(15 days)
Not Found
None
No
The summary describes a passive MR coil, which is a hardware component for image acquisition, and there is no mention of AI/ML in the intended use, device description, or specific sections for AI/ML details.
No
The intended use states that the device is an accessory to produce images as an aid to diagnosis/treatment. It does not directly perform any therapeutic function.
Yes
The device is described as an "accessory to produce images of the anatomy of interest, as an aid to diagnosis / treatment," which directly indicates its role in the diagnostic process.
No
The device description explicitly states "Models HRB-127-32 High Resolution Brain Coil," which refers to a physical coil used in conjunction with an MR scanner. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the coil is an accessory to an MR scanner to produce images of anatomy as an aid to diagnosis/treatment. This describes a device used in vivo (within the living body) for imaging, not a device used in vitro (outside the living body) to examine specimens like blood, urine, or tissue.
- Device Description: The device is described as a "High Resolution Brain Coil," which is a component of an MR imaging system.
- Input Imaging Modality: The input is an "MR scanner," which is an imaging device used on patients.
- Anatomical Site: The anatomical site is the "head," indicating use on a patient.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The coil is indicated for use, on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the anatomy of interest, as an aid to diagnosis / treatment.
Product codes
MOS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR scanner
Anatomical Site
head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 Department of Health & Human Services USA. The logo features a stylized image of an eagle with three stripes forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2008
Mr. Jeff Wilkinson Manager, Quality & Regulatory InVivo Corporation 3545 SW 47th Ave. GAINESVILLE FL 32608
Re: K082916
Trade/Device Name: Models HRB-127-32 High Resolution Brain Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 26, 2008 Received: September 30, 2008
Dear Mr. Wilkinson:
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. Iisting 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 (RMA), 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.
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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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.
Sincerely yours.
forque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section C -- Statement of Indications for Use
Applicant: Invivo Corporation 510(k) number (if known): _ Device Name: Models HRB-127-32 High Resolution Brain Coil
Indications for use:
The coil is indicated for use, on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the anatomy of interest, as an aid to diagnosis / treatment.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | or | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| (Optional Format 1-2-96) |
Helmut Reiner
(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number _
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Section D - Intended Use of the Device
Intended use of the predicate device described in this submission:
Model HRH-127-8 Head Array Coil is intended to be used in conjuction with a magnetic resonance scanner to acquire images of the head that can be interpreted by a trained physician.
Intended use of the modified device described in this submission:
Model HRB-127-32 High Resolution Brain Coil is intended to be used in conjuction with a magnetic resonance scanner to acquire images of the head that can be interpreted by a trained physician.
The indications for use have not changed as a result of the modification.