(49 days)
The Alpha 5000 Wrist Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the wrist and hand in Magnetic Resonance Imaging Systems. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Alpha 5000 Wrist Coil is designed to provide Magnetic Resonance Images of the hand and wrist. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MR scanner manufactured by Toshiba Medical Systesm, Inc.
Anatomic Regions: Wrist and hand Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 0.35T MRI system is indicated for use as an NMR device that produces 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.
The Alpha 5000 Wrist Coil is a two element quadrature receive-only coil. The coil has a rigid enclosure with windows on top to facilitate patient handling. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The provided text describes a submission for a Magnetic Resonance Imaging Accessory, specifically the Alpha 5000 Wrist Coil. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with acceptance criteria and performance metrics for a novel AI device.
Therefore, many of the requested categories for AI/algorithm performance and study design are not applicable to this document. The submission explicitly states "No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act," indicating that formal acceptance criteria beyond substantial equivalence to existing devices were not required or provided.
Here's a breakdown of the relevant information from the provided text, and where information is not available:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the Alpha 5000 Wrist Coil in the way one would for an AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The reported "performance" focuses on shared design and functional characteristics with these predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (Alpha 5000 Wrist Coil) |
|---|---|
| Intended Use: Imaging of the wrist and hand. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| Indications for Use: Identical to routine MRI imaging. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| Coil Enclosure Material: Flame Retardant Polyurethane, Flame Retardant Polycarbonate, Kydex Acryclic/PVC, Delrin. | Similar to predicate device (Hi-Res 9000 Phased Array Carotid Coil, K001210) |
| Coil Design: 2 element saddle receive-only quadrature coil. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| Decoupling: Switching diode decoupling. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| 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 predicate device (Alpha 7000 Wrist Coil, K972205) |
| Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| 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 predicate device (Alpha 7000 Wrist Coil, K972205) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission for an MRI coil, not an AI or algorithm-driven device that would involve a test set of data samples. The evaluation is based on engineering design, materials, and functional equivalence to existing 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. There is no "test set" or "ground truth" establishment in the context of an AI/algorithm for this device. The evaluation relies on regulatory review of the device's characteristics against predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See #3.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. See #3.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it's not an AI or machine learning product.
9. How the ground truth for the training set was established
Not applicable. See #8.
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Ko31143
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Alpha 5000 Wrist Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.1515 Danner DriveAurora, 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 Alpha 5000 Wrist Coil is a receive-onlyquadrature RF coil, used for obtaining diagnosticimages of the wrist and hand in MagneticResonance Imaging Systems. The Alpha 5000 WristCoil is designed for use with the Toshiba OPART0.35T MRI system manufactured by ToshibaMedical Systems, Inc. The indications for use arethe same as for standard MR Imaging. |
| 8. Device Description: | The Alpha 5000 Wrist Coil is a two elementquadrature receive-only coil. The coil has a rigidenclosure with windows on top to facilitate patienthandling. The open, patient friendly design easespatient handling and positioning and maximizespatient comfort. The coil elements and accessoryelectronics are enclosed in a rigid plastic housing,which is fire rated and has a high impact and tensilestrength. |
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9. Safety and Effectiveness
| Alpha 5000 Wrist Coil ProductFeatures | Comparison to predicate device or other 510(k)cleared products |
|---|---|
| Intended Use: Imaging of the wrist andhand. | -Similar to the Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205) |
| Indications for Use: Identical to routineMRI imaging. | -Similar to the Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205) |
| Coil Enclosure Material:Flame Retardant PolyurethaneFlame Retardant PolycarbonateKydex Acyrlic/PVCDelrin | -Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments, Inc.(K001210) |
| Coil Design: 2 element saddle receive-only quadrature coil. | -Similar to the Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205) |
| Decoupling: Switching diodedecoupling. | -Similar to the Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205) |
| 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 Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205) |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power. | -Similar to the Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205) |
| 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 Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205) |
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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 symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2003
Ms. Christie Shumaker Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K031143
Trade/Device Name: Alpha 5000 Wrist Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 2, 2003 Received: April 18, 2003
Dear Ms. Shumaker:
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. Iisting 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
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): K031143
Device Name: Alpha 5000 Wrist Coil
Indications for Use: The Alpha 5000 Wrist Coil is designed to provide Magnetic Resonance Images of the hand and wrist. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MR scanner manufactured by Toshiba Medical Systesm, Inc.
Anatomic Regions: Wrist and hand Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 0.35T MRI system is indicated for use as an NMR device that produces 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)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
2031143
§ 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.