(49 days)
Not Found
No
The device description and intended use clearly define it as a passive RF coil for MRI, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is used for obtaining diagnostic images for diagnosis, not for treating a condition or disease.
No
The device is a receive-only coil used to obtain images for an MRI system. It does not interpret images or provide a diagnosis itself, but rather aids in acquiring the images that a trained physician then interprets to make a diagnosis.
No
The device description clearly describes a physical RF coil with a rigid enclosure, coil elements, and accessory electronics, indicating it is a hardware device, not software-only.
Based on the provided information, the Alpha 5000 Wrist Coil is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Alpha 5000 Function: The Alpha 5000 Wrist Coil is a component of an MRI system. It is used to receive signals from the patient's body during an MRI scan to create images. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for obtaining diagnostic images of the wrist and hand in Magnetic Resonance Imaging Systems. The images are then interpreted by a trained physician.
Therefore, the Alpha 5000 Wrist Coil is a medical device used for imaging, not an IVD device used for analyzing specimens.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
wrist and hand
Head and whole body (for the 0.35T MRI system)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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
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 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 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. | |
| 8. Device Description: | 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. |
Please turn over
1
9. Safety and Effectiveness
| Alpha 5000 Wrist Coil Product
Features | Comparison to predicate device or other 510(k)
cleared products |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the wrist and
hand. | -Similar to the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (K972205) |
| Indications for Use: Identical to routine
MRI imaging. | -Similar to the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (K972205) |
| Coil Enclosure Material:
Flame Retardant Polyurethane
Flame Retardant Polycarbonate
Kydex Acyrlic/PVC
Delrin | -Similar to the Hi-Res 9000 Phased Array Carotid
Coil manufactured by USA Instruments, Inc.
(K001210) |
| Coil Design: 2 element saddle receive-
only quadrature coil. | -Similar to the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (K972205) |
| Decoupling: Switching diode
decoupling. | -Similar to the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (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 the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (K972205) |
| Radio Frequency Absorption: Coil is a
receive only coil and does not transmit
RF power. | -Similar to the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (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 the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (K972205) |
2
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.
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 Brogdon
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): 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