(497 days)
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No
The document describes standard MRI system components and functions (scanning control, image reconstruction, image/archive management, post-processing tools) without mentioning AI, ML, or related concepts. The focus is on image acquisition and basic processing, not intelligent analysis or interpretation.
No
The device is described as a diagnostic imaging device, and its images are intended to be useful in "diagnosis determination," not therapy.
Yes
Justification: The "Intended Use / Indications for Use" section explicitly states "The Supernova C5 is intended for use as a diagnostic imaging device" and "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination".
No
The device description explicitly states it is a 0.35T permanent magnet MRI system composed of hardware components including a Magnet, RF Coils, Patient Couch, System Cabinet, and computer system, in addition to software.
Based on the provided information, the Supernova C5 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic imaging device" that produces images of the internal structure of the human body. IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description details components of an MRI system, which is an imaging modality, not a device for analyzing biological samples.
- Input Imaging Modality: The input is Magnetic Resonance Imaging (MRI), which is an imaging technique, not a method for analyzing biological specimens.
- Anatomical Site: It operates on the human head, body, or extremities, which are parts of the living body, not specimens taken from the body.
In summary, the Supernova C5 is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Supernova C5 is intended for use as a diagnostic imaging device which can produce transverse, sagittal, coronal and oblique cross-sectional images of the internal structure of the human head, body or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Supernova C5 is a 0.35T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, RF Coils , Patient Couch, System Cabinet, computer system. The system software based on Windows XP or Windows 7 is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
Mentions image processing
Reconstruction responsible for the efficient processing of raw data to generate MR images.
Analysis - contains the image post-processing tools
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic resonance
Anatomical Site
human head, body or extremities
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests:
- Customer requirement analyze
- System requirement analyze
- Detail design
- Design reviews
- Unit and integration level testing
- Verification testing, including System and Manual testing
- Safety testing, including SAR, dB/dt, and acoustic noise
- Performance testing, including SNR and uniformity
- Validation testing
Risk management, compliant with ISO 14971:2007, identified hazards, sequences of events, and resultant harms: developed, implemented, and tested risk-controlling mitigations: and evaluated residual risks.
Clinical tests:
Sample clinical images were obtained for all receive coils and pulse sequences included with the system.
Conclusion: The conclusions drawn from the nonclinical and clinical tests that demonstrate that Supernova C5 is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Liaoning Kampo Medical System Co., Ltd. % Mr. Shao Kai Quality Engineer No. 9. Yaodu Street. Benxi Economic Development Area Benxi, Liaoning 117004 CHINA
Re: K131737
Trade/Device Name: Supernova C5 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 19, 2013 Received: September 25, 2013
Dear Mr. Kai:
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 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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
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 Industry and Consumer Education 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.
Michael D'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131737
Device Name Supernova C5 MRI System
The Supernova C5 is intended for use as a diagnostic imaging device transyerse, sagittal, coronal and oblique cross-sectional images of the internal structure of the human head, body or extremities.
The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
Form Approved: OMB No. 0910-0120
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Image /page/3/Picture/0 description: The image shows a logo with the text "KMPO" in a stylized font. The letters are primarily gray, except for the "M", which is orange. The logo has a modern and geometric design.
510 (k) Summary
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92
1.0 Contact Information
Title : Quality Engineer Tel : 86-414-5555322 Fax : 86-24-45689287 E-Mail : shaok@kampo.cn
2.0 Establishment Name and Address
Liaoning Kampo Medical System Co.,Ltd. No.9, Yaodu Street, Benxi Economic Development Area,Liaoning,P.R.China Post Code : 117004
3.0 Submission Date
May 31, 2013,revised September 19,2014
4.0 Device Information
| Trade Name: | Supernova C5 MRI System |
|---|---|
| Product Model: | Supernova C5 |
| Classification name: | 21 CFR Part 892.1000 |
| Magnetic resonance diagnostic device | |
| Product Code: | LNH |
| Device Class: | Class II |
5.0 Predicate Device(s)
| 510(k)# | Device | Original Applicant | Decision Date |
|---|---|---|---|
| K071154 | Superstar 0.35T | NEUSOFT MEDICAL SYSTEMS | |
| CO., LTD | 05/10/2007 |
Page 1 of 5
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Image /page/4/Picture/0 description: The image shows a logo with the letters "KMPO" in a stylized font. The letters are a combination of orange and gray colors. The "K" and "P" are gray, while the "M" is orange. The letters are bold and have rounded edges, giving the logo a modern and professional look.
