(48 days)
No
The summary does not mention AI, ML, or any related terms, and the described functionalities (image acquisition, noise reduction, motion correction, water/fat separation) are standard MRI techniques.
No
The device is described as a "diagnostic imaging modality" used to "produce crosssectional transaxial, coronal, sagittal, and oblique images" for the purpose of "diagnosis" when interpreted by a trained physician. It is not indicated for treating any conditions or providing therapeutic benefits.
Yes
The "Intended Use / Indications for Use" section explicitly states that Vantage Elan systems are indicated for use "as a diagnostic imaging modality." It further clarifies that the images produced "yield information that can be useful in diagnosis."
No
The device description explicitly states it is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware device. While it includes software components for image acquisition and display, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Vantage Elan system is an MRI system. It produces images of the internal structures of the body in vivo (within the living body) using magnetic fields and radio waves.
- Intended Use: The intended use clearly states that it produces images of anatomic structures of the head or body for diagnostic imaging. This is an in vivo diagnostic process.
- Device Description: The description details the physical components and technology of an MRI scanner, not a device that analyzes biological samples.
Therefore, the Vantage Elan system falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vantage Elan systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- ·Proton density (PD) (also called hydrogen density) ·Spin-lattice relaxation time (T1) ·Spin-spin relaxation time (T2)
- ·Flow dynamics
·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Product codes
LNH
Device Description
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K171597. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Elan uses 1.4m short and 4.1 ton light weight magnet. It includes the Pianissimo™ Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met. Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria.
T2 Map Using Pre-Contrast Pulses was evaluated utilizing phantom and volunteer images. It was concluded that T2 maps can be generated using the data acquired using pre-contrast pulses.
WFS DIXON (Water Fat Separation) was evaluated utilizing phantom images. Testing verified that water signals and fat signals are separated in the water image and the fat image, respectively.
2D-RMC (Real Time Motion Correction) for EPI was evaluated utilizing phantom and volunteer images. Testing verified the use of 2DRMC in scanning with SEEPI2D sequence is effective.
MR image quality metrics were performed, utilizing volunteer images, to evaluate SpineLine+, KneeLine+, 500EVOI Knee, Quick Star, and Fast 3D mode. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met. Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria.
T2 Map Using Pre-Contrast Pulses was evaluated utilizing phantom and volunteer images. It was concluded that T2 maps can be generated using the data acquired using pre-contrast pulses.
WFS DIXON (Water Fat Separation) was evaluated utilizing phantom images. Testing verified that water signals and fat signals are separated in the water image and the fat image, respectively.
2D-RMC (Real Time Motion Correction) for EPI was evaluated utilizing phantom and volunteer images. Testing verified the use of 2DRMC in scanning with SEEPI2D sequence is effective.
