Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

Device Description

The Philips Medical Systems, M1275B Component Compact Monitor is a multi-parameter module.

AI/ML Overview

The provided document, K020531 for the Philips Medical Systems M1275B Component Compact Monitor, does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the format typically required for AI/algorithm performance.

This 510(k) submission primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K013199) rather than presenting a detailed performance study as one might expect for a novel AI/ML device. The document describes a traditional medical device (a multi-parameter monitor) and its updated multi-parameter module.

Here's a breakdown of the available information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it states:

"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims."

This indicates that the acceptance criteria were the existing specifications and performance of the predicate device. The performance reported is that the new device met these predicate specifications and achieved substantial equivalence.

Regarding items 2-9, which are typically relevant for AI/ML performance studies, the document does not contain this information because it is not an AI/ML device submission. It's a hardware medical device. Therefore, the following information is not applicable or not provided in this 510(k) submission:

2. Sample size used for the test set and the data provenance: Not applicable. Performance was likely assessed through bench testing, simulated scenarios, and potentially limited clinical verification against existing monitors, but specific "test sets" of patient data as understood in AI/ML are not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physiological monitor would be established by physical measurements and calibrated equipment.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a hardware monitor, not an interpretive AI system that human readers would use in conjunction with.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its monitoring function, but this refers to a different context (AI algorithm performance) and is therefore not applicable to the information provided.

7. The type of ground truth used: For a multi-parameter monitor measuring physiological parameters (ECG, blood pressure, etc.), the ground truth would be established by comparison to other validated medical devices, calibrated sensors, and established physical measurement principles. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device," implying the predicate device's performance served as the benchmark.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) submission for the Philips M1275B Component Compact Monitor, Release A.02, with M3001A Multi-Parameter Module, is for a traditional medical device (a physiological monitor). Its "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a previously cleared predicate device (K013199) and meeting the existing specifications and performance standards of that predicate. The document explicitly states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." The type of detailed performance study and ground truth establishment described in your request is specific to AI/ML devices and is therefore not found in this submission.

Summary

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KO20531

MAR 2 0 2002

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 CFR §807.92.

The submitter of this premarket notification is: Dave Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085

978 659 3178 Tel: 978 685 5624 Fax: Email: dosborn@hsgmed.com

This summary was prepared on 13 February, 2002

1. The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. Classification names are as follows:

Device Panel	Classification	ProCode	Description
Panel 73Anesthesiology	868.1400, II	CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
	868.2375, II	BZQ	Monitor, BreathingFrequency
	868.2480, II	LKD	Monitor, Carbon-Dioxide,Cutaneous
	868.2500, II	KLK	Monitor, Oxygen,Cutaneous, for Infant notunder Gas Anesthesia
Panel 74Cardiovascular	870.1025, III	DSI	Detector and Alarm,Arrhythmia
	870.1025, III	MLD	Monitor, ST Segment withAlarm
	870.1025, III	MHX	Monitor, Physiological,Patient (with arrhythmiaDetection or alarms)
	870.1100, II	DSJ	Alarm, Blood-Pressure
	870.1110, II	DSK	Computer, Blood-Pressure
	870.1130, II	DXN	System, Measurement,Blood-Pressure, Non-Invasive
	870.1435, II	DXG	Computer, Diagnostic,Pre-Programmed, Single-Function
	870.1915, II	KRB	Probe, Thermodilution
	870.2060, II	DRQ	Amplifier and SignalConditioner, TransducerSignal
	870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & RateAlarm)
	870.2340, II	DPS	Electrocardiograph
	870.2340, II	MLC	Monitor, ST Segment
	870.2370, II	KRC	Tester, Electrode,Surface,Electrocardiograph
	870.2450, II	DXJ	Display, Cathode-RayTube, Medical
	870.2600, II	DRJ	System, SignalIsolation

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Device Panel	Classification	ProCode	Description
	870.2700, II	DQA	Oximeter
	870.2770, II	DSB	Plethysmograph, Impedance
	870.2800, II	DSH	Recorder, Magnetic Tape,Medical
	870.2810, I	DSF	Recorder, Paper Chart
	-	MSX	System, Network andCommunication,Physiological Monitors
Panel 80GeneralHospital	880.2910, II	FLL	Thermometer, electronic,clinical

1. The new device is substantially equivalent to the previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199.
1. The modification is a new multi-parameter module.
The new device has the same Indications for Use, for use by 5. health care professionals whenever there is a need for monitoring the physiological parameters patients, as the legally marketed predicate device.
1. The new device has the same technological characteristics as the legally marketed predicate device.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a bird with three wavy lines extending from its body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

Mr. Dave Osborn Quality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K020531

Trade Name: Philips Medical Systems, M1275B Component Monitor, Release A.02, with M3001A Multi-Parameter Module Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: February 14, 2002 Received: February 19, 2002

Dear Mr. Osborn:

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. Dave Osborn

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,

Walter Tunn

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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Page _/ of _/

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: Philips Medical Systems, M1275B Component Compact Monitor, Release A.02, with M3001A Multi-Parameter Module.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.

Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

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

Prescription Use	✓	OR	Over-The-Counter
Use(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices

510(k) Number: K026531

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.