" that of the predicate.
For the external vital signs measurement devices, the ground truth was their operation as independent, FDA-approved devices. The study aimed to show "equivalent" operation when integrated with the CareStation.
For safety, mechanical, electrical, EMC, and environmental aspects, the ground truth would be the specifications outlined in the applicable international standards.

8. The sample size for the training set:

This information is not applicable as the CareStation 126S Videophone is not an AI/ML device that requires a training set in the conventional sense. The testing focuses on hardware functionality and equivalence to predicate devices.

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

This information is not applicable as no training set was used for an AI/ML algorithm.

Summary

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OCT 1 0 2003

Motion Media Technology Inc.

tion Media

510K Summary

Submitter

Motion Media Technology Inc. 6714 Netherlands Drive Wilmington, NC 28405 Telephone: (910) 395-6100 Facsimile: (910) 395-6108

Contact Persons

Stuart Ross Motion Media Technology Inc. Tel: (910) 395-6100 Fax: (910) 395-6108

Chris Sumner Motion Media Technology Inc. Tel: (910) 395-6100 Fax: (910) 395-6108

031863

Date Prepared

June 8, 2003

Device Information

Trade Name:	CareStation 126S Videophone
Common Name:	Tele Homecare System with Electronic Stethoscope
Classification Name:	Radio Frequency Physiological Signal Transmitter and Receiverwith Electronic Amplifying Stethoscope

Device Description

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Substantial Equivalence

As a multifunction device, the CareStation system is substantially equivalent to the following predicate systems: With respect to the transmission of patient vital signs information from external measurement devices. it is equivalent to the CareCompanion Nurse Station / Care Companion Patient Station (#K020584). With respect to the integrated electronic stethoscope, it is equivalent to the CareTone II Telephonic Stethoscope (#K963678). With respect to the pulse oximetry accessory, it is equivalent to the Zymed Easi-View Telemetry System (#K001308).

In addition, the following devices can be used with the CareStation system to provide the external vital signs monitoring functions: Criticare Vital Signs Monitor (#K884216) by Criticare Systems Inc., NIBP Monitor UA-767PC (#K982481) by A&D Engineering, Inc., Digital Weight Scale UC-321 (exempt under 21 CFR 800.2700) by A&D Engineering Inc., Ferraris KOKO Peak Pro (#K013489) by PDS Healthcare Products Inc, Freestyle Blood Glucose Monitor (#K000582) by Therasense.

The CareStaton and its predicate systems have the same general use: to provide the capability for health care professionals to monitor the vital signs and/or heart and breath sounds of their patients from remote locations.

The main functional difference between the systems are the CareStation extends the capabilities of remote auscultation by providing a real-time video and audio link along with the heart, breath, and bowel sounds.

Intended Use

The CareStation 126S is intended to be used upon prescription of an authorized healthcare provider by patients to provide two-way video, audio, and data communications including patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site.

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Brief Description of Non-Clinical Testing

Testing was performed to validate the functional performance of the CareStation. In particular, specific performance testing of the integrated digital stethoscope functions was performed to show that the performance exceeds and thus meets substantial equivalency of the predicate device. Further, testing was performed with each vital signs measurement device to show that they operate equivalently when used with the CareStation as when operated as independent devices.

The CareStation has been subjected to performance testing to applicable safety, mechanical, electrical, electromagnetic compatibility (EMC), and environmental standards. Such specifications for the reference appropriate international standards. All specifications were met.

Brief Description of Clinical Testing

Clinical study information was not submitted for the purposes of demonstrating substantial equivalence to the predicate devices.

Conclusion

The indications for use of the digital stethoscope feature of the CareStation system is consistent with that in labeling for electronic stethoscopes legally marked in the United States as well as that in the FDA classification regulation under 21 CFR 870.1875(b) for this generic type of device.

The indications for use of the accessory pulse oximeter sensor with the CareStation system is consistent with that in labeling for pulse oximeters legally marketed in the United States as well as that in the FDA classification under 21 CFR 870.2700 (b) for this generic type of device.

The results of testing the CareStation with the integrated electronic stethoscope, pulse oximeter, and other vital signs measurement devices indicate that the device is substantially equivalent to it's predicate devices and does not raise any new questions of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, and a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Motion Media Technology Inc. c/o Mr. Stuart R. Ross Chief Technology Officer Motion Media Technology Inc. 6714 Netherlands Drive Wilmington, NC 28405

Re: K031863

Trade Name: CareStation 126S Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: September 12, 2003 Received: September 22, 2003

Dear Mr. Ross:

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 - Mr. Stuart R. Ross

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 may be obtained 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.

MefarMep
Bram B. Zuckerman, M.D.

Zuckerma Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section D: Indications For Use

Applicant:

Motion Media Technology Inc.

510(k) Number (if known):

CareStation 126S Device Name:

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Mmeme for BDZ (Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K031863

Prescription Use (Per 21 CFR 801.109)	✓
---------------------------------------	--------------

OR
Over-the-counter Use ____6714 Netherlands Drive, Wilmington, NC 28405

Tel: (910) 395-6100 Fax: (910) 395-6108

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).