(12 days)
The Superopen 0.23T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the 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 (Ti), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use are as follows:
Anatomical Region: Head, Neck, Shoulder, Breast, Wrist, Ankle, Body, Spine, Knee, Extremities
Nucleus excited: Proton
Diagnostic uses: T1,T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Imaging processing
Imaging capabilities: 2D, 3D Spin Echo( SE ) Turbo spin echo (TSE) Short time inversion recovery (STIR); Fast STIR, IRFFE, IRSE, Fast IR, IR TSE Fluid attenuated inversion recovery (FLAIR); Fast FLAIR 2D,3D Fast Field Echo (FFE) T1/T2/N-Fast field echo (FFE); N-Fast filed echo 3D; T1-Fast field echo 3D; Dual echo (DE);DTSE; DSE; MR angiography FE, FFE 3D; Echo Planar Imaging (EPI)
The Superopen 0.23T (modified) is a 0.23T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, Gradient Coils, RF Coils, Magnet Electronics, Patient Couch, Gradient Amplifier Cabinet, Scan Cabinet, Operator Console, Intercom system. The system software based on Windows XP is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
The Superopen 0.23T (modified) system used the same materials, construction and operating principle as our existing marketed product, Superopen 0.23T MRI system (K062860) and Superstar 0.35T(K071154)
The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria. This 510(k) submission relates to an MRI system (Superopen 0.23T) and primarily focuses on establishing substantial equivalence to previously marketed predicate devices (Superopen 0.23T (K062860) and Superstar 0.35T (K071154)).
The key takeaway from the document regarding performance and testing is:
- Non-clinical test: "The device has been evaluated for performance, biocompatibility and effectiveness as well as electrical, mechanical, chemical, biocompatibility safety and has been found to substantially equivalent to Superopen 0.23T and Superstar 0.35T."
- Clinical test: "No clinical test conducted."
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific study is not available in this document. The manufacturer explicitly states that no clinical tests were conducted for this submission. The substantial equivalence was based on non-clinical evaluations comparing the modified device to its predicates.
{0}------------------------------------------------
K082485
510(k)
Attachment 1
SEP 0 9 2008
Summary of Safety and Effectiveness
Page 1 of 2
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
General Information:
| Product Name: | Superopen 0.23T |
|---|---|
| Product Model: | NAM-P023A |
| CFR Section: | 21 CFR Part 892.1000Magnetic resonance diagnostic device |
| Classification Name: | System, Magnetic Resonance Imaging |
| Product Code: | LNH |
| Device Class: | Class II |
| Applicable Standard: | IEC60601-1, Medical electrical equipment - Part 1: GeneralRequirements for SafetyIEC60601-2-33, Medical electrical equipment - Part 2-33: Particularrequirements for the safety of magnetic resonance equipment formedical diagnosis21 CFR Subchapter J, Radiological HealthIEC60825-1, Safety of laser products-Part1:Equipment classification,requirement and user's guideDICOM 3.0NEMA MS Series (MS1 - MS8) |
| Manufacture andDistributor: | Neusoft Medical Systems Co., Ltd.No.3-11, Wenhua Road, Heping District,Shenyang, ChinaPost Code : 110004 |
| Submitter: | Contact : TianyanfangTitle : Manager of Q&R DepartmentTel : 86-24-83660649Fax : 86-24-83780480E-Mail : Tianyanfang@neusoft.comSummary prepared : April 2th, 2008 |
{1}------------------------------------------------
Safety and Effectiveness information
Intended Uses:
The Superopen 0.23T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the 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 (Ti), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Device Description:
The Superopen 0.23T (modified) is a 0.23T permanent magnet MRI system. It is composed of Magnet and Magnet Enclosure, Gradient Coils, RF Coils, Magnet Electronics, Patient Couch, Gradient Amplifier Cabinet, Scan Cabinet, Operator Console, Intercom system. The system software based on Windows XP is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
The Superopen 0.23T (modified) system used the same materials, construction and operating principle as our existing marketed product, Superopen 0.23T MRI system (K062860) and Superstar 0.35T(K071154)
Predicated Device:
K062860: Superopen 0.23T K071154: Superstar 0.35T Statement of Substantial Equivalence:
The Superopen 0.23T (modified) system is the upgrade version of Superopen 0.23T MRI system(K062860). It is comparable and substantially equivalent to the Superopen 0.23T MRI system and Superstar 0.35T(K071154) in that they are similar in technology and intended uses. Both of these systems are open-magnet MR Imaging System, use Gradient Subsystem to provide controlled and uniform gradient magnet fields in the X, Y and Z planes, and use RF Subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console's computer that has an interfactive user interface, and the system produces 2D and 3D image that can be filmed or electronically stored for future review. Both of these systems have the traditional MRI unit.
- a. Non-clinical test: The device has been evaluated for performance, biocompatibility and effectiveness as well as electrical, mechanical, chemical , biocompatibility safety and has been found to substantially equivalent to Superopen 0.23T and Superstar 0.35T.
- b. Clinical test: No clinical test conducted.
Conclusion: The device was evaluated against Superopen 0.23T (K062860) and Superstar 0.35T(K071154) for all performance, safety & effectiveness requirements. According to the comparison based on the requirements of 21.CFR 807.87, we state that these devices are substantially equivalent.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
DEC 16 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neusoft Medical Systems Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road Newtown CT 06470
Re: K082485
Trade/Device Name: Superopen 0.23T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 22, 2008 Received: August 28, 2008
Dear Mr. Borsai:
This letter corrects our substantially equivalent letter of September 9, 2008.
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 (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.
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
{3}------------------------------------------------
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Herbert Lehman
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letters 'Ko' followed by the numbers '82485'. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.
Neusoft
510(k)
Attachment 2
Indications for Use
510(k) Number:
Page 1 of 1
Device Name: Superopen 0.23T
The Superopen 0.23T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRJ system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the 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.
The indications for use are as follows:
Anatomical Region: Head, Neck, Shoulder, Breast, Wrist, Ankle, Body, Spine, Knee, Extremities Nucleus excited: Proton Diagnostic uses: T1,T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Imaging processing Imaging capabilities: 2D, 3D Spin Echo( SE ) Turbo spin echo (TSE) Short time inversion recovery (STIR); Fast STIR, IRFFE, IRSE, Fast IR, IR TSE Fluid attenuated inversion recovery (FLAIR); Fast FLAIR 2D,3D Fast Field Echo (FFE) T1/T2/N-Fast field echo (FFE); N-Fast filed echo 3D; T1-Fast field echo 3D; Dual echo (DE);DTSE; DSE; MR angiography FE, FFE 3D; Echo Planar Imaging (EPI)
Prescription Use: YES
Over-The-Counter Use: NO
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF DEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K082485 |
§ 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.