(30 days)
Intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
Philips M1175A/76A/77A Component Monitoring System ● Philips V24/V26 patient monitor .
The provided document is a 510(k) summary for the Philips M1175A/76A/77A Component Monitoring System and Philips V24/V26 Patient Monitor. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a new AI/ML device.
Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-driven devices, are not present in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format for performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" reported is that the device "meets all reliability requirements and performance claims" and that "test results showed substantial equivalence."
| Acceptance Criteria (Inferred from substantial equivalence) | Reported Device Performance |
|---|---|
| Device performance and reliability are equivalent to predicate devices (K003038, K001333, K990125, K981576, K971910, and K903771) | Device "meet[s] all reliability requirements and performance claims." "Test results showed substantial equivalence." |
| Functionality in monitoring, recording, and alarming multiple physiological parameters is equivalent to predicate devices. | Device "has the same intended use as the legally marketed predicate devices." |
| Technological characteristics are equivalent to predicate devices. | Device "has the same technological characteristics as the legally marketed predicate devices." |
| Compliance with relevant specifications (e.g., AAMI SP-10 for blood pressure validation). | Modification provides a choice of validation references according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients. |
2. Sample sizes used for the test set and the data provenance
The document does not specify a distinct "test set" sample size or data provenance in the context of evaluating a new algorithm or AI performance. The testing described involves "system level tests, integration tests, and safety testing from hazard analysis." These are likely internal verification and validation activities rather than a clinical study with a specific patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe the establishment of ground truth by experts for a test set, as it is a 510(k) submission for substantial equivalence based on hardware and software modifications, not an AI/ML diagnostic or prognostic device requiring expert-adjudicated ground truth.
4. Adjudication method for the test set
Not applicable, as no external expert-adjudicated test set is described.
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
Not applicable. This submission predates widespread AI/ML integration into medical devices requiring MRMC studies to demonstrate human-AI collaboration benefits. The device monitors physiological parameters, and there is no mention of "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML algorithm in the modern sense. The "algorithm" is part of the overall monitoring system, and its performance is evaluated as part of the total system functionality and reliability. The document does not isolate "algorithm-only" performance from the device's integrated operation.
7. The type of ground truth used
The concept of "ground truth" as typically applied to AI/ML (e.g., pathology, clinical outcomes) is not explicitly discussed. The "truth" for this device's performance would be derived from:
- Predicate device specifications: The new device's performance is compared against the established performance and specifications of the legally marketed predicate devices.
- Industry standards: Compliance with standards like AAMI SP-10 for blood pressure validation.
- Internal specifications: Meeting the manufacturer's own design and reliability requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is described.
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KO14159 JAN 1 8 2002
p/12
510 (k) Summary 9.0
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: Dave Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085
Tel: 978 659 3178 978 685 5624 Fax: Email: dosborn@hsgmed.com
This summary was prepared on 17 December, 2001
-
- The names of these devices are:
- Philips M1175A/76A/77A Component Monitoring System ●
- Philips V24/V26 patient monitor .
Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 73Anesthesiology | 868.1400, II | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| 868.2375, II | BZQ | Monitor, BreathingFrequency | |
| 868.2480, II | LKD | Monitor, Carbon-Dioxide,Cutaneous | |
| 868.2500, II | KLK | Monitor, Oxygen,Cutaneous, for Infant notunder Gas Anesthesia | |
| Panel 74Cardiovascular | 870.1025, III | DSI | Detector and Alarm,Arrhythmia |
| 870.1025, III | MLD | Monitor, ST Segment withAlarm | |
| 870.1025, III | MHX | Monitor, Physiological,Patient (with arrhythmiaDetection or alarms) | |
| 870.1100, 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 | |
| 870.1915, II | KRB | Probe, Thermodilution | |
| 870.2060, II | DRQ | Amplifier and SignalConditioner, TransducerSignal | |
| 870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer & RateAlarm) | |
| 870.2340, II | DPS | Electrocardiograph | |
| 870.2340, II | MLC | Monitor, ST Segment |
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| 870.2370, II | KRC | Tester, Electrode,Surface,Electrocardiograph | |
|---|---|---|---|
| 870.2450, II | DXJ | Display, Cathode-RayTube, Medical | |
| 870.2600, I | DRJ | System, Signal Isolation | |
| 870.2700, II | DQA | Oximeter | |
| 870.2770, II | DSB | Plethysmograph, Impedance | |
| 870.2800, II | DSH | Recorder, Magnetic Tape,Medical | |
| 870.2810, I | DSF | Recorder, Paper Chart | |
| - | MSX | System, Network andCommunication,Physiological Monitors | |
| Panel 80GeneralHospital | 880.2910, II | FLL | Thermometer, electronic,clinical |
-
- The modification provides a choice of validation references, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.
-
- The new devices have the same intended use as the legally marketed predicate devices. They are intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
-
- The new devices have the same technological characteristics as the legally marketed predicate devices.
-
- Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration 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 demonstrate that modified devices meet all reliability requirements and performance claims.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JAN 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dave Osborn Ouality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K014159
Trade Name: Philips M1175A/76A/77A Component Monitoring System and Philips V24/V26 Patient Monitor with M1008B and software release CMS C.1 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: December 17, 2001 Received: December 19, 2001
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
N. O'Neill
am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips M1175A/76A/77A Component Monitoring System and Philips V24/V26 patient monitor with M1008B and software release CMS C.1
Indications for Use: Intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
OR
Over-The-Counter
Division of Cardiovascular & Respiratory Devices
510(k) Number K01454
1 1
§ 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.