(41 days)
Not Found
No
The description focuses on the physical design and technical specifications of an MRI coil, with no mention of AI or ML for image processing or analysis.
No
The device is described as a coil for a Magnetic Resonance Imaging (MRI) system, intended to produce diagnostic images that can be interpreted by a trained physician. It is explicitly stated as a "receive-only coil for high resolution diagnostic imaging," which means its purpose is to aid in diagnosis, not to treat a condition.
Yes
The device, an MRI coil, produces images which are explicitly stated to be "diagnostic images of the foot and ankle that can be interpreted by a trained physician." This indicates its role in aiding diagnosis.
No
The device description clearly outlines a physical hardware component (a coil) with specific dimensions, materials, and connections designed to work with an MRI system. It is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to produce diagnostic images of the foot and ankle using Magnetic Resonance Imaging (MRI). This is an in vivo (within a living organism) diagnostic process, not an in vitro (outside of a living organism, typically involving biological samples) process.
- Device Description: The device is a coil used in conjunction with an MRI scanner to receive RF signals from the body. This is a component of an imaging system, not a device that analyzes biological samples.
- Input Imaging Modality: The input is Magnetic Resonance Imaging (MRI), which is an in vivo imaging technique.
- Anatomical Site: The device is used on the foot and ankle, which are parts of the living body.
IVDs are typically used to examine biological samples such as blood, urine, tissue, etc., to diagnose diseases or conditions. This device is used to create images of the internal structures of the body directly.
N/A
Intended Use / Indications for Use
The dS FootAnkle 16ch 1.5T Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The proposed dS FootAnkle 16ch 1.5T Coil is designed for use with Magnetic Resonance Imaging (MRI) systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.
The proposed dS FootAnkle 16ch 1.5T Coil is a volume phased array receive-only coil for high resolution diagnostic imaging of foot and ankle with coil housing dimensions to be 14.46x8.13x12.65 inches. The coil is constructed on molded polycarbonate (Lexan 925) former using Kapton rigid-Flex PCB (loop elements) and FR-4 PCB (feedboard, interface boards) and urethane-jacketed cable to connect to MR system. The coils provide unilateral images (Left and Right) of the anatomy of interest. The coil is designed for high resolution diagnostic imaging of the foot and ankle anatomical regions.
The coil pads are made of Urethane foam with Polyscan coating with one of the Base Plate Pad to comfort other foot (not being imaged) have PolyDry Healthcare Fabric Exterior.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
foot and ankle
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
Bench performance testing includes both non-clinical testing and clinical demonstrations of the representative anatomic region (foot and ankle imaging) using FDA-cleared Philips 1.5T scanner. The non-clinical testing characterizes the Signal-to-Noise Ratio (SNR), Image Quality and special purpose of the RF receive-only coil. The clinical demonstration DICOM images were reviewed by a clinical radiologist to confirm the image quality is adequate. The images and supporting attestation statements by the radiologist are provided in Appendix 5, Clinical Evaluation. Non-clinical verification and validation test results demonstrate that the proposed dS FootAnkle 16ch 1.5T Coil complies with the device specifications, identified international and FDA-recognized consensus standards, and device specific guidance document entitled "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices"; and meets the acceptance criteria and is adequate for its intended use.
The proposed dS FootAnkle 16ch 1.5T Coil does not require clinical study since substantial equivalence to the predicate device was demonstrated with the following attributes: Design features; Indication for use; Technological characteristic; Non-clinical performance testing; and Safety and effectiveness.
