MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370

K050951 · Cibernet Systems Corp. · DXH · Jul 19, 2005 · Cardiovascular

Device Facts

• Record ID: K050951
• Device Name: MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370
• Applicant: Cibernet Systems Corp.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The MedStar System II 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 II is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System II 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 II is intended for sale by or on the order of a physician only.

Device Story

MedStar System II facilitates remote physiological data transmission; comprises portable MedStar Unit and Collection Server. MedStar Unit connects to various patient monitors (e.g., glucose, NIBP, EKG, pulse oximeter, spirometer, temperature, prothrombin time) via serial ports; stores data locally; encodes data using DTMF for telephone line transmission. Collection Server (PC-based with communications board) receives, decodes, and stores data for transfer to Hospital Information Systems. Used in out-of-hospital settings (patient home) and clinical environments (Disease Management Centers, clinics, physician offices). Operated by patients (at home) and healthcare professionals (at remote site). Enables remote review of patient data by clinicians to support clinical decision-making and disease management.

Clinical Evidence

Bench testing only. No clinical data presented. Testing established accuracy and performance to specifications.

Technological Characteristics

Portable battery-operated unit in impact-resistant plastic enclosure; LCD screen; push-button controls; serial communication ports; standard phone jacks. Data transmission via DTMF over telephone lines. Collection server utilizes PC processor with dedicated communications board. Connectivity via serial protocols to compatible patient monitors.

Indications for Use

Indicated for out-of-hospital monitoring of any patient requiring such monitoring. Not for direct patient use.

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

• MedStar System (K020534)
• HomMed Sentry IIIB-F Patient Monitor System (K040651)
• Viterion 100 TeleHealth Monitor (K030419)

Submission Summary (Full Text)

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JUL 1 9 2005

## Section 16. 510(k) Summary

## Section 16.a Date Summary Prepared

March 28, 2005

## Section 16.b Company Information

Establishment:

Official Correspondent:

Cybernet Medical. 727 Airport Blvd. Ann Arbor MI 48108

Eric Lichtenstein Director 727 Airport Blvd. Ann Arbor MI 48108 [phone] [phone] (fax)

## Section 16.c Name of Device

Proprietary:

Common/Usual:

Classification:

MedStar System II

MedStar

Radiofrequency physiological signal transmitter and receiver (§870.2910, DRG)

## 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 II, as well as testing to accepted industry standards. In addition, bench testing was conducted to establish the MedStar System II's accuracy and performance to specification. The predicate devices are as follows:

| Device Name | Manufacturer | 510(k) Number |
|------------------------------------------------|-----------------------------|---------------|
| MedStar System | Cybernet Medical | K020534 |
| HomMed Sentry IIIB-F Patient<br>Monitor System | HomMed LLC | K040651 |
| Viterion 100 TeleHealth Monitor | Viterion TeleHealthcare LLC | K030419 |

The MedStar System II's Intended Use, Indications for Use, feature set and performance specifications are similar to those of the above three predicate devices.

Cybernet Medical 510(k) Summary for MedStar System II 000295

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## Section 16.e Device Description & Technological Characteristics

The MedStar Monitoring System II 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.

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.

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

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

| Device | Clearance<br>Information | Communication<br>Protocols |
|---------------------------------------------------------|---------------------------------------------------|----------------------------|
| Blood/Glucose Monitor<br>Lifescan SureStep | K984261 | Available |
| Blood/Glucose Monitor<br>Lifescan OneTouch Ultra | K024194 | Available |
| Weight Scale - A&D Medical UC-300 | Scales Exempt from<br>Premarket Notification, per | Available |
| Weight Scale - A&D Medical UC321 | 21CFR880.2720 | Available |
| Weight Scale - A&D Medical UC321PL | | Available |
| NIBP Monitor<br>A&D Medical UA-767PC | K982481 | Available |
| EKG Monitor<br>King of Hearts Express | K920984 | Not Applicable |
| King of Hearts Express 3X | K920984 | |
| Pulse Oximeter - Nonin PalmSat 2500 | K002690 | Available |
| Spirometer - PDS Healthcare KP+LFM | K013489 | Available |
| Temperature<br>Welch Allyn Suretemp Plus | K030580 | Available |
| Prothrombin Time<br>ITC ProTime Microcoagulation System | K010599 | Available |

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KOEDQ51 p 3 /3

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 to a Hospital Information System for review by a healthcare professional.

## Section 16.f Intended Use

The MedStar System II 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 II is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System II 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 II 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 Cybernet Medical MedStar System (K020534), the HomMed LLC HomMed Sentry IIIB-F Patient Monitor System (K040651) and the Viterion TeleHealthcare LLC Viterion 100 TeleHealth Monitor (K030419).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2005

+

Cybernet Systems Corp. c/o Mr. Eric Lichtenstein Regulatory Affairs 727 Airport Blvd. Ann Arbor, MI 48108-1639

Re: K050951

Trade Name: MedStar System II Regulation Number: 21 CFR 870.2920 Regulation Name: Electrocardiograph Telephone Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DXH Dated: June 17, 2005 Received: June 27, 2005

Dear Mr. Lichtenstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarel be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costicule 71ct (11cc) that to novice, subject to the general controls provisions of the Act. The I ou may, merelore, manel the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is crassified (soc above) ins. Existing major regulations affecting your device can may be subject to such additional controlions, Title 21, Parts 800 to 898. In addition, FDA may ou round in ther announcements concerning your device in the Federal Register.

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Page 2 - Mr. Eric Lichtenstein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualice of a substitive complies with other requirements of the Act
that FDA has made a determination that your device Earch agemains. You mus that FDA has made a decemination and your as rounder Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listing or any Federal statutes and regulations administers on registration and listing (2)
comply with all the Act's requirements, including, including recurses as set comply with all the Act s requirements, incriating, our review matice requirements as set
CFR Part 807); labeling (21 CFR_Part 801); good manufacturing practice the electroni CFR Part 807); labeling (21 CFR Fall on (21 ); good manatt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 11 CFP, 1000-105 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections 951 clevice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a l This letter will allow you to begin marketing your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket notification. The PDA inding of subsantial equivalies of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 81), please
rs the latest of the many of the 164 to the regulation entitled If you desire specific advice for your ac not on 6. Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regul contact the Office of Compliance at (2017 391 - 107.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain "Misbranding by reference to premarket nothilders the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of D11 or [phone] or at its Internet address [phone] 01 (301) 11:5 0097 01:50 amain.html

Sincerely yours,

Bhimmon for

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

510(k) Number (if known):K050951

2

Device Name: MedStar System II

Indications For Use:

The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring.

Flooplan would on Server is intended for use in a Disease Management Center, The associated Gollootion Scility, Medical Clinic or Physician's Office.

Lilliputian

Eric Lichtenstein Regulatory Affairs, Cybernet Medical

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.L. Zimmer

Sian-Off n of Cardlovascular Devices

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