(29 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and there are no other indicators of AI/ML use in the description or performance studies.
No.
The device is intended for monitoring, recording, and alarming of physiological parameters, not for providing therapy.
No
The device is indicated for monitoring, recording, and alarming of physiological parameters, not for diagnosis.
No
The device description explicitly lists "Philips MP20, MP30, MP30, MP50, MP60, MP70 and MP90 Patient Monitors," which are hardware devices. The summary also mentions "system level tests, performance tests, and safety testing from hazard analysis" and "reliability requirements and performance claims," all indicative of a hardware-based medical device.
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 physiological parameters of patients (adults, pediatrics, and neonates) in a hospital setting. This involves measuring vital signs and other bodily functions directly from the patient.
- Device Description: The device is described as a "Patient Monitor." Patient monitors are used to observe and track a patient's physiological state in real-time.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Testing of samples: IVDs are used to test samples taken from the human body (like blood, urine, tissue). This device monitors parameters directly from the patient.
- Diagnosis of disease: While the monitoring data can be used by healthcare professionals to aid in diagnosis, the device itself is not performing a diagnostic test on a sample.
- Reagents or assays: IVDs typically involve the use of reagents or assays to perform the diagnostic test. There is no mention of these in the description.
The device is clearly a patient monitoring device, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters wforevients. Intended for monitoring, recording and alarming of or paciences. Ological 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/tcpC02) is restricted to neonatal patients only.
Product codes (comma separated list FDA assigned to the subject device)
DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, DRW, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
Not Found
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 assessment of the formationality, and reliability characteristics of verification, validation, and cesting activeres esteristics of performance, function of performance, for the performance, functionality, and reflabsity, and predicate. Testing the modified device with respect co cre preats, and safety involved system level tests, performance costs, and on the based on testing from hazard analysis. Pass/Fail criteria were based on testing from hazard analysis. Passy and creating and test the specifications cleared for the predicate assults demonstrate results showed substantial equivalence. The results mete all results showed substantial equivarenoom that the Philips IntelliVue Patient Monitor meets all that the Philips Incellive racess. reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K992273, K014159, K040357, K041235, K041956, K042845, K050141
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 2 2 2005
510 (k) Summary
This summary of 510(k) safety and effectiveness information is
t the summer by the versions versions of the Safe Medical This summary of 510 (K) salety and errecessor entered in and Submitted In accordance and 21 C.F.R. §807.92.
- The submitter of this premarket notification is: Egon Pfeil Egon Freir
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany 9-71034 Boebfingen) Country
Tel: ++49 7031 463-1926 Fax: ++49 7031 463-2442 e-mail: egon.pfeil@philips.com
This summary was prepared on March 22, 2005.
-
- The names of the devices are the Philips MP30, MP30, MP50,
Classified of Chilips Totallilles Patient Monitor Classification The names of the devices are the firstips with and the mannel of the mannel of the securities and names are as follows:
- The names of the devices are the Philips MP30, MP30, MP50,
| 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 modification is the introduction of Release C.00 software The modiffeation is the at monitor devices, MP20, MP30, MP30, MP40, For the Incerrivas packed , and M3014A Capnography Extension interfacing the Philips Mainstream CO2 Sensor model M2501A (K042601) .
-
- The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, marketed predicate devices. multiple physiological parameters of recording, and draimend neonates in hospital environment and adures, pearsort within hospital environments.
-
- The modified devices have the same technological characteristics as the legally marketed predicate devices.
2
-
- Verification, validation, and testing activities establish the
ssent of the formationality, and reliability characteristics of verification, validation, and cesting activeres esteristics of performance, function of performance, for the performance, functionality, and reflabsity, and predicate. Testing the modified device with respect co cre preats, and safety involved system level tests, performance costs, and on the based on
testing from hazard analysis. Pass/Fail criteria were based on testing from hazard analysis. Passy and creating and test the specifications cleared for the predicate assults demonstrate
results showed substantial equivalence. The results mete all results showed substantial equivarenoom
that the Philips IntelliVue Patient Monitor meets all that the Philips Incellive racess.
reliability requirements and performance claims.
::
- Verification, validation, and testing activities establish the
3
Image /page/3/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.
APR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Egon Pfeil Senior Regulatory Affairs Engineer Cardiac and Monitoring Systems Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2, 71034 Böblingen, GERMANY
Re: K050762
Troover Name: The Philips IntelliVue MP20, MP30, MP30, MP40, MP50, MP60, MP70 and MP90 Patient Monitors, Release C.00 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment Measurement and alarm) Regulatory Class: II Product Code: MHX Dated: March 22, 2005 Received: March 24, 2005
Dear Mr. Pfeil:
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 mendments, 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 (1 writ), it has 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. Pfeil
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 and ifound (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicellents as 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), n 93se 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,
Ginette Y. Michaud m.D.
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 IntelliVue MP20, MP30, MP40, MP50, MP60, Device Name: MP70 and MP90 Patient Monitors, Release C.00.
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters wforevients. Intended for monitoring, recording and alarming of or paciences. Ological 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/tcpC02) is restricted to neonatal patients only.
Over-The-Counter Use No Prescription Use yes AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of _
Ainslie em
Livision Sign-Off Division of Anesthesiology, General Hospital, Infaction Control, Dental Devices
510(k) Number: K990162