MR image quality metrics were performed, utilizing volunteer images, to evaluate SpineLine+, KneeLine+, 500EVOI Knee, Quick Star, and Fast 3D mode. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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March 10, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K210164
Trade/Device Name: Vantage Elan 1.5T, MRT-2020, V6.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 19, 2021 Received: January 21, 2021
Dear Ms. Reyes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Vantage Elan 1.5T, MRT-2020, V6.0
Indications for Use (Describe)
Vantage Elan systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- ·Proton density (PD) (also called hydrogen density) ·Spin-lattice relaxation time (T1) ·Spin-spin relaxation time (T2)
- ·Flow dynamics
·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
1. CLASSIFICATION and DEVICE NAME
| Classification Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Regulation Number: | 90-LNH (Per 21 CFR § 892.1000) |
| Trade Proprietary Name: | Vantage Elan 1.5T, MRT-2020, V6.0 |
| Model Number: | MRT-2020 |
2. SUBMITTER'S NAME
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Canon Medical Systems Corporation
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Contact Person
Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 E-mail: jfreyes@us.medical.canon
Official Correspondent/U.S. Agent
Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon
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-
- MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED January 15, 2021
-
- DEVICE NAME Vantage Elan 1.5T, MRT-2020, V6.0
-
- TRADE NAME Vantage Elan 1.5T, MRT-2020, V6.0
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
-
- DEVICE CLASSIFICATION Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
13. PRODUCT CODE
90-LNH
14. PREDICATE DEVICE
Predicate Device: Vantage Elan 1.5T, MRT-2020, M-Power GX (K171597) Reference Device: Vantage Orian 1.5T, MRT-1550, V6.0 (K193021)
TABLE No. 1: Primary Predicate Device
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| System | Vantage Elan 1.5T, | ||
| MRT-2020, V6.0 | Vantage Elan 1.5T, | ||
| MRT-2020, M-Power GX | Vantage Orian 1.5T, | ||
| MRT-1550, V6.0 | |||
| Marketed By | Canon Medical Systems | ||
| USA, Inc. | Canon Medical Systems | ||
| USA, Inc. | Canon Medical Systems | ||
| USA, Inc. | |||
| 510(k) Number | This Submission | K171597 | K193021 |
| Clearance Date | July 21, 2017 | June 3, 2020 |
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15. REASON FOR SUBMISSION
Modification of a cleared device
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K171597. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Elan uses 1.4m short and 4.1 ton light weight magnet. It includes the Pianissimo™ Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system.
18. SUMMARY OF CHANGE(S)
This submission is to report the following software functionalities have been added:
- Additional Software Functionalities and Improvements:
- SpineLine+ (Spinal Scan Positioning Support Function): Provides automatic positioning o assistance for spine imaging. SpineLine was previously cleared under K141472. As compared to SpineLine, SpineLine+ offers improved detection of the axial plane along the intervertebral space.
- o KneeLine+: When the basic planes of the knee are to be scanned, this application makes it possible to set the slice plane more easily than before. After a 3D image is acquired, it is used to obtain the three planes (sagittal, axial and coronal) after adjusting the angle of the knee. The obtained images can be used to set the plane of the positioning ROI. If necessary, the orientation and position of the detected basic planes can be adjusted by scan positioning operation in the Scan Plan (Locator) window.
- surevol Knee: Using a 3D image as an input, the region of the knee is determined and the VOI O for shimming scan, map scan, or presaturation is detected. The detected VOI can be used for knee scan positioning. If necessary, the VOI can be checked and the orientation and position of the VOI can be adjusted in the Scan Plan (Locator) window.
- R-wave Monitoring: The range of the R-R intervals for data acquisition can be determined. If O the R-R intervals at the time of data acquisition is out of range, data acquisition is performed again.
- T2 Map Using Pre-Contrast Pulses: ECG gating or peripheral pulse gating is used in scanning o with FFE2D sequences, and different Pre-contrast pulses are used to obtain multiple TEeff images.
- Windows 10: Windows 10 has been applied to V6.0 Software. O
6
● Sequence Enhancements:
- Quick Star: Data acquisition is started from the center of the k-space in a radial pattern in the O in-plane direction in the k-space and in a Cartesian pattern in the slice direction. Because the data near the center of the k-space is acquired repeatedly, data acquisition with Quick Star is relatively unaffected by motion.
- Fast 3D mode: Fast 3D mode can be used to increase imaging efficiency. Two types of Fast 3D O mode (Multiple and Wheel) are available. Multiple is technique for acquiring two parallel SE lines continuously in a single shot. Wheel is technique for acquiring signals at the center of the k-space in a deformed wheel pattern in the PE-SE plane.
- WFS DIXON (Water Fat Separation): WFS option previously applicable to FE3D sequences is O added to FSE2D sequences.
