(78 days)
Not Found
No
The description focuses on the physical components and function of an RF coil for MRI, with no mention of AI or ML for image processing or analysis.
No
The device is used for obtaining diagnostic images, which aids in the determination of a diagnosis, not for providing therapy.
Yes
The device is a component of an MRI system, which produces images interpreted by a trained physician to determine a diagnosis. This clearly supports its role in the diagnostic process.
No
The device description explicitly states it consists of "two RF coil elements" and "associated circuitry," which are hardware components. It is a physical coil used in an MRI system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Mark 5000 Quadrature Shoulder Coil is an RF coil used in Magnetic Resonance Imaging (MRI) systems. It is a component of the imaging system itself, used to acquire signals from the patient's body in vivo (within the living organism).
- Intended Use: The intended use is to obtain diagnostic images of the shoulder and adjacent regions. This is a direct imaging process of the patient's anatomy, not an analysis of a biological specimen.
Therefore, the device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Mark 5000 Quadrature Shoulder Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark 5000 Quadrature Coil is designed for use with the Opart 0.35 Tesla MRI scanner manufactured by Toshiba Medical Systems Inc.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Mark 5000 Quadrature Shoulder Coil consists of two RF coil elements in a quadrature design. The coil elements and associated circuitry are enclosed to prevent any exposure to the patient or environment. The coil electronics are enclosed in both the rigid housing and the vinyl coated PVC foam. The coil is positioned on the patient's shoulder during imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Shoulder and adjacent regions
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 0 6 2002
.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..
SUMMARY OF SAFETY AND EFFECTIVENESS
KO13854
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Mark 5000 Quadrature Shoulder Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive, |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-562-1000; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been |
| issued under Section 514 of the Food, Drug and | |
| Cosmetic Act. | |
| 7. Intended Use: | The Mark 5000 Quadrature Shoulder Coil is a |
| receive-only specialty RF coil, used for obtaining | |
| diagnostic images of the shoulder and adjacent | |
| regions in Magnetic Resonance Imaging systems. | |
| The indications for use are the same as for standard | |
| MR Imaging. The Mark 5000 Quadrature Coil is | |
| designed for use with the Opart 0.35 Tesla MRI | |
| scanner manufactured by Toshiba Medical Systems | |
| Inc. | |
| 8. Device Description : | The Mark 5000 Quadrature Shoulder Coil consists |
| of two RF coil elements in a quadrature design. The | |
| coil elements and associated circuitry are enclosed | |
| to prevent any exposure to the patient or | |
| environment. The coil electronics are enclosed in | |
| both the rigid housing and the vinyl coated PVC | |
| foam. The coil is positioned on the patient's shoulder | |
| during imaging. |
Mark 5000
1
9. Safety and Effectiveness:
| Mark 5000 Quadrature Shoulder Coil
Product Features | Comparison to Predicate or other 510(k) cleared
products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Shoulder imaging applications | -Similar to the Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments Inc. (K893143)
-Similar to the Quadrature Shoulder Coil manufactured
by Hitachi Medical Systems America (K992650) |
| Indications for Use
Identical to routine MRI imaging | -Similar to the Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments Inc. (K893143) |
| Coil Enclosure Material
Vinyl coated EVA foam
Polyurethane Plastic | -Similar to the Quadrature Shoulder Coil manufactured
by Hitachi Medical Systems America (K992650)
-Similar to the Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments Inc. (K893143) |
| Coil Design
Receive-only Quadrature design | -Similar to the Quadrature Shoulder Coil manufactured
by Hitachi Medical Systems America (K992650) |
| Decoupling
Switching diode decoupling | -Similar to the Mark 5000 Shoulder Coil manufactured
by USA Instruments Inc. (K893143) |
| Prevention of RF Burns
Does not transmit RF power;
decoupling isolates the coil elements
from RF fields during RF transmission;
coil elements and circuitry are
enclosed in a non-conductive housing. | -Similar to the Mark 5000 Shoulder Coil manufactured
by USA Instruments Inc. (K893143) |
| Radio Frequency Absorption
Coil is a receive only coil and does not
transmit RF power; power deposition
during imaging is limited by SAR
algorithm | -Similar to the Mark 5000 Shoulder Coil manufactured
by USA Instruments Inc. (K893143) |
| Formation of Resonant Loop
Decoupling isolates the coil elements
from RF fields during RF transmission;
length of cable and stiffness does not
permit looping | -Similar to the Mark 5000 Shoulder Coil manufactured
by USA Instruments Inc. (K893143) |
1 - 4 - 4 -
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
Ms. Tori Masiella Regulatory Specialist USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K013854
Trade/Device Name: Mark 5000 Quadrature Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 21, 2001 Received: November 20, 2001
Dear Ms. Masiella:
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 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); 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
This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_ Ko/ 38 5 4
Device Name: Mark 5000 Quadrature Shoulder Coil
Indications for Use: The Mark 5000 Quadrature Shoulder Coil is a receive-only Indications for USe. The Mant 0000 Quanostic images of the shoulder and quadrature HF Coli, used for obtaining alsgring systems. The Mark 5000
surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 surrounding regions in Magnetio Front frames imaging of Justiba Opart 0.35Tesla Quadrature Onoulder Soll by Toshiba Medical Systems, Inc.
Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Toshiba Opart MRI system is indicated for use as an NMR device that The Toshiba Opart Milli System is indication of protons exhibiting produces images that. (1) office prometers (proton density, spin lattice NWH Sighali, (2) depend upon Nim Pparamon time T2) display the soft tissue relaxation time 11, Spir-Spiritoliation interpreted by a trained physician,
structure of the head and whole body. When interpreted by a trained of se structure of the nead and whole bouty.
these images yield information that can be useful in the determination of a diagnosis.
(Please do not WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013854 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|