Indicated for central monitoring of multiple 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

M3290A IntelliVue Information Center Software Release E.01 and IntelliVue Clinical Network on VLAN. The modification is a change that permits operation of the IntelliVue Clinical Network on customer provided IEEE 802.1q compatible VLAN network infrastructure.

AI/ML Overview

This 510(k) pertains to a software update (Release E.01) for the M3290A IntelliVue Information Center and its operation on a VLAN. The submission focuses on demonstrating substantial equivalence to previously cleared versions of the device, rather than presenting a de novo study with acceptance criteria and performance metrics for a new medical device. The document primarily highlights that the updated device maintains the same performance, functionality, and reliability characteristics as its predicate devices.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, and expert involvement for a new device's performance evaluation is not explicitly provided in this 510(k) summary. The document emphasizes verification, validation, and testing activities to ensure the updated software and network capabilities meet established specifications for the predicate device.

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

1. A table of Acceptance Criteria and the Reported Device Performance:

Feature/Metric	Acceptance Criteria (Implied)	Reported Device Performance
System performance, functionality, and reliability	Must meet specifications cleared for the predicate device(s).	Meets all reliability requirements and performance claims.
Operation on VLAN network infrastructure	Compatibility and stable operation with IEEE 802.1q compatible VLAN networks.	Demonstrates that IntelliVue Clinical Network on VLAN infrastructure meets all reliability requirements and performance claims.
Indications for Use	Must be consistent with the legally marketed predicate device.	Same Indications for Use as the legally marketed predicate device (central monitoring, cardiac arrhythmia, ST segment monitoring for adult, pediatric, and neonatal patients).
Technological Characteristics	Must be consistent with the legally marketed predicate device.	Same technological characteristics as the legally marketed predicate device.

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

Sample Size for Test Set: Not specified. The document states "Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis." This suggests a battery of tests rather than a single, defined patient-data test set.
Data Provenance: Not specified. Given the nature of the update (software and network compatibility), the testing might have been primarily internal engineering and software validation, rather than extensive clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The ground truth for this type of software and network update would likely be based on technical specifications and expected system behavior, rather than expert clinical consensus on patient data.

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

Not specified. Adjudication methods are typically used for clinical endpoints where there's variability in interpretation among experts, which is not directly applicable to a software and network compatibility update.

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:

No MRMC study was done or mentioned. This is a software and network compatibility update for a physiological monitor, not an AI-assisted diagnostic tool.

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

The testing described ("system level tests, integration tests, environmental tests, and safety testing") would inherently involve evaluation of the algorithm and system performance in a standalone manner (without specific human-in-the-loop clinical performance evaluation as might be done for diagnostic AI). However, this isn't a standalone AI performance study.

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

For this type of device update, the "ground truth" would be the successful adherence to pre-defined technical specifications, functional requirements, and reliability standards of the predicate device, as well as successful operation within the new VLAN environment. This is an engineering and software validation ground truth, not a clinical diagnostic ground truth.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "training" would be the development and refinement of the software, and the "test" would be the verification/validation.

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

Not applicable, as no training set for machine learning was used.

Summary

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MAY 1 2 2004

8.0 510 (k) Summary

summary of 510(k) safety and effectiveness information រ ន This 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:

Philips Medical Systems

This summary was prepared on 12 April, 2004.

1. The name of this device is the M3290A IntelliVue Information Center Software Release E.01 and IntelliVue Clinical Network on VLAN. Classification names are as follows:

Classification	ProCode	Description
None	74 MHX	Physiological Monitor, PatientMonitor
870.1025, II	74 DSI	Arrhythmia Detector and Alarm
870.1025, II	74 MLD	Monitor, ST Alarm
870.2800, II	74 DSH	Recorder, Magnetic Tape, Medical
870.2300, II	74 MSX	System, Network and Communication,Physiological Monitors

1. The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software and IntelliVue Clinical Network cleared under K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, & K040357.
1. The modification is a change that permits operation of the IntelliVue Clinical Network on customer provided IEEE 802.1q compatible VLAN network infrastructure.
1. The new device has the same Indications for Use as the legally marketed predicate device. For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST seqment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms .
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, integration tests, environmental 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 IntelliVue Clinical Network on VLAN infrastructure meets all reliability requirements and performance claims.

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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2004

Philips Medical Systems c/o Mr. Dave Osborn Quality Program Manager 3000 Minuteman Road Andover, MA 01810

Rc: K040955

KU40933
Trade Name: M3290A Intellivue Information Center Software, Release E.01, and Intellivue Clinical Network on VLAN Regulation Number: 21 CFR 870. 1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: April 12, 2004 Received: April 13, 2004

Dear Mr. Osborn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor > I <<<<> pc device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) is regars actment date of the Medical Device Amendments, or to continered prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de vices mat nave been rechasined in avere approval of a premarket approval application (PMA). and Cosmetor rear (11ct) the device, subject to the general controls provisions of the Act. The I ou may, mereleve, maniel 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 may be subject to such additions, 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 Please be advised that I DA s issuation of a backed complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, with 801); good manufacturing practice requirements as set CFK Fatt 607), labeling (21 OFR Part 820); and if applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product launtion control pro herems (2) ====================================================================================================================================== Fins icher while anow you to begin maining of substantial equivalence of your device to a legally premaired notification. THPT BAT maining of casification 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 If you desire specific at nee 101 ) 594-4646. Also, please note the regulation entitled, Comact the Office of Comment of Comment of notification" (21CFR Part 807.97) you may obtain. I whisoralium by reference to premiesponsibilities under the Act may be obtained from the Oinci general information on your respectional 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,

Dna Heiseku for

Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K040 455

M3290A IntelliVue Information Center Software, Device Name: M3290A Incellivae IntelliVue Clinical Network on VLAN

Indications for Use:

mandate is our Indicated for central monitoring on and clinician decides to monitor and neonatur pacients) and neonatal patients cardiae arriferma of adult patients to gain information for and/OL ST Segment of adaily of treatment, or to exclude causes of symptoms.

Prescription Use yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dna Xuelu

Page 1 of 1

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.