(12 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related terms, and the device description is not available to provide further clues.
No
The device is described as producing diagnostic images, not as providing treatment or therapy. Its intended use is for diagnosis, which is distinct from therapeutic application.
Yes
The device is described as producing "diagnostic images of the head and neck," which are then "interpreted by a trained physician," indicating its role in diagnosis.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use mentions being used "in conjunction with a Magnetic Resonance Scanner," which is a hardware device, but this doesn't definitively state whether the submitted device itself is software-only or a hardware accessory/component for the scanner.
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.
- Device Function: The intended use describes the device as being used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck. This indicates the device is part of an imaging system that works externally to the patient's body to create images, rather than analyzing samples taken from the body.
- Input Modality: The input imaging modality is a Magnetic Resonance Scanner, which is an imaging technology, not a method for analyzing biological samples.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.
Product codes
90 MOS
Device Description
Model NVA-63-8-A and NVA-63-16-A Neurovascular Array Coils
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
head and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized emblem featuring three curved lines resembling a bird or a flame. The emblem is black, and the text is also in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2004
Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186
Re: K042103
Trade/Device Name: NVA-63-8-A and NVA-63-16-A Neurovascular Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS
Dated: August 2, 2004 Received: August 4, 2004
Dear Mr. Schubert:
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). and Obsincere for , too) year 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 such 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 that i 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); 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
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to ocgin maneeting your device of your device to a legally premarket nothcation. The PDA miding of become 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 If you desire specific advice for your dones on one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Adultionally, for questions on the promote the regulation entitled, "Misbranding Other of Comphance at (301) 59 1 489 (21CFR Part 807.97) you may obtain. Other general by reletection on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Solless http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section C – Statement of Indications for Use:
Applicant: MRI Devices Corporation 510(k) number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Model NVA-63-8-A and NVA-63-16-A Neurovascular Array Coils
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.
The indications for use of the device have not changed as a result of the modification described in this Special 510(k).
Concurrence of CDRH, Office of Device Evaluation (ODE)
or Over-The-Counter Use _ Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Nancy Brogdon
(Division Sign-Off) Coursion of Reproductive, Ab a Radiological Devices ו (((k) Number