(32 days)
Not Found
No
The device description explicitly states that the design and materials are no different from standard MRI coil technology, and there is no mention of AI or ML in the document.
No.
The device is described as an MRI antenna family used to produce diagnostic images. It is explicitly stated that the images are for interpretation by a trained physician, which points to a diagnostic, rather than therapeutic, purpose.
Yes
The device produces "diagnostic images" that "can be interpreted by a trained physician," which are key characteristics of a diagnostic device. Its purpose is to facilitate targeted imaging for diagnosis.
No
The device description explicitly states the devices are "MRI antenna sets" and describes their physical construction using "EVA foam cover around a flexible circuit board," indicating they are hardware components.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an MRI antenna set (coil) used in conjunction with an MRI scanner to produce diagnostic images. It is a component of an imaging system, not a test performed on a biological sample.
- Intended Use: The intended use is to facilitate imaging of specific anatomical regions.
- Device Description: The description details the physical components of an MRI coil.
- Input Imaging Modality: The input is Magnetic Resonance, which is an imaging technique, not a method for analyzing biological samples.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The family is to be used in conjunction with a GE 1.5T and GE 3.0T Magnetic Resonance Scanner, to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions that can be interpreted by a trained physician.
The intended use for the device family is to provide MRI antenna sets to facilitate targeting imaging of the orbit region and mandible region.
- Tissue of the brain and face with emphasis on the orbits, and of the mandible joint of the head.
Product codes
MOS
Device Description
The devices are a 1.5T Orbit and Mandible Array and a 3.0T Orbit and Mandible Array. The designs and materials used to manufacture each coil are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing is formed by an EVA foam cover around a flexible circuit board. The two devices in this family are identical except for the tuned frequency. For this reason, it is warranted to bundle these two devices into one 510(k) submission.
The following devices are bundled in this submission.
| Device Name | Model Number | Operational Field Strength of MRI System |
|---|---|---|
| 1.5T Orbit and Mandible Array | 994GE1500 | 1.5T |
| 3.0T Orbit and Mandible Array | 992GE3000 | 3.0T |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
orbits and surrounding anatomy, mandible regions, Tissue of the brain and face, mandible joint of the head.
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)
Non-clinical tests:
The coils have similar dimension in the head area and have induced similar fields by the transmit coils that stimulate them. The predicate and current submission were compared by similar risk management efforts, as listed below, and determined to be substantially equivalent.
- Sensitivity Profile
- SNR Analysis
- Hazard Analysis
- FMEA
- Blocking Analysis
- Heat Tests
Clinical tests:
Analyses in all 3-planes (sagittal, coronal and transverse) were run to show that the anatomies of the submitted and predicate coils have substantial equivalence; the predicate device images the complete brain including orbits, and the Orbit & Mandible Family submission simply dedicates to a more local, higher-resolution performance on the orbits and mandible.
Final Discussion:
As described in the Design section. above, the submission is for smaller loops dedicated more closely to the patient's face, with the coils offering no energy source, and exhibiting strong decoupling: thus, the study determines that the submitted device is as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pediatric Array Coil (K951649)
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
Orbit and Mandible Array Family
Resonance Innovations LL
| Section 8. 510(k) Summary | K133986 | JAN 27 2014 |
|---|---|---|
| Submitter's Name: | Resonance Innovations LLC | |
| Submitter's Address: | 9840 South 140th St., Suite 8 | |
| Omaha, NE 68138 | ||
| Submitter's Telephone: | 402-934-2650 | |
| Submitter's Contact: | Randall Jones, President | |
| Date 510(k) summary prepared: | January 22, 2014 | |
| Name of the device, including the trade or proprietary name if applicable, the common | ||
| or usual name and the classification name, if known: |
| Proprietary Name: | Orbit and Mandible Array Family |
|---|---|
| Common or Usual Name: | MRI coil(s) |
| Classification Name: | Coil, Magnetic Resonance, Specialty |
| Classification Code: | MOS |
| Predicate Device: | Pediatric Array Coil (K951649) |
Description of the Device
The devices are a 1.5T Orbit and Mandible Array and a 3.0T Orbit and Mandible Array. The designs and materials used to manufacture each coil are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing is formed by an EVA foam cover around a flexible circuit board. The two devices in this family are identical except for the tuned frequency. For this reason, it is warranted to bundle these two devices into one 510(k) submission.
