(23 days)
M3290A: 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.
M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The Philips M3290A IntelliVue Information Center Software Release F.0 and M4840A Philips Telemetry System II with M4841A patient device.
This Philips submission for the M3290A IntelliVue Information Center Software Release F.0 and M4840A Philips Telemetry System II with M4841A patient device describes modifications (changes in ECG chest lead support, NBP limit alarms, and network functionality) and asserts substantial equivalence to a previously cleared predicate device (K040357). The documentation does not contain a detailed study with specific acceptance criteria and device performance metrics, as would typically be presented for de novo device approval or significant design changes requiring new clinical validation.
Instead, the submission states that:
"Verification, validation, and testing activities have successfully established the performance, functionality, and reliability characteristics of the new devices with respect to the predicates. 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 devices and test results showed substantial equivalence. The results successfully demonstrate that patient monitoring system functionality meets all reliability requirements and performance claims and is substantially equivalent to the predicate devices."
This indicates that the modifications were evaluated against the established performance specifications of the predicate device, and the testing confirmed that the changes did not degrade performance below those existing benchmarks.
Therefore, not all questions can be directly answered as the provided text does not contain a discrete study with defined acceptance criteria and performance data for this specific submission's modifications. The information below reflects what can be extracted or inferred from the provided text regarding the evaluation approach.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria and detailed device performance metrics (true positive rate, false positive rate, sensitivity, specificity, accuracy, AUC, F1-score) are not explicitly stated for the modified device. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." This implies that the device maintained the performance characteristics of its predicate.
| Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|
| Maintain performance specifications of predicate device (K040357) | Performance shown to be substantially equivalent to predicate device for all functions (including new ECG chest lead and NBP limit alarms) |
| Meet all reliability requirements | Successfully demonstrated |
| Meet all performance claims | Successfully demonstrated |
| Pass system level tests | Passed |
| Pass integration tests | Passed |
| Pass environmental tests | Passed |
| Pass safety testing from hazard analysis | Passed |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not specified. The testing described includes "system level tests, integration tests, environmental tests, and safety testing from hazard analysis," which are typically internal engineering and validation tests rather than clinical studies with patient data in the context of AI/ML evaluation.
- Data provenance: Not specified. Given the nature of the modifications (adding support for an ECG chest lead, NBP alarms, network functionality), the testing likely involved controlled testing environments and simulated data, potentially with some real physiological data from internal archives if applicable, but no geographically or retrospectively/prospectively defined clinical dataset is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The evaluation focused on technical performance and substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert ground truth labels for a dataset.
4. Adjudication method for the test set
- Not applicable/Not specified. There is no mention of a human adjudication process for establishing ground truth for a test set.
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 comparative effectiveness study was performed or mentioned. This submission does not describe an AI/ML algorithm intended to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device itself is a patient monitoring system, which includes automated capabilities like arrhythmia detection and ST segment monitoring. The testing described implicitly evaluates these "standalone" functionalities against their specifications, as part of assessing substantial equivalence to the predicate. However, specific performance metrics for individual algorithms (e.g., arrhythmia detection algorithm sensitivity) are not provided in this summary.
7. The type of ground truth used
- For the technical and safety testing conducted, the ground truth would be based on device specifications, engineering requirements, and regulatory standards. For example, in testing NBP alarms, the ground truth would be the defined NBP limits and whether the system correctly triggered an alarm when those limits were exceeded based on simulated or measured blood pressure values. For ECG lead support, the ground truth would be the accurate acquisition and display of the ECG signal via the new lead.
8. The sample size for the training set
- Not applicable. This device, as described in this 2004 submission, is a traditional medical device (patient monitor) with pre-specified algorithms, not a machine learning or AI device that undergoes a training phase with a distinct training set.
9. How the ground truth for the training set was established
- Not applicable. As noted above, this is not an AI/ML device that requires a training set and associated ground truth establishment.
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K041741
page 1 of 1
Page 46 of 58
JUL 2 1 2004
8.0 510(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:
| Barry WyshogrodRegulatory EngineerPhilips Medical SystemsCardiac and Monitoring Systems3000 Minuteman RoadAndover, MA 01810 | Tel: (978) 659-7383Fax: (978) 685-5624Email: barry.wyshogrod@philips.com |
|---|---|
| This summary was prepared on June 25, 2004. |
- The name of this device is the Philips M3290A IntelliVue Information Center Software Release F.0 2. and M4840A Philips Telemetry System II with M4841A patient device. Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, II | 74 MHX | Physiological Monitor, Patient Monitor (with arrhythmia detectionor alarms) |
| 870.1025, II | 74 MLD | Monitor, ST Alarm |
| 870.1130, 11 | 74 DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| 870.2300, II | 74 MSX | System, Network and Communication, Physiological Monitors |
| 870.2700, II | 74 DQA | Oximeter |
| 870.2800, II | 74 DSH | Recorder, Magnetic Tape, Medical |
| 870.2910, II | 74 DRG | Transmitters and Receivers, Physiological Signal,Radiofrequency |
- The new device is substantially equivalent to the previously cleared M3290A IntelliVue Information 3. Center Software and M4840A Philips Telemetry System II, cleared under K040357.
- The modification is a change that adds support for an additional ECG chest lead (vector), adds NBP 4. limit alarms, and adds support for additional network functionality.
- The new device has the same Indications for Use as the legally marketed predicate devices: 5.
M3290A: 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.
M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities.
- The new device has the same technological characteristics as the legally marketed predicate device. റ്.
- Verification, validation, and testing activities have successfully established the performance, 7. functionality, and reliability characteristics of the new devices with respect to the predicates. 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 devices and test results showed substantial equivalence. The results successfully demonstrate that patient monitoring system functionality meets all reliability requirements and performance claims and is substantially equivalent to the predicate devices.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2004
Phillips Medical Systems c/o Mr. Barry Wyshogrod Regulatory Engineer Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810
Re: K041741
K04771
Trade Name: M3290A Intellivue Information Center Software Release F.0 and M4840A Phillips Telemetry System II including M4841A Patient Device Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: July 8, 2004 Received: July 9, 2004
Dear. Mr. Wyshogrod:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled is (2) for the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to this 2011-07-11 accordance with the provisions of the Federal Food, Drug, devices mat nave been require approval of a premarket approval application (PMA). The Cobinete Free ( 100 ( 100 ) was the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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. Barry Wyshogrod
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease of action that I Dr wines on that your device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must or uny I edelar sthates 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 Of that 0077, incenting (21 CFR Part 820); and if applicable, the electronic form in the quality by brovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comiter provisions (seting your device as described in your Section 510(k) This lotter will and in your your finding of substantial equivalence of your device to a legally premaince notinetatem " mesults 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 If you dome office of Compliance at (301) 594-4648. Also, please note the regulation entitled, Connect the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Other general 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 vours,
Neil R.T. Ogden
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):
Device Name:
Indications For Use:
M3290A IntelliVue Information Center Software Release F.0 and M4840A Philips Telemetry System II including M4841A patient device.
M3290A: 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.
M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Neil RP Ogden
Sign on
(Division Sian-Off Division of Cardiovascular
510(k) Number K041741
AND/OR
Prescription Use Yes (Part 21 CFR 801 Subpart D) Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
§ 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.