(21 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Intended use: For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.
The Philips M3046B Compact Portable Patient Monitors. The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable Patient Monitors and Accessories.
The provided document is a 510(k) summary for the Philips M3046B Compact Portable Patient Monitors, detailing a software modification (Release B.00). It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI-powered device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML medical devices, is not present in this document.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is unavailable.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or corresponding reported device performance values for the modified software. It generally states that "Pass/Fail criteria were based on the specifications cleared for the predicate device" and that "Test results showed substantial equivalence."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified quantitatively in the document. Pass/Fail criteria were based on specifications of predicate devices. | "Test results showed substantial equivalence." "The results demonstrate that the Philips M3046B Compact Portable Patient Monitors meets all reliability requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not specify the sample sizes (e.g., number of patients, number of cases, length of recordings) used for these tests, nor the data provenance (country of origin, retrospective/prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As this is a software update for a physiological monitor, "ground truth" would likely refer to the accuracy of physiological parameter measurements (e.g., ECG, NIBP, SpO2) against reference standards or expert interpretation of waveforms/events. However, no details on panel of experts or their qualifications are mentioned.
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, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided and is irrelevant to this submission. The device is a patient monitor, not an AI-assisted diagnostic tool that requires human reader interpretation. The purpose of the submission is to demonstrate the safety and effectiveness of a software update for a physiological monitor, not to evaluate human performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes "system level tests, performance tests, and safety testing," which would imply standalone performance evaluation of the device's functions. However, specific details about such testing are not provided, and the term "standalone" as typically used in AI/ML performance studies isn't explicitly used here. The context implies that the device's algorithmic performance (e.g., for parameter measurement, arrhythmia detection) was evaluated against established specifications of predicate devices.
7. The Type of Ground Truth Used
The document implies that "Pass/Fail criteria were based on the specifications cleared for the predicate device." For a physiological monitor, "ground truth" would typically involve:
- Reference Devices/Standards: Comparing measurements (e.g., blood pressure, SpO2, ECG heart rate) against highly accurate reference devices.
- Known Physiological Events: Testing the ability to correctly detect and alarm for known physiological events (e.g., arrhythmias).
- Simulated Data: Using standardized clinical scenarios or simulated waveforms.
The document does not explicitly state the specific type of ground truth used, but given the nature of the device, it would align with these types.
8. The Sample Size for the Training Set
This information is not provided in the document. As this is a software update for an existing physiological monitor, it's unlikely that the software involves a machine learning model that requires a "training set" in the sense of modern deep learning. The software is likely based on fixed algorithms or rule-based systems.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is likely not applicable, as explained in point 8.
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K052707 p.112
7.0 510(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 CFR 807-92.
- The submitter of this pre-market notification is: Michael J. Doyle Philips Medical Systems - Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810 United States Tel: 978-659-3198 Fax: 978-659-3819 Email: mike.doyle@philips.com
This summary was prepared on September 26, 2005.
- The names of the devices are the Philips M3046B Compact Portable Patient Monitors. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CirculatorySystem Devices | 870.1025, II | MHX | Monitor, Physiological,Patient (with arrhythmiadetection or alarms) |
| 870.1110, II | DSJ | Alarm, Blood Pressure | |
| 870.1110, II | DSK | Computer, Blood Pressure | |
| 870.1130, II | DXN | System, Measurement,Blood Pressure, Non-Invasive | |
| 870.1435, II | DXG | Computer, Diagnostic,Pre-programmed, Single-function | |
| 870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer & RateAlarm | |
| 870.2340, II | DPS | Electrocardiograph | |
| 870.2700, II | DQA | Oximeter | |
| 870.2850, II | DRS | Extravascular BloodPressure Transducer | |
| 870.2900, I | DSA | Cable, Transducer andElectrode, incl. Patientconnector | |
| Anesthesiology& RespiratoryTherapy | 868.1400, II | CCK | Analyzer, Gas, |
| GeneralHospital andPersonal Use | 880.2910, II | FLL | Thermometer, Electronic,Clinical |
- The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K971910,
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К981576, К990972, К991773, К992273, К993383, К000822, К001057, K001333, and K003621.
-
The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable Patient Monitors and Accessories.
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The modified devices have the same intended use as the legally marketed predicate devices. They are intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatric, and neonates in healthcare environments and during transport within healthcare environments.
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The modified devices have the same technological characteristics as the legally marketed predicate devices.
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Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testinq 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 the Philips M3046B Compact Portable Patient Monitors meets all reliability requirements and performance claims.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems c/o Mr. Michael J. Doyle Regulatory Specialist 3000 Minuteman Road Andover, MA 01810
Re: K052707
Trade Name: M3046B Compact Portable Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: September 27, 2005 Received: September 29, 2005
Dear Mr. Doyle:
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. Michacl J. Doyle
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mesa Aoy
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): K052707
Device Name: Philips M3046B Compact Portable 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 use: For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.
| Prescription Use: | Yes |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| 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)
Moth
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number: K052707
Page _ of _
§ 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.