(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a wireless network adapter modification.
No.
The device is used for monitoring, not for treating any condition.
No
Explanation: While the device monitors physiological parameters, the provided text does not explicitly state that it is used for diagnosis. Its purpose is described as "monitoring, recording and alarming of multiple physiological parameters," which is distinct from making a medical diagnosis.
No
The device description explicitly states it is a modification to existing hardware (Philips MPxx IntelliVue Patient Monitors) and involves a physical component (an optional 802.11 wireless network adapter).
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 parameters directly from the patient's body (like heart rate, blood pressure, etc.).
- Device Description: The device is a "Patient Monitor" that measures physiological parameters. The modification is related to wireless connectivity for this monitoring function.
- 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.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on biological samples to diagnose diseases or conditions. This device is designed to monitor the patient's vital signs directly.
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 environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCQ2) 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, 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
Device Description
The modification is a change that creates, an optional, 802.11 wireless network adapter for the Philips MPxx IntelliVue patient monitors.
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 / healthcare environments and transport within healthcare 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. 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 (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.
K014159, K021778, K030038, K032858, K040304, K040183, K040357, K041235, K41741, K042845, K050141, K050762, K051106
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
NOV 1 8 2005
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: Tapan D. Shah Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 Tel: 978 659 7681 Fax: 978 685 5624 e-mail: tapan.shah@philips.com
This summary was prepared on October 14, 2005.
-
- The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors with 802.11 Wireless LAN 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 | |||
| §870.2900, I | DSA | Cable, Transducer and | |
| Electrode, incl. Patient | |||
| Connector |
1
| Anesthesiology
and Respiratory
Therapy (12624) | $870.2910, II | DRG | Transmitters and Receivers,
Physiological Signal,
Radiofrequency |
|-------------------------------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| | $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)
Neurological
(12513) | $880.2910, II | FLL | Thermometer, Electronic,
Clinical |
| | $882.1400, II | GWR | Electroencephalograph |
- 4 . The modification is a change that creates, an optional, 802.11 wireless network adapter for the Philips MPxx IntelliVue patient monitors.
-
- 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 healthcare environment and during transport within healthcare environments.
- The modified devices have the same technological characteristics 6. 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
2
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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2005
Philips Medical Systems c/o Mr. Tapan D. Shah Regulatory Affairs Engineer 3000 Minuteman Road Andover, MA 01810-1099
Re: K052961
Trade Name: MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors with 802.11 Wireless LAN Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DRG Dated: October 19, 2005 Received: October 21, 2005
Dear Mr. Shah:
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. Tapan D. Shah
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/cdrl/industry/support/index.html.
Sincerely yours,
Bhimmataylor
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):
The Philips MP20, MP30, MP40, MP50, MP60, MP70,and Device Name: MP90 IntelliVue Patient Monitors, with 802.11 Wireless LAN
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 environments. The MP40 and MP50 are additionally intended for use in MP20, MP30, transport situations within healthcare environments.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.
Prescription Use yes-AND/OR (Part 21 CFR 801 Subpart D)
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)
Bhimma
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