- 2D-RMC (Real Time Motion Correction) for EPI: 2D Real-time Motion Correction is available for O Diffusion Weighted Imaging to mitigate respiratory motion artifacts during abdominal examinations. 2D-RMC option is newly applied to EPI sequences (previously applicable to FASE3D and FFE3D).
| Item | Subject Device:
Vantage Elan 1.5T,
MRT-2020, V6.0 | Predicate Device:
Vantage Elan 1.5T,
MRT-2020, M-Power GX | Notes |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------|
| Static field strength | 1.5T | 1.5T | Same |
| Operational Modes | Normal and 1st Operating
Mode | Normal and 1st Operating Mode | Same |
| i. Safety parameter
display | SAR, dB/dt | SAR, dB/dt | Same |
| ii. Operating mode
access requirements | Allows screen access to 1st
level operating mode | Allows screen access to 1st level
operating mode | Same |
| Maximum SAR | 4W/kg for whole body
(1st operating mode specified
in IEC 60601-2-33:
2010+A1:2013+A2:2015) | 4W/kg for whole body
(1st operating mode specified in
IEC 60601-2-33: 2010+A1:2013) | Same |
| Maximum dB/dt | 1st operating mode specified in
IEC 60601-2-33: 2010 +A1:2013
+A2:2015 | 1st operating mode specified in
IEC 60601-2-33: 2010 +A1:2013 | Same |
| Potential emergency
condition and means
provided for shutdown | Shutdown by Emergency Ramp
Down Unit for collision hazard
for ferromagnetic objects | Shutdown by Emergency Ramp
Down Unit for collision hazard
for ferromagnetic objects | Same |
19. SAFETY PARAMETERS
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K171597.
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21. INDICATIONS FOR USE
Vantage Elan systems are indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- Proton density (PD) (also called hydrogen density)
- Spin-lattice relaxation time (T1)
- Spin-spin relaxation time (T2) ●
- . Flow dynamics
- Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Risk Management activities for new software functionalities are included in this submission. The test methods used are the same as those submitted in the previously cleared submission of the predicate device, Vantage Elan 1.5T, MRT-2020, M-Power GX (K171597). A declaration of conformity with design controls is included in this submission.
23. SAFETY
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.
This device is based upon the same technologies, materials and software as the predicate device. Risk activities were conducted in concurrence with established medical device development standards and guidance. Additionally, testing was done in accordance with applicable recognized consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA):
LIST OF APPLICABLE STANDARDS
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012
- IEC60601-1-2 (2014) ●
- IEC60601-1-6 (2010), Amd.1 (2013)
- IEC60601-2-33 (2010), Amd.1 (2013), ● Amd.2 (2015)
- IEC60825-1 (2007)
- IEC62304 (2006), Amd.1 (2015) ●
- IEC62366 (2007), Amd.1 (2014) .
- NEMA MS 1 (2008)
- NEMA MS 2 (2008)
- NEMA MS 3 (2008) ●
- NEMA MS 4 (2010)
- NEMA MS 5 (2010) ●
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24. TESTING
Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met. Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria.
T2 Map Using Pre-Contrast Pulses was evaluated utilizing phantom and volunteer images. It was concluded that T2 maps can be generated using the data acquired using pre-contrast pulses.
WFS DIXON (Water Fat Separation) was evaluated utilizing phantom images. Testing verified that water signals and fat signals are separated in the water image and the fat image, respectively.
2D-RMC (Real Time Motion Correction) for EPI was evaluated utilizing phantom and volunteer images. Testing verified the use of 2DRMC in scanning with SEEPI2D sequence is effective.
MR image quality metrics were performed, utilizing volunteer images, to evaluate SpineLine+, KneeLine+, 500EVOI Knee, Quick Star, and Fast 3D mode. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
25. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the Vantage Elan 1.5T, MRT-1550, V6.0 is substantially equivalent to the previously cleared predicate device, Vantage Elan 1.5T, MRT-1550, M-Power GX, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Elan 1.5T, MRT-1550, V6.0 are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Elan 1.5T, MRT-1550, V6.0 do not change the indications for use or the intended use of the device. Based upon bench testing, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.