(267 days)
The Expression MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.
The Expression MRI Patient Monitoring System (Model 865214) is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving magnetic resonance (MR) environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MR environment. The Expression MRI Patient Monitoring System (Model 865214) includes monitoring capabilities for wireless electrocardiogram (ECG), wireless pulse oximetry (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, respiration, end-tidal CO2 (EtCO2), oxygen, and anesthetic agents.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study for Expression MRI Patient Monitoring System (Model 865214)
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent verification and validation testing of its performance specifications. The results are summarized below:
| Parameter | Specification | Reported Device Performance (Conclusion) |
|---|---|---|
| Pulse Oximetry (SpO2) | ||
| Saturation Range | 1-100% | Pass |
| Saturation Accuracy | ± 3% at 70-100% | Pass (ARMS specification of 3 for 70-100% saturation) |
| Pulse Rate Range | 30-250 BPM | Pass |
| Pulse Rate Accuracy | ± 2% or 1 BPM, whichever is greater | Pass |
| Temperature | ||
| Measurement Range | 20-44°C | Pass |
| Accuracy | ±0.5°C | Pass |
| Anesthetic Agents Monitoring | ||
| Measurement Range | ||
| Halothane | 0-5.0 Vol% | Pass |
| Enflurane | 0-5.0 Vol% | Pass |
| Isoflurane | 0-5.0 Vol% | Pass |
| Sevoflurane | 0-8.0 Vol% | Pass |
| Desflurane | 0-18.0 Vol% | Pass |
| CO2 | 0-10.0 Vol% | Pass |
| Nitrous Oxide | 0-100% | Pass |
| Accuracy | Halothane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol% | Pass |
| Enflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Isoflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Sevoflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol%, ±0.40 Vol% at 5.00-8.00 Vol% | Pass | |
| Desflurane: ±0.15 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol%, ±0.40 Vol% at 5.00-10.00 Vol%, ±0.60 Vol% at 10.0-15.0 Vol%, ±1.0 Vol% at 15.0-18.0 Vol% | Pass | |
| CO2: ±0.10 Vol% at 0-1.00 Vol%, ±0.20 Vol% at 1.00-5.00 Vol%, ±0.30 Vol% at 5.00-7.00 Vol%, ±0.50 Vol% at 7.00-10.00 Vol% | Pass | |
| Flow rate | Adult mode: 200mL/min (+/-20mL/min); Neonatal mode: 150mL/min (+/-15mL/min) | Pass |
| Respiration Rate | 2 - 60 rpm (+/-1 rpm) | Pass |
| Auto ID Threshold | (Primary agent ID) 0.15% | Pass |
| Zero Drift Rate | Automatically zeroes at least every four hours or for every ±1°C temperature change from the last stored stable operating temperature | Pass |
| Display Resolution | 0.1% Volume | Pass |
| Multiple Agents Alarm Threshold | Upon detection of more than one agent of >0.15 Vol% | Pass |
MRI Susceptibility (MR Compatibility):
- 1.5T MR Imaging System (T1W FFFE, T1W IR, T2W SE EPI scans): Met performance specifications.
- 3.0T MR Imaging System (T1W FFE, T1W IR TSE, T2W SE EPI scans): Met performance specifications.
- Conditions of use (static magnetic field strength, specific absorption rate, scan duration, gradient field switching rate, device proximity to the magnet bore): Met MR conditions of use stated in labeling.
The document also mentions compliance with various voluntary standards for safety and performance (e.g., IEC 60601 series, ANSI/AAMI, ASTM, ISO) and hazard analysis/risk management (ISO 14971), all of which were "Pass."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set in the performance specification verification and validation. It mentions:
- General Performance Verification: "All patient monitoring parameters of the Expression MRI Patient Monitoring System (Model 865214) were verified according to the performance specifications."
- SpO2 Accuracy Validation: "Pulse oximetry (SpO2) accuracy... compared to arterial blood CO-oximetry for validation."
