(56 days)
Not Found
No
The description focuses on the physical design and function of an MRI coil, with no mention of AI or ML for image processing, analysis, or any other function.
No
The device is described as a receive-only phased array RF coil used for obtaining diagnostic images for MRI, which assists in diagnosis and does not provide therapeutic treatment.
No
Explanation: The device is an RF coil used in Magnetic Resonance Imaging Systems to obtain images. It produces images that, when interpreted by a trained physician, can be useful in the determination of a diagnosis, but the device itself does not make the diagnosis.
No
The device description explicitly states it is a "multi-element phased array receive-only coil" with "elements and associated circuitry enclosed in a housing made of plastic materials." This describes a physical hardware component, not a software-only device.
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 for diagnosis, monitoring, or screening.
- Device Function: The CTL Body / Spine Array Coil is a component of an MRI system. It's a receive-only coil that helps acquire images of the spine within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to obtain diagnostic images of the spine using Magnetic Resonance Imaging. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) diagnostic test.
The device is clearly described as a component of an MRI system used for imaging the spine directly in the patient. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CTL Body / Spine Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The CTL Body / Spine Coil is designed for use with Array the Rhapsody™1.0T MRI scanner manufactured by Siemens Medical Systems.
The CTL Body / Spine Array Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The CTL Body / Spine Array Coil is designed for use with the Siemens Rhapsody™ 1.0Tesla scanner.
Anatomic Regions: Spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody™ 1.0Tesla 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 vield 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 CTL Body Spine Array Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has a removable anterior section for imaging the anterior cervical region. The coil also has three bridges consisting of coil elements for enhanced imaging of the thoracic and lumbar spine. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have 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
spine region (cervical, thoracic and lumbar anatomy), spine anatomy, head and whole body
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
FEB 0 5 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
Kol4086
-
- Device Name :
- Classification :
Magnetic Resonance Imaging Accessory
CTL Body / Spine Array Coil
- Proprietary Name :
Class II
-
Establishment Registration #:
-
Manufacture Facility Location:
-
- Performance Standard:
- Intended Use:
- 1529041 USA Instruments, Inc 1515 Danner Drive
Aurora, Ohio 44202, USA Telephone: 330-562-1000; Fax: 330-562-1422.
No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
The CTL Body / Spine Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The CTL Body / Spine Coil is designed for use with Array the Rhapsody™1.0T MRI scanner manufactured by Siemens Medical Systems.
-
- Device Description: The CTL Body Spine Array Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has a removable anterior section for imaging the anterior cervical region. The coil also has three bridges consisting of coil elements for enhanced imaging of the thoracic and lumbar spine. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.
1
9. Safety and Effectiveness
.....
| CTL Body / Spine Array Coil Product
Features | Comparison to predicate device or other 510(k)
cleared product |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the spine. | -Similar to the Premier 7000 C/T/L Spine Coil
manufacture by USA Instruments, Inc. (K980157)
-Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| Indications for Use: Identical to routine
MRI imaging | -Similar to the Premier 7000 C/T/L Spine Coil
manufacture by USA Instruments, Inc. (K980157)
-Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| Coil Material:
Polyurethane Plastic
Polycarbonate Plastic | -Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| Coil Design: Receive-only phased array
design | -Similar to the Premier 7000 C/T/L Spine Coil
manufacture by USA Instruments, Inc. (K980157)
-Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| Decoupling: RF Chokes with Switching
Diodes | -Similar to the Premier 7000 C/T/L Spine Coil
manufacture by USA Instruments, Inc. (K980157)
-Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| 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 Premier 7000 C/T/L Spine Coil
manufacture by USA Instruments, Inc. (K980157)
-Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| Radio Frequency Absorption: Coil is a
receive only coil and does not transmit
RF power | -Similar to the Premier 7000 C/T/L Spine Coil
manufacture by USA Instruments, Inc. (K980157)
-Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
| Formation of Resonant Loops:
Decoupling isolates coil elements from
RF fields during RF transmission. Length
of cable and stiffness
does not permit looping | -Similar to the Premier 7000 C/T/L Spine Coil
manufacture by USA Instruments, Inc. (K980157)
-Similar to the Magna 5000 CTL Spine Coil
manufactured by USA Instruments, Inc. (K994345) |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three overlapping human profiles, which are meant to represent the department's mission of protecting the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2002
Mr. Rony Thomas Vice President USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K014086
Trade/Device Name: CTL Body/Spine Array Coil MRI Specialty Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: December 7, 2001 Received: December 11, 2001
Dear Mr. Thomas:
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 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):____________________________________________________________________________________________________________________________________________________
Device Name: CTL Body / Spine Array Coil
Indications for Use: The CTL Body / Spine Array Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The CTL Body / Spine Array Coil is designed for use with the Siemens Rhapsody™ 1.0Tesla scanner.
Anatomic Regions: Spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody™ 1.0Tesla 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 vield 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) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, and Radiological Devices | ||
| 510(k) Number | K014086 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|