(115 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found". While the device performs complex physiological monitoring and includes clinical decision support tools like the SSC Sepsis Protocol and Integrated Pulmonary Index, the summary does not indicate that these functions utilize AI or ML algorithms. The description focuses on data acquisition, display, alarming, and data management, which are standard functions of patient monitors.
No
The "Intended Use / Indications for Use" section explicitly states "Not therapeutic devices."
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes." This indicates a diagnostic capability.
No
The device description clearly states that the MX500 and MX550 are "display units with a TFT LCD flat panel display and built-in CPU" and that they "acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management." This indicates the device includes significant hardware components beyond just software.
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 monitors are for "monitoring the physiological parameters of patients." This involves measuring and displaying vital signs and other physiological data directly from the patient's body.
- Device Description: The device description details how the monitors acquire "multiple physiological patient signals" via connected external measurement modules. These modules perform measurements like ECG, SpO2, NBP, invasive blood pressure, temperature, etc., which are all direct measurements from the patient.
- Lack of In Vitro Activity: An In Vitro Diagnostic device is specifically designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. There is no mention of the device or its connected modules analyzing any biological specimens.
The device is a patient monitor that measures physiological parameters in vivo (within the living body).
N/A
Intended Use / Indications for Use
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are additionally intended for use in transport situations within hospital environments.
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI 1).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DRT, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRQ, DPS, MLC, DRW, KRC, DRJ, DQA, DSP, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KÖI, GWR, GWS, FLL
Device Description
The Intelli Vue Patient Monitors MX500 and MX550 are modification of the legally marketed IntelliVue Patient Monitor MP50.
The MX500 and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The models MX500 and MX550 differ only in the size of their flat panel displays: MX500 has a 12" and MX550 has a 15" display.
The MX500 and MX550 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module, any one of the M3012A. M3015A/B or M3016A Measurement Server Extensions. plug-in measurement modules M1006B Invasive Blood Pressure, M1011A Intravascular SQ2, M1012A C.O. /CCO, M1014A Spirometry, M1020B SpQ2, M1027A EEG, M1029A Temperature, 865383 NMT, 865115 IntelliBridge EC10, to the 865298 (TcG10) Transcutaneous Gas Module and to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO, Intravascular SO2, Spirometry, EEG and NMT.
The MX500 and MX550 acquire multiple physiological patient signals (via connected external measurement modules). display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.
The MX500 and MX550 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital.
The MX500 and MX550 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.
The MX500 and MX550 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or WLAN.
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.
ST segment monitoring: adult patients only.
Transcutaneous gas measurement (tcGas): neonatal patients only.
BIS: adult and pediatric patients.
Integrated Pulmonary Index (IPI): adult and pediatric (1 to 12 years) patients only.
Pulse Pressure Variation (PPV): adult patients only.
NMT Module: adult and pediatric patients.
Intended User / Care Setting
Trained healthcare professionals in a hospital environment.
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)
- Testing according to recognized consensus standards: IEC 60601-1-2:2001 +A1:2004 (EMC), IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety), IEC 60601-1-8:2003 (Alarms), IEC 62304:2006 (Software life cycle processes). All applicable requirements have been met.
- Environmental testing (temperature, humidity), mechanical testing (shock, vibration, and free fall). All specified test requirements have been met. The tests confirmed that the IntelliVue Patient Monitor MX500 and MX550 worked safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, and storage.
- Regression testing on the IntelliVue Patient Monitor MX500 and MX550. The performed regression testing comprised function tests of all physiological measurement parameters (which remain unchanged in this submission), recorder module, display, battery functionality, battery operating and charging time, human interface, external interfaces, alarming system, and tests as identified by the hazard analysis. All specified criteria have been met. The tests demonstrated that the IntelliVue Patient Monitor MX500 and MX550 worked safely, effectively, and correctly in accordance with specifications and labeling claims in the intended environment of use.
- Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
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.