The data provenance is not specified (e.g., country of origin, retrospective or prospective), but the tests appear to be laboratory-based verification and validation studies using "patient simulators and test equipment" under "worst-case environment" and "actual use conditions."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. For the SpO2 accuracy, the ground truth was established by "arterial blood CO-oximetry." For other physiological parameters, the ground truth was likely derived from calibrated test equipment or patient simulators.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing described is primarily objective verification against predetermined specifications (e.g., "Pass" or "Fail" based on whether the device met the numerical specifications).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC study was reported. This device is a physiological patient monitor, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described ("Verification and Validation of Performance Specifications" and "Validation of SpO2 Accuracy") represents standalone algorithm performance through testing the output specifications of the device against known inputs from simulators or blood analyses. Human interaction is for setup and interpretation, but the core measurement and display of parameters is algorithmic.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- SpO2 Accuracy: Arterial blood CO-oximetry.
- Other Physiological Parameters (Temperature, Pulse Rate, Anesthetic Agents, CO2, Respiration Rate): Implied to be established by calibrated reference standards, patient simulators, or test equipment.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The device's underlying technology and algorithms for physiological monitoring are based on established scientific principles and engineering, not a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for machine learning, this question is not applicable. The device's functionality relies on established physiological measurement principles.
{0}------------------------------------------------
K090785 pg iofs
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
.
SUBMITTER INFORMATION
| Establishment / Sponsor Name:Establishment / Sponsor Address: | Invivo Corporation12501 Research ParkwayOrlando, FL 32826 USA | DEC 1 5 2009 |
|---|---|---|
| Manufacturer Name:Manufacturer Address: | Philips Medical Systems3000 Minuteman RoadAndover, MA 01810 | |
| Company Phone: | (407) 275-3220 | |
| Company Fax: | (407) 249-2022 | |
| Person to contact regardingquestions: | Rusty KellyQuality & Regulatory Manager, Invivo Corporation(407) 455-6166Rusty.Kelly@philips.com | |
| Establishment RegistrationNumber: | 1051786 (Sponsor)1217116 (Manufacturer) | |
| Date Summary Prepared: | March 18, 2009 |
Date Summary Prepared:
DEVICE IDENTIFICATION
Generic Device Name: Trade / Proprietary Name:
Classification:
MRI multi-parameter patient monitor Expression MRI Patient Monitoring System (Model 865214) Class II
{1}------------------------------------------------
K090785 pg 2 of 8
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
CLASSIFICATION
| Device Panel | Description | ProductCode | CFRSection | Classification |
|---|---|---|---|---|
| Monitor, Physiological, Patient (withoutarrhythmia detection or alarms) | MWI | 870.2300 | II | |
| Cardiovascular | Alarm, Blood Pressure | DSJ | 870.1100 | II |
| Computer, Blood Pressure | DSK | 870.1110 | II | |
| System, Measurement, Blood Pressure, Non-Invasive | DXN | 870.1130 | II | |
| Monitor, Cardiac (incl. Cardiotachometer & RateAlarm) | DRT | 870.2300 | II | |
| Cable, Transducer and Electrode, Patient(including connector) | DSA | 870.2900 | II | |
| Oximeter | DQA | 870.2700 | II | |
| Analyzer, Gas, Carbon-dioxide, Gaseous-phase | CCK | 868.1400 | II | |
| Monitor, Breathing Frequency | BZQ | 868.2375 | II | |
| Anesthesiology | Analyzer, Gas, Enflurane, Gaseous Phase(anesthetic concentration) | CBQ | 868.1500 | II |
| Analyzer, Gas, Halothane, Gaseous Phase(anesthetic concentration) | CBS | 868.1620 | II | |
| Analyzer, Gas, Nitrous Oxide, Gaseous Phase(anesthetic concentration) | CBR | 868.1700 | II | |
| Analyzer, Gas, Oxygen, Gaseous Phase | CCL | 868.1720 | II | |
| Analyzer, Gas, Desflurane, Gaseous-Phase(anesthetic concentration) | NHO | 868.1500 | II | |
| Analyzer, Gas, Isoflurane, Gaseous-Phase(anesthetic concentration) | NHQ | 868.1500 | II | |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase(anesthetic concentration) | NHP | 868.1500 | II | |
| GeneralHospital | Thermometer, Electronic, Clinical | FLL | 880.2910 | II |
INTENDED USE
The Expression MRI Patient Monitoring System (Model 865214) is intended to monitor vital The Expression NRTP anders MRI procedures and to provide signals for synchronization for the signs for patients andergoing Mrch Proceent Monitoring System (Model 865214) is intended for use by healthcare professionals.
{2}------------------------------------------------
K090785 pg 3 of 8
· 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
DEVICE DESCRIPTION
The device description of the modified device has not changed from that of the predicate device as a result of the modification.
