MEDSTAR SYSTEM, MODELS 533-300

K020534 · Cybernet Medical · DXH · Feb 11, 2003 · Cardiovascular

Device Facts

• Record ID: K020534
• Device Name: MEDSTAR SYSTEM, MODELS 533-300
• Applicant: Cybernet Medical
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The MedStar System is intended to transfer patient physiological data from a range of patient monitors to a remote station, such as a Disease Management Center, for subsequent transfer by a Hospital Information System for review by a healthcare professional. The MedStar System is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System is not used directly with a patient. The MedStar Unit is intended for Out-of-Hospital Use. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office. The MedStar System is intended for sale by or on the order of a physician only.

Device Story

MedStar System facilitates remote transmission of physiological data from patient monitors to a central server. Input: serial data from blood glucose monitors, weight scales, NIBP monitors, or audio EKG data. MedStar Unit (portable, battery-operated, LCD display, push-button control) stores serial data, performs DTMF encoding, and transmits via telephone lines. Collection Server (PC with communications board) receives/decodes data, stores it, and transfers to Hospital Information Systems. Used in out-of-hospital settings by patients; server used in clinical settings by healthcare professionals. Enables remote review of patient data, supporting clinical decision-making for out-of-hospital monitoring.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System consists of a portable MedStar Unit (impact-resistant plastic enclosure, LCD, serial ports, phone jacks) and a Collection Server (PC with custom electronics board). Data transmission via DTMF encoding over telephone lines. Connectivity: serial interface to patient monitors, telephone line to server. Power: battery-operated unit.

Indications for Use

Indicated for patients requiring out-of-hospital monitoring. Intended for use in disease management centers, hospitals, clinics, or physician offices.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Home Care Monitoring System, AvidCare Corp. (K010029)
• Model EHC 400 Desktop Patient Station, Cybercare Technologies Inc. (K003257)
• PaceArt Central Station CPTS 86-12, PaceArt Inc. (K915632)

Submission Summary (Full Text)

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# Section 16. SECTION 16. 510(k) SUMMARY.

Section 16.a Date Summary Prepared February 15, 2002

Section 16.b Company Information

Establishment:

Official Correspondent:

FEB 1 1 2003

Cybernet Medical. 727 Airport Blvd. Ann Arbor MI 48108

David A. C. Green Regulatory Affairs Consultant for Cybernet Medical. 1460 Golfcrest Place Vista, CA 92083 [phone] [phone] (fax)

# Section 16.c Name of Device

Proprietary:

Common/Usual:

Classification:

MedStar System

MedStar

Telephone Electrocardiograph transmitter and receiver (§870.2920/74DXH)

# Section 16.d Equivalent Devices

Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for predicate devices and for the MedStar System, as well as testing to accepted industry standards. In addition. bench testing was conducted to establish the MedStar System's accuracy and performance to specification. The predicate devices are as follows:

- Home Care Monitoring System, AvidCare Corp., K010029 ●
- Model EHC 400 Desktop Patient Station, Cybercare Technologies Inc., K003257 ●
- PaceArt Central Station CPTS 86-12, PaceArt Inc., K915632 ●

# Section 16.e Device Description & Technological Characteristics

The MedStar Monitoring System comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center.

Data is transmitted via telephone lines to the associated data collection server at the remote site.

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Data is transmitted via telephone lines to the associated data collection server at the remote site.

The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display.

Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors.

Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets.

Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks.

Collection Server comprises a Personal Computer-type Processor Unit The incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.

The MedStar System accepts serial data from the following patient monitors or measurement devices:

| Device | Communication Protocol |
|--------------------------------------------|------------------------|
| Blood/Glucose Monitor<br>Lifescan SureStep | Available |
| Weight Scale - A&D Medical UC-300 | Available |
| Weight Scale - A&D Medical UC-321 | Available |
| NIBP Monitor -<br>A&D Medical UA-767PC | Available |

Monitored/measured data is transferred from a patient monitor/measurement device, e.g. a Blood/Glucose Monitor or Weight Scale, via that unit's serial data port under the control of a serial port protocol. The data is then stored in the MedStar Unit prior to undergoing Dual Tone Multiple Frequency, DTMF, encoding to facilitate phone line transmission to a remote site, such as a Disease Management Center.

A Collection Server comprising a Personal Computer with an additional communications board, receives and decodes the transmitted data and stores the data locally for subsequent transfer by a Hospital Information System for review by a healthcare professional.

In addition to transferring encoded data from the three measurement devices described above, EKG data may also be transferred directly from an EKG Monitor to the Collection Server, via phone line, using an EKG Monitor's standard audio data output.

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#### Section 16.f Intended Use

The MedStar System is intended to transfer patient physiological data from a range of patient monitors to a remote station, such as a Disease Management Center, for subsequent transfer by a Hospital Information System for review by a healthcare professional. The MedStar System is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System is not used directly with a patient.

The MedStar Unit is intended for Out-of-Hospital Use. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office. The MedStar System is intended for sale by or on the order of a physician only.

The intended use, patient population and environment of use are the same or similar to the predicate devices, the Avid Care Corporation Home Care Monitoring System, K010029, the Cybercare Technologies Model EHC 400 Desktop Patient Station, K003257 and the PaceArt Central Station CPTS 86-12, K915632.

#### Section 16.g Certification Statement

In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:

Cybernet Medical believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.

Eric D. Lichtenstein Product Development Manager Cybernet Medical.

David A. C. Queen

David A. C. Green Regulatory Affairs Consultant for Cybernet Medical.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines forming a profile of a head and shoulders.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Cybernet Medical c/o Mr. David A.C. Green Regulatory Consultant BBP Consultants Inc. 1460 Golfcrest Place Vista, CA 92083

Re: K020534

Trade Name: MedStar System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: November 29, 2002 Received: December 2, 2002

Dear Mr. Green:

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. David A.C. Green

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.

K. Bruce D. Zuckerman, M.D.

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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#### INDICATIONS FOR USE STATEMENT 2.g

| Applicant: | Cybernet Medical. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K020534 |
| Device Name: | MedStar System |
| Indications for Use: | The MedStar System is indicated for Out-of-Hospital Use with any patient<br>requiring Out-of-Hospital monitoring<br>The associated Collection Server is intended for use in a Disease<br>Management Center, Hospital or Hospital -Type facility, Medical Clinic or<br>Physician's Office. |

Yes (Per 21 CFR 801.109). Prescription Use:

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

NCATTM

(Division Sign-Off) Division of Cardiovascular Devices

**510(k) Number** K020534

Prescription Use _____________________________________________________________________________________________________________________________________________________________

or

OTC Use ______________________________________________________________________________________________________________________________________________________________________