(87 days)
Not Found
Not Found
No
The device description explicitly states that the technology is "no different from standard MRI coil technology that has existed for years" and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an MRI antenna set used for imaging and diagnosis, not for treating a disease or condition.
Yes
The device is an MRI antenna set used for "targeting imaging of various musculoskeletal extremity regions." Imaging, particularly with MRI, is a diagnostic modality. The intended uses listed, "Soft tissue and bone imaging of the extremities" and "Magnetic resonance peripheral angiography," are diagnostic procedures.
No
The device description explicitly details physical components like "form fitting MRI antenna sets," "individual coils," "semi-rigid housing," "semi-flexible flaps and/or padding," and "integrated pre-amplifier circuitry," indicating it is a hardware device, not software-only.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an "MRI antenna set" used to "facilitate targeting imaging of various musculoskeletal extremity regions using a GE 3.0T MRI scanner." It is a component of an imaging system that works externally to the patient's body to acquire images.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on substances taken from the body.
The device is an accessory for an MRI system, which is an imaging modality used for diagnostic purposes, but the device itself is not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The intended use for the device family is to provide form fitting MRI antenna sets to facilitate targeting imaging of various musculoskeletal extremity regions using a GE 3.0T MRI scanner. The Indications for use are:
- Soft tissue and bone imaging of the extremities as allowed by the MRI system. .
- Magnetic resonance peripheral angiography.
Product codes
MOS
Device Description
The individual coils that comprise the Extremity Coil Family interface with a 3.0 Tesla, 8channel MRI scanner.
All coils included in the Extremity Set are extremely similar in design, construction, materials and operation. There are slight variations in physical size (to accommodate differing patient sizes), and slight physical housing variations (required to optimize the image quality depending on the extremity anatomy). The designs and matcrials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a semi-rigid housing in conjunction with semi-flexible flaps and/or padding that facilitates close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest on a broad size variation of patient anatomy. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
musculoskeletal extremity regions, Soft tissue and bone of the extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
1.5T ScanMed PV Array
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
Extremity Coil Family
ﺔ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ Resonance Innovations LLC
Section 8. 510(k) Summary
MAY 2 0 2013
ﻮﻳﺘﺮﻭﺩ ﺷﻨﺘﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨ
Submitter's Name, Address, telephone number, a contact person and date the summary was prepared:
| Submitter's Name:
Submitter's Address: | Resonance Innovations LLC
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: | February 15, 2013 |
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: | Extremity Coil Family |
|---|---|
| Common or Usual Name: | MRI coil(s) |
| Classification Name: | Coil, Magnetic Resonance, Specialt |
| Classification Code: | MOS |
| Predicate Device: | 1.5T ScanMed PV Array |
Description of the Device
The individual coils that comprise the Extremity Coil Family interface with a 3.0 Tesla, 8channel MRI scanner.
| Device Model Number | Device Description |
|---|---|
| 148GE3000 | Distal Extremity Coil |
| 169GE3000 | Long Bone Coil - large |
| 308GE3000 | Elbow Coil |
All coils included in the Extremity Set are extremely similar in design, construction, materials and operation. There are slight variations in physical size (to accommodate differing patient sizes), and slight physical housing variations (required to optimize the image quality depending on the extremity anatomy). The designs and matcrials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a semi-rigid housing in conjunction with semi-flexible flaps and/or
Page 43 of 225
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ﺔ ".
padding that facilitates close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest on a broad size variation of patient anatomy. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry. For these reasons, it is warranted to bundle these devices into one 510(k) submission.
Page 44 of 225
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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 caduceus symbol, which is a staff with two snakes coiled around it. Above the symbol, the text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. Below the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is also arranged in a circular fashion.
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
May 20, 2013
Resonance Innovations, LLC % Randall Jones, Director of Engineering President & CEO 9840 S. 140th Street, Suite 8 OMAHA NE 68138
Re: K130457
Trade/Device Name: Extremity Coil Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: May 14, 2013 Received: May 15, 2013
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. Isting 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
3
Page 2 - Mr. Randall Jones
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.
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/Resourcesfor You/Industrv/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/default.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.
Michael D. O'Hara
for
Janine M. 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): K130457
Device Name: Extremity Coil Family
Indications for Use:
The intended use for the device family is to provide form fitting MRI antenna sets to facilitate targeting imaging of various musculoskeletal extremity regions using a GE 3.0T MRI scanner. The Indications for use are:
- Soft tissue and bone imaging of the extremities as allowed by the MRI system. .
- Magnetic resonance peripheral angiography.
Prescription Use X (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)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K130457
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