MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701

K043354 · Invivo Research, Inc. · DRT · Jan 10, 2005 · Cardiovascular

Device Facts

• Record ID: K043354
• Device Name: MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
• Applicant: Invivo Research, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Jan 10, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Vision Telepak Telemetry Transmitter is a portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.

Device Story

Vision Telepak Telemetry Transmitter is a portable, wireless patient monitor; captures ECG and SpO2 vital signs from critically ill adult and pediatric patients. Device transmits data wirelessly to ESCORT Vision Central Station or ESCORT Series bedside monitors for clinician review. Used in hospital settings; operated by healthcare staff. Enhancements over predicate include reduced physical size and transition from 9V to 2 AA battery power. Output allows continuous patient monitoring, facilitating clinical decision-making and patient safety.

Clinical Evidence

Bench testing only. Performance testing compared the modified Vision Telepak to the predicate (K970763) to verify accuracy and precision against a reference laboratory system. Device passed environmental and non-clinical testing per UL-2601-1 and EN 60601-1-2.

Technological Characteristics

Portable wireless telemetry transmitter; ECG and SpO2 sensing; powered by 2 AA batteries. Complies with UL-2601-1 and EN 60601-1-2 standards. Connectivity via wireless transmission to central station or bedside monitors.

Indications for Use

Indicated for monitoring vital signs (ECG and SpO2) in critically ill adult and pediatric patients within hospital environments.

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

• MTS Option for the Escort II Monitor (K970763)

Submission Summary (Full Text)

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K043354

JAN 1 0 2005

### 510(k) Summary

| Submitted By: | Medical Data Electronics, Inc. |
|-----------------------------------|-----------------------------------------------|
| | 12601 Research Parkway |
| | Orlando, FL 32826 |
| | [phone] |
| | [phone] (fax) |
| Contact: | Neil Battiste |
| | Director of Regulatory Affairs |
| Date of Preparation: | December 3, 2004 |
| Establishment Registration<br>No: | 1051786 |
| Device Name: | Vision Telepak™ Telemetry Transmitter |
| Common/Classification<br>Name: | Monitor, Cardiac |
| Device Classification: | Class II |
| Regulation Number: | CFR 870.2300 and 870.2700 |
| Classification Panel: | Division of Cardiovascular |
| Product Code: | 74DRT and 74DQA |
| Predicate Device: | MTS Option for the Escort II Monitor, K970763 |

#### Device Description:

The Vision Telepak Telemetry Transmitter unit is a portable, wireless, patient monitor intended to be used for monitoring the ECG and SpO2 vital signs of critically ill and pediatric patients. The Telepak unit is used in all areas of the hospital which utilize telemetry transmitters for ECG and/or SpO2 monitoring. The Telepak transmits vital sign information to an ESCORT Vision Central Station or an ESCORT Series bedside monitor. Both the central station and beside monitors were cleared under K970763.

#### Intended Use:

The Vision Telepak Telemetry Transmitter is a portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.

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KD43354

# Comparison to the Predicate Device:

The Vision Telepak Telemetry Transmitter and the MTS Option for the Escort II Monitor are both portable monitors which are used to monitor ECG and Sp02. Both systems transmit vital sign information to either an ESCORT Vision Central Station or an ESCORT Series bedside monitor.

The systems differ in that the Telepak unit has been enhanced by reducing the size which makes the product easier to handle. In addition, the Telepak unit now requires 2 AA batteries instead of a 9v battery.

# Environmental and Non-Clinical Testing:

Applicable environmental and non-clinical testing was performed per UL-2601-1 and EN 60601-1-2 as well as other applicable standards and procedures. The Vision Telepak Telemetry Transmitter passed all tests.

# Performance Testing:

The study conducted to compare equivalency of the MTS Option for the Escort II Monitor 510(k) cleared device to the modified Vision Telepak Telemetry Transmitter met the performance requirements for accuracy and precision relative to the reference laboratory system. Equivalent performance in meeting user requirements was determined.

# Conclusion:

The test results demonstrate the Vision Telepak Telemetry Transmitter is substantially equivalent to the MTS Option for the Escort II Monitor.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 graphic of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2005

Invivo Research, Inc. c/o Mr. Neil Battiste Director of Regulatory Affairs Medical Data Electronics 12601 Research Parkway Orlando, FL 32826

Re: K043354

K04555+
Trade Name: Vision Telepak™ Telemetry Transmitter Trade Name: Vision Telepan
Regulation Number: 21 CFR 870.2300 and 21 CFR 870.2700 Regulation Number - 21 CFR 676.2500 and 25 - CFC - CF - Cardiotachometer and rate alarm) and Oximeter Regulatory Class: II (two) Product Code: DRT and DQA Dated: December 03, 2004 Received: December 06, 2004

Dear Mr. Battiste:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivale referenced above and have decimined the actrised predicate devices marketed in interstate for use stated in the encrosule) to regally manced promotion interestions of the Foderal Food. Drug commerce prior to May 28, 1970, the charger and the provisions of the Federal Food, Drug, devices that have been recassified in accordance who was areas approval applications (PMA).
and Cosmetic Act (Act) that do not require approval approval applicions of the Act and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, seeject to the gentrator for annual registration, listing of
general controls provisions of the Act include requirements for any are an general controls provisions of the net net netalie sequilibitions 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 classified (sec above) mio chairs and regulations affecting your device can
may be subject to such additional controls. Tim may be subject to such additional controlist. Existing major of 998. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addit be found in the Code of Pouch Ingerning your device in the Federal Register.

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Page 2 – Mr. Neil Battiste

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that FDA s issuates of a vadevice complies with other requirements of the Act that TDA has made a determination an administered by other Federal agencies. You must of any Federal statutes and regulations daminders, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, morealing, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product fadiation control provisions (Decleons over device as described in your Section 510(k) I his letter will anow you to ocgin manketing your antial equivalence of your device to a legally premarket notheadon. The PDA midning of backers 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 If you desire specific arvice for your ac now of the regulation of the regulation entitled, contact the Office of Compilance wa (== t notification" (21CFR Part 807.97) you may obtain. IMISURANGING by Telefone to promasibilities under the Act may be obtained from the Other general information on your responsible 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,

B. Zimmerman for
R.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

K043354 510(k) Number (if known): Device Name: Vision Telepak™ Telemetry Transmitter

Indications for Use:

The Vision Telepak™ Telemetry Transmitter is portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.

× Prescription Use (21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Brimmer

(Division Sign-Off) Division of Cardiovase 510(k) Number