(63 days)
ArtoScan, Ortho 8000, Rx-4000
Not Found
No
The summary describes standard MRI technology and image processing, but does not mention AI, ML, or related concepts.
No
The device is described as an MRI system intended to produce images for diagnostic purposes, not to treat or cure a disease or condition.
Yes
The device is described as producing MRI images that, when reviewed by a medical practitioner, can "render medical information of the region under review," which is a diagnostic purpose.
No
The device description explicitly states it is a "transportable, permanent-magnet MRI system" with a "surface magnet/coil assembly" and associated electronics and a cart, indicating it is a hardware device with integrated software for control and processing.
Based on the provided information, the OrthoVu-1000 is not an IVD (In Vitro Diagnostic) device.
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 performed outside of the living body (in vitro).
- OrthoVu-1000 Function: The OrthoVu-1000 is an MRI system that produces images of human extremities within the living body (in vivo). It uses magnetic and radio frequency energy applied directly to the patient.
- Intended Use: The intended use is to produce images for review by a medical practitioner to render medical information. This is a diagnostic imaging function, not an in vitro test.
Therefore, the OrthoVu-1000 falls under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The OrthoVu-1000 is intended to produce MRI images of human extremities, which when reviewed by a qualified medical practitioner, can render medical information of the region under review.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The OrthoVu-1000 is a transportable, permanent-magnet MRI system, which uses a surface magnet/coil assembly to perform nuclear magnetic resonance imaging of human anatomy with particular emphasis on the imaging of extremities. This system utilizes a non-homogeneous magnetic field, developed by a single device head, which applies magnetic and radio frequency (RF) energy and then detects the resultant spin echoes. A computer system controls excitation and performs processing and imaging functions. The control and imaging computer as well as the associated electronics package is mounted on a cart with a magnet assembly which can be manually positioned in the correct orientation to perform the desired imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
human extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical practitioner
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)
The OrthoVu-1000 has been tested for conformance with NEMA standards MS1-MS8 except MS6. Further testing for conformance with applicable international standards is planned prior to release.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ArtoScan, Ortho 8000, Rx-4000
Reference Device(s)
Not Found
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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Image /page/0/Picture/1 description: The image shows a sequence of numbers and letters. The sequence starts with the letter 'K', followed by the number '98'. Then, there is the number '18', and the sequence ends with the number '98'. The numbers and letters are written in a handwritten style.
OrthoVu-1000 MagneVu 510(k) Premarket Notification
Appendix VIII, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
| A. | Submitted By: | MagneVu |
|---|---|---|
| 2225 Faraday Avenue, Suite F | ||
| Carlsbad, California, 92008 | ||
| Tel: | (760) 929-8000 | |
| Fax: | (760) 929-8100 | |
| Contact Person: | Bob Rose | |
| Manager, Regulatory Affairs | ||
| B. | Device Trade Name: | OrthoVu-1000 |
| Common Name: | Magnetic Resonance Imaging System | |
| Classification Name: | Magnetic Resonance Diagnostic Device | |
| C. | Predicate Device: | ArtoScan |
| Ortho 8000 | ||
| Rx-4000 |
Device Description: D.
The OrthoVu-1000 is a transportable, permanent-magnet MRI system, which uses a surface magnet/coil assembly to perform nuclear magnetic resonance imaging of human anatomy with particular emphasis on the imaging of extremities. This system utilizes a non-homogeneous magnetic field, developed by a single device head, which applies magnetic and radio frequency (RF) energy and then detects the resultant spin echoes. A computer system controls excitation and performs processing and imaging functions. The control and imaging computer as well as the associated electronics package is mounted on a cart with a magnet assembly which can be manually positioned in the correct orientation to perform the desired imaging.
1
Indications for Use: E.
The OrthoVu-1000 is intended to produce MRI images of human extremities, which when reviewed by a qualified medical practitioner, can render medical information of the region under review.
F. Technological Comparison:
two dimension Fourier transform techniques.
The OrthoVu-1000 and predicate devices are intended to generate MRI images of the human body with the OrthoVu-1000, the ArtoScan and Ortho 8000, intended specifically for imaging of extremities. As with the ArtoScan and Ortho 8000 devices, the OrthoVu-1000 uses a permanent magnetic to generate the static magnetic field. The OrthoVu-1000 and predicate devices are designed to excite hydrogen nuclei and acquire data using two dimension multislice, multiecho acquisition modes. In addition, the devices reconstruct images using
II. Testing
The OrthoVu-1000 has been tested for conformance with NEMA standards MS1-MS8 except MS6. Further testing for conformance with applicable international standards is planned prior to release.
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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three overlapping lines forming the body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1008 માણિ
Bob Rose Manager, Regulatory Affairs MagneVu 2225 Faraday Avenue, Suite F Carlsbad, California 92008
Re:
K981898 OrthoVu-1000 Magnetic Resonance Imaging System Dated: May 27, 1998 Received: June 1, 1998 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Rose:
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 use stated in the enclosure) to 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 (2) 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/cdrb/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 98 1898
OrthoVu-1000 Device Name:
Sponsor Name: MagneVu Inc.
Indications for Use
The OrthoVu-1000 is intended to produce MRI images of human extremities, which when reviewed by a qualified medical practitioner, can render medical information of the region under review.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ্ট্রা Over-The-Counter Use
William Yu
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number