(70 days)
Not Found
No
The description focuses on the physical components and intended use of an RF coil for MRI, with no mention of AI or ML capabilities.
No.
The device is used to obtain diagnostic images and aid in diagnosis, not to treat a medical condition.
Yes
The "Intended Use / Indications for Use" states that the device is used to obtain "diagnostic images" and that the images "yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly details physical components made of polyurethane, fiberglass, and plastic alloy, indicating it is a hardware device (an RF coil) used in conjunction with an MRI system.
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 Extremity Coil is a component of an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to create diagnostic images. It does not perform any tests on biological samples.
- Intended Use: The intended use is to obtain diagnostic images of the knee and foot anatomy using MRI. This is an imaging procedure, not an in vitro test.
Therefore, the Extremity Coil falls under the category of a medical device used for imaging, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Extremity Coil is a specialty receive-only RF coil, used to obtain diagnostic images of the knee and foot anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Extremity Coil is designed for use with the Rhapsody 1.0T MRI Scanners manufactured by Siemens Medical Systems, Inc.
The Extremity Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the knee and foot in Magnetic Resonance Imaging systems. The Extremity Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI scanner manufactured by Siemens Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The Siemens Rhapsody 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
90 MOS
Device Description
The Extremity Coil package consists of a knee coil (two sizes: small and large ) and an attachable foot coil. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane , fiberglass, and ABS/PVC plastic alloy, which are fire rated and have high impact and tensile strength. The Knee Coil is mechanically split into two halves for easier coil handling and more accurate positioning of the patient's knee in the coil. The foot Coil is contoured to accommodate the foot and is mechanically attached to the knee coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
knee and foot, head and whole body
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)
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
Jan 8 2002
a provincia in the provincial provincial provincial provincial provincial provincial provincial provincial provincial provincial provincial provincial provincial provincial p
SUMMARY OF SAFETY AND EFFECTIVENESS
·
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Extremity 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 Extremity Coil is a specialty receive-only RF |
| coil, used to obtain diagnostic images of the knee | |
| and foot anatomy in Magnetic Resonance Imaging | |
| systems. The indications for use are the same as | |
| for standard MR Imaging. The Extremity Coil is | |
| designed for use with the Rhapsody 1.0T MRI | |
| Siemens Medical | |
| Scanners manufactured by | |
| Systems, Inc. | |
| 8. Device Description: | The Extremity Coil package consists of a knee coil |
| (two sizes: small and large ) and an attachable foot | |
| coil. The electrical circuitry is enclosed in a durable | |
| housing assembly made of polyurethane , fiberglass, | |
| and ABS/PVC plastic alloy, which are fire rated and | |
| have high impact and tensile strength. The Knee | |
| Coil is mechanically split into two halves for easier | |
| coil handling and more accurate positioning of the | |
| patient's knee in the coil. The foot Coil is contoured | |
| to accommodate the foot and is mechanically | |
| attached to the knee coil. |
:
:
1
9. Safety and Effectiveness
·
. ..........
.
12/11/2017
| Extremity Coil
Product Features | Comparison to predicate device or other 510(k)
cleared product |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:
Knee and Foot Imaging Applications | -Similar to the Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040)
-Similar to the Leo 7000 Quadrature Knee coil
manufactured by USA Instruments, Inc. (K971246) |
| Indications for Use
Identical to routine MRI imaging | -Similar to the Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040)
-Similar to the Leo 7000 Quadrature Knee coil
manufactured by USA Instruments, Inc. (K971246) |
| Coil Material
•
Flame retardant Polyurethane
ABS plastic alloy
Fiberglass | -Similar to the Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040) |
| Coil Design
Two channel receive only Phased
Array Design | -Similar to the Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040) |
| Decoupling
RF Chokes with Switching Diodes | -Similar to the Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040)
-Similar to the Leo 7000 Quadrature Knee coil
manufactured by USA Instruments, Inc. (K971246) |
| 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 Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040)
-Similar to the Leo 7000 Quadrature Knee coil
manufactured by USA Instruments, Inc. (K971246) |
| Radio Frequency Absorption
Coil is a receive only coil and does not
transmit RF power | -Similar to the Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040)
-Similar to the Leo 7000 Quadrature Knee coil
manufactured by USA Instruments, Inc. (K971246) |
| Formation of Resonant Loops
Decoupling isolates coil elements
from RF fields during RF
transmission, Length of cable and
stiffness does not allow permit looping | -Similar to the Legend 5000 Knee and Foot Coil
manufactured by USA Instruments, Inc. (K994040)
-Similar to the Leo 7000 Quadrature Knee coil
manufactured by USA Instruments, Inc. (K971246) |
2
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern around the edge. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 JAN
Mr. Rony Thomas Vice President Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K013592
Trade/Device Name: Extremity Coil MRI specially coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 24, 2001 Received: October 30, 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): __ イ o / 35 タク
Device Name: Extremity Coil
Indications for Use: The Extremity Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the knee and foot in Magnetic Resonance Imaging systems. The Extremity Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI scanner manufactured by Siemens Medical Systems, Inc.
Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Siemens Rhapsody 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)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
OR
Over-The-Counter Use
(Optional Format 1-2-96)