(115 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 nond/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The modification is a change that provides support for the MRx Monitor/Defibrillator and the M3177 Trend Display.
The provided document, K062271, is a 510(k) summary for the Philips Medical Systems M3290A IntelliVue Information Center Software Release J.00. This document primarily describes the substantial equivalence of the new device to previously cleared predicate devices and the scope of its intended use. It largely refers to previous clearances and does not detail new, specific performance studies with acceptance criteria for this particular software release.
The relevant section for performance claims is Section 7 of the 510(k) Summary, which states: "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 web software interface functionality meets all reliability requirements and performance claims."
Based on this, the document asserts that the new software release meets the same performance standards as its predicate devices, but it does not provide specific numerical acceptance criteria or detailed study results within this particular submission.
Therefore, for this specific 510(k) submission, the requested information detailing acceptance criteria and studies proving the device meets them cannot be fully provided as it is not explicitly present in the given text. The submission instead relies on the equivalence to previously cleared devices which presumably had such studies.
Here's a breakdown of what can be inferred or explicitly stated from the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Performance | Based on specifications cleared for predicate device(s) | "Test results showed substantial equivalence." |
| Functionality | Based on specifications cleared for predicate device(s) | "Test results showed substantial equivalence." |
| Reliability | Based on specifications cleared for predicate device(s) | "Results demonstrate that web software interface functionality meets all reliability requirements and performance claims." |
| Safety | Based on specifications cleared for predicate device(s) | "Test results showed substantial equivalence." |
| Integration | N/A (tested as part of "integration tests") | "Test results showed substantial equivalence." |
| Environmental | N/A (tested as part of "environmental tests") | "Test results showed substantial equivalence." |
Limitations: The document does not provide specific numerical or qualitative acceptance criteria for these metrics, nor does it present detailed performance results beyond a statement of substantial equivalence to the predicate and meeting reliability requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any test sets used in verification and validation. It also does not provide information on the data provenance (e.g., country of origin, retrospective/prospective). The testing focused on system-level, integration, environmental, and safety tests, which typically do not involve patient data in the same way clinical studies might.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of the device (information center software that supports monitoring, including arrhythmia and ST segment), ground truth would likely be established based on accepted clinical standards or reference devices, but the process is not detailed here.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study is mentioned. The document describes system-level, integration, environmental, and safety testing, not comparative effectiveness studies with human readers.
6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Study Was Done
The document refers to verification, validation, and testing activities, including system-level functional tests. This implies that the software's performance was evaluated independently against its specifications. However, specific details of an "algorithm-only" performance study (e.g., for arrhythmia detection accuracy independent of clinician interpretation) are not provided. The device itself is an "Information Center Software," implying it presents data to a clinician, so its performance is inherently linked to human interpretation to some degree.
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used. For monitoring devices like this, ground truth would typically come from:
- Reference measurements: Gold-standard devices or manual assessment using established clinical protocols for physiological parameters.
- Consensus: For subjective interpretations or complex events like arrhythmias, expert consensus could be used if human review was part of the ground truth process.
The provided text does not elaborate on how ground truth was established for the tests mentioned.
8. The Sample Size for the Training Set
This information is not applicable. The device is described as "software release J.00" for an information center, supporting existing monitors. There is no indication that this software uses machine learning algorithms that would require a "training set" in the conventional sense. The testing focuses on system functionality, integration, and reliability, rather than the performance of a newly developed predictive algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as no training set for machine learning is indicated.
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8.0 510 (k) Summary
NOV 3 V 2006
510(k) safety and effectiveness information is This summary of 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
- The submitter of this premarket notification is:
This summary was prepared on 3 August, 2006.
-
- The name of this device is the M3290A IntelliVue Information Center Software Release J.00 (for M3140, M3145, M3151, M3154, M3155, M3169, M3170, and M3177). 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 |
-
- The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K993907, K993171, & K964832 and the IntelliVue Patient Monitor under K053522, K051106, K041235, & K032858.
-
- The modification is a change that provides support for the MRx Monitor/Defibrillator and the M3177 Trend Display.
-
- The new device has the same Indications for Use as the leqally 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 segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms .
-
- The new device has the same technological characteristics as the legally marketed predicate device.
-
- 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 web software interface functionality meets all reliability requirements and performance claims.
Page 1 of 1
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 U 2006
Phillips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K062271
Trade Name: M3290A IntelliVue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170, and M3177) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: November 17, 2006 Received: November 20, 2006
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/fimmman for
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): K062271
M3290A IntelliVue Information Center Software Release J.00 Device Name: (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 nond/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use No____________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (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)
Blumunma
Division Slan-Off Division of Cardioy 510(k) Number
Page _________________________________________________________________________________________________________________________________________________________________________ ー
§ 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.