(24 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No
The device is a patient monitor, which measures and displays physiological parameters, but does not provide therapy. Its intended use is for monitoring, recording, and alarming, not for direct treatment or intervention.
Yes
The device is indicated for "monitoring, recording and alarming of multiple physiological parameters," which aligns with the definition of a diagnostic device that measures and observes physiological parameters to aid in diagnoses.
No
The device description explicitly states "The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue 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 device.
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 the patient (adults, pediatrics, neonates) in a hospital setting. This involves directly measuring things like heart rate, blood pressure, oxygen saturation, etc., from the patient's body.
- 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.
- Lack of Mention of Samples: The description does not mention the analysis of any biological samples.
The device is a patient monitor, which is a type of medical device used for direct physiological monitoring of a living patient, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 IntelliVue Patient Monitors, Release B.1. are Indicated for use by health care professionals for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates. Models 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 / 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, DSH, DSF, DRS, DSA, MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
The modification is the introduction of Release B.1 software for the IntelliVue patient monitor devices MP40, MP50, MP60, MP70 and MP90, and the introduction of the models MP20 and MP30.
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 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 endrate. 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.
Key Metrics
Not Found
Predicate Device(s)
K014159, K021778, K032858, K040304, K040183, K040357
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
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: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 e-mail: markus.stacha@philips.com
This summary was prepared on May 07, 2004.
-
- The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, 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) | |||
| $870.2340, 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 modified devices are substantially equivalent to 3. previously cleared Philips devices marketed pursuant to K014159, K021778, K032858, K040304, K040183 and K040357.
-
- The modification is the introduction of Release B.1 software for the IntelliVue patient monitor devices MP40, MP50, MP60, MP70 and MP90, and the introduction of the models MP20 and MP30.
-
- 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 environment and during transport 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 performance, functionality, and reliability characteristics of the modified device with respect to the endrate. 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.
3
Image /page/3/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers. The image is in black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2004
Mr. Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen Germany
Re: K041235
Trade/Device Name: Philips IntelliVue Patient Monitors (Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90) Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and alarm Regulatory Class: II Product Code: MHX, DQA Dated: May 7, 2004 Received: May 11, 2004
Dear Mr. Stacha:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & na re re re read have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in 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, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, incresery maxis 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 if your de vice is onashined (600 as controls. Existing major regulations affecting your device can may be subject to saterial 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. Markus Stacha
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issuated on a basevice complies with other requirements of the Act that FDA has made a decorminancis as administered by other Federal agencies. You must of any Federal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, with and manufacturing practice requirements as set CFR Part 807), labeling (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This product factation confecting your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification: The PDF Imaling of cation 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 If you desire specific advice 101 Jour ac 1100 1100 - 4646. Also, please note the regulation entitled, comact the Office of Compunance as (S = ) = = = = = = = = = = = = = = = = = = = = = = = = other general information on your responsibilities under the Act from the Division of Small other general 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,
Ken Mulvey
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): Ko41235-
The Philips MP20, MP30, MP40, MP50, MP60, MP70 and Device Name: Deviorname.
MP90 IntelliVue Patient Monitors, Release B.1.
Indications for Use: Indicated for use by health care professionals multanons for Ose. Indreason monitoring the physiological parameters whenever there is a neou br monitoring, recording and alarming of of of patients. Inconded frameters of adults, pediatrics and neonates murtiple physiological paramotes MP20, MP30, MP40 and MP50 are intended for use in transport situations within additionally hospital environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp0₂ / tcpCO₂) is restricted to neonatal patients only.
Over-The-Counter Use _ No Use Prescription 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)
Auyi Takom
510(k) Number.