The Expression MRI Patient Monitoring System (Model 865214) is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving magnetic resonance (MR) environment.
A combination of wireless communication, radio frequency (RF) shielding, digital signal r recessing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MR environment.
The Expression MRI Patient Monitoring System (Model 865214) includes monitoring capabilities for wireless electrocardiogram (ECG), wireless pulse oximetry (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, respiration, end-tidal CO2 (EtCO2), oxygen, and anesthetic agents.
SUBSTANTIAL EQUIVALENCE
The Expression MRI Patient Monitoring System (Model 865214) is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(K) No. | Clearance Date |
|---|---|---|---|
| 3160 MRI Patient Monitoring System | Invivo Corporation | K053462 | January 18, 2006 |
| PICOSAT II SpO2 Pulse OximetryModule | Philips MedicalSystems | K081937 | August 29, 2008 |
COMPARISON TO PREDICATE DEVICE
The Expression MRI Patient Monitoring System (Model 865214) and the primary predicate device, the 3160 MRI Patient Monitoring System which received clearance to market under 510(k) K053462 on January 18, 2006, are identical with respect to indications for use, intended J ro(x) 1005 102 of valian it is the devices are multi-parameter patient monitors use, and fundantenal betenis for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
The primary differences between the Expression MRI Patient Monitoring System (Model 865214) and the predicate device are listed below:
{3}------------------------------------------------
K090785 pg 4of8
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
- Minor hardware and cosmetic modifications were implemented to the external . appearance of the device.
- SpO2 detection and measurement is completed with the Philips Medical Systems . PICOSAT II SpO2 Pulse Oximetry Module, which was cleared to market under 510(k) K081937 on August 29, 2008.
- Body temperature measurement is completed with the Lumasense Technologies, Inc. . Multichannel Fluoroptic Thermometer.
- Labeling was modified to instruct the user of the proper patient application of the . Multichannel Fluoroptic Thermometer.
- Anesthetic agents monitoring parameters were improved. .
- Oxygen (02) monitoring parameters were improved. .
- Labeling was modified to include the improved performance specifications of pulse . oximetry, temperature monitoring, anesthetic agents monitoring, and oxygen monitoring.
Additional modifications to the predicate device that have been implemented since the predicate device's clearance to market in 510(k) K053462 on January 18, 2006 are listed below. All modifications were documented in the Invivo Corporation Quality System and are implemented in the modified Expression MRI Patient Monitoring System (Model 865214).
- Minor software modifications were implemented to permit the operator to choose a . distinct Pediatric menu option for non-invasive blood pressure monitoring. (The predicate device was cleared to market on January 18, 2006 with the ability to measure NIBP for adult, pediatric, and neonatal patients using adult mode with an adult cuff, or neonatal mode with a neonatal cuff.) The modification added a distinct menu option for "pediatric" patients. The pediatric mode is intended for use on patients who have low pulse amplitude sensitivity and therefore, cannot achieve NIBP detection in adult mode, as described in the operations manual. Pediatric mode uses the same measurement algorithm and technology as adult mode, but improves the measurement acquisition consistency on this patient population with low pulse amplitude sensitivity. Verification and validation testing completed on patient simulators did not raise any issues regarding the safety and effectiveness of the device and clinical data was not required to substantiate claims of safety and effectiveness.
- A non-invasive blood pressure cuff measuring 9-25cm was introduced. The cuff is . available for use on patients that are categorized by the FDA as part of the pediatric population. However, final determination of whether the cuff should be used on a particular patient is dependent on the trained clinician who should consider the patient's limb size and body weight per the instructions in the operations manual. The cuff is constructed of the same material as the adult and neonatal cuffs which were distributed with the predicate device and have been in marketing distribution since 1994 by the cuff manufacturer. Therefore, biocompatibility testing to ISO 10993 was not required. Verification and validation testing completed on patient simulators did not raise any issues regarding the safety and effectiveness of the predicate device and clinical data was not required to substantiate claims of safety and effectiveness.
{4}------------------------------------------------
K090785
Pg Sof8
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
- Minor modifications to the operations manual were implemented to define and explain . the pediatric mode for non-invasive blood pressure.
- Minor modifications were implemented to the off-the-shelf radio in the Display Control . Unit and Wireless Processing Unit to reduce ferrous materials for improved communication in the MRI environment, permitting closer proximity of the device to the magnet bore.
