(262 days)
What the user is asking from me here is to find the "Reference Device(s) K/DEN number" in the text and list it out for them.
First, I will look for the section titled "Reference Device(s):".
I found the section: "# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text. Not Found"
Within this section, the text clearly states "Not Found".
Therefore, the requested information is "Not Found".
No
The document describes a standard MRI system with image processing capabilities, but there is no mention of AI, ML, or related terms.
No
The intended use states that it is a "diagnostic 2D & 3D imaging system", not a therapeutic one.
Yes
The 'Intended Use / Indications for Use' section explicitly states "Non-invasive, non-ionizing diagnostic 2D & 3D imaging system".
No
The device description explicitly details multiple hardware components including a magnet subsystem, gradient subsystem, RF subsystem, and a computer system with specific hardware specifications (CPU, RAM, Hard Disk). This indicates it is a hardware-based medical device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities." This describes an in vivo (within the living body) imaging system, not a device used to examine specimens in vitro (outside the living body).
- Device Description: The description details an MRI system, which is a type of medical imaging equipment used to visualize internal structures of the body. This aligns with in vivo diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (like blood, urine, tissue), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Vaya MRI SYSTEM is a medical imaging device used for in vivo diagnosis, not an IVD.
N/A
Intended Use / Indications for Use
Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.
Diagnostic Image capabilities include:
- Sagittal section images
- Cross section & curved cross section images
- Transverse section images
- Coronal section images
- 2D Fast Spin Echo
- 2D Inversion Recovery
- 2D Fast Inversion Recovery
- 2D Dual Slice Acquisition
- 2D/3D Spin Echo
- 2D/3D Gradient Echo
- 2D/3D Gradient Echo w/ Rephasing
- 2D/3D Steady State Acquisition w/ rewind Gradient Echo (SARGE)
- MR Angiography Image Processing
- MR Angiography Half Echo/High Resolution High Definition
- 2D/T1/T2 Weighted Imaging
- T1/T2 Proton Density Measurements
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
The Vaya MRI SYSTEM is functionally similar to most existing MRI systems. General specifications are as follows:
Magnet Subsystem
0.35 Telsa C-Shaped Compact Permanent Magnet Optimized Pole Design Homogeneity +/- 10 ppm with30 cm DSV Dimension 110cm x 160cm x 180cm Detachable Patient Table 2nd Detachable Patient Table Gradient Subsystem Strenath: 10mT/m Rise Time: 0.6ms Air Cooled RF Subsystem Quadrature Head Coil Quadrature Body/Spine Coil 3 Solenoid Coils for Extremities, Shoulder and C Spine Low Noise Preamplifier (0.5 dB Noise Figure) Digital RF Electronics Maximum Transmitter Power 5kW
Computer System
Host Computer: Dual Pentium CPU True Multi-tasking NT Environment All JAVA Language Programming RAM: 128MB Hard Disk: 2.1GB Image Capacity: 9000 256x256 1.7 GB WORM Archiving Remote System Maintenance Console Patient Registration Scanning Post-Processing & Image Enhancement (option) Display & Analysis Package Archiving User Defined Protocols User Specific Menus View Console (option) DICOM Compliant Laser Camera Interface Via 3M Protocol Laser Camera (option) CD Rewritable Drive (option) Protocols As Described on the Intended Use Page Site Requirements 5 Gauss Line 15" x 15" Maximum 3 Phase AC Power20kVA No Water Requirement
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, spine, torso, abdomen and extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
STILL
POINT
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1. Device Name:
Virga™ MRI SYSTEM Trade Name:
Common Name(s): MRI System
Classification Name(s): magnetic resonance diagnostic device
2. Establishment Name & Registration Number:
Name: MILLENNIUM TECHNOLOGY, INC. Number: Pending
3. Classification:
& 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.
[53 FR 5078, Feb. 1, 1989]
Device Class: Class II Classification Panel: Radiology Devices Panel Product Code(s): 90LNH
4. Section 514 Compliance
MILLENNIUM TECHNOLOGY, INC. intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
5. Performance Standards
Food and Drug Administration mandated Performance standards MRI systems are not in effect. MILLENNIUM TECHNOLOGY, INC. will comply with all voluntary Performance Standards applicable to MRI systems. At the present time, various performance standards such as ASTM, ISO, QSR/CGMP and in-house SOP standards are used.
1
6. Special Controls:
MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect, including:
(a) The provisions of § 1005.1 through 1005.24 are applicable to electronic products, which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.
(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.
