(14 days)
Not Found
No
The summary describes a passive hardware component (an MRI coil) and does not mention any software or processing capabilities that would involve AI or ML.
No
The device is used to produce diagnostic images of the wrist and hand, which aids in diagnosis rather than providing therapy. It is described as a "receive only coil" for a magnetic resonance scanner, indicating its function in imaging.
Yes
The device is described as producing "diagnostic images of the wrist and hand that can be interpreted by a trained physician," explicitly stating its role in diagnosis.
No
The device description explicitly details a physical hardware component, a "six channel phased array receive only coil" with a "rigid enclosure" and "clamshell design," which is a hardware medical device, not software only.
No, 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: This device is a magnetic resonance imaging (MRI) coil. Its function is to receive radiofrequency signals from the body during an MRI scan to produce images. It does not analyze biological samples.
- Intended Use: The intended use is to "produce diagnostic images of the wrist and hand." This is a function of an imaging device, not an IVD.
Therefore, based on the provided information, this device clearly falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 1.5T Wrist Array Coil is a six channel phased array receive only coil. The coil has a rigid enclosure which is fire-rated and has impact and tensile strength. The mechanical housing is designed to follow the natural contours of the hand and wrist anatomy. The clamshell design allows the coil to open for patient positioning and alignment without electrical connections between the halves. The mechanical package also includes an adapter plate which can be used to help position patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance
Anatomical Site
wrist and hand
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)
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
510(k) SUMMARY OF SAFETY AND EFFECTIVI
- Applicant: Quality Electrodynamics (QED) 777 Beta Drive Mayfield Village, OH 44143 Phone (440) 638-5106
00: 3 : 2037
2. Contact:
Christie Zydyk VP & GM, Regulatory Affairs, Quality Assurance, & Corporate Communications
3. Date prepared:
September 14, 2007
- Tradename: SPEEDER 1.5T Wrist Coil
5. Common name:
Coil, magnetic resonance, specialty
6. Classification:
21 CFR 892.1000
7. Equivalent Device
HRW-63-8 Wrist Array Coil by MRI Devices, K050622
8. Device Description
The 1.5T Wrist Array Coil is a six channel phased array receive only coil. The coil has a rigid enclosure which is fire-rated and has impact and tensile strength. The mechanical housing is designed to follow the natural contours of the hand and wrist anatomy. The clamshell design allows the coil to open for patient positioning and alignment without electrical connections between the halves. The mechanical package also includes an adapter plate which can be used to help position patients.
9. Intended Use
For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.
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Image /page/1/Picture/0 description: The image shows handwritten text. The text at the top reads "KC72935". Below that, the text reads "Page 2 of 2". The handwriting appears to be cursive.
510(k) SUMMARY OF SAFETY AND EFFECTIVEN
10. Comparison with Predicate Devices
| 510(k) # | Device | Manufacturer |
|---|---|---|
| K050622 | HRW-63-8 Wrist Array Coil | MRI Devices |
| K031143 | Alpha 5000 Wrist Coil | USA Instruments |
| K972205 | Alpha 7000 Wrist Coil | USA Instruments |
The 1.5T Wrist Array Coil and predicate devices are designed for use in conjunction with magnetic resonance scanners to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician. The 1.5T Wrist Array Coil and the predicate devices have similar designs and are constructed of similar materials. The main differences are the system interface and the number of channels.
11. Conclusion
it is the opinion of Quality Electrodynamics that the 1.5T Wrist Array Coil wrist coil is substantially equivalent to the above-listed legally marketed predicate devices. Use of the Quality Electrodynamics coil does not result in any new potential hazards
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2007
Quality ElectroDynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 24th Street NW BUFFALO MN 55313
Re: K072935
Trade/Device Name: 1.5T Wrist Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 16, 2007 Received: October 17, 2007
Dear Mr, Job:
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 (PMA), 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.
3
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 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
4
Indications for Use
510(k) Number (if known): K072935
Device Name: 1.5T Wrist Array Coil
Indications for Use:
For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician
Prescription Use
X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
forgie M. Whan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices الرئيس الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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