(51 days)
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. 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.
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.
The provided text is a 510(k) summary for a Magnetic Resonance Imaging (MRI) Shoulder Coil. It does not describe a study involving "acceptance criteria" and "reported device performance" in the way one would for a new AI/software device that needs performance metrics like sensitivity, specificity, etc. This document is a premarket notification for a physical medical device (an MRI coil) based on substantial equivalence to predicate devices, not a study proving effectiveness with specific performance criteria against a ground truth.
Therefore, many of the requested fields are not applicable to this type of submission. However, I will extract the relevant comparative information provided.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence for a physical medical device (MRI coil), there are no explicit "acceptance criteria" in terms of performance metrics commonly associated with AI/software devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the features and intended use being similar or identical to legally marketed predicate devices. The "reported device performance" is the assertion of these similarities.
| Feature / Criteria (Implied) | Reported Device "Performance" (Comparison to Predicate) |
|---|---|
| Intended Use | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Indications for Use | Identical to routine MRI imaging; Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Coil Enclosure Material | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Coil Design | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Decoupling | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Prevention of RF Burns | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Radio Frequency Absorption | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
| Formation of Resonant Loop | Similar to Mark 5000 Phased Array Shoulder Coil (K983143) and Phased Array Shoulder Coil (K945778) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study with a "test set" of data in the context of an AI/software device. The submission focuses on technical and functional equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" derived from expert consensus on a test set (e.g., image annotations) is discussed for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an MRI coil, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices, and the demonstration that the new device shares similar characteristics and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/software device.
9. How the ground truth for the training set was established
Not applicable.
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Kol 35 41
DEC 1 4 2001
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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, USATelephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Shoulder is a receive-only phased array RF coil,used for obtaining diagnostic images of theshoulder and adjacent regions in MagneticResonance Imaging systems. The indications foruse are the same as for standard MR Imaging. TheShoulder Coil is designed for use with the Rhapsody(1.0Tesla) MRI scanner manufactured by SiemensMedical Systems Inc. |
| 8. Device Description : | The Shoulder Coil consists of two volume RF coilelements in a quadrature design. The elements andassociated circuitry are enclosed in a flexible vinylenclosure housing. |
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9. Safety and Effectiveness
| Shoulder Coil Product Features | Comparison to Predicate Device or other 510(k)Cleared Product |
|---|---|
| Intended UseShoulder imaging applications | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)- Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
| Indications for UseIdentical to routine MRI imaging | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)- Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
| Coil Enclosure MaterialVinyl coated PVC FoamDelrin AcetylPolyurethane Plastic | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)-Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
| Coil DesignTwo channel receive-only phased arraycoil | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)- Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
| DecouplingSwitching diode decoupling | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)-Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
| Prevention of RF BurnsDoes not transmit RF power; decouplingisolates the coil elements from RF fieldsduring RF transmission; coil elementsand circuitry are enclosed in a non-conductive housing. | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)-Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
| Radio Frequency AbsorptionCoil is a receive only coil and does nottransmit RF power; power depositionduring imaging is limitedby SARalgorithm | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)-Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
| Formation of Resonant LoopDecoupling isolates the coil elementsfrom RF fields during RF transmission:length of cable and stiffness does notpermit looping | -Similar to Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143)- Similar to Phased Array Shoulder Coilmanufactured by Medical Advances Inc. (K945778) |
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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.
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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
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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
§ 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.