(30 days)
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.
The IntelliVue Information Center Software is central station software that runs on off-the-shelf Wir interest and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips M3290B IntelliVue Information Center Software:
Based on the provided text (K102495), the device in question is the M3290B IntelliVue Information Center Software release A.0.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics in a table format. Instead, it refers to a qualitative assessment against predicate device specifications.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Adherence to predicate device specifications | "Test results showed substantial equivalence." |
| Meeting defined reliability requirements | "The M3290B IntelliVue Information Center Software meets all defined reliability requirements." |
| Meeting performance claims | "The M3290B IntelliVue Information Center Software meets all... performance claims." |
| Functionality consistent with predicate device | Verified through "system level tests, performance tests, and safety testing." |
| Safety consistent with predicate device | Verified through "hazard analysis." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any test set (e.g., number of patients, number of cases).
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for a test set. This type of study does not appear to have been conducted based on the provided information.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as a specific test set requiring expert adjudication is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence to predicate devices, not on comparing performance with and without AI assistance for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The entire device is an "algorithm only" (software) system that provides information to human users. The testing described is for the standalone software performance, not in comparison to human-in-the-loop performance. The verification and validation activities were for the software itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The concept of "ground truth" as typically understood in AI/ML validation (e.g., pathology, expert labels) is not explicitly detailed. Instead, the document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies that the 'ground truth' for the software's functions (e.g., displaying physiological waves, parameters, generating alarms) was adherence to the established performance and functional specifications of the previous, cleared versions of the software.
8. The Sample Size for the Training Set:
The document does not mention a training set sample size. This is likely because the device is a software update (release A.0) to an existing, cleared product (IntelliVue Information Center Software) and not presented as a machine learning model that requires a distinct "training set" for its development. The testing focused on verification and validation of the new release against established specifications, not on training a new algorithm.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, the method for establishing its ground truth is not applicable/not provided.
Summary of Findings:
The K102495 submission for the M3290B IntelliVue Information Center Software is a 510(k) premarket notification asserting substantial equivalence to previously cleared predicate devices. The study detailed is not a clinical performance study involving patient data, expert adjudication, or AI model training. Instead, it describes a series of verification and validation (V&V) activities (system level tests, performance tests, safety testing, hazard analysis) to demonstrate that the new software release meets the specifications and reliability requirements of its predicate. The "acceptance criteria" were essentially the specifications already cleared for the predicate device, and the "study" was the V&V process that confirmed the new release met these existing criteria.
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K102495 Pl
Philips Medical Systems
Patient Monitoring Quality & Regulatory Group 3000 Minuteman Road Mailstop 0480 Andover, MA 01810 Tel: (978) 659-3000 Fax: (978) 685-5624
SEP 3 0 2010
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:
Theresa Poole Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099
Tel: 978 659 7621 Fax: 978 685 5624 Email: theresa.poole@philips.com
This summary was prepared on 30 August 2010.
The name of this device is the IntelliVue Information Center Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| None | 74 MHX | Physiological Monitor, Patient Monitor |
| 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 |
The M3290B IntelliVue Information Center (IIC) is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 provieted pursuant to K081983, K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832.
The IntelliVue Information Center Software is central station software that runs on off-the-shelf Wir interest and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry
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K102495 P2/2
devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.
The device has the same Indications for Use and Intended Use Statement as the legally marketed predicate devices.
The device has the same technological characteristics as the legally marketed predicate devices.
Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. 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 M3290B IntelliVue Information Center Software 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 & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Theresa Poole Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road, MS 0480 Andover, Massachusetts 01810-1099
SEP 30 2010
Re: K102495
Device Name: M3290B IntelliVue Information Center Software release A.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient physiological monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (Two) Product Codes: MHX, DSI, MLD, DSH, MSX Dated: August 30, 2010 Received: August 31, 2010
Dear Ms. Poole:
..
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Theresa Poole
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 nf 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
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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ODE Indications Statement 3.1
Indications for Use
510(k) Number (if known): KIO2495
Device Name: M3290B IntelliVue Information Center Software Release A.0
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).
W.M.S.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K102475
Confidential
Page 9
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SEP 3 0 2010
§ 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.