(32 days)
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.
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.
The provided text is a 510(k) summary for the "Orbit and Mandible Array Family" MRI coils. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, many of the requested sections about clinical studies, reader studies, and ground truth establishment are not applicable or cannot be extracted from this document.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence to a predicate device based on design, materials, chemical composition, energy source, and non-clinical tests. The "performance" is implicitly deemed acceptable if it's "as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies."
| Performance Metric (Implicit) | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | As safe and effective as the legally-marketed predicate device (Pediatric Array Coil K951649) | "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." This is based on non-clinical tests including Sensitivity Profile, SNR Analysis, Hazard Analysis, FMEA, Blocking Analysis, and Heat Tests. The design also emphasizes smaller dedicated loops closer to the patient's face, offering no energy source, and exhibiting strong decoupling, implying enhanced safety and effectiveness for its specific target anatomies compared to a broader brain coil. The document also states, "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." |
| Image Quality | Ability to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions. | "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." This implies the images are of diagnostic quality, and for the target regions, potentially higher resolution. |
| Biocompatibility | Biocompatible construction | "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." |
| Insulation | Insulating qualities proven | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical tests and comparisons to a predicate device, rather than a clinical study with a "test set" in the context of an AI/algorithm validation. The "analyses in all 3-planes" mentioned under clinical tests refer to showing substantial equivalence in imaging capabilities, not a study involving patient data with a defined sample size for performance evaluation. No sample size for a test set is provided, and thus, data provenance cannot be determined.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document discusses device characteristics and equivalence, not an AI/algorithm where ground truth would be established by experts for a test set. The images are intended to be "interpreted by a trained physician," but this refers to the end-user clinical interpretation, not ground truth establishment for a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring ground truth adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for MRI coils, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (MRI coil), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the ability of the coil to produce diagnostic images, which is assessed through non-clinical performance characteristics and comparison to a predicate device's established performance.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
{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 8Omaha, 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 commonor 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 Strengthof 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
§ 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.