VITALLINK3 MOBILE VITAL SIGNS SYSTEM

K073094 · Telemedic Systems, Ltd. · MWI · Jan 4, 2008 · Cardiovascular

Device Facts

• Record ID: K073094
• Device Name: VITALLINK3 MOBILE VITAL SIGNS SYSTEM
• Applicant: Telemedic Systems, Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Jan 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

The VitalLink3 (VL3) Mobile Vital Signs System is intend for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs from patients in remote locations and transmit the data, real time, to a medical professional at a Medical Call Center / Medical Service Provider in order to help determine the patient's transportation needs.

Device Story

VitalLink3 (VL3) is a portable, modular vital signs monitor for remote patient assessment. Inputs: 6/12 lead EKG, NiBP, SpO2, pulse, core temperature. Sensors communicate with VL3 unit via Bluetooth RF link. VL3 features integrated display for real-time data viewing, programmable soft keys for communication management, and onboard memory. Data transmitted in real-time via dialup, Ethernet, satellite phone, satellite data, cellular, or 802-11 b/g networks to a remote Medical Call Center. Clinical Interface software (installed on clinician PC) receives, decrypts, and displays data for clinician review. Output informs patient transport decisions. Used by clinicians at call centers to assess patients in remote environments (land, air, sea). Benefits include enabling remote clinical oversight and timely transport triage.

Clinical Evidence

Bench testing only. Device evaluated against recognized standards including IEC60601-1 (safety), IEC60601-1-2 (EMC), IEC60601-2-27 (EKG monitoring), DO-160 (airborne environmental conditions), IEC60529 (enclosure protection), and IEC60068-2 series (vibration/free fall). No clinical data presented.

Technological Characteristics

Modular system comprising VL3 monitor and sensor components. Connectivity via Bluetooth RF (sensors to monitor) and various WAN/LAN options (monitor to remote center). Power: battery-operated. Form factor: portable, fabric-cased. Software: proprietary Clinical Interface application for PC. Standards: IEC60601-1, IEC60601-1-2, IEC60601-2-27, DO-160, IEC60529, IEC60068-2-6, IEC60068-2-32.

Indications for Use

Indicated for patients in remote locations (land, aircraft, sea) requiring vital signs monitoring (6/12 lead EKG, NiBP, SpO2, pulse, core temperature) for transport decision-making by remote medical professionals.

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

• VitalLink1200 (K010732)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the number K073094 in a handwritten font. Below the number is the text 'p. 1/4', also in a handwritten font. The number and text are in black ink and the background is white. The image appears to be a scan or photograph of a document.

Image /page/0/Picture/1 description: The image shows the logo for TeleMedic Systems. The logo consists of a square with a plus sign on top and a line graph inside. The text "TeleMedic Systems" is to the right of the square.

JAN - 4 2008

Revision A 112307

## 2.0 510 (k) Summary

Data Prepared on: 24 October 2007 Date Revised on: 23 November 2007 (Revision A)

- 1. Submitter: TeleMedic Systems Ltd TeleMedics House 10 Billetfield Taunton Somerset TA1 3NN
- 2. Contact Person

| Name: | Gerald L Buss |
|-----------|--------------------------------|
| Position: | Chief Operating Officer |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | gbuss@UK. TeleMedicSystems.com |

#### 3. Device Identification

Trade Name / Proprietary Name: VitalLink3 Mobile Vital Signs System Common Name: Portable vital signs monitor

| 4. Classification name and reference | |
|-----------------------------------------------------------------------------|---------------------------------------------|
| Monitor, Physiological, Patient (Without<br>Arrhythmia Detection or Alarms) | CFR 870.2300, Class II<br>Product Code: MWI |
| Transmitters and Receivers,<br>Physiological signal, radio/frequency | CFR 870.2910, Class II<br>Product Code: DRG |

- 5. Indications for use
The VitalLink3 Mobile Vital Signs Monitor is intended for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs data from patients in remote locations and transmit that data, in real time, to

TeleMedic Systems TeleMedic House - 10 Briletfield - Taunton - Taun SNN - UK T [phone] F +44 +0) 8701 +17425 - E info (i)telemedicaystems com - W www.telemedios.stems.co.n

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Image /page/1/Picture/0 description: The image shows a logo for a company called "TeleMedic Systems". The logo consists of a stylized plus sign enclosed in a square. The words "TeleMedic" are stacked on top of the word "Systems" and are located below the square and plus sign.

INTERIOR
PAINT

Revision A 112307 medical professional located at a call centre / different location in order to help determine the patients transport needs.

#### 6. Device Description

The VitalLink3 System is a modular hardware/software system for acquiring, monitoring and/or communicating patient vital signs data.

The VitalLink system acquires vital signs date from patients in remote locations (on land, in aircraft or on ships at sea) and communicates the data in real time to a medical professional at a call centre (Medical Service provider) in order to help determine the patient's need for transportation to a medical facility.

The VitalLink® System is comprised of the following discrete units:

- a. The VitalLink3 (VL3) monitors 4 vital sign parameters: 6/12 lead EKG, Non-invasive blood pressure (NiBP), blood oxygen saturation (SpO2), pulse rate and core temperature. The VitalLink user interface includes a built in display for viewing collected data real time and a series of programmable soft keys for choosing communication preferences and manage communications with a medical service provider. The VitalLink also has onboard memory for storing the data collected from the parameters.
The Vitall ink is delivered to users in a fabric case with integrated compartments for the VitalLink3, the sensor components, battery chargers, labelling, and consumable accessories.

