(16 days)
No
The document describes a passive RF coil for MRI, which is a hardware component for signal acquisition, not a software or processing device that would typically incorporate AI/ML. There are no mentions of AI, ML, or image processing algorithms.
No
The device is described as a receive-only RF coil used for obtaining diagnostic images, which are then used by a trained physician to determine a diagnosis. It does not provide any treatment or therapy.
Yes
The device obtains "diagnostic images" and the images "yield information that can be useful in the determination of a diagnosis" when interpreted by a trained physician, indicating its role in the diagnostic process.
No
The device description explicitly states it is a "receive-only, quadrature phased array RF coil" with "elements and associated circuitry enclosed in a semi-flexible housing," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pelvic Array Coil is an accessory for an MRI system. Its function is to receive radiofrequency signals from the body during an MRI scan to create diagnostic images. It does not analyze samples taken from the body.
- Intended Use: The intended use is to obtain diagnostic images of the pelvis and hips using magnetic resonance imaging. This is an in vivo (within the living body) diagnostic procedure, not an in vitro one.
Therefore, the Pelvic Array Coil is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MRI system manufactured by GE Medical Systems.
Indications for Use: The Pelvic Array Coil is designed to provide Magnetic Resonance Images of the pelvis, including the hips. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MR scanner.
Anatomic Regions: pelvis, including the hips Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T 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
90 MOS
Device Description
The Pelvic Array Coil is a receive-only, quadrature phased array RF coil, used for obtaining diagnostic MR images of the pelvis, including the hips. The elements and associated circuitry are enclosed in a semi-flexible housing that 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
pelvis, including the hips
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
033753
DEC 1 7 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Pelvic Array Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., |
| 1515 Danner Drive | |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-995-8572; 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 Pelvic Array Coil is a receive only phased |
| array RF coil used for obtaining diagnostic images | |
| of the pelvis, including the hips, in magnetic | |
| resonance imaging systems. The Pelvic Array Coil | |
| is designed for use with the GE Signa 1.5T MRI | |
| system manufactured by GE Medical Systems. | |
| 8. Device Description: | The Pelvic Array Coil is a receive-only, quadrature |
| phased array RF coil, used for obtaining diagnostic | |
| MR images of the pelvis, including the hips. The | |
| elements and associated circuitry are enclosed in a | |
| semi-flexible housing that is fire rated and has a high | |
| impact and tensile strength. |
Please turn over
1
9. Safety and Effectiveness
| Insightec Pelvic Array Coil product
features | Comparison to predicate device or other 510(k)
cleared products |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the pelvis,
including the hips | -Similar to the Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209) |
| Indications for Use: Identical to routine
MRI imaging | -Similar to the Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209) |
| Coil Enclosure Material:
Delrin Acetal,
Flame Retardant PVC,
Flame Retardant Polyurethane
Vinyl Coated EVA Foam | -Similar to the Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209)
-Similar to the Mark 5000 Quadrature Shoulder Coil
manufactured by USA Instruments, Inc. (K013854) |
| Coil Design: Receive-only quadrature
phased array coil | -Similar to the Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209) |
| Decoupling: Switching diode decoupling | -Similar to the Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209) |
| 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 Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209) |
| Radio Frequency Absorption: Coil is a
receive only coil and does not transmit
RF power | -Similar to the Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209) |
| 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 Insight Plus 9000 Torso and Pelvis
Coil manufactured by USA Instruments, Inc.
(K001209) |
:
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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2003
Ms. Christie Shumaker Manager. OA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K033753
Trade/Device Name: Pelvic Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS
Dated: November 26, 2003 Received: December 1, 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, 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.
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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
Page 2
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Pelvic Array Coil
Indications for Use: The Pelvic Array Coil is designed to provide Magnetic Resonance Images of the pelvis, including the hips. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MR scanner.
Anatomic Regions: pelvis, including the hips Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T 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)
Rancy Borden
(Division Sign Division of Reproductive, and Radiological Devices 510(k) Number