(17 days)
Not Found
Nothing to extract
No
The summary describes a passive device (a coil) used in conjunction with an MRI scanner and contains no mention of AI, ML, or image processing capabilities.
No.
The device is used to produce images for interpretation by a physician, indicating a diagnostic rather than therapeutic purpose.
Yes
The device is used to produce images that can be interpreted by a trained physician, which aligns with the purpose of diagnostics (identifying or determining the nature of a disease or condition).
No
The device description explicitly states "HRK-123 Knee Array Coil," which is a hardware component used in Magnetic Resonance Scanners. The summary does not mention any software component as the primary or sole function of the device.
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 images using a Magnetic Resonance Scanner for interpretation by a physician. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: It's a "Knee Array Coil," which is a component used in an MRI scanner to acquire images of the knee.
- Input Imaging Modality: Magnetic Resonance Scanner is an imaging modality, not a method for analyzing biological samples.
- Anatomical Site: The device interacts directly with the patient's knee, not with a biological specimen.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is part of an imaging system used to visualize internal structures.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to produce images that can be interpreted by a trained physician.
Product codes
90 MOS
Device Description
HRK-123 Knee Array Coil
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
Knee
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 (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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Schubert Chief Technology Officer MRI Devices Corporation N27W23676 Paul Rd. PEWAUKEE WI 53072
Re: K050299
FEB 2 4 2005
Trade/Device Name: HRK-123 Knee Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 7, 2005 Received: February 7, 2005
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.
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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter with acation. The FDA finding of substantial equivalence of your device to a legally prematice notification: "The starsification 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 rryou desire specific at neve of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allot, prease note the regulation on your responsibilities under the Act from the 007. 77. Tou may obtain burers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
Nancy C. Brogdon 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 Model HRK-123 Knee Array Coil, February 7, 2005
Section C - Statement of Indications for Use
Applicant: MRI Devices Corporation S10(k) number (if known): A 1050 2 99 510(K) Hamber (II hal HRK-123 Knee Array Coil
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce To be used in conjuntion wee that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription ીકભ
Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
David le heppner
ar: (){{} ** eproductive, Ab ancal Devices mher _________________________________________________________________________________________________________________________________________________________________________