(51 days)
The Crystal 5000 Phased Array TMJ Coil is a receive-only phased array RF coil used for obtaining diagnostic images of the temporo-mandibular joint, condyle, and mandible in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Proview™ (0.23Tesla) MRI scanner manufactured by Marconi Medical Systems Finland.
The Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner.
The indications for use are the same as for standard imaging:
The Marconi Medical Systems Proview 0.23Tesla system is indicated for use as a diagnostic imaging device that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton 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.
The Crystal 5000 Phased Array TMJ Coil is a phased array receive only coil. The elements and associated circuitry are enclosed in housing made of plastic materials, which are fire rated and have high impact and tensile strength.
The provided document is a 510(k) premarket notification for a medical device cleared in 2001. This type of regulatory submission, particularly for
a device developed at this time, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in efficacy studies for newer, more complex devices
or AI/ML-driven technologies.
Therefore, many of the requested items (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies,
standalone performance) are not applicable to this type of submission. The safety and effectiveness are established through comparison to a predicate device.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
The "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to existing predicate devices. The
performance is described by comparing the features of the Crystal 5000 Phased Array TMJ Coil to these predicates.
| Feature / Acceptance Criteria (demonstration of substantial equivalence) | Reported Device Performance (as compared to predicate) |
|---|---|
| Intended Use: Imaging of the temporo-mandibular joint, condyle, and mandible. | Similar to 405GE-64 Phased Array TMJ Coil manufactured by IGC Medical Advances (K944773) Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Indications for Use: Identical to routine MRI imaging. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Coil Enclosure Material: PVC Plastic Alloy, Polyurethane. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Coil Design: Receive-only phased array coil. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Decoupling: Switching Diode decoupling. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| 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 Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Radio Frequency Absorption: Coil is a receive-only coil and does not transmit RF power. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| 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 Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
Study Details:
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new clinical study with a test set of patient data to evaluate performance. The comparison is feature-based against existing cleared devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There was no specific "test set" in the context of diagnostic performance evaluation for which ground truth needed to be established by experts.
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Adjudication method for the test set: Not applicable. No test set was used in this manner.
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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 a passive MRI accessory (a coil), not an AI-driven image analysis tool. It does not involve human readers interpreting images with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an MRI coil, not an algorithm.
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The type of ground truth used: The "ground truth" for this type of submission is implicitly the established safety and effectiveness of the predicate devices. The new device is shown to be substantially equivalent in its design and function to these already-cleared devices, implying a similar safety and performance profile.
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The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established: Not applicable.
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KO i 3528
DEC 1 3 2001
SUMMARY OF SAFETY AND EFFECTIVENESS DEC : 2 2001
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Crystal 5000 Phased Array TMJ 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 Crystal 5000 Phased Array TMJ Coil is areceive-only phased array RF coil used for obtainingdiagnostic images of the temporo-mandibular joint,condyle, and mandible in Magnetic ResonanceImaging systems. The indications for use are thesame as for standard MR Imaging. The Crystal 5000Phased Array TMJ Coil is designed for use with theProview™ (0.23Tesla) MRI scanner manufactured byMarconi Medical Systems Finland. |
| 8. Device Description : | The Crystal 5000 Phased Array TMJ Coil is aphased array receive only coil. The elements andassociated circuitry are enclosed in housing made ofplastic materials, which are fire rated and have highimpact and tensile strength. |
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9. Safety and Effectiveness
| Crystal 5000 Phased Array TMJ CoilProduct Features | Comparison to predicate or other 510(k) clearedproducts |
|---|---|
| Intended Use:Imaging of the temporo-mandibularjoint, condyle, and mandible. | - Similar to 405GE-64 Phased Array TMJ Coilmanufactured by IGC Medical Advances (K944773)-Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
| Indications for Use:Identical to routine MRI imaging | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
| Coil Enclosure Material:PVC Plastic AlloyPolyurethane | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
| Coil Design:Receive-only phased array coil | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
| Decoupling:Switching Diode decoupling | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
| Prevention of RF Burns: Does nottransmit RF Power, Decoupling isolatesthe coil elements from RF fields duringRF transmission, Coil elements andcircuitry are enclosed in a non-conductive housing. | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
| Radio Frequency Absorption:Coil is a receive only coil and does nottransmit RF power. | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
| Formation of Resonant Loop:Decoupling isolates the coil elementsfrom RF fields during RF transmission,Length of cable and stiffness does notpermit looping | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments (K001210) |
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Mr. Rony Thomas Vice President, Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K013528 Trade/Device Name: Crystal 5000 Phased Array TMJ Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 19, 2001 Received: October 23, 2001
Dear Mr. Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated 776, 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 general controls profice, 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 r rouse of active made a determination that your device complies with other requirements of the Act the r Drileral 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.
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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 noutication. The I Dri incing of succian 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 IT you desire spooline active 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 Additionally, for questions on any persons. Also, please note the regulation entitled, "Misbranding Other of Ochipmanted and (2007) Cation" (21 CFR Part 807.97). Other general information on by relected to promation the Act may be obtained from the Division of Small Manufacturers, your responsionnes and Consumer at its toll-free number (800) 638-2041 or (301) 443-6597 nternet.onal and Ocess http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
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: Crystal 5000 Phased Array TMJ Coil
Indications for Use: The Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The provide Magnetic Freemay TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner.
Anatomic Regions: Temporo-mandibular Joint Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Marconi Medical Systems Proview 0.23Tesla system is indicated for use as I no Maroni Modical eye that: (1) correspond to the distribution of arr NMR exhibiting NMR signal, (2) depend upon NMR parameters (proton provide online relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted display the bon 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) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | ✓ OR Over-The-Counter Use (Optional Format 1-2-96) |
| (Division Sign-Off) | Nancy Brogdon |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K08528 |
§ 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.