(18 days)
Not Found
Not Found
No
The summary describes a hardware component (array coils) for an MRI scanner and does not mention any software or processing capabilities that would suggest AI/ML.
No
The device is used to produce diagnostic images, meaning it helps identify a condition, rather than treat or provide therapy for it.
Yes
The device is used to produce "diagnostic images" that are "interpreted by a trained physician," directly implying its role in diagnosis.
No
The device description explicitly states "Cardiovascular Array Coils," which are hardware components used in Magnetic Resonance Scanners.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce diagnostic images of internal body systems (cardiovascular, pulmonary, renal, and abdominal) using a Magnetic Resonance Scanner. This is a form of in vivo imaging, meaning it's used to examine the inside of a living body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not analyze specimens.
- Device Description: The device is described as "Cardiovascular Array Coils," which are components used within an MRI system to acquire signals from the body.
Therefore, the function and application of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular, pulmonary, renal, and abdominal systems that can be interpreted by a trained physician.
Product codes
MOS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
cardiovascular, pulmonary, renal, and abdominal systems
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 the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 2 8 2006
Mr. Thomas Schubert Chief Technology Officer Invivo Corporation 3545 SW 47th Ave. GAINESVILLE FL 32608
Re: K061952
Trade/Device Name: Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 20, 2006 Received: July 10, 2006
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). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/11 description: The image is a black and white logo with the text "1906-2006" at the top. Below the text is the abbreviation "PA" in large, bold letters. Underneath the abbreviation is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a circular border.
Protecting and Promoting Public Health
1
Page 2 -
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); 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 begin 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Special 510(K) Application, Device Modification Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils June 20, 2006
Page 3 of 35
Section C - Statement of Indications for Use
Applicant:
Device Name:
Invivo Corporation 510(k) number (if known): Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular, pulmonary, renal, and abdominal systems that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
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V
David A. Ingram
(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number __