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 Description

The modified ESCORT II+ 400 Series (ESCORT Prism) monitor is identical to the to the currently marketed device with the exception of 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.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way typically found for AI/ML devices. Instead, it is a 510(k) summary for a patient monitoring device (ESCORT II+ 400 Series Monitor) seeking clearance based on substantial equivalence to a predicate device.

The document focuses on:

Device Description: The device is a patient monitor with various options like cardiac monitor, pulse oximetry, NIBP, etc.
Modification: The key change in the modified device from the predicate is the use of Masimo technology for pulse oximetry, which "requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion," unlike the predicate which used Nellcor technology requiring user action for 'C-Lock' for limited patient perfusion.
Substantial Equivalence: The submission claims substantial equivalence to the predicate device because the modified device has the same intended use and similar technological characteristics, with the exception of the pulse oximeter's signal processing.
Testing: It states that "Testing of the modified ESCORT II+ 400 Series (ESCORT Prism) 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." However, no specific performance metrics, acceptance criteria, or study results are detailed.

Therefore, I cannot provide the requested table and study information because the provided text does not include:

A table of acceptance criteria and reported device performance: There are no quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific thresholds for physiological parameters) mentioned, nor are there any reported performance metrics from a study against such criteria.
Sample size, data provenance, ground truth details, or adjudication methods for a test set: The document mentions "V&V testing" but provides no details about the methodology, data used, or how ground truth was established for any performance evaluation.
Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is relevant for AI/ML diagnostic tools where human readers interpret results. The ESCORT II+ is a patient monitor, and its clearance is based on technological equivalence for vital sign monitoring, not on enhancing human interpretation of images or complex data.
Standalone (algorithm-only) performance: While the device uses new signal processing for pulse oximetry, the document does not present it as an "algorithm only" performance study in the context of typical AI/ML submissions. The device itself is a standalone monitor.
Ground truth type for performance evaluation: No specific ground truth type (e.g., pathology, outcomes) is mentioned, as no detailed performance study results are provided.
Training set details: Since no AI/ML model training is described, there's no mention of a training set or how its ground truth was established.

In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence for a physical patient monitoring device, not a detailed performance study for an AI/ML algorithm with specific acceptance criteria.

Summary

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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: 818-768-6411 Telefax: 818-768-4197 Email: dave.trueblood@medicaldataelectronics.com
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	ClassificationNumber	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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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)

Over-the-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).