ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR

K992411 · Medical Data Electronics · DRT · Aug 18, 1999 · Cardiovascular

Device Facts

• Record ID: K992411
• Device Name: ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
• Applicant: Medical Data Electronics
• Product Code: DRT · Cardiovascular
• Decision Date: Aug 18, 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 II+ 400 Series 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, CO2, breathing frequency, cardiac output, invasive/noninvasive blood pressure, temperature, and pulse oximetry (SpO2). Device processes physiological signals to display real-time patient data to clinicians. Modified version incorporates Masimo pulse oximetry technology, replacing previous Nellcor technology. Masimo technology eliminates need for user-invoked 'C-Lock' signal processing to manage motion or limited perfusion, allowing automatic signal handling. Clinicians use output for patient assessment and clinical decision-making in critical care settings.

Clinical Evidence

Bench testing only. Verification and validation testing conducted to ensure mitigation of hazards and compliance with safety standards, consistent with testing performed on the predicate device.

Technological Characteristics

Portable patient monitor; modular design supporting ECG, CO2, blood pressure, temperature, and pulse oximetry. Key modification: integration of Masimo pulse oximetry technology for automated signal processing of motion and perfusion artifacts, replacing Nellcor 'C-Lock' technology. Device operates as a standalone monitor in hospital environments.

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 II+ 400 Series (ESCORT Prism) Monitor (K992411)

Submission Summary (Full Text)

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AUG 18 1999

K992411

# ATTACHMENT 4

## 510(k) Summary

July 19, 1999 Date

- David M. Trueblood Contact Regulatory Affairs Manager Medical Data Electronics 12720 Wentworth Street Arleta, California 91331 Telephone: [phone] Telefax: 818-768-4197 Email: [e-mail]
Device Name

- Common Patient Monitor, Vital Signs Monitor 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
ESCORT II+ 400 Series (ESCORT Prism) Monitor

- The classification names and classifications of the Options available for the Classification ESCORT II+ 400 Series (ESCORT Prism) 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 |

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| Predicate | ESCORT® II+ 400 Series (ESCORT Prism™) Monitor |
|-----------|------------------------------------------------|
| Device | |

- The modified ESCORT II+ 400 Series (ESCORT Prism) monitor is Device identical to the to the currently marketed device with the exception of the Description 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 Electronics ESCORT II+ 400 Series 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 II+ 400 Series (ESCORT Prism) has the same Characteristics 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 II+ 400 Series (ESCORT Prism) Testing monitors 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 II+ Model 400 Series (ESCORT Prism) Monitor is safe, effective and substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a bird, possibly an eagle, with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

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

Re: K992411 Trade Name: ESCORT® II+ 400 Series Monitors (ESCORT Prism™) Regulatory Class: III Product Code: DRT, DQA, DTE July 19, 1999 Dated: 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation may result in In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 requlations.

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### Page 2 - Mr. David M. Trueblood

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 Also, please note the regulation Compliance at [phone]. entitled, "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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

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

Enclosure

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# ATTACHMENT 2

## Indications for Use Statement

Page 1_of_ 1

8992411 510(k) Number (if known): 鄭毅雄秘

Device Name: ESCORT II+ 400 Series (ESCORT Prism) Monitor

Indications for Use:

The Medical Data Electronics ESCORT II+ 400 Series 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Oaks Mell

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use_

(Optional Format 1-2-96)