(24 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
The name of this device is the MX40 patient monitor.
The provided text describes a 510(k) premarket notification for the Philips MX40 patient monitor. However, the information regarding specific acceptance criteria, detailed study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics is very limited.
Here's an analysis of what can be extracted and what is missing, presented in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specifications cleared for the predicate device (TRx4841A, IntelliVue Telemetry System Transceiver) | "Test results showed substantial equivalence." "The results demonstrate that MX40 patient monitor meets all defined reliability requirements and performance claims." Note: The specific "specifications" and "reliability requirements and performance claims" are not detailed in the provided text. The text only states that the new device has "the same technological characteristics as the legally marketed predicate devices." This implies that the performance targets were to match the predicate, but specific numerical targets or results are not given. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document mentions "system level tests, performance tests, and safety testing," but does not indicate whether these involved clinical data, simulated data, or a combination, nor does it mention the country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Ground Truth Establishment: Not mentioned. Given the nature of a patient monitor, "ground truth" would likely involve comparison to established reference standards or expert clinical assessment, but this is not detailed.
4. Adjudication method for the test set
- Adjudication Method: Not mentioned.
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
- MRMC Study: No, this is not an MRMC comparative effectiveness study. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a patient monitor, and its performance would inherently be "standalone" in terms of its physiological measurement and alarm functions. However, the text does not explicitly refer to 'algorithm-only' or 'human-in-the-loop' performance. The evaluations were focused on the device's ability to "monitor and record" and "generate alarms," which are intrinsic functions of the device itself.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. For a patient monitor, ground truth would typically refer to the true physiological state or precise measurements obtained from a gold standard reference device, or expert clinical assessment. The document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics," suggesting an engineering and performance testing approach rather than an explicit "ground truth" in the clinical evaluation sense, although clinical validity would be part of overall performance.
8. The sample size for the training set
- Sample Size for Training Set: This device is a physiological monitor, not a machine learning or AI-driven system that would typically have a "training set" in the common understanding of those terms. Therefore, this information is not applicable or provided.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable (as explained in point 8).
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document broadly states that "Verification, validation, and testing activities" were conducted. These activities involved:
- System level tests: Evaluation of the integrated system.
- Performance tests: Assessment of the device's functional capabilities (e.g., accuracy of physiological parameter measurement, alarm generation).
- Safety testing from hazard analysis: Ensuring the device meets safety requirements.
The acceptance criteria for these tests were based on the existing "specifications cleared for the predicate device" (TRx4841A, IntelliVue Telemetry System Transceiver). The study concluded that the new device, MX40 patient monitor, exhibited "substantial equivalence" to the predicate device and "meets all defined reliability requirements and performance claims."
In essence, the provided text describes a regulatory submission where the new device's equivalence to a cleared predicate device was established through a series of internal verification and validation tests, rather than a detailed clinical trial with extensive ground truth establishment and expert review. The focus was on demonstrating that the new device performs as reliably and effectively as its legally marketed predecessors according to their established specifications.
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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: 978 659 4348 Fax: 978 685 5624 Email: claire.arakaki@philips.com
This summary was prepared on 10 December 2010.
The name of this device is the MX40 patient monitor. Classification names are as follows:
. "
. . . . . . . . . . .
| Classification | ProCode | Description |
|---|---|---|
| none | 74 MHX | Physiological Monitor, Patient Monitor |
| §870.1025, II | DSI | Detector and alarm, arrhythmia |
| §870.1025, II | MLD | Monitor, ST Segment with Alarm |
| §870.1025, II | MHX | Monitor, Physiological, Patient (with arrhythmiadetection or alarms) |
| §870.2350, II | DRW | Electrocardiograph, Lead Switching Adapter |
| §870.2700, II | DQA | Oximeter |
| §870.2900, I | DSA | Cable, Transducer and Electrode, incl. PatientConnector |
| §870.2300, II | MSX | System, Network and Communication, PhysiologicalMonitors |
| §870.2910, II | DRG | Transmitters and Receivers, Physiological Signal,Radiofrequency |
The new device is substantially equivalent to the previously cleared TRx4841A, IntelliVue Telemetry System Transceiver marketed pursuant to K040357, K041741, K081793, K062392, and K063725. Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.
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 predicate devices. .
JAN - 7 2011
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K103646
p2/2
JAN - 7 2011
. "…
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 MX40 patient monitor meets all defined reliability requirements and performance claims.
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Page 70
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized symbol with three curved lines resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged vertically along the left side of the symbol. The text is in a smaller font size compared to the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
JAN - 7 2011
Philips Medical Systems c/o Ms. Claire Arakaki Regulatory Affairs Specialist 3000 Minuteman Road, MS 0480 Andover, MA 01810-1099
Re: K103646
Trade/Device Name: Philips MX40 IntelliVue patient monitors Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: December 10, 2010 Received: December 14, 2010
Dear Ms. Arakaki:
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 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. 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); 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/CentersOfTices/CDRH/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/Resourcesfor You/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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Indications for Use
JAN - 7 2011
510(k) Number (if known):
Device Name: _ _ _ _ MX40 IntelliVue Patient Monitor
Indications for Use:
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K103646 |
§ 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.