(78 days)
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.
The Mark 5000 Quadrature Shoulder Coil is a receive-only quadrature RF Coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Quadrature Shoulder Coil is designed for use with the Toshiba Opart 0.35Tesla MRI system manufactured by Toshiba Medical Systems, Inc.
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 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.
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.
The provided text describes a 510(k) premarket notification for the Mark 5000 Quadrature Shoulder Coil, a Magnetic Resonance Imaging Accessory. This submission focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.
Therefore, many of the requested sections (including specific acceptance criteria, test results, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance) are not detailed in this document. The submission primarily relies on direct comparison to existing devices to demonstrate safety and effectiveness.
Here's a breakdown of the information that can be extracted or deduced from the provided text, along with a clarification for unavailable information:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Implied) Reported Device Performance Safety: 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."- Compared to similar features in predicate devices (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."- Compared to similar features in predicate devices (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."- Compared to similar features in predicate devices (K893143). Effectiveness/Functionality: Intended Use "Shoulder imaging applications" - Similar to Mark 5000 Phased Array Shoulder Coil (K893143) and Quadrature Shoulder Coil by Hitachi (K992650). Indications for Use "Identical to routine MRI imaging" - Similar to Mark 5000 Phased Array Shoulder Coil (K893143). Coil Design "Receive-only Quadrature design" - Similar to Quadrature Shoulder Coil by Hitachi (K992650). Decoupling "Switching diode decoupling" - Similar to Mark 5000 Shoulder Coil (K893143). Compatibility Designed for use with the Opart 0.35 Tesla MRI scanner manufactured by Toshiba Medical Systems Inc. (Implied acceptance criterion based on the product's design and stated intended use in conjunction with this specific scanner.) - This is a functional specification rather than a performance claim to be proven by a study in this document. Note: The "acceptance criteria" above are inferred from the safety and effectiveness comparisons made to predicate devices. The document does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics from a study.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document relies on comparison to predicate devices and general design principles rather than a clinical performance study with a test set of images or patients.
- Data Provenance: Not applicable, as no specific test set data is presented.
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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. No ground truth establishment for a test set is described.
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Adjudication method for the test set:
- Not applicable. No test set or adjudication process is described.
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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:
- No MRMC comparative effectiveness study was done. This device is an MRI accessory (a coil), not an AI-based image analysis tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an MRI coil, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The submission focuses on device design, safety features, and functional equivalence to predicate devices, not on diagnostic accuracy based on ground truth data.
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The sample size for the training set:
- Not applicable. This is an MRI accessory (coil), not an AI-based system requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of the Study (or lack thereof) to Prove Device Meets Acceptance Criteria:
The provided document is a 510(k) premarket notification, which establishes substantial equivalence for a medical device. For this device (Mark 5000 Quadrature Shoulder Coil), the "study" to prove it meets acceptance criteria primarily consists of comparison to legally marketed predicate devices. The manufacturer asserts that the new device is as safe and effective as the predicates by demonstrating similarities in:
- Intended Use and Indications for Use: Stated to be identical or similar to predicate devices (K893143, K992650).
- Design Characteristics: Such as coil enclosure material, coil design (receive-only quadrature), and decoupling mechanism, which are compared to predicates (K893143, K992650).
- Safety Features: Explaining how it prevents RF burns, manages RF absorption, and avoids resonant loop formation, drawing parallels to the established safety of predicate devices (K893143).
The FDA's determination of substantial equivalence (K013854) means they agreed that the device is as safe and effective as the predicate devices, thereby permitting it to be marketed. This regulatory pathway does not typically require new clinical or performance studies demonstrating discrete acceptance criteria, but rather a robust comparison to products already proven safe and effective.
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FEB 0 6 2002
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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, 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 Mark 5000 Quadrature Shoulder Coil is areceive-only specialty RF coil, used for obtainingdiagnostic images of the shoulder and adjacentregions in Magnetic Resonance Imaging systems.The indications for use are the same as for standardMR Imaging. The Mark 5000 Quadrature Coil isdesigned for use with the Opart 0.35 Tesla MRIscanner manufactured by Toshiba Medical SystemsInc. |
| 8. Device Description : | The Mark 5000 Quadrature Shoulder Coil consistsof two RF coil elements in a quadrature design. Thecoil elements and associated circuitry are enclosedto prevent any exposure to the patient orenvironment. The coil electronics are enclosed inboth the rigid housing and the vinyl coated PVCfoam. The coil is positioned on the patient's shoulderduring imaging. |
Mark 5000
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9. Safety and Effectiveness:
| Mark 5000 Quadrature Shoulder CoilProduct Features | Comparison to Predicate or other 510(k) clearedproducts |
|---|---|
| Intended UseShoulder imaging applications | -Similar to the Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments Inc. (K893143)-Similar to the Quadrature Shoulder Coil manufacturedby Hitachi Medical Systems America (K992650) |
| Indications for UseIdentical to routine MRI imaging | -Similar to the Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments Inc. (K893143) |
| Coil Enclosure MaterialVinyl coated EVA foamPolyurethane Plastic | -Similar to the Quadrature Shoulder Coil manufacturedby Hitachi Medical Systems America (K992650)-Similar to the Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments Inc. (K893143) |
| Coil DesignReceive-only Quadrature design | -Similar to the Quadrature Shoulder Coil manufacturedby Hitachi Medical Systems America (K992650) |
| DecouplingSwitching diode decoupling | -Similar to the Mark 5000 Shoulder Coil manufacturedby USA Instruments Inc. (K893143) |
| Prevention of RF BurnsDoes not transmit RF power;decoupling isolates the coil elementsfrom RF fields during RF transmission;coil elements and circuitry areenclosed in a non-conductive housing. | -Similar to the Mark 5000 Shoulder Coil manufacturedby USA Instruments Inc. (K893143) |
| Radio Frequency AbsorptionCoil is a receive only coil and does nottransmit RF power; power depositionduring imaging is limited by SARalgorithm | -Similar to the Mark 5000 Shoulder Coil manufacturedby USA Instruments Inc. (K893143) |
| Formation of Resonant LoopDecoupling isolates the coil elementsfrom RF fields during RF transmission;length of cable and stiffness does notpermit looping | -Similar to the Mark 5000 Shoulder Coil manufacturedby USA Instruments Inc. (K893143) |
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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" 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.
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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. Brogdon
Nancv 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):_ 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) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 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.