(28 days)
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.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors with 802.11 Wireless LAN. The modification is a change that creates, an optional, 802.11 wireless network adapter for the Philips MPxx IntelliVue patient monitors.
The provided 510(k) summary for the Philips IntelliVue Patient Monitors with 802.11 Wireless LAN does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria, as typically found for AI/ML-based medical devices.
Instead, this submission is for a modification (the addition of an 802.11 wireless network adapter) to existing patient monitors. The focus is on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo evaluation of novel performance.
Here's a breakdown of what can be extracted and what is not present in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly detailed in the provided document in the context of specific quantitative metrics for the wireless LAN performance.
The document states: "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."
This indicates that:
- Acceptance Criteria: Were based on "specifications cleared for the predicate device." These specific criteria (e.g., latency, throughput, signal strength, reliability) are not listed.
- Reported Device Performance: The summary states "test results showed substantial equivalence" and "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." No quantitative performance data for the wireless LAN is given.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided for the specific wireless LAN testing. The document generally refers to "system level tests, performance tests, and safety testing" without detailing the sample sizes (e.g., number of test cases, duration of tests, number of devices tested) or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. The device is an integrated patient monitor with a wireless component, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for its core function. The "ground truth" here would relate to engineering specifications and performance standards for wireless communication and patient monitoring, not clinical expert consensus on interpretations of data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Similar to point 3, adjudication methods like 2+1 or 3+1 statistical consensus are typically used for clinical image or signal interpretation ground truth, not for evaluating the performance of a wireless network adapter in a medical device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable/not provided. MRMC studies are used to assess the diagnostic performance of human readers, often with and without AI assistance, usually for interpreting medical images or complex data. This submission is for a hardware modification (wireless LAN) to a patient monitor, not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. The device is a patient monitor, which operates with human interaction and is not solely an "algorithm" in the conventional AI sense. The wireless LAN is a component of a larger system.
7. The Type of Ground Truth Used
The "ground truth" for the testing described would be based on engineering specifications and established performance standards for patient monitoring devices and wireless communication. For example, standards for signal integrity, data transmission rates, latency, security, and reliability in a medical environment would serve as the ground truth against which the wireless LAN's performance was measured. No clinical outcomes data or pathology reports would typically be relevant for this type of device modification.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The document describes a hardware modification and associated performance testing, not the development or training of an AI/ML algorithm. Therefore, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
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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 |
|---|---|---|---|
| CirculatorySystem 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 oralarms) | |
| §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 SignalConditioner, Transducer Signal | |
| §870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer & Rate Alarm) | |
| §870.2300, II | MSX | System, Network andCommunication, PhysiologicalMonitors | |
| §870.2340, II | DPS | Electrocardiograph | |
| §870.2340, II | MLC | Monitor, ST Segment | |
| §870.2350, II | DRW | Electrocardiograph, LeadSwitching 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 PressureTransducer | |
| §870.2900, I | DSA | Cable, Transducer andElectrode, incl. PatientConnector |
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| Anesthesiologyand RespiratoryTherapy (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 (AnestheticConcentration) | |
| $868.1500, II | NHO | Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHP | Analyzer, Gas, Sevoflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHQ | Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1620, II | CBS | Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,Gaseous-Phase (AnestheticConcentration) | |
| $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, forInfant not under Gas Anesthesia | |
| GeneralHospital andPersonal 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
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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.
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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.
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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
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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
ાર
§ 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).