(66 days)
No
The summary describes a modification to a flexible coil for MRI, focusing on hardware changes and performance metrics related to image quality (uniformity, SNR). There is no mention of AI, ML, image processing algorithms, or data sets typically associated with AI/ML development.
No.
The device is used for Magnetic Resonance Imaging, which is a diagnostic imaging technique, not a therapeutic one. The description focuses on image acquisition and quality for diagnosis.
Yes
The device is a flexible coil for Magnetic Resonance Imaging, which is an imaging modality used for diagnostic purposes of small extremity joints.
No
The device description explicitly states the modification is the addition of a "flexible coil," which is a hardware component used in MRI.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: This device is a flexible coil for Magnetic Resonance Imaging (MRI). MRI is an imaging technique that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve the examination of specimens taken from the body.
- Intended Use: The intended use is "Magnetic Resonance Imaging of small extremity joints." This clearly describes an imaging procedure performed directly on the patient, not on a specimen.
Therefore, based on the provided information, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Magnetic Resonance Imaging of small extremity joints.
Product codes
90 MOS
Device Description
The modification is the addition of a flexible coil to image the elbow, hand, ankle, foot, and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (K944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
elbow, hand, ankle, foot, and other small extremity joints.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The Elscint 0.5T and 2T Flex Coils have acceptable uniformity and higher SNR than the Shoulder Coil. The images produced by the Flex Coils are better than those produced using the Shoulder Coils on the same systems.
Key Metrics
Not Found
Predicate Device(s)
K945791, K954039, K962618, K944331
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SUMMARY OF SAFETY AND EFFECTIVENESS
- Device Name: Flex Coil for the Prestige, Privilege, and Gyrex V-EP.
1.2 Classification Name: Magnetic Resonance Diagnostic Device
1.3 Submitter: Elscint, Inc., 505 Main St., Hackensack, NJ 07601
1.4 510(k) Number:____________________________________________________________________________________________________________________________________________________________ SEP 1 5 127
- Device Modification Description
The modification is the addition of a flexible coil to image the elbow, hand, ankle, foot, and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (K944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems.
- Predicate Devices: The predicate devices are the 2T Prestige (K945791), Privilege (K954039), and Gyrex V-EP (K962618) systems with their shoulder coils, and the General Purspose Flex Coil (K944331).
4. Safety
- The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, do not apply to . passive coils.
- Electric shock hazards are avoided by enclosures designed to comply with clause . 16 of the IEC-601-1 safety standard.
- Rough surfaces and sharp corners and edges which may cause injury or damage . are avoided by design according to clause 23 of the IEC-601-1 standard.
- . The coil enclosures and protective covers are flame rated better than CPAI-84.
- . No software modifications have been made.
- . All of the patient contacting materials are identical to those used in the predicate Flexible Coil (K944331).
- The current modifications do not affect the site planning, installation, or service . manuals, and do not require any new safety labeling.
5. Effectiveness
The Elscint 0.5T and 2T Flex Coils have acceptable uniformity and higher SNR than the Shoulder Coil. The images produced by the Flex Coils are better than those produced using the Shoulder Coils on the same systems.
6. Substantial Equivalency Statement
Based on the above, it is Elscint's opinion that the 2T-Prestige, Privilege, and Gyrex V-EP systems with their new Flex Coils are substantially, equivalent to the predicate devices in terms of safetv and effectiveness.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, suggesting movement or flight. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1997
Benv Sherer Safety Officer Elscint, Inc. 505 Main Street Hackensack, NJ 07601 K972592 Flex Coil for Gyrex 0.5T and 2.0T MRI System Dated: July 10, 1997 Received: July 11, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Sherer:
We have reviewed your Section SI0(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
W. Liao Yu
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page ____ of ____ of__________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Flex Coil for Gyrex 0.5T and 2T Systems Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Magnetic Resonance Imaging of small extremity joints.
(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, ENT, and Radiological Devices | |
| 510(k) Number | K972592 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use _______ (Optional Format 1-2-96) |