Key Metrics
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2016
Invivo Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th street, NW BUFFALO MN 55313
Re: K162177
Trade/Device Name: dS FootAnkle 16ch 1.5T Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 31, 2016 Received: September 1, 2016
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162177
Device Name dS FootAnkle 16ch 1.5T Coil
Indications for Use (Describe)
The dS FootAnkle 16ch 1.5T Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitted by: | Invivo Corporation
3545 SW 47th Ave
Gainesville, FL 32608 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Name | Invivo Corporation |
| Establishment
Registration Number: | 1056069 |
| Contact Person: | Ken Revennaugh
Title: Director of Quality and Regulatory
Invivo Corporation
3545 SW 47th Ave
Gainesville, FL 32608
Phone: (352) 384-8590
E-mail: ken.revennaugh@philips.com |
| Date Prepared: | August 30, 2016 |
| Trade Name: | dS FootAnkle 16ch 1.5T Coil |
| Common Name: | Magnetic resonance diagnostic device |
| Classification Name: | Coil, Magnetic Resonance, Specialty |
| Classification
Regulation Number: | 892.1000 |
| Classification: | Class II |
| Classification Panel: | Radiology |
| Product code: | MOS |
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Device Description:
The proposed dS FootAnkle 16ch 1.5T Coil is designed for use with Magnetic Resonance Imaging (MRI) systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.
The proposed dS FootAnkle 16ch 1.5T Coil is a volume phased array receive-only coil for high resolution diagnostic imaging of foot and ankle with coil housing dimensions to be 14.46x8.13x12.65 inches. The coil is constructed on molded polycarbonate (Lexan 925) former using Kapton rigid-Flex PCB (loop elements) and FR-4 PCB (feedboard, interface boards) and urethane-jacketed cable to connect to MR system. The coils provide unilateral images (Left and Right) of the anatomy of interest. The coil is designed for high resolution diagnostic imaging of the foot and ankle anatomical regions.
The coil pads are made of Urethane foam with Polyscan coating with one of the Base Plate Pad to comfort other foot (not being imaged) have PolyDry Healthcare Fabric Exterior.
Variations between the proposed dS FootAnkle 16ch 1.5T Coil and currently marketed and predicate device FAC-63 Foot and Ankle Coil include MR system compatibility and a 16channel connection to the MRI system. Mechanical design changes include modifications to the connector to permit the 16-channel connection and the specified MR system compatibility. In addition, modifications to the overall dimensions improve workflow as well as meet customer requirements.
Proposed changes to the device
- Coil housing material changed from Lexan 950 to Lexan 925 for ease of availability with ● no impact to device safety and effectiveness
- Coil pad coating changed from Guardian MPGX to Polyscan coating for ease of availability with no impact to device safety or effectiveness.
- Channel count was increased from 8 channels to 16 channels to meet the customer/market needs with no impact on device to safety and effectiveness.
- The overall coil dimensions were changed from 12.75" x 7.04" x 11.23" to 14.46" x 8.13" x 12.65" to accommodate more channels with no impact to device safety and effectiveness.
The proposed Model dS FootAnkle 16ch 1.5T Coil will operate with the Philips 1.5T MRI Scanners with dStream capabilities. The proposed Model dS FootAnkle 16ch 1.5T Coil is a 16-channel receive-only coil.
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Photograph:
Image /page/5/Picture/2 description: The image shows a white, plastic device that appears to be a medical instrument or part of a larger machine. It has a handle on top and a base with elongated slots. The device is sitting on a reflective surface, which creates a mirror image of the object. The background is a gradient of light colors, which helps to highlight the shape and form of the device.
Patient Safety
Description of design that assures that the coil will remain decoupled:
Each coil incorporates a redundant decoupling strategy. A fast recovery back-to-back PIN diode pair is placed in series with an inductor across a capacitor. The inductor is tuned to shift the resonant frequency of the coil. There is also a fuse in series with the loop that would break loop resonance in event of high currents. During system transmit pulses, a DC voltage is supplied to each of the 16 channels of the array by the MRI system. This voltage drives the PIN diodes so they conduct, thus engaging the decoupling circuit. The coil resonant frequency then shifts away from the system resonant frequency. The coil thus becomes a very poor receiver of RF energy at the system operating frequency during the transmit pulses.
In the event that the coil is placed in the magnet and the operator neglects to plug in the coil, the PIN diodes function as a passive decoupling system. In this case, the decoupling takes place without the need for the voltage supplied by the MRI system.
