(51 days)
Not Found
No
The summary describes a passive RF coil for MRI, with no mention of AI/ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is a receive-only RF coil used for obtaining diagnostic images in MRI systems, which is for diagnostic purposes, not therapeutic.
Yes
The device is used for obtaining "diagnostic images" of the shoulder and adjacent regions using Magnetic Resonance Imaging (MRI) systems, which is a diagnostic imaging modality.
No
The device description explicitly states it consists of physical components like RF coil elements, circuitry, and an enclosure, indicating it is a hardware 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: The description clearly states the Shoulder Coil is a "receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems." This is a component used in an imaging system that visualizes the inside of the body, not a test performed on a sample taken from the body.
- Input Modality: The input modality is Magnetic Resonance Imaging, which is an in-vivo imaging technique, not an in-vitro diagnostic method.
The device is a component of an MRI system used for diagnostic imaging, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Shoulder is a receive-only phased array 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 Shoulder Coil is designed for use with the Rhapsody (1.0Tesla) MRI scanner manufactured by Siemens Medical Systems Inc.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Shoulder Coil consists of two volume RF coil elements in a quadrature design. The elements and associated circuitry are enclosed in a flexible vinyl enclosure housing.
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
Kol 35 41
DEC 1 4 2001
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | 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 Shoulder is a receive-only phased array 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 | |
| Shoulder Coil is designed for use with the Rhapsody | |
| (1.0Tesla) MRI scanner manufactured by Siemens | |
| Medical Systems Inc. | |
| 8. Device Description : | The Shoulder Coil consists of two volume RF coil |
| elements in a quadrature design. The elements and | |
| associated circuitry are enclosed in a flexible vinyl | |
| enclosure housing. |
:
:
.........
1
9. Safety and Effectiveness
| Shoulder Coil Product Features | Comparison to Predicate Device or other 510(k)
Cleared Product |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Shoulder imaging applications | -Similar to Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143)
- Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
| Indications for Use
Identical to routine MRI imaging | -Similar to Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143) - Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
| Coil Enclosure Material
Vinyl coated PVC Foam
Delrin Acetyl
Polyurethane Plastic | -Similar to Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143)
-Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
| Coil Design
Two channel receive-only phased array
coil | -Similar to Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143) - Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
| Decoupling
Switching diode decoupling | -Similar to Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143)
-Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
| 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 Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143)
-Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
| 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 Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143)
-Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
| 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 Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143) - Similar to Phased Array Shoulder Coil
manufactured by Medical Advances Inc. (K945778) |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
Mr. Rony Thomas Vice President, Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K013541 Trade/Device Name: Shoulder Coil MRI Specialty Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 24, 2001 Received: October 24, 2001
Dear Mr. Thomas:
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 (OS) 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. Snogdin
Nancy 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):_____________________________________________________________________________________________________________________________________________________
Device Name: Shoulder Coil
Indications for Use: The Shoulder Coil is a receive-only phased array RF coil, indications for OSC. The Shoulder and surrounding regions in used for obtaining diagnooils imaging systems. The Shoulder Coil is designed for use Magnetic Hesonanoe Imaging Syother manufactured by Siemens Medical Systems, Inc.
Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody system is indicated for use as an NMR device that rno Olonions images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, 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) OR Over-The-Counter Use Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproduction, Assistant,
and Radiological Devices
510(k) Number: KM3544