(28 days)
i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.
ii. Magnetic resonance angiography.
The 3.0T Pediatric Head and Spine Array, Catalog #808GE3000, interfaces with the G.E. 3.0 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inouts and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) submission for a medical device (MRI accessory coil) and primarily details the device description, intended use, and substantial equivalence to a predicate device, leading to FDA clearance.
There is no information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Ground truth establishment, including the number and qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance studies.
- Types of ground truth used (e.g., pathology, outcomes data).
- Training set sample size or how its ground truth was established.
The document states that the new device has "minor changes to the size and physical orientation of the individual elements" and "the materials, use, and safety features are equivalent." It also notes that "Both are receive-only MRI antennas so no energy is imparted to the patient." This suggests that the clearance was based on demonstrating substantial equivalence in design and function, rather than extensive performance testing against acceptance criteria as might be seen for devices with more complex diagnostic or algorithmic components.
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Kob 1170
Appendix D: 510(k) Submission for Pediatric Head/Spine
510(k) Summary
| 1. | Manufacturer Name & Address: | Resonance Innovations LLC12530 Harney CircleOmaha, NE 68154 | |||
|---|---|---|---|---|---|
| Establishment Registration No.:Applicant/Contact Person:Applicant Contact Info : | 1932898Randall Jones, Dr.Eng.Phone: 402-934-2650Fax: 402-778-9699Email: info@scanmed.com | MAY 2 5 2006 | |||
| Date Prepared: | April 22, 2006 | ||||
| 2. | Device common name:Specific Device Trade Name:Classification: | MRI Accessory Coil3.0T Pediatric Head and Spine ArrayClass II/Radiology/LNH | |||
| 3. | Unmodified Device Trade Name:Unmodified Device 510(k) No.: | 1.5T Pediatric Array #801GE1500K951649. |
Device Description: The 3.0T Pediatric Head and Spine Array, Catalog #808GE3000, 4. interfaces with the G.E. 3.0 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inouts and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.
ર. Intended Use Statement:
- i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.
- ii. Magnetic resonance angiography.
Note that the intended use is not substantively different than that of the unmodified device (below).
- Soft tissue and bone imaging of the spine and brain as allowed by the 1. MRI system.
- Magnetic resonance angiography. ii.
- The modified device has the same technological characteristics as the unmodified device 6. with only minor changes to the size and physical orientation of the individual elements of the multi-element or multi-channel MRI antenna (coil). The materials, use, and safety features are equivalent. Both are receive-only MRI antennas so no energy is imparted to the patient.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 5 2006
Randall W. Jones, Dr. Eng. President Resonance Innovations LLC 12530 Harney Circle OMAHA NE 68154
Re: K061170
Trade/Device Name: 3.0T Pediatric Head and Spine Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 22, 2006 Received: April 27, 2006
Dear Dr. 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.
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.
Image /page/1/Picture/10 description: The image shows a logo with the text "Protecting and Promoting Public Health" written below it. The logo is circular and contains the letters "FDA" in the center. The years "1906-2006" are written at the top of the circle, and the word "Centennial" is written below the letters "FDA". There are also three stars below the word "Centennial".
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I least be advised that i Dr is issualled of aevice 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); the Act 3 requirements, morading, varilist minute ments as set forth in the quality fabeling (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) I his letter with anow yourse ough maing of substantial equivalence of your device to a legally prematication. "The PDF Imaning of basification 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.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 Also, please the regalation 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kob 1170
Appendix A: 510(k) Submission for Pediatric Head/Spine
Statement of Indications for Use
The new device labeled the 3.0T Pediatric Head and Spine Array will have no substantive change in the Indications for Use over the predicate (unmodified) device, 1.5T Pediatric Array (K951649).
The intention of the new device is to expand the anatomical coverage provided by the device by modifying the patient-user interface in terms of altering the size and anatomical location of some of the array's individual resonators, as well as adding resonators. The new device also adds parallel imaging compatibility.
The Intended Use Statements remain virtually identical to those of the unmodified device. These statements follow.
- i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.
- ii. Magnetic resonance angiography.
Prescription Use
Nancy Borden
§ 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.