Description of electrical isolation of the patient from the surface coil electrical conductors:
The electrical conductors are etched on a flexible circuit board. The circuit board is encased in a plastic housing. The plastic housing wall and/or foam is provided with a minimum of 3 mm thickness. At no time it is possible for the coil conductors to touch the patient. The cable exits the coil inferior to the patient's foot. The cable is of such a length as to reach the MRI system
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coil port, but has very little additional length which would allow the cable to become looped or to come in contact with the patient-a potentially hazardous condition. The cable also has an insulating jacket, which increases separation of the cable if it did somehow become looped.
Indications for Use:
The dS FootAnkle 16ch 1.5T Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.
Predicate Device Information:
| Predicate Device Name | Predicate 510(k)
Submission Reference |
|----------------------------|------------------------------------------|
| FAC-63 Foot and Ankle Coil | K050514 |
Safety and Effectiveness:
The proposed dS FootAnkle 16ch 1.5T Coil labeling contain instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via Invivo Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via the product development process, verification and validation testing and safety features provided by the MRI Scanners.
Technological Characteristics:
The technological characteristics of the proposed dS FootAnkle 16ch 1.5T Coil is exactly the same as the currently marketed and predicate device FAC-63 Foot and Ankle Coil.
The technological characteristic of a receive-only radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest. This technological characteristic of the proposed dS FootAnkle 16ch 1.5T Coil has not changed as compared to the technological characteristic of the currently marketed and predicate device FAC-63 Foot and Ankle Coil.
Based on the information provided above, the proposed dS FootAnkle 16ch 1.5T Coil is considered substantially equivalent to the currently marketed and predicate device FAC-63 Foot and Ankle Coil (K050514) in terms of technological characteristics.
The proposed dS FootAnkle 16ch 1.5T Coil utilizes the same technological characteristic as the predicate FAC-63 Foot and Ankle Coil. Both have similar design, intended use, patient safety features, housing materials, overall dimensions, and operating principals; and substantially equivalent in their performance and effectiveness for their intended uses.
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Following is the comparison of technological characteristics between the currently marketed and predicate device FAC-63 Foot and Ankle Coil and proposed dS FootAnkle 16ch 1.5T Coil:
| Table-01 | |||
|---|---|---|---|
| Comparison of the Technological Characteristics of the Predicate Device and the Proposed Device | |||
| Device Features | Predicate Device | ||
| K050514 | |||
| FAC-63 Foot and Ankle | |||
| Coil | Proposed Device | ||
| dS FootAnkle 16ch | |||
| 1.5T Coil | Comments | ||
| Indications for Use | To be used in | ||
| conjunction with a | |||
| Magnetic Resonance | |||
| Scanner to produce | |||
| diagnostic images of the | |||
| foot and ankle that can be | |||
| interpreted by a trained | |||
| physician | The dS FootAnkle 16ch | ||
| 1.5T Coil is intended to | |||
| be used in conjunction | |||
| with a Magnetic | |||
| Resonance Scanner to | |||
| produce diagnostic | |||
| images of the foot and | |||
| ankle that can be | |||
| interpreted by a trained | |||
| physician. | Addition of | ||
| proposed coil name | |||
| to the indication for | |||
| use statement does | |||
| not affect its intent | |||
| use as well as | |||
| impact device's | |||
| safety and | |||
| effectiveness. | |||
| Coil Dimensions | |||
| Length x Width x | |||
| Height | 12.75 x 7.04 x 11.23 | ||
| inches | 14.46 x 8.13 x 12.65 | ||
| inches | The change in | ||
| dimensions is to | |||
| accommodate more | |||
| channels. No impact | |||
| to device safety and | |||
| effectiveness. | |||
| Coil Frequency | 63.87 MHz | Identical | No Change |
| Coil Design | Receive-only, Phased | ||
| Array | Identical | No Change | |
| Magnetic Field | |||
| Orientation (B0) | Horizontal | Identical | No Change |
| Coil Geometry | |||
| Housing Design | One piece housing | Identical | No Change |
