PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER by PHILIPS MEDICAL SYSTEMS

Indications for Use (M3046A): For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.

Indications for Use (MP40/50/60/70/90) : Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

Device Description

The modification is the creation of a new measurement extension for the Philips patient monitor family (supported by the M3001A multi-measurement server).

AI/ML Overview

The provided text describes a 510(k) submission for the "Hemodynamic Extension to the Multi-measurement Server - M3012A." However, the available information is very high-level and does not contain detailed acceptance criteria or results from a clinical study as typically found in comprehensive performance reports for devices like AI algorithms.

The document states that "Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems." It mentions "system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing." The "Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices."

Based on the provided text, a detailed table of acceptance criteria and reported device performance (especially for a medical AI device), as well as many of the other requested details, cannot be extracted. This is because the submission refers to a hardware extension for a patient monitor and its performance testing focuses on system reliability and compliance with predicate device specifications, rather than a clinical effectiveness study of an AI algorithm's diagnostic or predictive performance.

Let's break down what can be answered based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document mentions:

"Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices."
"The test results showed substantial equivalence. The results demonstrate that the Measurement Server Extension meets all the reliability requirements and performance claims."

Critical missing information: Specific performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device), numerical thresholds for acceptance, or a detailed breakdown of what "all the reliability requirements and performance claims" entail. This document describes a hardware extension, not an AI model, so the type of performance metrics would be related to signal integrity, accuracy of measurements, reliability, etc., rather than the interpretative performance of an AI.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Critical missing information: The document states testing was conducted "using simulated systems," but no sample size for a test set (e.g., number of patients, cases, data points) or data provenance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Critical missing information: Since the testing was done on "simulated systems" and focuses on hardware reliability and not clinical interpretation, there is no mention of human experts establishing ground truth for a test set in the context of diagnostic or predictive performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Critical missing information: Not applicable to the type of testing described.

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

Critical missing information: Not applicable. This is not a study of an AI algorithm's impact on human performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Critical missing information: Not applicable. This document is not describing an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Critical missing information: The "ground truth" for the tests described would be based on the known parameters of the "simulated systems" and reference measurements, rather than clinical ground truth like pathology or outcomes.

8. The sample size for the training set

Critical missing information: Not applicable, as this is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Critical missing information: Not applicable.

Summary Table of Extracted Information:

Information Requested	Extracted Information / Status
1. Acceptance Criteria & Reported Performance	Acceptance Criteria: "Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices."Reported Performance: "The test results showed substantial equivalence. The results demonstrate that the Measurement Server Extension meets all the reliability requirements and performance claims." Critical Missing: Specific quantitative criteria and performance metrics.
2. Test Set Sample Size & Data Provenance	Sample Size: Not specified. Testing was "using simulated systems." Data Provenance: Not applicable, as it involved simulated systems, not clinical data from specific countries or retrospective/prospective studies.
3. Number & Qualifications of Experts for Ground Truth	Not applicable. Testing involved simulated systems, not human interpretation requiring expert ground truth for clinical diagnostic/predictive performance.
4. Adjudication Method for Test Set	Not applicable.
5. MRMC Comparative Effectiveness Study (AI impact on humans)	Not applicable. This notification is for a hardware extension to a patient monitor, not an AI algorithm.
6. Standalone Algorithm Performance	Not applicable. This notification is for a hardware extension.
7. Type of Ground Truth Used	Ground truth would be based on known parameters of the simulated systems and reference measurements / engineering specifications. Critical Missing: Specific details beyond "simulated systems."
8. Training Set Sample Size	Not applicable. This is for a hardware extension, not an AI algorithm.
9. Ground Truth Establishment for Training Set	Not applicable.

In conclusion, the provided 510(k) summary is for a hardware component with its associated verification and validation, not an AI-powered diagnostic or predictive device. Therefore, most of the requested details concerning clinical studies, expert-adjudicated ground truth, and AI performance metrics are not present in this document.

Summary

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NOV 21 2003

K033444

510 (k) Summary 9.0

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is: Tapan D. Shah Requlatory Affairs Engineer Cardiac and Monitoring Systems 3000, Minuteman Road Andover, MA - 01810 USA Tel: (978) 659 7681 Fax: (978) 685 5624 Email: tapan.shah@philips.com
  This summary was prepared on October 27, 2003
1. The name of this device is Hemodynamic Extension to the Multi-measurement Server - M3012A.
  Classification names are as follows:

RegulationNumber	Classification Name
870.2850	Extravascular Blood Pressure Transducer
870.1435	Computer, Diagnostic, Pre-Programmed, Single-Function
870.2900	Cable, Transducer and Electrode, Patient (includingconnector)
870.1110	Computer, Blood Pressure
870.1915	Probe, Thermodilution
870.1100	Alarm, Blood Pressure
870.2060	Amplifier and Signal Conditioner, Transducer Signal
870.2600	System, Signal Isolation
880.2910	Thermometer, electronic, clinical

1. The new device is substantially equivalent to previously cleared devices marketed pursuant to K882609, K002758, K020531, K032858, and K992273.
1. The modification is the creation of a new measurement extension for the Philips patient monitor family (supported by the M3001A multi-measurement server).
1. The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment or mobile environment for patient transport monitoring, the device is intended for measuring and alarming multiple physiological parameters and waves in adult, pediatric, and neonatal patients.
1. The new device has the same technological characteristics as the legally marketed predicate devices.

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1. Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems. Testing included system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence. The results demonstrate that the Measurement Server Extension meets all the reliability requirements and performance claims.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

NOV 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Mr. Tapan D. Shah Regulatory Affairs Engineer Cardiac and Monitoring Sytems 3000 Minuteman Road Andover, MA 01810

Re: K033444

Trade Name: Philips Medical Systems M3012A - Hemodynamic Extension to the Multi-Measurement Server Regulation Number: 21 CFR §870.1025 Regulation Name: Patient Physiological Monitor (arrhythmia detection and alarm) Regulatory Class: Class III (three) Product Code: MHX Dated: October 27, 2003 Received: October 29, 2003

Dear Mr. Shah:

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.

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. Tapan D. Shah

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), 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) you may obtain. 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 vours.

Nga nep

Zuckerman. N Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3.1 ODE Indications Statement

Indications for Use Statement

510(k) Number (if known)

Philips M3012A Hemodynamic Extension to the Device Name Multi-Measurement server
Indications for Use (M3046A): For monitoring, Indications for recording and alarming of multiple physiological Use parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.

Indications for Use (MP40/50/60/70/90) : Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Mexas Mey
for (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K033444

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.