CARESTATION 126S VIDEOPHONE

K031863 · Motion Media Technology, Inc. · MWI · Oct 10, 2003 · Cardiovascular

Device Facts

• Record ID: K031863
• Device Name: CARESTATION 126S VIDEOPHONE
• Applicant: Motion Media Technology, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

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. 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 Story

CareStation 126S is a standalone videophone system for home-based remote patient monitoring. It connects to a caregiver's office via standard telephone lines using internal modems. Inputs include real-time video/audio, integrated electronic digital stethoscope sounds, and data from external vital signs measurement devices (e.g., pulse oximeter, BP monitor, glucose monitor). The system transmits these inputs to a remote caregiver station for display and review. The device acts as a diagnostic aid; it does not provide real-time alarms. Healthcare providers use the transmitted data and audio/video link to support clinical decision-making. The system facilitates remote auscultation and vital sign assessment, potentially improving access to care for patients at home.

Clinical Evidence

No clinical data was submitted. Substantial equivalence was demonstrated through bench testing, including functional performance testing of the integrated digital stethoscope and verification that external vital signs measurement devices operate equivalently when connected to the CareStation as when used independently. The device was also subjected to safety, mechanical, electrical, electromagnetic compatibility (EMC), and environmental testing to applicable international standards.

Technological Characteristics

Standalone videophone system with integrated electronic digital stethoscope and optional pulse oximetry sensor. Connectivity via standard telephone network using internal modems. Supports 1-3 external vital signs measurement devices. Complies with applicable safety, mechanical, electrical, EMC, and environmental standards. No specific software algorithm class or material specifications provided.

Indications for Use

Indicated for patients requiring remote monitoring of vital signs (heart, lung, bowel sounds, SpO2, pulse, BP, temperature, glucose, weight, peak flow) via two-way video/audio/data link. Contraindicated for patients requiring direct medical supervision or emergency intervention.

Regulatory Classification

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.

Predicate Devices

• CareCompanion Nurse Station / Care Companion Patient Station (K020584)
• CareTone II Telephonic Stethoscope (K963678)
• Zymed Easi-View Telemetry System (K001308)

Reference Devices

• Criticare Vital Signs Monitor (K884216)
• NIBP Monitor UA-767PC (K982481)
• Digital Weight Scale UC-321
• Ferraris KOKO Peak Pro (K013489)
• Freestyle Blood Glucose Monitor (K000582)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone]

#### Contact Persons

Stuart Ross Motion Media Technology Inc. Tel: [phone] Fax: [phone]

Chris Sumner Motion Media Technology Inc. Tel: [phone] Fax: [phone]

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 Receiver<br>with Electronic Amplifying Stethoscope |

or

#### 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.

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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

## 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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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.

## 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 [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 may be obtained 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/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:

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div style="text-align:center;">Mmeme for BDZ</div> <div style="text-align:center;">(Division Sign-Off)</div> <div style="text-align:center;">Division of Cardiovascular Devices</div> |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K031863 |

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> |
|---------------------------------------|--------------|
|---------------------------------------|--------------|

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

Tel: [phone] Fax: [phone]