M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00

• K Number: K081983
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Date Cleared: 2008-08-22 ( 42 days)
• Product Code: MHX , DSH , DSI , MLD , MSX
• Regulation Number: 870.1025
• Type: Special
• Panel: Cardiovascular
• Reference & Predicate Devices: K080461 , K062271 , K050742 , K041741 , K040955 , K040357 , K031403 , K023698 , K021422 , K011093 , K001057 , K000854 , K993907 , K993171 , K964832
• Predicate For: K102495 , K131032

Intended Use

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 L.0

AI/ML Overview

This Philips Medical Systems 510(k) submission (K081983) for the M3290A IntelliVue Information Center Software, Release L.0, primarily focuses on demonstrating substantial equivalence to predicate devices based on modifications that add new features and integrations. The document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study that statistically proves the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection or ST-segment monitoring).

Instead, the submission emphasizes 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 M3290A IntelliVue Information Center Software, Release L.0 meets all defined reliability requirements and performance claims."

This statement indicates that the testing performed was primarily to ensure the new software release maintained equivalence to the previously cleared versions and met established internal specifications and safety requirements, rather than presenting a de novo clinical performance study against specific, quantifiable acceptance criteria for diagnostic accuracy.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert qualifications, and comparison studies are not available in the provided document.

Here's a breakdown of what is and is not present, based on the input:

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Acceptance Criteria and Device Performance

• 1. A table of acceptance criteria and the reported device performance:

  • Not provided. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device," but these specific criteria and the corresponding performance results (e.g., accuracy, sensitivity, specificity for arrhythmia detection) are not detailed.

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

  • Not provided. The document mentions "system level tests, performance tests, and safety testing," but does not specify sample sizes for any test sets or the origin/nature of the data used in these tests.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

  • Not provided. Given that specific performance metrics and test sets are not detailed, information about expert ground truth establishment is absent.

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

  • Not provided.

• 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:

  • Not provided and not applicable for this type of device. The device is a patient monitoring information center software, not an AI-assisted diagnostic tool that would typically involve human readers. The mention of "Integration of the ST/AR J.0 algorithm (K080461)" suggests algorithmic processing within the device itself, not necessarily for human interpretation improvement in an MRMC study context.

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

  • Likely yes, implicitly, but no specific study details are provided. The testing mentioned (system level, performance, safety) for the "ST/AR J.0 algorithm" integration would imply standalone performance evaluation against specifications, but no data is presented.

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

  • Not provided. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device." For physiological monitoring, ground truth often involves expert review of raw physiological waveforms or correlation with other established diagnostic methods, but specifics are missing here.

• 8. The sample size for the training set:

  • Not provided. This information is typically relevant for machine learning algorithms, and while an "ST/AR J.0 algorithm" is mentioned, no details about its development or training are included in this 510(k) summary.

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

  • Not provided.

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Summary Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices by detailing new features and stating that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." It indicates that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, it does not provide the specific acceptance criteria, reported performance metrics, or the detailed study design elements requested in the prompt, such as sample sizes, data provenance, expert qualifications, or ground truth establishment methods for a clinical performance study. The submission appears to rely on the established performance of its predicate devices and internal verification activities for the new software release.

Summary

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Philips Medical Systems

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:

Claire Arakaki Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099

Tel: [phone] Fax: [phone] Email: [e-mail]

This summary was prepared on 8 July 2008.

The name of this device is the M3290A IntelliVue Information Center Software, Release L.0 Classification names are as follows:

Classification	ProCode	Description
none	74 MHX	Physiological Monitor, Patient Monitor
870.1025, II	74 MLD	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

• 2. The new device is substantially equivalent to the previously cleared M3290A Intelli Vue Information Center Software, Release J.0 marketed pursuant to K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832.
• 3. The modification made to the device include the addition of the following features:
  • . Support for the Wireless TAAP feature
  • Addition of the Manual Data Laboratory (Lab) Entry application .
  • Support of the ST baseline synchronization with the IntelliVue MPxx Patient Monitors
  • Support for the printing of the predefined reports generated from the wireless IntelliVue MPxx . Patient Monitors
  • . New data communication protocol used between the IntelliVue Patient Monitors and the IIC (SCADA protocol)

Tel: [phone] Fax: [phone]

Confidential

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• Support for the Philips patient monitors operating in the Customer Supplied Clinical Network . (wireless network)
• Addition of HL7 parameters for VistA compliance .
• Integration of the ST/AR J.0 algorithm (K080461) .
• న. The new device has the same Indications for Use and Intended Use as the legally marketed predicate devices.
• The new device has the same technological characteristics as the legally marketed 6. predicate devices.
• 7. 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 M3290A IntelliVue Information Center Software, Release L.0 meets all defined reliability requirements and performance claims.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2008

Philips Medical Systems c/o Ms. Claire Arakaki Regulatory Affairs Specialist 3000 Minuteman Road, MS0480 Andover, MA 01810-1099

Re: K081983

Trade/Device Name: M3290A IntelliVue Information Center Software, Release L.0 Regulation Number: 21 CFR 870.1025 Regulation Names: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DSH, MSX Dated: August 6, 2008 Received: August 8, 2008

Dear Ms. Arakaki:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for woo cavaior 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). and Cosmotic For (110) that the device, subject to the general controls provisions of the Act. The r ou may, alerte or visions of the Act include requirements for annual registration, listing of general bonative profice, 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 ic may of receive for 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 - Ms. Claire Arakaki

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

ellomell
Bram D. Zuckerman

Bram D. Zuckerman, M.D. 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): K08198 3

Device Name: M3290A IntelliVue Information Center Software Release L.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170, and M3177)

Indications for Use:

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.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

lee

n of Cardiovascular Devices

Kogleg 510(k) Number

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.