(88 days)
No
The document describes a passive MRI coil and does not mention any software or algorithms that would incorporate AI/ML.
No
The device is described as a diagnostic tool used to obtain images for determining a diagnosis, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "used for obtaining diagnostic images and spectra" and that the images "provide information that can be useful in the determination of the diagnosis."
No
The device description explicitly states it is a "12 element quadrature, transmit/receive coil" with "Coil elements and associated circuitry enclosed in a rigid former," indicating it is a physical hardware component used in MRI.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body. They perform tests in vitro (outside the body) to provide information about a person's health.
- This device is an MRI coil. MRI coils are external components used with an MRI scanner to generate and receive radiofrequency signals. They are used to create images of the body in vivo (within the body).
- The intended use clearly states it's for obtaining diagnostic images and spectra of the infant head and body. This is a function of an imaging device, not an IVD.
- The device description details the physical characteristics of an MRI coil.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Neonate (Head, Body) Coil is a quadrature transmit/receive coil used for obtaining diagnostic images and spectra of the (pre- and term) infant head in 1,5 and 3,0 Tesla General Electric, Siemens Medical Solutions and Philips Medical Systems' Magnetic Resonance Imaging (MRI) scanners and magnetic resonance compatible incubator systems. Indications for use are same as that for standard MR imaging.
The Neonate Coils when used in conjunction with the MRI systems or Neonate coils when used with the MRI compatible incubator and in conjunction with the MRI systems provide imaging of the infant head and body (torso). When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Product codes
90 MOS
Device Description
The Neonate (Head, Body) Coil is a 12 element quadrature, transmit/receive coil. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The coil design facilitates scanning of pre-term and term newborn babies with different head and body sizes and maximizes comfort and ease of use.
Neonate Head Coil for GE, Siemens and Philips 3.0T Neonate Head and Body Coils for Philips 1.5T
3.0T Philips T/R Head Coil 3.0T Siemens T/R Head and Knee Coils (manufactured by [formerly USA Instruments], GE Medical, Aurora, OH) 1.5T Neonate Body Coil (K023929) In general, Neonate Coils are similar to Advanced Imaging Research's FDA cleared 1.5T T/R Neonate (Head, Body) Coils in all aspects (K023929), as follows:
Intended use - Proton 1H 1D, 2D, 3D T1, T2 weighting, proton density, chemical shift, diffusion weighted imaging, angiography, functional MRI, chemical shift imaging, spectroscopy
Coil Enclosure Material - Polycarbonate, polyurethane plastic .. Coil Design - 12 element, quadrature transmit/receive design Transmit/Receive Switching - Fast active pin-diode circuitry Prevention of RF Burns - Transmit and receive channels are isolated with pin-diodes; coil elements and associated circuitry are enclosed in plastic housing Radio-Frequency Absorption - Radio-frequency power deposition is limited in the coil specific file embedded in the MRI and by SAR algorithm of the MRI scanner Formation of Resonance Loops - Active diodes and RF fuses isolate the coil elements from whole body RF coil transmit; length and routing of output cable does not permit looping
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
infant head, infant body (torso)
Indicated Patient Age Range
pre- and term infant
Intended User / Care Setting
trained physician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to demonstrate that the 3.0 T Neonate Head Coils meet the predetermined acceptance criteria
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The characters are 'K083541'.