K122439, K120366, K113441, K113657, K110474, K 110622, K 102562, K 093268, K 083517, K 082633, K 082583, K 071426, K 063315, K062283, K061610, K061052, K060541, K060221, K053522, K052961, K052801, K050762. K050141, K042845, K041235, K040304, and K032858
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
Image /page/0/Picture/0 description: The image shows the text "K131872 Page 1 of 5" on the left side and the word "PHILIPS" in large, bold, black letters on the right side. The text on the left indicates a document identifier and page number. The word "PHILIPS" is prominently displayed, suggesting it is a logo or brand name.
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.
-
- Submitter of this premarket notification
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
- Submitter of this premarket notification
OCT 17 2013
This summary was prepared on June 21, 2013.
-
- The name and classification of the device
Trade name: IntelliVue Patient Monitor MX500 and MX550 Common name: Multiparameter Patient Monitor
- The name and classification of the device
Classification:
·
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | |||
| Devices | §870.2300, II | DRT | Monitor, Cardiac (incl. Cardiotachometer |
| & Rate Alarm) | |||
| §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 | |||
| §870.2340, 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 | |
| §870.2770, II | DSB | Plethysmograph, Impedance | |
| §870.2800, II | DSH | Recorder, Magnetic tape, Medical | |
| §870.2810, I | DSF | Recorder, Paper Chart |
Page 138 of 142
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Page 2 of 5
a de la
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| §870.2850, II | DRS | Extravascular Blood Pressure Transducer | |
| §870.2900, I | DSA | Cable, Transducer and Electrode, incl. | |
| Patient Connector | |||
| - | MSX | ||
| §870.2910, II | DRG | Transmitters and Receivers, Physiological | |
| Signal, Radiofrequency | |||
| Anesthesiology | |||
| Devices | §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 | |
| §868.1880, II | BZC | Data calculator Pulmonary-function | |
| §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 | |||
| §868.2775 II | KOI | Electrical peripheral nerve stimulator | |
| Neurological Devices | §882.1400, II | GWR | Electroencephalograph |
| §882.1420, I | GWS | Analyzer, Spectrum, | |
| Electroencephalograph Sigmal | |||
| General Hospital and | |||
| Personal Use Devices | §880.2910, 11 | FLL | Thermometer, Electronic, Clinical |
-
- The subject devices Philips IntelliVue Patient Monitors MX500 and MX550. software Rev. K.10, are substantially equivalent to the previously cleared Philips IntelliVue Patient Monitor MP50 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K 110622, K 102562, K 093268, K 083517, K 082633, K 082583, K 071426, K 063315, K062283, K061610, K061052, K060541, K060221, K053522, K052961, K052801, K050762. K050141, K042845, K041235, K040304, and K032858.
- Description of the device 4.
The Intelli Vue Patient Monitors MX500 and MX550 are modification of the legally marketed IntelliVue Patient Monitor MP50.
2
Image /page/2/Picture/0 description: The image shows the text "K131872 Page 3 of 5" on the left side and the word "PHILIPS" in large, bold letters on the right side. The text on the left appears to be a document identifier and page number. The word "PHILIPS" is the brand name.
The MX500 and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The models MX500 and MX550 differ only in the size of their flat panel displays: MX500 has a 12" and MX550 has a 15" display.
The MX500 and MX550 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module, any one of the M3012A. M3015A/B or M3016A Measurement Server Extensions. plug-in measurement modules M1006B Invasive Blood Pressure, M1011A Intravascular SQ2, M1012A C.O. /CCO, M1014A Spirometry, M1020B SpQ2, M1027A EEG, M1029A Temperature, 865383 NMT, 865115 IntelliBridge EC10, to the 865298 (TcG10) Transcutaneous Gas Module and to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO, Intravascular SO2, Spirometry, EEG and NMT.
The MX500 and MX550 acquire multiple physiological patient signals (via connected external measurement modules). display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.
The MX500 and MX550 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital.
The MX500 and MX550 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.
The MX500 and MX550 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or WLAN.
-
- Intended Use
The subject devices IntelliVue Patient Monitor MX500 and MX550 have the same intended use as the legally marketed predicate IntelliVue Patient Monitor MP50.