FUNDAMENTAL SCIENTIFIC TECHNOLOGY
The fundamental scientific technology employed in the Expression MRI Patient Monitoring System (Model 865214) as modified, has not changed from that of the predicate device as a result of the modification.
PERFORMANCE DATA
The performance data included in this notification establishes substantial equivalence of the modified device, the Expression MRI Patient Monitoring System (Model 865214), to the predicate device which received market clearance in 510(k) K053462 on January 18, 2006. The modified device was evaluated to the following safety and performance tests:
- Voluntary standards .
- Verification and validation of performance specifications .
- Verification and validation of MR compatibility .
- Validation of SpO2 Accuracy .
- Quality demonstration through HALT .
In all testing, the device was verified using a worst-case environment.
Voluntary Standards
The Expression MRI Patient Monitoring System (Model 865214) was evaluated to the following I the expression result where applicable per FDA Guidance titled "Use of Standards in Substantial Equivalence Determination. "
General Requirements for Safety
- IEC 60601-1 .
- IEC 60601-1-1 .
- IEC 60601-1-2 ●
- IEC 60601-1-4 ●
- IEC 60601-1-8 .
Particular Requirements for Safety and Performance
- ANSI / AAMI BP22 ●
- ANSI / AAMI EC13 .
{5}------------------------------------------------
K090785
pg 6 of 8
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
- ANSI / AAMI EC38 ●
- ANSI / AAMI EC53 .
- ANSI / AAMI SP10 .
- ASTM E1112 .
- ASTM F1456 .
- IEC 60601-2-27
- IEC 60601-2-30
- IEC 60601-2-34
- ISO 9919
- ISO 21647
Hazard Analysis / Risk Management
- ISO 14971 .
Verification and Validation of Performance Specifications
Verlication and Vanuation of the Expression MRI Patient Monitoring System (Model All patient monitoring parameters of the Expressions. The conclusions of all test 60.214) Welc Vernice accoraing to ne performing to as intended within the performance specifications.
results indicate "pass"; the device operates as intended within the perf Tesults of design verification and validation do not raise issues regarding the safety and Results of design verification and vindation as not required to substantiate claims of safety and effectiveness.
A summary of the verification and validation protocol and conclusion for parameters which A summary of the vertheation and vanualities processes included in the following tables:
| Pulse Oximetry (SpO2) | ||
|---|---|---|
| Parameter | Specification | Conclusion |
| Saturation Range | 1-100% | Pass |
| Saturation Accuracy | $\pm$ 3% at 70-100% | Pass |
| Pulse Rate Range | 30-250 BPM | Pass |
| Pulse Rate Accuracy | $\pm$ 2% or 1 BPM, whichever is greater | Pass |
| Temperature | ||
|---|---|---|
| Parameter | Specification | Conclusion |
| Measurement Range | 20-44°C | Pass |
| Accuracy | ±0.5°C | Pass |
| Anesthetic Agents Monitoring | ||
|---|---|---|
| Parameter | Specification | Conclusion |
| Measurement Range | Halothane: 0.50 Vol% | Pass |
| Enflurane: 0-5.0 Vol% | Pass | |
| Isoflurane: 0-5.0 Vol% | Pass | |
| Sevoflurane: 0-8.0 Vol% | Pass |
Page 6 of 8
{6}------------------------------------------------
K090785
pg 7 of 8
| Anesthetic Agents Monitoring | ||
|---|---|---|
| Accuracy | Desflurane: 0-18.0 Vol% | Pass |
| CO2: 0-10.0 Vol% | Pass | |
| Nitrous Oxide: 0-100% | Pass | |
| Halothane: ±0.15 Vol% at 0-1.00 Vol% | Pass | |
| Halothane: ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Enflurane: ±0.15 Vol% at 0-1.00 Vol% | Pass | |
| Enflurane: ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Isoflurane: ±0.15 Vol% at 0-1.00 Vol% | Pass | |
| Isoflurane: ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Sevoflurane: ±0.15 Vol% at 0-1.00 Vol% | Pass | |
| Sevoflurane: ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Sevoflurane: ±0.40 Vol% at 5.00-8.00 Vol% | Pass | |
| Desflurane: ±0.15 Vol% at 0-1.00 Vol% | Pass | |
| Desflurane: ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| Desflurane: ±0.40 Vol% at 5.00-10.00 Vol% | Pass | |
| Desflurane: ±0.60 Vol% at 10.0-15.0 Vol% | Pass | |
| Desflurane: ±1.0 Vol% at 15.0-18.0 Vol% | Pass | |
| CO2: ±0.10 Vol% at 0-1.00 Vol% | Pass | |
| CO2: ±0.20 Vol% at 1.00-5.00 Vol% | Pass | |
| CO2: ±0.30 Vol% at 5.00-7.00 Vol% | Pass | |
| CO2: ±0.50 Vol% at 7.00-10.00 Vol% | Pass | |
| Adult mode: 200mL/min (+/-20mL/min) | Pass | |
