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 currently marketed device with the exception of the functionality of the Pulse Oximeter (SpO2) options available. The predicate device, incorporating Nellcor MP204 technology, does not predicate de id signal processing techniques to compensate for patient motion. The modified device, incorporating Nellcor MP405 technology, incorporates features to compensate for patient motion.

AI/ML Overview

This K014294 submission describes the ESCORT II+ 400 Series (ESCORT Prism) Monitor, a patient monitor for vital signs. The primary change from the predicate device is an updated Pulse Oximeter (SpO2) option incorporating Nellcor MP405 technology, which includes signal processing techniques for patient motion compensation.

The provided documentation does not include a detailed study that defines specific acceptance criteria for the device's performance (e.g., accuracy, precision) and then presents test results to demonstrate compliance with these criteria. Instead, the submission states that "Testing of the modified ESCORT II+ 400 Series (ESCORT Prism) monitors was conducted by MDE to ensure mitigation of hazards. V&V conducted on the modified device to safety standards are the same as those conducted on the predicate device." This indicates a verification and validation approach focused on safety standards and equivalence to the predicate, rather than a clinical performance study with specific acceptance criteria as typically defined for algorithm-driven devices.

Therefore, I cannot populate the table and answer all the questions as requested, because the provided text does not contain the necessary information regarding detailed acceptance criteria or a specific performance study.

However, based on the available information, I can address some points:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided document. The submission implies that the acceptance criteria are met by demonstrating substantial equivalence to the predicate device and by ensuring the device meets safety standards ("mitigation of hazards").
Reported Device Performance: Not explicitly reported in terms of specific metrics (e.g., accuracy, sensitivity, specificity, or specific SpO2 accuracy values) in the provided document. The primary "performance" reported is that the modified device "incorporates features to compensate for patient motion" in its Pulse Oximeter function, improving upon the predicate's lack of such compensation.

2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-validated test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device, which includes an algorithm (for motion compensation in SpO2). The statement that "Testing... ensures mitigation of hazards" and V&V "to safety standards are the same as those conducted on the predicate device" implies testing of the device's functionality, including its algorithms, though specific "standalone" performance metrics are not given.
7. The type of ground truth used: Not explicitly stated. For a vital signs monitor, ground truth typically comes from highly accurate reference instruments or invasive measurements, but this is not detailed in the provided text.
8. The sample size for the training set: Not applicable, as this is a medical device submission, not a specific AI algorithm training submission with a distinct training set described. Nellcor MP405 technology is mentioned as being incorporated, which likely involves proprietary algorithms developed by Nellcor, but details of their training data are not part of this 510(k) submission.
9. How the ground truth for the training set was established: Not applicable. (See point 8)

Summary

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K014294

JAN 2 5 2002

ATTACHMENT 4

510(k) Summary

December 27, 2001 Date

Greg Alkire Contact Director, Regulatory Affairs Medical Data Electronics 12720 Wentworth Street Arleta, California 91331 818-768-6411 Telephone: Telefax: 818-768-4197 Email: Galkire@emailmde.com
ESCORT II+ 400 Series (ESCORT Prism) Monitor

Device Name

Patient Monitor, Vital Signs Monitor Common May Include Options: Name Carbon Dioxide Analyzer Cardiac Monitor Cardiac Output Computer Breathing Frequency Monitor Recorder Invasive Blood Pressure RF Physiological Transmitter/Receiver Temperature Defibrillator Noninvasive Blood Pressure External Pacer Pulse Oximetry
Classification The classification names and classifications of the Options available for the 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	11
Recorder	870.2810	II
RF Physiological Transmitter/Receiver	870.2910	11
	870.5300	11
DefibrillatorExternal Pacer	870.3600	II

The ESCORT Prism monitor is classified as a Class II Device.

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ESCORT II+ 400 Series (ESCORT Prism) Monitor Predicate 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 MP204 technology, does not predicate de id signal processing techniques to compensate for patient motion. The modified device, incorporating Nellcor MP405 technology, incorporates features to compensate for patient motion.

The Medical Data Electronics ESCORT II+ 400 Series Monitor is a Indications The Medical Datient monitor intended to be used for monitoring vital signs of For Use critically ill adult, pediatric and neonatal patients in the hospital environment.

Technological The modified ESCORT II+ 400 Series (ESCORT Prism) has the same I echnological The mountied 25 secteristics as the predicate device with the exception of the type of signal processing utilized for pulse oxygen saturation and pulse rate information incorporated in the modified device.

Testing of the modified ESCORT II+ 400 Series (ESCORT Prism) Testing Testing of the modieted by MDE to ensure mitigation of hazards. V&V monitors was conduction of the modified device to safety standards are the same as those conducted on the predicate device.

Medical Data Electronics, in accordance with the FFDCA and 21 CFR Conclusions Part 807 and data included in this premarket notification, concludes that i art 601 and addid 100 Series (ESCORT Prism) Monitor is safe, effective and substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Mr. Greg Alkire Medical Data Electronics, Inc. 12723 Wentworth Street Arleta, CA 91331

Re: K014294

ESCORT II+ 400 Series (ESCORT Prism) Monitor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: DQA Dated: December 26, 2001 Received: December 28, 2001

Dear Mr. Alkire:

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. In addition, if you wish to change or expand the current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.

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. Greg Alkire

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

V. Parker Tull

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory 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

510(k) Number (if known): __

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 moritor 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)

Division of Cardiovascular & Respiratory Devices
510(k) Number K014294

Prescription Use √
(Per 21 CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).