FEB 2 4 2009
- Manufacturer : Advanced Imaging Research, Inc. 4700 Lakeside Avenue, Suite 400 (Physical Location) Cleveland, OHIO 44114 PO Box 603220 (Use for Correspondence) Cleveland, OHIO 44103 1262 E 49th Street, Suite 400 (Courier Address) Cleveland, OHIO 44114 Phone: 216-426-1461 216-426-1180 Fax: 2. Registration Number: 3004036149 3. Contact: Ravi Srinivasan, President Phone: 216-426-1461 Fax: 216-426-1180 email: ravi(@advimg.com 4. Device Name: Magnetic Resonance Diagnostic Device Proprietary Name: Neonate Head Coil, Neonate Body Coil ડી Type of Submission: Traditional 6. Classification of Device: 21CFR 892.1000 Class of Device: Class II Product Code; 90 MOS (Magnetic Resonance Specialty Coil) 7. Intended Use: The Neonate (Head, Body) Coil is a quadrature transmit/receive coil used for obtaining diagnostic images and spectra of the (pre- and term) infant head in 1,5 and 3,0 Tesla General Electric, Siemens Medical Solutions and Philips Medical Systems' Magnetic Resonance Imaging (MRI) scanners and magnetic resonance compatible incubator systems. Indications for use are same as that for standard MR imaging.
-
- Device Description:
The Neonate (Head, Body) Coil is a 12 element quadrature,
- Device Description:
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1
p.4
transmit/receive coil. Coil elements and associated circuitry are enclosed in a rigid former to prevent any exposure to patient or environment. The coil design facilitates scanning of pre-term and term newborn babies with different head and body sizes and maximizes comfort and ease of use.
Neonate Head Coil for GE, Siemens and Philips 3.0T Neonate Head and Body Coils for Philips 1.5T
3.0T Philips T/R Head Coil 3.0T Siemens T/R Head and Knee Coils (manufactured by [formerly USA Instruments], GE Medical, Aurora, OH) 1.5T Neonate Body Coil (K023929)
In general, Neonate Coils are similar to Advanced Imaging Research's FDA cleared 1.5T T/R Neonate (Head, Body) Coils in all aspects (K023929), as follows:
Intended use - Proton 1H 1D, 2D, 3D T1, T2 weighting, proton density, chemical shift, diffusion weighted imaging, angiography, functional MRI, chemical shift imaging, spectroscopy
Indications for Use - The Neonate Coils when used in conjunction with the MRI systems or Neonate coils when used with the MRI compatible incubator and in conjunction with the MRI systems provide imaging of the infant head and body (torso). When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Coil Enclosure Material - Polycarbonate, polyurethane plastic ..
Coil Design - 12 element, quadrature transmit/receive design
Transmit/Receive Switching - Fast active pin-diode circuitry
Prevention of RF Burns - Transmit and receive channels are isolated with pin-diodes; coil elements and associated circuitry are enclosed in plastic housing
Radio-Frequency Absorption - Radio-frequency power deposition is limited in the coil specific file embedded in the MRI and by SAR algorithm of the MRI scanner
ਹੈ. Marketed Device:
Comparison to Predicate:
2
Formation of Resonance Loops - Active diodes and RF fuses isolate the coil elements from whole body RF coil transmit; length and routing of output cable does not permit looping
- Summary of Studies:
Testing was performed to demonstrate that the 3.0 T Neonate Head Coils meet the predetermined acceptance criteria
Conclusion:
It is the opinion of Advanced Imaging Research that the Neonate (Head, Body) Coils herein are substantially equivalent to Advanced Imaging Research's Neonate (Head, Body) Coils (K023929). Testing and usage of the 3.0T Neonate Coils does not result in any new potential hazards.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 9 4 2009
Mr. Ravi Srinivasan, M.S. President Advanced Imaging Research, Inc. 4700 Lakeside Avenue, Suite 400 CLEVELAND OH 44114-3834
Re: K083541
Trade/Device Name: Neonate Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 21, 2008 Received: January 15, 2009
Dear Mr. Srinivasan:
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 such 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.
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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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K083541
Device Name: _________________________________________________________________________________________________________________________________________________________________ Neonate Coils
Indications For Use;
The Neonate Colls when used in conjunction with the MRI systems or Neonate colls when used with the MRI compatible incubator and in conjunction with the MRI systems provide imaging of the infant head and body (torso). When interpreted by a trained physician, these images provide Information that can be useful in the determination of the diagnosis.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) :
Concurrence of ODRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number J
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