The following devices are bundled in this submission.
| Device Name | Model Number | Operational Field Strength
of MRI System |
|-------------------------------|--------------|---------------------------------------------|
| 1.5T Orbit and Mandible Array | 994GE1500 | 1.5T |
| 3.0T Orbit and Mandible Array | 992GE3000 | 3.0T |
Indications for Use
The family is to be used in conjunction with a GE 1.5T and GE 3.0T Magnetic Resonance Scanner, to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions that can be interpreted by a trained physician.
The intended use for the device family is to provide MRI antenna sets to facilitate targeting imaging of the orbit region and mandible region.
- Tissue of the brain and face with emphasis on the orbits, and of the mandible joint 0 of the head.
1
Orbit and Mandible Array Family
K133986
Resonance Innovations LLC Page 2 of 2
Technological Characteristics
The differences between the predicate and the current submission are described, below,
- 1.) Design. The submission is for a smaller subset of anatomies of the larger predicate. itself having elements close to the patient's orbits. Very much similarly, this new submission of the Orbit & Mandible Family utilizes smaller dedicated loops closer to the patient's face.
- 2.) Material. The distinction between the predicate and Orbit & Mandible Family group is non-substantive in that they both have insulating qualities proven by dielectric withstand testing, and have passed liquid ingress testing.
- 3.) Chemical Composition. Both products, the predicate and the recent submission, have biocompatible construction as demonstrated by cytotoxicity testing and by their history of use in previously cleared devices.
- 4.) Encrgy Source. Both of these products are receive-only coils not generating their own power, but rather stimulated by the MRI system as an energy source.
Non-clinical tests
The coils have similar dimension in the head area and have induced similar fields by the transmit coils that stimulate them. The predicate and current submission were compared by similar risk management efforts, as listed below, and determined to be substantially equivalent.
- Sensitivity Profile ●
- SNR Analysis .
- Hazard Analysis ●
- FMEA .
- Blocking Analysis .
- Heat Tests �
Clinical tests
Analyses in all 3-planes (sagittal, coronal and transverse) were run to show that the anatomies of the submitted and predicate coils have substantial equivalence; the predicate device images the complete brain including orbits, and the Orbit & Mandible Family submission simply dedicates to a more local, higher-resolution performance on the orbits and mandible.
Final Discussion
As described in the Design section. above, the submission is for smaller loops dedicated more closely to the patient's face, with the coils offering no energy source, and exhibiting strong decoupling: thus, the study determines that the submitted device is as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies.
2
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 stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27,2014
RESONANCE INNOVATIONS LLC RANDALL JONES PRESIDENT 9840 SOUTH 140TH ST., SUITE 8 OMAHA NE 68138
Re: KI33986
Trade/Device Name: Orbit and Mandible Array Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: December 31, 2013 Received: January 06, 2014
Dear Mr. Jones:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2-Mr. Jones
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mikara M. O'Hara
For
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
.
510(k) Number (if known): K133986
Device Name: Orbit and Mandible Array Family
Indications for Use:
The Indications for use are as follows:
- · The family is to be used in conjunction with a GE 1.5T and GE 3.0T Magnetic Resonance Scanner, to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions that can be interpreted by a trained physician.
- · The intended use for the device family is to provide MRI antenna sets to facilitate targeting imaging of the orbit region and mandible region.
- o Tissue of the brain and face with emphasis on the orbits, and of the mandible joint of the head.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological IIcalth