| Housing Thickness | 3mm insulation | ||
| minimum | Identical | No Change | |
| Decoupling Method | LC Tank Circuit | Identical | No Change |
| Number of | |||
| Channels/ | |||
| Preamplifiers | 8 channels / 8 | ||
| preamplifiers | 16 channels / 16 | ||
| preamplifiers | The number of | ||
| channels was | |||
| increased to meet the | |||
| customer and market | |||
| needs. No impact to | |||
| device safety and | |||
| effectiveness. | |||
| Table-01 | |||
| Comparison of the Technological Characteristics of the Predicate Device and the Proposed Device | |||
| Device Features | Predicate Device | ||
| K050514 | |||
| FAC-63 Foot and Ankle | |||
| Coil | Proposed Device | ||
| dS FootAnkle 16ch | |||
| 1.5T Coil | Comments | ||
| Housing Material | Lexan 950 | Lexan 925 | Both are similar |
| materials and have | |||
| been used in current | |||
| products. No impact | |||
| to device safety and | |||
| effectiveness. | |||
| Base Pad | Urethane Foam with | ||
| Guardian MPGX coating | Urethane Foam with | ||
| Polyscan Coating | Both are similar | ||
| materials and have | |||
| been used in current | |||
| products. No impact | |||
| to device safety and | |||
| effectiveness. | |||
| Base Plate Pad | EVA Foam Covered with | ||
| CFMS | PolyDry Healthcare | ||
| Fabric Exterior | Both are similar | ||
| materials with no | |||
| impact to device | |||
| safety and | |||
| effectiveness. | |||
| System Connector / | |||
| Compatibility | ODU CDAS Connector | ||
| for Philips Scanner | Identical | No Change |
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Non-Clinical Performance Testing Information:
The proposed dS FootAnkle 16ch 1.5T Coil complies with the following international and FDA-recognized consensus standards:
- IEC 60601-1, 3rd edition ●
- IEC 60601-2-33, 3rd edition ●
- ISO 14971, 2nd edition 0
- ISO 10993-1, 2nd edition ●
- Device specific draft guidance document, entitled "Submission of Premarket ● Notifications for Magnetic Resonance Diagnostic Devices - July 14, 2015"
Bench performance testing includes both non-clinical testing and clinical demonstrations of the representative anatomic region (foot and ankle imaging) using FDA-cleared Philips 1.5T scanner. The non-clinical testing characterizes the Signal-to-Noise Ratio (SNR), Image Quality and special purpose of the RF receive-only coil. The clinical demonstration DICOM images were reviewed by a clinical radiologist to confirm the image quality is adequate. The images
9
and supporting attestation statements by the radiologist are provided in Appendix 5, Clinical Evaluation.
Non-clinical verification and validation test results demonstrate that the proposed dS FootAnkle 16ch 1.5T Coil
- Complies with the device specifications, identified international and FDA-recognized . consensus standards, and device specific guidance document entitled "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices"
- Meets the acceptance criteria and is adequate for its intended use. .
Therefore, the proposed dS FootAnkle 16ch 1.5T Coil is as safe and effective as the predicate device FAC-63 Foot and Ankle Coil (K050514) in terms of safety and effectiveness.
Summary of Clinical Data:
The proposed dS FootAnkle 16ch 1.5T Coil does not require clinical study since substantial equivalence to the predicate device was demonstrated with the following attributes:
- Design features; ●
- Indication for use;
- Technological characteristic:
- Non-clinical performance testing; and
- Safety and effectiveness ●
Conclusion:
The proposed dS FootAnkle 16ch 1.5T Coil is substantially equivalent to the currently marketed and predicate device FAC-63 Foot and Ankle Coil (K050514) in terms of design features, principals of operation, technological characteristic, indications for use, magnetic system compatibility, and safety and effectiveness. Additionally, the non-clinical performance (verification and validation) tests, which complied with the device specifications and requirements specified in the international and FDA-recognized consensus standards demonstrated that the proposed device dS FootAnkle 16ch 1.5T Coil meets the acceptance criteria and is adequate for the established intended use. The electrical isolation methods, decoupling method and housing material are similar for the predicate device.
The results of both non-clinical and device performance tests demonstrate that the proposed device is as safe, as effective, and performs as well as the predicate device.