(111 days)
Not Found
No
The summary describes a modification to an existing patient monitoring system, specifically adding a wireless connection option. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is used for monitoring physiological parameters and generating alarms, not for treating any condition.
No
The device is for monitoring and recording physiological parameters, not for diagnosing conditions.
No
The device description explicitly states that the modification is a change to existing hardware (Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver) to add a wireless connection, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring the physiological parameters of patients." This involves measuring vital signs and other bodily functions directly from the patient.
- Device Description: The description details patient monitors and a telemetry system transceiver, which are devices used for real-time patient monitoring.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to monitor the body directly. This device falls under the category of patient monitoring equipment.
N/A
Intended Use / Indications for Use
- Intended Use: "The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarminq of multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals."
- 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 and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals."
Product codes (comma separated list FDA assigned to the subject device)
DSI, MLD, MHX, DXG, DRQ, DRT, DPS, MLC, DRW, KRC, DRJ, DQA, DSH, DSF, DSA, MSX, DRG, BZQ
Device Description
"The modification is a change that adds wireless connection between the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver as an alternative to the existing cable connection."
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 and pediatrics
Intended User / Care Setting
- Intended User: Health care professionals
- Care Setting: Hospital environments and during transport inside hospitals
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 devices with respect to the predicates. Testing involved system level tests, safety, EMC, performance, environmental and functionality tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results successfully demonstrate that the Philips MP5 and MP5T IntelliVue Patient Monitors with Philips TRx4841A IntelliVue Telemetry System Transceiver meet all 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.
K062392, K063725, K040357, and K041741
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.
Not Found
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
KOS 1793
510 (k) Summary
OCT 1 4 2008
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 Fax: ++49 7031 463-2442 Tel: ++49 7031 463-2840, e-mail: markus.stacha@philips.com
This summary was prepared on June 23, 2008.
-
- The names of the devices are: Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | |||
| Devices | $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) | |||
| $870.1435, II | DXG | Computer, Diagnostic, Pre- | |
| Programmed, Single-Function | |||
| $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 | |||
| $870.2600, I | DRJ | System, Signal Isolation | |
| $870.2700, II | DQA | Oximeter | |
| $870.2800, II | DSH | Recorder, Magnetic tape, | |
| Medical | |||
| $870.2810, I | DSF | Recorder, Paper Chart | |
| $870.2900, I | DSA | Cable, Transducer and | |
| Electrode, incl. Patient | |||
| Connector | |||
| - | MSX | System, Network and | |
| Communication, Physiological | |||
| Monitors | |||
| $870.2910, II | DRG | Transmitters and Receivers, | |
| Physiological Signal, | |||
| Radiofrequency | |||
| Anesthesiology | |||
| Devices | $868.2375, II | BZQ | Monitor, Breathing Frequency |
1
-
- The modification is a change that adds wireless connection between the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver as an alternative to the existing cable connection.
-
- The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarminq of multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
-
- 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 devices with respect to the predicates. Testing involved system level tests, safety, EMC, performance, environmental and functionality tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results successfully demonstrate that the Philips MP5 and MP5T IntelliVue Patient Monitors with Philips TRx4841A IntelliVue Telemetry System Transceiver meet all reliability requirements and performance claims.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The eagle is enclosed in a circle with the words "U.S. Department of Health and Human Services, USA" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 14
Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems c/o Mr. Egon Pfeil Regulatory Affairs Engineer Hewlett-Packard-Str. 2, D-71034 Boeblingen. Germany
Re: K081793
Trade/Device Name: Philips MP5 and MP51 IntelliVue Patient Monitors, and Philips 1 Rx4841 A Intelli Vue Telemetry System Transceiver Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II (Two) Product Code: MHX Dated: September 12, 2008 Received: September 15, 2008
Dear Mr. Stacha:
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.
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
3
Page 2 - Mr. Egon Pfcil
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
2 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K081793
Device Name:
Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver.
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 and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Prescription Use (Part 21 CFR 801 Subpart D)
yes AND/OR 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 CDRM, Office of Device Evaluation (ODE)
Hth Stin /M Bruckermey
(Division Sign-On) /
Division of Cardiovascular Devices
510(k) Number