(14 days)
Indications for Use (M3046A): For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.
Indications for Use (MP60 & MP70): Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in health care facilities.
The modification is primarily a software-based change that incorporates a Data Export function communication protocol to transfer data from the patient monitors to an external computer or external device (a data client). This protocol is a connection oriented, message based request/response protocol.
This document is a 510(k) summary for Philips Medical Systems' M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 IntelliVue Patient Monitors with Portal Technology. The submission is for a software-based change that incorporates a Data Export function communication protocol.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:
The document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds with corresponding numerical targets) nor does it report detailed device performance metrics against such criteria.
The submission is for a software modification related to data export, and the verification testing mentioned is focused on "functional level tests and safety testing from the risk analysis." This suggests the primary focus of the testing was to ensure the new data export function worked as intended and did not introduce new safety hazards, rather than evaluating specific clinical performance metrics like arrhythmia detection accuracy.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document states: "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis."
There is no information provided regarding:
- The sample size of any test set (e.g., number of patients, number of data points).
- Data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
There is no mention of experts or ground truth establishment in the context of a clinical validation test set. Given the nature of the submission (software change for data export) and the description of the testing, it's highly unlikely that clinical experts were used to establish a "ground truth" in the way they would be for a diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As no expert review for ground truth is described, there is no adjudication method provided.
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 conducted or reported. The device is a patient monitor with data export functionality, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a patient monitor, which is inherently a standalone device. The software modification is for data export. The "verification testing activities" are likely evaluating the functionality of this data export and the overall system's safety and effectiveness. However, it's not a standalone AI algorithm in the contemporary sense. The document does not describe specific algorithmic performance metrics in isolation.
8. The sample size for the training set:
No training set is mentioned. This type of device and the described modification (data export) would not typically involve machine learning or a training set in the conventional sense.
9. How the ground truth for the training set was established:
As no training set is mentioned, there is no information on how ground truth was established for it.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a software-based modification related to data export. It does not contain the detailed clinical validation study data (acceptance criteria, test set details, expert ground truth, MRMC studies, training set information) that would be expected for a novel diagnostic or AI-powered device. The "verification testing activities" described are more aligned with engineering performance and safety testing for the new functionality.
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DEC 0 4 2002
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: David Osborn Philips Medical Systems Cardiac & Monitoring Systems 3000 Minuteman Road 01810-1099 Andover, MA Tel: 978 659 3178 978 685 5624 Fax: e-mail: d.g.osborn@ieee.org
This summary was prepared on November 18, 2002
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- The names of the devices are the M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 IntelliVue Patient Monitors with Portal Technology. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CirculatorySystem Devices(12625) | $870.1025, III | DSI | Detector and alarm, arrhythmia |
| $870.1025, III | MLD | Monitor, ST Segment with Alarm | |
| $870.1025, III | MHX | Monotor, Physiological, Patient(with arrhythmia detection oralarms) | |
| $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, Transducer Signal | |
| $870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer & Rate Alarm) | |
| $870.2340, II | DPS | Electrocardiograph | |
| $870.2340, II | MLC | Monitor, ST Segment | |
| $870.2350, II | DRW | Electrocardiograph, LeadSwitching Adapter | |
| $870.2370, II | KRC | Tester, Electrode, Surface,Electrocardiograph | |
| $870.2450, II | DXJ | Display, Cathode-Ray Tube,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 |
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| $870.2850, II | DRS | Extravascular Blood PressureTransducer | |
|---|---|---|---|
| $870.2900, I | DSA | Cable, Transducer andElectrode, incl. PatientConnector | |
| - | MSX | System, Network andCommunication, PhysiologicalMonitors | |
| Anesthesiologyand RespiratoryTherapy (12624) | $868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,Gaseous-Phase |
| $868.1500, II | CBQ | Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHO | Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHP | Analyzer, Gas, Sevoflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHQ | Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1620, II | CBS | Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,Gaseous-Phase (AnestheticConcentration) | |
| $868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | |
| $868.2375, II | BZQ | Monitor, Breathing Frequency | |
| $868.2480, II | LKD | Monitor, Carbon Dioxide,Cutaneous | |
| $868.2500, II | KLK | Monitor, Oxygen, Cutaneous, forInfant not under Gas Anesthesia | |
| General Hospitaland Personal Use(12520) | $880.2910, II | FLL | Thermometer, Electronic,Clinical |
| Neurological(12513) | $882.1400, II | GWR | Electroencephalograph |
| $882.1420, I | GWS | Analyzer, Spectrum,Electroencephalogram Signal |
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- The modification is primarily a software-based change that incorporates a Data Export function communication protocol to transfer data from the patient monitors to an external computer or external device (a data client). This protocol is a connection oriented, message based request/response protocol.
-
- The new devices have the same intended use as the legally marketed predicate devices. When used in the hospital environment and/or in medical transport, they are intended for the monitoring, recording,
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K023871
page 3 of 3
and alarming of multiple physiological parameters of adults, pediatrics, and neonates.
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- The new devices have the same technological characteristics as the legally marketed predicate devices.
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- Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 04 2002
Philips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810
Re: K023871
Trade Name: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 IntelliVue Patient Monitors with Portal Technology
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: November 19, 2002 Received: November 20, 2002
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 Osbo
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 (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.
Q.G.Tich
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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Page 1 of 1.
510(k) Number (if known):
The M3046A (M2/M3/M4) Compact Portable Patient Device Name: Monitor and MP60 & MP70 IntelliVue Patient Monitors with Portal Technology
Indications for Use (M3046A): For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.
Indications for Use (MP60 & MP70): Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in health care facilities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(21 CFR 801.109) X
OR
10
Over-The-Counter (Per
Yolanda
(Division Sign Off)
510(k) Number K023374
(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.