(28 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or specific performance metrics typically associated with AI/ML algorithms. The testing described focuses on system-level performance and equivalence to predicate devices.
No
The device is described as a "Patient Monitor" and its intended use is for "monitoring, recording and alarming of multiple physiological parameters", not for treating or preventing a disease or condition.
No
The device is indicated for monitoring, recording, and alarming of physiological parameters, not for diagnosing medical conditions.
No
The device description explicitly states "The Philips MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor," which are hardware devices. The summary also describes testing involving "system level tests" and "performance tests," which are typical for hardware-inclusive medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring physiological parameters of patients in vivo (within the living body). This includes ECG, ST segment monitoring, and transcutaneous gas measurement. IVD devices, by definition, are used to examine specimens derived from the human body in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a patient monitor, which is a type of medical device used for real-time physiological monitoring of a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on specimens outside the body.
Therefore, the Philips IntelliVue Patient Monitor, as described, falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.
Product codes
DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, DRW, KRC, DXJ, DRJ, DQA, DSB, DRS, DSF, MSA, MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The names of the devices are the Philips MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor.
The modification is the introduction of Release B.0 software for the IntelliVue patient monitor devices, MP60, MP70 and MP90, and the introduction of the models MP40 and MP50.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, pediatrics, and neonates
Intended User / Care Setting
health care professionals, hospital environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001664, K021778, K030038, K031481
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
OCT 1 0 2003
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: Hauke Schik Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany ++49 7031 463-2442 Tel: ++49 7031 463-2031 Fax: e-mail: hauke.schik@philips.com
This summary was prepared on September 8, 2003.
- The submitter of this premarket notification is: Hauke Schik Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany ++49 7031 463-2442 Tel: ++49 7031 463-2031 Fax: e-mail: hauke.schik@philips.com
-
- The names of the devices are the Philips MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Circulatory | |||
| System Devices | |||
| (12625) | $870.1025, III | DSI | Detector and alarm, arrhythmia |
| $870.1025, III | MLD | Monitor, ST Segment with Alarm | |
| $870.1025, III | MHX | Monitor, Physiological, Patient | |
| (with arrhythmia detection 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 Signal | |
| Conditioner, 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, Lead | |
| Switching 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 | |
| $870.2850, II | DRS | Extravascular Blood Pressure | |
| Transducer | |||
| $870.2900, I | DSA | Cable, Transducer and | |
| Electrode, incl. Patient | |||
| Connector |
1
| | | MSX | System, Network and
Communication, Physiological
Monitors |
|------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| Anesthesiology
and Respiratory
Therapy (12624) | $868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,
Gaseous-Phase |
| | $868.1500, II | CBQ | Analyzer, Gas, Enflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHO | Analyzer, Gas, Desflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHP | Analyzer, Gas, Sevoflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHQ | Analyzer, Gas, Isoflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1620, II | CBS | Analyzer, Gas, Halothane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,
Gaseous-Phase (Anesthetic
Concentration) |
| | $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, for
Infant not under Gas Anesthesia |
| General Hospital
and 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 |
- The new devices are substantially equivalent to previously 3. cleared Philips devices marketed pursuant to K001664, K021778, K030038 and K031481.
-
- The modification is the introduction of Release B.0 software for the IntelliVue patient monitor devices, MP60, MP70 and MP90, and the introduction of the models MP40 and MP50.
-
- The new devices have the same intended use as the leqally marketed predicate devices. When used in the hospital environment, they are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates.
-
- The new devices have the same technoloqical characteristics as the legally marketed predicate devices.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the
10 3385
2
Testing involved system level tests, performance predicate. 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 IntelliVue Patient Monitor meets all reliability requirements and performance claims.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design that resembles an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Philips Medizin Systeme Böblingen GmbH c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard-Str. 2 71034 Böblingen GERMANY
Re: K032858
Trade Name: The Philips Intellivue M40, M50, MP60, MP70 and MP90 Patient Monitors, Release B.0. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: September 9, 2003 Received: September 12, 2003
Dear Mr. Schik:
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.
4
Page 2 - Mr. Hauke Schik
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. 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 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 vours.
Mefremyr
C. Peter R. Zohman, M.D.
fa
D. Zuckerman, M.D. Bram Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: The Philips IntelliVue MP40, MP50, MP60, MP70, and MP90 Patient Monitors, Release B.0.
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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mesa May
Prescription Use CFR 801.109)
Over-The-Counter (Per 21
510(K) Number K032856
(Optional Format 1-2-96)
10