For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Description

PIC Software Release D.02.
PIC Software, Release D.02.
Application Server Software, Release A.0.
UDP Server Software, Release A.0.
TCP/IP PC Client Software, Release A.0
UDP PC Client Software, Release A.0.

AI/ML Overview

The provided text describes a 510(k) summary for the PIC Software Release D.02. This submission focuses on software modifications rather than clinical performance studies typically associated with detailed acceptance criteria for diagnostic devices. Therefore, the information requested about acceptance criteria, study design, and ground truth establishment, which are common for AI/ML-based diagnostic devices, is not explicitly available in this document.

However, based on the text, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific quantitative acceptance criteria or detailed reported device performance metrics in a tabular format. Instead, it makes a general statement:

Acceptance Criterion	Reported Device Performance
Specifications cleared for predicate devices	"Test results showed substantial equivalence. The results demonstrate that the software functionality meets all reliability requirements and performance claims."

Explanation: The acceptance criteria were based on the existing specifications of the predicate devices (HP CentralVue Software device, K964832, K993171, K993907, K001057, and K011093). The device was deemed to meet these criteria by demonstrating "substantial equivalence" and satisfying "all reliability requirements and performance claims" through verification, validation, and testing activities.

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

This information is not provided in the document. The text mentions "system level tests, integration tests, and safety testing from hazard analysis," but does not specify the sample size of data (e.g., patient records, physiological waveforms) used for these tests, nor their provenance (country of origin, retrospective/prospective).

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

This information is not provided in the document. As this is a software modification submission and not a clinical performance study involving diagnostic interpretation, the concept of "ground truth" derived from expert consensus for a test set is not applicable or detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document. The nature of the testing described (system, integration, safety) does not suggest a need for expert adjudication of results in the way a diagnostic algorithm's output would typically be evaluated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done as described in the provided text. The submission focuses on software changes and their substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device is a "Philips M3290A Information Center Software" which serves to "display physiologic waves, parameters and, trends, to format data... and the secondary annunciation of alarms." It also provides "primary annunciation of alarms, and configuration and control access for networked telemetry monitors." While the software performs functions independently (e.g., alarm annunciation, data display), the document does not explicitly describe a "standalone" performance study in the context of a diagnostic algorithm without human input for interpretation. The software acts as a central monitoring system. The functionality implies it provides information that humans (clinicians) will then use.

7. The Type of Ground Truth Used:

The document does not explicitly mention the "type of ground truth" in the context of a diagnostic dataset (e.g., pathology, outcomes data, expert consensus). Instead, the "ground truth" for the software's performance validation was based on:

Predicate device specifications: The new device's performance was compared against the established specifications and expected behavior of the legally marketed predicate devices.
Reliability requirements and performance claims: The software functionality was tested to ensure it met pre-defined reliability requirements and performance claims inherent to its intended use (displaying physiological data, alarming).

8. The Sample Size for the Training Set:

This information is not provided in the document. As this is a software modification submission for a central monitoring system, it's unlikely to involve a "training set" in the sense of machine learning for diagnostic image analysis or similar AI applications. The software's logic and algorithms are likely based on established physiological monitoring principles rather than being "trained" on a large dataset.

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

This information is not applicable/provided. Since a training set for machine learning or AI is not described, the method for establishing its ground truth is also not discussed. The software's functionality is rooted in engineering specifications and physiological monitoring standards rather than learned patterns from a dataset.

Summary

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MAY 1 5 2002

9.0 510(k) Summary

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.

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

978 659 3178 Tel: 978 685 5624 Fax: Email: d.g.osborn@ieee.org

This summary was prepared on May 1, 2002.

The name of this device is the PIC Software Release D.02.

PIC Software, Release D.02 .
Application Server Software, Release A.0 .
UDP Server Software, Release A.0 .
TCP/IP PC Client Software, Release A.0 ●
UDP PC Client Software, Release A.0. .

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
	870.2800, II	74 DSH	Recorder, MagneticTape, Medical
	870.2300, II	74 MSX	System, Network andCommunication,PhysiologicalMonitors

1. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832, K993171, K993907, K001057, and K011093.
1. The modification is a software-based change that adds tabular trends to the trend review capability and permits ICA compatible applications to be served to both PIC Software and other clients.
1. The new device has the same intended use as the legally marketed They are used to display physiologic waves, predicate devices. parameters and, trends, to format data for compliant strip chart recorders, to format data for printed reports, and the secondary annunciation of alarms for up to 16 patients from other networked medical devices at a centralized location. To provide retrospective review of alarms, physiologic waves and parameters. And to provide

103

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primary annunciation of alarms, and configuration and control access for networked telemetry monitors at a centralized location.

021422

104

1. The new device has the same technological characteristics as the legally marketed predicate devices.
1. Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the software functionality meets all reliability requirements and performance claims.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2002

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

Re: K021422

Trade Name: Philips M3290A Information Center Software, Revision D.02 Philips M2387A Application Server Software for M2385A, Release A.0 Philips M2389A UDP Server Software, Release A.0 Philips M2390A TCP/IP PC Client, Release A.0 Philips M2391A UDP PC Client, Release A.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: May 2, 2002 Received: May 3, 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.

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Page 2 - Ms. Dave Osborn

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. 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,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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K021422

Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips M3290A Information Center Software, Release D.02 Philips M2387A Application Server Software for M2385A, Release A.0 Philips M2389A UDP Server Software, Release A.0 Philips M2390A TCP/IP PC Client, Release A.0 Philips M2391A UDP PC Client, Release A.0

Indications for Use: For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

(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 K021422

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.