| Flow rate | Neonatal mode: 150mL/min (+/-15mL/min) | Pass |
| Respiration Rate | 2 - 60 rpm (+/-1 rpm) | Pass |
| Auto ID Threshold | (Primary agent ID) 0.15% | Pass |
| Zero Drift Rate | Automatically zeroes at least every four hours or for every ±1°C temperature change from the last stored stable operating temperature | Pass |
| Display Resolution | 0.1% Volume | Pass |
| Multiple Agents Alarm Threshold | Upon detection of more than one agent of >0.15 Vol% | Pass |
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Verification and Validation of MR Susceptibility
The Expression MRI Patient Monitoring System (Model 865214) was verified using a 3.0T MRI The Expression Article as a 1.5T MRI system. These devices were verified by documention within the performance specifications while being subjected to 3.0T and 1.5T magnetic fields using simulators and test equipment under actual use conditions. The following scans were used to simulate normal and worst-case scenario conditions:
- 1.5T MR Imaging System
- T1W FFFE
{7}------------------------------------------------
K090785 pg 8 of 8
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
- TIW IR
- T2W SE EPI
3.0T MR Imaging System
- · TIW FFE
- · TIW IR TSE
- · T2W SE EPI
All test results indicate "pass"; the Expression MRI Patient Monitoring System (Model 865214) met the performance specifications as stated in the device labeling for use in the 1.5T and 3.0T MRI environments.
Additional testing to verify the performance of the Expression MRI Patient Monitoring System in the following conditions of use was also completed:
- static magnetic field strength .
- specific absorption rate .
- scan duration .
- gradient field switching rate .
- device proximity to the magnet bore .
All test results indicate "pass"; the Expression MRI Patient Monitoring System (Model 865214) met the MR conditions of use as stated in the device labeling.
Validation of SpO2 Accuracy
Pulse oximetry (SpO2) accuracy of the Expression MRI Patient Monitoring System (Model I unse oximely (OPOD) are the specified measurement range of 70-100% of arterial blood oxygen saturation as compared to arterial blood CO-oximetry for validation. Test results show that the Expression MRI Patient Monitoring System (Model 865214) passes an ARMS specification of 3 for the range of 70-100% oxygen saturation.
Quality Demonstration Through HALT
Quality demonstration testing is being performed using highly accelerated life tests to show Quality domoner requirement specifications and ensure longevity of the Expression MRI Patient Monitoring System (Model 865214) within the use model. Preliminary test results I anonstrate that the device meets the mechanical customer requirement specifications over the use life of the device.
Conclusion
The conclusion of all safety and performance testing confirms that all identified risks have been mitigated and the Expression MRI Patient Monitoring System (Model 865214) operates as designed and intended within the performance specifications.
The test results demonstrate that the modified Expression MRI Patient Monitoring System (Model 865214) is substantially equivalent to the predicate device cleared to market via 510(k) K053462 on January 18, 2006.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Invivo Corporation c/o Mr. Rusty Kelly Quality & Regulatory Manager 12501 Research Parkway Orlando, FL 32826
DEC 1 5 2009
Re: K090785
Trade/Device Name: MRI Patient Monitoring System, Model 865214 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: MWI Dated: November 18, 2009 Received: November 20, 2009
Dear Mr. Kelly:
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 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.
{9}------------------------------------------------
Page 2 - Mr. Rusty Kelly
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); medical device reporting (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications for Use
510(k) Number (if known):_K090785
Device Name: MRI Patient Monitoring System (Model 865214)
Indications for Use: The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.
The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.
Prescription Use:
X (Part 21 CFR 801 Subpart D)
AND/OR Over-the Counter Use:
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.P
Page l of 1_
Division of Cardiovascular Devices
(Division Sign-Off)
510(k) Number
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).