- Intended Use
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are additionally intended for use in transport situations within hospital environments.
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI I).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
Page 140 of 142
3
Image /page/3/Picture/0 description: The image shows the text "K131872 Page 4 of 5" on the left side and the word "PHILIPS" in large, bold, black letters on the right side. The text on the left indicates a document number and page number. The word "PHILIPS" is prominently displayed, suggesting it is a brand name or title.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (I to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
Technological Characteristics 6.
The subject devices IntelliVue Patient Monitors MX500 and MX550 have the same range of functions as the legally marketed predicate IntelliVue Patient Monitor MP50. MX500 and MX550 reuse unchanged external measurement modules and measurement accessories as already used by the predicate MP50.
MX500 and MX550 have the same relevant-technological characteristics as the predicate MP50 with regard to energy sources. portability, user interface, and robustness.
Compared to the predicate MP50, the MX500 and MX550 have modified technological characteristics with regard to the usage of state of the art hardware components such as widescreen display, CPU. memories and interfaces, regarding a more compact form factor, resulting in slightly different dimensions and weight, regarding environmental conditions and operating time with internal battery.
The housing of the MX500 and MX550 is made of plastic whereas the housing of the predicate Intelli Vue Patient Monitor MP50 is made of plastic and partly of magnesium alloy. The MX500 and MX550 reuse plastic materials of the predicate MP50. Biocompatibility aspects are not affected because the devices do not have contact with patients.
The fundamental scientific technology of the new IntelliVue Patient Monitors MX500 and MX550 is the same as that of the predicate IntelliVue Patient Monitor MP50. The differences in technological characteristics between the subject devices MX500 and MX550 and the predicate device MP50 do not diminish safety or effectiveness.
4
K131872 Page 5 of 5
7. Summary of V&V activities
- Testing according to the recognized consensus standards:
- IEC 60601-1-2:2001 +A1:2004 (EMC) .
- IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety) .
- IEC 60601-1-8:2003 (Alarms) ●
- . IEC 62304:2006 (Software life cycle processes)
All applicable requirements have been met.
-
Environmental testing (temperature, humidity), mechanical testing (shock, vibration, and free fall).
All specified test requirements have been met. The tests confirmed that the Intelli Vue Patient Monitor MX500 and MX550 worked safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, and storage. -
Regression testing on the IntelliVue Patient Monitor MX500 and MX550. The performed regression testing comprised function tests of all physiological measurement parameters (which remain unchanged in this submission), recorder module, display, battery functionality, battery operating and charging time, human interface, external interfaces, alarming system, and tests as identified by the hazard analysis.
All specified criteria have been met. The tests demonstrated that the Intelli Vue Patient Monitor MX500 and MX550 worked safely, effectively, and correctly in accordance with specifications and labeling claims in the intended environment of use.
8. Conclusion
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate.
Testing comprised regression tests, electrical and mechanical safety tests, EMC tests, and environmental tests.
- 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 Intelli Vue Patient Monitor MX500 and MX550 meet all defined reliability requirements and performance claims.
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2013
Philips Medizin Systeme Boblingen GmbH c/o Mr. Markus Stacha Sr. Regulatory Affairs Engineer Hewlett-Packard Str. 2 71034 Böblingen, Germany
Re: K131872
Trade/Device Name: IntelliVue Patient Monitors MX500 and MX550 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX, DRT, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRQ, DPS, MLC, DRW, KRC, DRJ, DQA, DSP, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KÖI, GWR, GWS, FLL Dated: September 20, 2013 Received: September 23, 2013
Dear Mr. Markus 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
6
Page 2 - Mr. Markus Stacha
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 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 (2 ) CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name: IntelliVue Patient Monitor MX500 and MX550
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alams for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are additionally intended for use in transport situations within hospital environments.
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI 1).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.
Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
Continued on next page
Over-The-Counter Use Prescription Use Yes No AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clue
Digitally signed by Owen P. Faris -S Date: 2013.10.17 15:44:16 -04'00'
Page 17 of 142
8
Indications for Use (continued)
The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (I to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The Intelli Vue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.