(60 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as a patient monitor for physiological parameters, which is used for monitoring, recording, and alarming, not for treating any condition.
No
The device is described as a patient monitor for monitoring, recording, and alarming multiple physiological parameters, which is for observation rather than diagnosis.
No
The device description explicitly states that the modification is the introduction of new software for existing patient monitor devices (Philips MP20, MP30, etc.). These are hardware devices that the software runs on.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring the physiological parameters of patients." This involves measuring vital signs and other bodily functions directly from the patient, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The device is a "Patient Monitor," which is a type of medical device used for real-time patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device 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. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCQz) is restricted to neonatal patients only.
Product codes
DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, MSX, DPS, MLC, DRW, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release C.01 software for the IntelliVue patient monitor devices. The modified devices have the same technological characteristics as the legally marketed predicate devices.
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, transport within 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 modified device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Perrorman criteria were based on the specifications clear 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)
K014159, K021778, K030038, K032858, K040304, K040183, K040357, K041235, K41741, K042845, K050141, 050762
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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 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 Tel: ++49 7031 463-2031 Fax: ++49 7031 463-2442 e-mail: hauke.schik@philips.com
This summary was prepared on April 28, 2005.
-
- The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Circulatory | |||
| System Devices | |||
| (12625) | $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 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) | |||
| $870.2300, II | MSX | System, Network and | |
| Communication, Physiological | |||
| Monitors | |||
| $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 |
1
K05i106/51
P2/3
| | $870.2900, I | DSA | Cable, Transducer and
Electrode, incl. Patient
Connector |
|------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| | $870.2910, II | DRG | Transmitters and Receivers,
Physiological Signal,
Radiofrequency |
| 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 modified devices are substantially equivalent to 3. previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141 and 050762.
- 4 . The modification is the introduction of Release C.01 software for the IntelliVue patient monitor devices
- The modified devices have the same intended use as the 5. legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospitgl environment and during transport within hospital environments.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
2
K051106/S1
p3/3
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability, characteristics of the modified device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Perrorman criteria were based on the specifications clear 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
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medizin Systeme Boeblingen GmbH c/o Mr. Hauke Schik Senior Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard-Str. 2 D-71034 Boeblingen Germany
Re: K051106
Trade Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, Release C.01 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: DXN Dated: June 8, 2005 Received: June 10, 2005
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.
JUL 1 - 2005
4
Page 2 - Mr. Hauk 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 (240) 276-0295. 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.
Sincerely yours,
During R. Vechner
( ) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): との5/1/06
:
Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, Release C.01
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. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCQz) is restricted to neonatal patients only.
Prescription Use Over-The-Counter Use No ಸಿಕೆಲ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
e R. Vichner
Off)
diovascular Devices
510(k) Number K051106