PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B by PHILIPS MEDICAL SYSTEMS

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.

Bispectral Index (BIS) monitoring is for use in monitoring the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. The Bispectral Index, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents*.

Device Description

Philips Medical Systems, M1275B Component Compact Monitor, Release A.04, with M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module. The modification is updated software and the ability to support the Philips M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module as well as the M2385A Application Server.

AI/ML Overview

The provided 510(k) summary focuses on the Philips Medical Systems, M1275B Component Compact Monitor. However, the document does not contain explicit acceptance criteria tables or detailed study results demonstrating the device's performance against specific metrics.

Instead, the submission states that:

"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 internal testing was conducted to ensure the device met the established specifications of its predicate devices, but the specific numerical acceptance criteria and reported performance values are not disclosed in this summary.

Given the information provided, it's not possible to populate the requested table comprehensively or answer all specific questions about a detailed performance study with quantitative results, as the provided text only refers to the existence of such testing and its conclusion of substantial equivalence.

However, based on the general statements and the context of a 510(k) submission, we can infer some information:

Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies that the device was expected to perform at least as well as the predicate devices across all measured parameters (e.g., accuracy of gas analysis, arrhythmia detection, blood pressure measurement, ECG performance). The "reported device performance" is simply stated as meeting "all reliability requirements and performance claims" and demonstrating "substantial equivalence" to the predicate.
Sample Size and Data Provenance: Not specified in the document. The testing described is internal verification and validation, likely conducted by the manufacturer.
Number of Experts and Qualifications: Not specified. This type of expert review is typically not required for the technical performance testing of a multi-parameter monitor unless a specific component (e.g., arrhythmia detection algorithm) involved subjective interpretation, which is not detailed here.
Adjudication Method: Not applicable. The testing described is objective performance and safety testing against predefined specifications, not subjective reviews requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned and typically not applicable for this type of medical device (a multi-parameter monitor). MRMC studies are common for diagnostic imaging algorithms to assess human-AI interaction.
Standalone Performance: Yes, the described "system level tests, performance tests, and safety testing" refer to the standalone performance of the device without human interaction being part of the performance metric itself.
Type of Ground Truth: The ground truth for this type of device would be objective, established reference standards for physiological measurements (e.g., calibrated gas mixtures for gas analyzers, known signal generators for ECG and arrhythmia detection, calibrated blood pressure cuffs for NBP, etc.). The document doesn't explicitly state the specific ground truth methodologies.
Sample Size for Training Set: Not applicable. This device is a physiological monitor, not an AI/ML-based diagnostic algorithm that learns from a training set in the way a deep learning model would. The "software update" mentioned is more likely a traditional software update rather than a new AI model.
How Ground Truth for Training Set was Established: Not applicable as there is no specific "training set" for an AI/ML model described.

In summary of what can be extracted from the provided text:

While detailed quantitative data is absent, the submission asserts that the Philips M1275B Component Compact Monitor underwent verification, validation, and testing activities. These tests demonstrated that its performance, functionality, and reliability were substantially equivalent to its predicate devices, meeting all established specifications and performance claims. The "Pass/Fail criteria were based on the specifications cleared for the predicate device." This constitutes the implicit acceptance criteria.

Summary

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K621778

JUL 1 7 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: Fax: 978 685 5624 Email: dosborn@hsgmed.com

This summary was prepared on 29 May, 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
Anesthesiologyand RespiratoryTherapy DevicesPanel (12624)	868.1400, II	CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
	868.1500, II	CBQ	Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration)
	868.1500, II	NHO	Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration)
	868.1500, II	NHP	Analyzer, Gas,Sevoflurane, Gaseous-Phase(Anesthetic Concentration)
	868.1500, II	NHQ	Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration)
	868.1620, II	CBS	Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration)
	868.1700, II	CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase(Anesthetic Concentration)
	868.1720, II	CCL	Analyzer, Gas, Oxygen,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
CirculatorySystem DevicesPanel (12625)	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

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Device Panel	Classification	ProCode	Description
	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-Ray Tube,Medical
	870.2600, I	DRJ	System, Signal Isolation
	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
GeneralHospital andPersonal UseDevices Panel(12520)	880.2910, II	FLL	Thermometer, electronic,clinical
NeurologicalDevices Panel(12513)	882.1400, II	GWR	Electroencephalograph
NeurologicalDevices Panel(12513)	882.1420, I	GWS	Analyzer, Spectrum,ElectroencephalogramSignal

1. The new device is substantially equivalent to the previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, K020531, and K021300, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1021A SvO2 Module marketed pursuant to K942843, the Philips M1027A EEG Module marketed pursuant to K992674, the Philips M1034A BIS Module marketed pursuant to K003038, and the Philips M2391A PC Client marketed pursuant to K021422.
The modification is updated software and the ability to support এ . to the Philips M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS Module as well as the M2385A Application Server.
1. The new device has the same Indications for Use, for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients, as the legally marketed predicate device.

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The new device has the same technological characteristics as the 6. 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

JUL 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dave Osborn Philips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810

Re: K021778

Philips Component Compact Monitor, Release A.04, M1275B Regulation Number: 870.2700, 882.1400, 870.1025 Regulation Name: Oximeter, Electroencephalograph, and Arrhythmia Detector and Alarm Regulatory Class: III Product Code: DQA, GWQ, and MHX Dated: May 29, 2002 Received: May 30, 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.

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.

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Page 2 - Mr. Dave Osborn

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) 594-4648. 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

Timothy A. Ulatowski

Timo Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page ______ of _______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips Medical Systems, M1275B Component Compact Monitor, Release A.04, with M1021A SvO2 Module, M1027A EEG Module, and M1034A BIS 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.

Gan TJ, Slass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg Bispectral Index Monitoring Allows Faster emergence and P. Improved Recovery from Propofol, Alfentanil, and Nitrous Oxide Anesthesia. Anesthesiology October 1997; (4) 87:808-15.

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

Prescription Use V Use (Per 21 CFR 801.109)

OR Over-The-C

(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device !- 10(k) Number

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).