6.0 Device Description
The Supernova C5 is a 0.35T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, RF Coils , Patient Couch, System Cabinet, computer system. The system software based on Windows XP or Windows 7 is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
Supernova C5 has been designed to comply with the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:
| Reference # | Title |
|---|---|
| IEC60601-1 | Medical electrical equipment - Part 1: General |
| Requirements for Safety | |
| IEC60601-2-33 | Medical electrical equipment--Part 1:General |
| requirements for safety-2. Collateral Standard: | |
| Electromagnetic compatibility—Requirements and | |
| tests | |
| MS 1-2008 | Determination of Signal-to-Noise Ratio (SNR) in |
| Diagnostic Magnet Resonance Imaging | |
| MS 2-2008 | Determination of Two-Dimensional Geometric |
| Distortion in Diagnostic Magnetic Resonance Images. | |
| MS3-2008 | Determination of Image Uniformity in Diagnostic |
| Magnetic Resonance Images | |
| MS4-2010 | Acoustic Noise Measurement Procedure for |
| Diagnostic Magnetic Resonance Imaging Devices | |
| MS5-2010 | Determination of Slice Thickness in Diagnostic |
| Magnetic Resonance Imaging. | |
| MS6-2008 | Determination of Signal-to-Noise Ratio and Image |
| Uniformity for Single-Channel, Non-Volume Coils in | |
| Diagnostic Magnetic Resonance Imaging (MRI) | |
| MS8-2008 | Characterization of the Specific Absorption Rate |
| (SAR) for Magnetic Resonance Imaging Systems | |
| MS9-2008 | Characterization of Phased Array Coils for Diagnostic |
| Magnetic Resonance Images (MRI) | |
| NEMA PS3.1 - | |
| 3.20 (2011) | Digital Imaging And Communications In Medicine |
| (DICOM) Set |
7.0 Indications for Use
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Image /page/5/Picture/1 description: The image shows the logo for KMPRO. The letters are in a sans-serif font, with the letters K, M, P, R, and O. The letter M is orange, while the other letters are gray. The letters are bold and have rounded corners.
The Supernova C5 is intended for use as a diagnostic imaging device which can produce transverse, sagittal, coronal and oblique cross-sectional images of the internal structure of the human head, body or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination
8.0 Technological Characteristics Comparison to Predicate Device
The Supernova C5 is comprised of the following functional modules, and the predicate device contains the same functional modules:
- Magnet - responsible for providing a homogeneity magnetic field in specified space.
- Gradient Coil generates a linear gradient field in specified space when excited by electric current.
- Gradient Amplifier provides high electric current for gradient coil ロ
- Transmit Coil generate a homogeneity RF field in specified space when driven by RF power
- RF Amplifier provides RF power for transmit coil ロ
- RX Coils receives the FID signal which has excited by the transmit coil and encoded by the gradient coil.
- Spectrometer receives parameters transferred from scan control to generate time sequence to control the operation of gradient amplifier, RF amplifier and RX coil. The signal from RX coil will be digitized and transferred to SW for further processing
- User Interface (SW) user can get desired images by proper operation in UI.
- � Acquisition - Receive MR raw data from spectrometer
- Reconstruction responsible for the efficient processing of raw data to � generate MR images.
- � Analysis - contains the image post-processing tools
- � Protocols - Supernova C5's each protocol is comprised at a pulse sequence, user parameters.
- � Scan Control - responsible for the real-time transfer of controlling orders for protocols, protocols parameters modifications, and dynamic information from the MR host in response to user or program requests
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Image /page/6/Picture/1 description: The image shows a logo with the letters "KMPO" in a stylized font. The "M" is orange, while the other letters are gray. The letters are bold and have rounded edges. The logo appears to be for an organization or company with the initials KMPO.
- Information System the central repository of all relevant MRI system � configuration, patient, study, scan, etc., parameters associated with the current patient study
- � Storage - obtains current patient and scan information, performs non-volatile local storage, exports images and data in DICOM format.
- Visualization implements all aspects of the user interface, including � scan protocols selection, controls to modify protocol parameters, image display, graphical slice prescription, and image review, save, and export.
- Patient couch provides a support for patient during scanning.
- Cover provides a shell for magnet
There is no differences between the Supernova C5 and the predicate device's intended use.
Both Supernova C5 and the predicate device can offer pulse sequences. Supernova C5 are optimized for whole body applications, and offer the imaging capabilities same as predicate device.
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.
9.0 Performance Data - Discussion of Non-Clinical Tests
Design controls quality assurance measures during the development of Supernova C5 include:
- Customer requirement analyze
- System requirement analyze
- Detail design
- Design reviews
- Unit and integration level testing
- Verification testing, including System and Manual testing
- Safety testing, including SAR, dB/dt, and acoustic noise
- Performance testing, including SNR and uniformity
- Validation testing
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Image /page/7/Picture/0 description: The image contains the text '510(k)'. This likely refers to a type of premarket submission to the FDA (Food and Drug Administration) to demonstrate that a medical device is safe and effective. The 510(k) pathway is a common route for medical device approval in the United States.
Image /page/7/Picture/1 description: The image shows the logo for KMPO. The letters are in a sans-serif font, with the 'A' in orange and the rest of the letters in gray. The 'A' has a small orange drip coming from the bottom left corner. The logo is simple and modern.
Risk management, compliant with ISO 14971:2007, identified hazards, sequences of events, and resultant harms: developed, implemented, and tested risk-controlling mitigations: and evaluated residual risks.
10.0 Safety Parameters
| Supernova C5 | Predicate Device | |
|---|---|---|
| Magnet field strength | 0.35T | 0.35T |
| Operating Modes | Normal Level | 1st Level Operating |
| IEC 60601-2-33 (2010-03) | Operating Mode | Mode |
| Safety Parameter Display | SAR, dB/dt | SAR, dB/dt |
| Max SAR |