Scope. The standards listed in this subchapter are prescribed pursuant to section ട്ട 1010.1 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [40 FR 32257, July 31, 1975]
4. Equivalent Predicate Device:
MILLENNIUM TECHNOLOGY, INC. believes that the Vog™ MRI SYSTEM is substantially equivalent to the following MRI system:
- AIRIS II M.R.I System, K961876, K974212, K980691 by Hitachi Medical Systems 1. America.
The comparison device represents an MRI system that is functionally and technologically equivalent. Equivalency can be drawn with respect to the design, intended use, clinical utility and "open design" configuration. To facilitate comparison of the Virge™ MRI SYSTEM to the comparison system identified above, a comparison table is provided below.
5. Device Description:
The Vaya MRI SYSTEM is functionally similar to most existing MRI systems. General specifications are as follows:
Magnet Subsystem
0.35 Telsa C-Shaped Compact Permanent Magnet Optimized Pole Design Homogeneity +/- 10 ppm with30 cm DSV Dimension 110cm x 160cm x 180cm Detachable Patient Table 2nd Detachable Patient Table Gradient Subsystem Strenath: 10mT/m Rise Time: 0.6ms Air Cooled RF Subsystem Quadrature Head Coil Quadrature Body/Spine Coil 3 Solenoid Coils for Extremities, Shoulder and C Spine Low Noise Preamplifier (0.5 dB Noise Figure) Digital RF Electronics Maximum Transmitter Power 5kW
2
Computer System
Host Computer: Dual Pentium CPU True Multi-tasking NT Environment All JAVA Language Programming RAM: 128MB Hard Disk: 2.1GB Image Capacity: 9000 256x256 1.7 GB WORM Archiving Remote System Maintenance Console Patient Registration Scanning Post-Processing & Image Enhancement (option) Display & Analysis Package Archiving User Defined Protocols User Specific Menus View Console (option) DICOM Compliant Laser Camera Interface Via 3M Protocol Laser Camera (option) CD Rewritable Drive (option) Protocols As Described on the Intended Use Page Site Requirements 5 Gauss Line 15" x 15" Maximum 3 Phase AC Power20kVA No Water Requirement
Applicant Name & Address: ર્ભ.
MILLENNIUM TECHNOLOGY, INC. 855 W. 12th Avenue Vancouver, B.C., Canada V5Z1M9 604.872.6039 - 604.872.0288 fax
7. Company Contact:
Regulatory Affairs MILLENNIUM TECHNOLOGY, INC. 855 W. 12th Avenue Vancouver, B.C., Canada V5Z1M9 604.872.6039 - 604.872.0288 fax
8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
3
9. Performance Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM. Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.
MILLENNIUM TECHNOLOGY. INC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act,
Special Controls: 10.
MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect, including:
(a) The provisions of § 1005.1 through 1005.24 are applicable to electronic products, which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.
(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.
ട്ട 1010.1 Scope. The standards listed in this subchapter are prescribed pursuant to section 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [40 FR 32257, July 31, 1975]
| FEATURE | VIRGO MRI SYSTEM | Hitachi | SE? |
|---|---|---|---|
| Indications for Use: | Non-invasive, non-ionizing diagnostic 2D & 3D imaging | ||
| system for use on the head, spine, torso, abdomen and | |||
| extremities. | Same | YES | |
| Design: | Open MRI | Open MRI | YES |
| Magnetic Field: | .35T | .30T | YES |
| Magnet Type: | Perm. | Perm. | YES |
| Origin: | Canada | Japan | YES |
| Manufacturer: | MTI | Hitachi | YES |
| Product Code: | 90LNH | 90LNH | YES |
| K - Number: | PENDING | K961876, K974212, K980691 | YES |
11. Summary Comparison Table:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999
Millenium Technology, Inc. C/O Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 Attn: David W. Schlerf
Re:
K990153 Virgo MRI System Dated: July 5, 1999 Received: July 23, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Schlerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for ase 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in . regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 - of
K 99 0153 510(k) Number :_
Virga™ MRI SYSTEM Device Name(s):
Intended Use(s) of the Device:
Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.
Diagnostic Image capabilities include:
- Sagittal section images
- Cross section & curved cross section images ●
- Transverse section images .
- Coronal section images ●
- 2D Fast Spin Echo ●
- 2D Inversion Recovery .
- 2D Fast Inversion Recovery ●
- 2D Dual Slice Acquisition ●
- 2D/3D Spin Echo ●
- 2D/3D Gradient Echo .
- 2D/3D Gradient Echo w/ Rephasing .
- 2D/3D Steady State Acquisition w/ rewind Gradient Echo (SARGE) ●
- MR Angiography Image Processing ●
- MR Angiography Half Echo/High Resolution High Definition ●
- 2D/T1/T2 Weighted Imaging ●
- T1/T2 Proton Density Measurements ●
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Yamil A. Seppern
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional format 1-2-96)