- b. Parameters: The EKG and SpO2 parameters identified in "6.a" above communicate with the VitalLink3 via a Bluetooth RF link. The parameters are paired with a VitalLink3 and the RF link tested just prior to when the device is packaged for shipping.
- c. Clinical Interface: The Clinical Interface is a TeleMedic Systems developed proprietary software application that receives data from a VitalLink®, decrypts the data and displays the information for use by medical professional / clinician in making a patient transport decision. The Clinical interface application is installed on a computer at the clinician's location.
- d. Communication Options: There are six (6) possible means by which the VitalLink® can be configured to communicate with the Clinical Interface: Dialup telephone landline, direct wired connection to an IP network (Ethernet), satellite phone, satellite based data services, cellular phone and wireless 802-11 b/g networks.

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Image /page/2/Picture/0 description: The image shows the logo for TeleMedic Systems. The logo consists of a square with rounded corners and a plus sign in the upper right corner. Below the square are the words "TeleMedic" on the first line and "Systems" on the second line. The text is in a simple, sans-serif font.

Revision A 112307

### 7. Statement of Substantial Equivalence

TeleMedic Systems believes that the VitalLinks is a modification of the VitalLink1200 (K010732) as it has the same indications for use and does not include a change in the fundamental science incorporated in the predicate device. Further, through a detailed comparison establishes substantially equivalent to the predicate device.

The INTENDED USE of the modified device as described in it labelling HAS NOT CHANGED.

- 8. Performance Standards
Section 514 performance standards have not been promulgated for this device. There are voluntary standards for this device some of which are FDA recognized. The FDA recognized standards are identified with an "4" in the following table.

| Standard Number | Standard<br>Organization | Standard Title | Rev | Date |
|-------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------------|
| ♦ IEC60601-1 | International<br>Electrotechnical<br>Commission | Medical Electrical Equipment.<br>Part 1: General Requirements<br>For Safety | 2 | 30-Dec-<br>1988 |
| ♦IEC60601-1-2 | International<br>Electrotechnical<br>Commission | Medical Electrical Equipment.<br>Part General Requirements For<br>Safety 2. Collateral Standard;<br>Electromagnetic Compatibility<br>Requirements and Tests | 2 | 29-Aug-<br>2005 |
| ♦ IEC60601-1<br>(Amendment1) | International<br>Electrotechnical<br>Commission | Medical Electrical Equipment.<br>Part 1: General Requirements<br>For Safety - Amendment 1 | - | 13-Nov-<br>1991 |
| ♦ IEC60601-1<br>(Amendment 2) | International<br>Electrotechnical<br>Commission | Medical Electrical Equipment.<br>Part 1: General Requirements<br>For Safety - Amendment 2 | - | 7-Mar-1995 |
| ♦ UL60601-1 (US<br>Deviations to<br>IEC60601-1) | Underwriters<br>Laboratories | Medical Electrical Equipment.<br>Part 1: General Requirements<br>For Safety | 1 | 25-Apr-<br>2003 |
| ♦ IEC60601-2-27 | International<br>Electrotechnical<br>Commission | Medical Electrical Equipment.<br>Part 2: Particular requirements<br>for the safety, including essential<br>performance, of<br>electrocardiographic monitoring<br>equipment | 2 | 29-Aug-<br>2005 |
| DO-160 | RTCA | Environmental Conditions and<br>Test Procedures for Airborne<br>Equipment | E | 9-Dec-2004 |
| IEC60529 | International<br>Electrotechnical<br>Commission | Degrees of Protection Provided<br>by Enclosures | 2.1 | 27-Feb-<br>2001 |

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K073094 p 4/4

Image /page/3/Picture/1 description: The image shows the logo for TeleMedic Systems. The logo consists of a square with a plus sign in the upper right corner. Inside the square is a graphic that appears to be a medical chart. Below the square are the words "TeleMedic Systems".

| | Revision A 112307 | | | |
|-------------------------|-------------------------------------------------|-------------------------------------------------------------------------------|-----|-----------------|
| Standard Number | Standard<br>Organization | Standard Title | Rev | Date |
| IEC60068-2-6 | International<br>Electrotechnical<br>Commission | Environmental testing - Part 2:<br>Tests - Test Fc: Vibration<br>(sinusoidal) | 6 | 31-Mar-<br>1995 |
| IEC60068-2-32 | International<br>Electrotechnical<br>Commission | Environmental testing - Part 2:<br>Tests - Test Ed: Free fall | 2 | 1-Jan-1975 |
| IEC60068-2-32<br>(amd2) | International<br>Electrotechnical<br>Commission | Amendment 2 - Environmental<br>testing. Part 2: Tests. Test Ed:<br>Free fall | 2 | 31-Oct-<br>1990 |

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Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TeleMedic Systems Ltd c/o Mr. Gerald L. Buss Chief Operating Officer 10 Billetfield Taunton, Somerset UNITED KINGDOM TA1 3NN

Re: K073094

VitalLink Mobile Vital Signs System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: November 23, 2007 Received: December 10, 2007

Dear Mr. Buss:

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. Gerald L. Buss

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 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/industry/support/index.html.

Sincerely vours.

Brimmer 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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Revision A 112307

# 1.0 Indications for use Statement

510(K) Number: _______________________________________________________________________________________________________________________________________________________________

VitalLink3 Mobile Vital Signs System Device Name:

Indications for use:

The VitalLink3 (VL3) Mobile Vital Signs System is intend for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs from patients in remote locations and transmit the data, real time, to a medical professional at a Medical Call Center / Medical Service Provider in order to help determine the patient's transportation needs.

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use | XXX |
|-------------------------|-----|
| OR Over-the Counter Use | |
| (Per 21 CRF 801.109) | |

*Division Sign-off*

| 510 (k) Number | K073094 |
|----------------|---------|
|----------------|---------|

Proprietary and Confidential - TeleMedic Systems Ltd. Unauthorized copying or distribution prohibited