ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR

K992413 · Medical Data Electronics · DRT · Aug 19, 1999 · Cardiovascular

Device Facts

• Record ID: K992413
• Device Name: ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
• Applicant: Medical Data Electronics
• Product Code: DRT · Cardiovascular
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Medical Data Electronics ESCORT 100/300 Series B Patient Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.

Device Story

Portable patient monitor for hospital use; monitors vital signs including ECG, SpO2, CO2, blood pressure, temperature, and cardiac output. Device processes physiological signals to display real-time patient data for clinicians. Modified version integrates Masimo pulse oximetry technology, replacing previous Nellcor technology. Masimo technology eliminates need for manual 'C-Lock' signal processing to manage motion or low perfusion. Clinicians use output for patient assessment and clinical decision-making in critical care settings. Benefits include improved signal reliability during patient motion or limited perfusion without requiring manual intervention.

Clinical Evidence

Bench testing only. V&V testing and safety standard testing were conducted to ensure mitigation of hazards and equivalence to the predicate device.

Technological Characteristics

Portable patient monitor; includes modules for ECG, SpO2, CO2, invasive/noninvasive blood pressure, temperature, and cardiac output. Incorporates Masimo pulse oximetry signal processing technology. Connectivity includes RF physiological transmitter/receiver. Class II/III device components.

Indications for Use

Indicated for monitoring vital signs of critically ill adult, pediatric, and neonatal patients in 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

• ESCORT 100/300 Series B (ESCORT II) Patient Monitor (K992413)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 19 1399

K992413

## ATTACHMENT 4

## 510(k) Summary

Date July 19, 1999

- David M. Trueblood Contact Regulatory Affairs Manager Medical Data Electronics 12720 Wentworth Street Arleta, California 91331 Telephone: [phone] Telefax: 818-768-4197 e-mail: dave.trueblood(@medicaldataelectronics.com
- ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Device Name

Patient Monitor, Vital Signs Monitor Common May Include Options: Name Cardiac Monitor Carbon Dioxide Analyzer Breathing Frequency Monitor Cardiac Output Computer Invasive Blood Pressure Recorder Temperature RF Physiological Transmitter/Receiver Noninvasive Blood Pressure Defibrillator Pulse Oximetry External Pacer

- The classification names and classifications of the Options available for Classification ESCORT® 100/300 Series B (ESCORT II) Patient Monitors are as follows:

| Option | Classification<br>Number | Class |
|---------------------------------------|--------------------------|-------|
| Cardiac Monitor | 870.2300 | II |
| Breathing Frequency Monitor | 868.2375 | II |
| Invasive Blood Pressure | 870.1110 | II |
| Temperature | 880.2910 | II |
| Noninvasive Blood Pressure | 870.1130 | II |
| Pulse Oximetry | 870.2700 | II |
| Carbon Dioxide Analyzer | 868.1400 | II |
| Cardiac Output Computer | 870.1435 | II |
| Recorder | 870.2810 | II |
| RF Physiological Transmitter/Receiver | 870.2910 | II |
| Defibrillator | 870.5300 | II |
| External Pacer | 870.3600 | III |

{1}------------------------------------------------

ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Predicate Device

The modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Device is identical to the to the currently marketed device with the exception of Description the functionality of the Pulse Oximeter (SpO2) Options available. The predicate device, incorporating Nellcor technology, requires user action to invoke special signal processing ('C-Lock') in order to better handle limited patient perfusion. The modified device, incorporating Masimo technology, requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion.

The Medical Data ESCORT® 100/300 Series B Patient Monitor is a Indications For Use portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.

Technological The modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor Characteristics has the same technological characteristics as the predicate device with the exception of the type of signal processing utilized for pulse oximeter patient information. The predicate device uses Nellcor 'C-Lock' signal processing in order to better cope with patient motion. The modified device requires no special processing to cope with patient motion or limited patient perfusion.

- Testing of the modified ESCORT® 100/300 Series B (ESCORT II) Patient Testing Monitor was conducted by MDE to ensure mitigation of hazards. V&V testing and testing of the modified device to safety standards are exactly the same as those conducted on the predicate device.
- Conclusions Medical Data Electronics, in accordance with the FFDCA and 21 CFR Part 807 and data included in this premarket notification, concludes that the modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor is safe, effective and substantially equivalent to the predicate device.

30

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

AUG 1 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David M. Trueblood Requlatory Affairs Manager Medical Data Electronics, Inc. .12720 Wentworth St. Arleta, CA 91331-4329

Re: K992413 Trade Name: ESCORT® 100/300 Series B (ESCORT® II)Patient Monitors Requlatory Class: III Product Code: DRT, DQA and DTE Dated: July 16, 1999 Received: July 20, 1999

Dear Mr. Trueblood:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

{3}------------------------------------------------

Page 2 - Mr. David M. Trueblood

response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## ATTACHMENT 2

## Indications for Use Statement

Page 1 of

510(k) Number (if known): Kaga2413

Device Name: ESCORT 100/300 Series B (ESCORT II)Patient Monitors

Indications for Use:

The Medical Data Electronics ESCORT 100/300 Series B Patient Monitor is a portable r ne modioal Buta Elook of he used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kalk Hill

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 94 2414 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)