(22 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No
The device is indicated for monitoring, recording, and alarming of physiological parameters, not for treating conditions.
No
The device is described as a patient monitor for physiological parameters, which is used for monitoring, recording, and alarming, not for diagnosing medical conditions.
No
The device description explicitly states that the modification is the introduction of new software for existing hardware devices (Philips IntelliVue Patient Monitors). The summary also mentions system-level tests and safety testing, which would involve the hardware components.
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, recording and alarming of multiple physiological parameters of patients." This involves measuring physiological signals directly from the patient's body (e.g., heart rate, blood pressure, oxygen saturation).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description refers to "Patient Monitors" and "monitoring physiological parameters." This aligns with devices that measure parameters in vivo (within the living body).
The information provided clearly indicates that this device is a patient monitor used for direct physiological measurement, not for testing samples outside the body.
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 healthcare facilities. The MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02) 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, BZC, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, MP40, MP50, MP60, MP70, MP80, and MP90
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 in hospital environment and during 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
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. 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
Not Found
Predicate Device(s)
K014159, K021778, K030038, K032858, K040304, K040183, K040357, K041235, K41741, K042845, K050141, 050762, K051106, K052801
Reference Device(s)
K960831, K963380, K982499, K030886
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
8.0 510 (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: Herbert van Dyk Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1734 Fax: ++49 7031 463-2442 e-mail: herbert.van_dyk@philips.com
This summary was prepared on December 16, 2005.
-
- The names of the devices are the Philips 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 |
COMPANY CONFIDENTIAL
1
| | $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 |
| | $868.1880, II | BZC | Data calculator Pulmonary-
function |
| | $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 previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300″ (K960831, K963380, K982499, and K030886)
-
- The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, MP40, MP50, MP60, MP70, MP80, and MP90
-
- The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital
COMPANY CONFIDENTIAL
2
environment and during transport within hospital environments.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
-
- 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. 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.
COMPANY CONFIDENTIAL
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle or bird-like figure with three stylized lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the central emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2006
Mr. Herbert Van Dyk Senior Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Street 2 D-71034 Boeblingen, Baden-Wttbg GERMANY
Re: K053522
Trade/Device Name: The Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.00 Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Mesasurement and Alarm) Regulatory Class: II Product Code: MHX Dated: December 16, 2005 Received: December 19, 2005
Dear Mr. Dyk:
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. Dyk
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,
Suita Y. Michael Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
The Philips MP40, MP50, MP60, MP70, MP80 and MP90 Device Name: IntelliVue Patient Monitors, Release D.00
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 healthcare facilities. The MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02) is restricted to neonatal patients only.
| Prescription
| (Part 21 CFR 801 Subpart D) | Use ___ yes_______________________________________________________________________________________________________________________________________________________________________ AND/OR |
|---|---|
| --------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Over-The-
(21 CFR
Over-The-Counter Use No (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)
Smöhiue
x be infrigy, Caneral Hot o Control, Denial Devices
053522