Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.

Device Description

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AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips M2/M3/M4 Compact Portable Patient Monitor:

This document primarily describes the substantial equivalence of the new device to previously cleared devices (M3 K971910 and K981576) and highlights a modification related to auscultatory validation. As such, the information provided is limited in detail regarding acceptance criteria and study specifics for the new device as a standalone entity, beyond the specific mention of non-invasive blood pressure (NIBP) validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Auscultatory validation reference according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.	Device performance correlates to auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions a "validation study."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used or their qualifications. It refers to "auscultatory reference standard," which typically implies human observers.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. The reference to "auscultatory reference standard" might suggest a consensus among observers if multiple were used, but this is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. The focus is on the device's performance against a reference standard, not its impact on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

A standalone performance study was done. The validation study evaluates the device's "performance correlates to auscultatory reference standard," implying the device's output is directly compared to the reference.

7. Type of Ground Truth Used

The type of ground truth used is an expert consensus/reference standard, specifically the "auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10" for non-invasive blood pressure measurements. Auscultatory methods rely on human listeners (experts) using a stethoscope to determine systolic and diastolic pressures.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for any training set. Given the context of a 510(k) for a patient monitor predominantly focused on substantial equivalence and a specific validation for NIBP, it's possible that a separate "training set" in the modern machine learning sense was not explicitly defined or extensively documented in this submission.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly describe how ground truth for a training set was established. The validation study focuses on comparing the device's NIBP measurements to an established auscultatory reference standard.

Summary

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K013427 p.1/2

NOV 2 9 2001

510 (k) Summary 8.0

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 15 October, 2001

1. The name of this device is Philips M2/M3/M4 Compact Portable Patient Monitor. Classification names are as follows:

Device Panel	Classification	ProCode	Description
Panel 74Cardiovascular	None	74 MHX	PhysiologicalMonitor, PatientMonitor
	870.1025, III	74 DSI	Arrhythmia Detectorand Alarm
	870.1025, III	74 MLD	Monitor, ST Alarm
	870.2350, II	74 DRW	Electrocardiographlead switchingadapter
	870.1100, II	DSJ	Alarm, Blood-Pressure
	870.1110, II	DSK	Computer, Blood-Pressure
	870.1130, II	DXN	System, Measurement,Blood-Pressure, Non-Invasive
	870.2300, II	74 DRT	Cardiac Monitor
	870.2340, II	74 FYW	Electrocardiograph
	870.1435, II	74 DXG	Computer, Diagnostic,Pre-programmed,Single Function
	870.2900, II	74 DSA	Cable, Transducer andElectrode, includingPatient Connector
	870.2850, II	74 DRS	Extravascular BloodPressure Transducer
Panel 73Anesthesiology	868.1400, II	73 CCK	Carbon Dioxide GasAnalyzer
Panel 80GeneralHospital	880.2910, II	80 FLL	Clinical ElectronicThermometer

1. The new device is substantially equivalent to the previously cleared M3 K971910 and K981576.
1. The modification provides an auscultatory validation reference, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.

3.5

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1. The new device has the same intended use as the legally marketed predicate devices. M3 is used for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.
1. The new device has the same technological characteristics as the legally marketed predicate devices.
1. The results of the validation study indicate that the device performance correlates to auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.

K013427

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2001

Mr. Dave Osborn Quality Program Manager Philips Medical Systems, Inc. Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01801

Re: K013427

Trade Name: Philips M3000A/M3046A, (M2/M3/M4) Compact Portable Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor Regulatory Class: Class III (three) Product Code: MHX Dated: November 12, 2001 Received: November 13, 2001

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,

N. O'Keefe Tiller

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013421

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips M3000A/M3046A, (M2/M3/M4) Compact Portable Patient Monitor .

Intended for monitoring, recording, and alarming of multiple physiological Indications for Use: moreations for Ose. " - Intented rowneonates in hospital and medical transport environments.

(Please do not write below this line-continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Usc Use V V CFR 801.109) (Optional Format 1-2-96) OR

Over-The-Counter

Division of Cardiovascular & Respiratory Devices
510(k) Number K013427

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.