(24 days)
Not Found
No
The description focuses on the hardware components and function of an RF coil for MRI, with no mention of AI or ML for image processing, analysis, or any other function.
No
The device is a chest coil used for imaging with an MRI scanner, not for treating a disease or condition. Its purpose is diagnostic, to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.
No
The device is a chest coil used to obtain an MR image of the regional distribution of hyperpolarized Xe in the lungs. It is a tool for image acquisition, not a diagnostic device itself.
No
The device description clearly details a physical RF coil constructed of circuit board material, antenna elements, and electronic components, indicating it is a hardware device.
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 Polarean XENOVIEW 3.0T Chest Coil is an accessory used with an MRI scanner to image the distribution of inhaled hyperpolarized xenon gas within the lungs. It is a physical component that interacts with the patient and the MRI system, not a test performed on a biological sample.
- Intended Use: The intended use clearly states it's for "imaging of lung ventilation" using MRI and inhaled gas. This is an in-vivo imaging procedure, not an in-vitro diagnostic test.
The device is a medical device used for imaging, specifically an RF coil for MRI.
N/A
Intended Use / Indications for Use
The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 123Xe frequency on a 3.0T MRI magnetic field in order to image 129Xe nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.
The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
lung, Chest
Indicated Patient Age Range
adults and pediatric patients aged 12 years and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
No clinical tests were required to demonstrate substantial equivalence.
Description of the test set, sample size, data source, and annotation protocol
No clinical tests were required to demonstrate substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Performance - Bench: Bench testing was repeated by Polarean for the new model of the Chest Coil with compatible MRI scanners to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards: NEMA MS 6-2008 (R2014) (Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging), NEMA MS 8-2016 (Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems), NEMA MS 14-2019 (Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems).
Electrical Safety and Electromagnetic Compatibility: Testing was repeated for the new model of the Chest Coil to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards: Basic Safety and Essential Performance (IEC 60601-1:2005/(R)2012 and A1:2012), Basic Safety and Essential Performance of MR Equipment (IEC 60601-2-33:2015), Electromagnetic Compatibility (IEC 60601-1-2:2020).
Biocompatibility: Testing was performed per ISO 10993-1:2018 to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2023
Polarean, Inc. % Rita King CEO MethodSense, Inc. 1 Copley Pkwy, Ste. 410 MORRISVILLE NC 27560
Re: K231647
Trade/Device Name: XENOVIEW 3.0T Chest Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: June 2, 2023 Received: June 5, 2023
Dear Rita King:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
D. Ky
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231647
Device Name XENOVIEW 3.0T Chest Coil
Indications for Use (Describe)
The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation of lung ventilation in adults and pediatric patients aged 12 years and older.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Polarean, Inc. K231647
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | Polarean, Inc.
PO Box 14805
Research Triangle Park, NC 27709-4805 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: (919) 313-3961
Fax: (919) 313-3979 |
| Company Contact: | Neil Wadehra
Title: VP of Operations
Email: nwadehra@polarean.com
Phone: (919) 206-7900 |
| Date Prepared: | June 2, 2023 |
| Trade Name: | XENOVIEW 3.0T Chest Coil |
| Common Name: | Coil, Magnetic Resonance |
| Classification: | Class II |
| Regulation Number: | 21 CFR 892.1000 |
| Classification Panel: | Radiology |
| Product Code: | MOS |
| Prior Submissions: | No prior submissions related to this 510(k). Device was previously
cleared per K212239. |
Predicate Device:
| Trade Name | Polarean XENOVIEW 3.0T Chest Coil |
|---|---|
| 510(k) Submitter / Holder | Polarean |
| 510(k) Number | K212239 |
| Requlation Number | 21 CFR 892.1000 Magnetic resonance diagnostic device |
| Classification | Class II |
| Classification Panel | Radiology |
| Product Code | MOS |
The predicate device has not been subject to a design-related recall.
4
Device Description
The Polarean XENOVIEW 3.0T Chest Coil (hereafter Chest Coil) is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 123Xe frequency on a 3.0T MRI magnetic field in order to image 129%e nuclei while the patient is positioned inside a compatible multi-nuclear-capable MRI scanner. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 1ª3 xe gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 149Xe in the lungs.
The coil is constructed of a durable, flexible circuit board material within which the antenna elements and all electronic components are contained. These components are electrically isolated from the rest of the coil packaging by being enclosed within suitable non-conductive, water-rated, and flame-rated materials. A layer of padding is located on either side of the coil circuitry to provide patient comfort and protection against potential heating generated by circuitry components. The RF coil is a "fixed matching and tuning device" (i.e. not tunable by the operator), thereby eliminating the need to tune and match it for every patient.
Indications for Use
The Polarean XENOVIEW 3.0T Chest Coil is to be used in coniunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
Substantial Equivalence
The Polarean XENOVIEW 3.0T Chest Coil is substantially equivalent to its predicate device, Polarean XENOVIEW 3.0T Chest Coil (K212239). This submission adds compatibility of the Chest Coil with Philips 3T MRI scanners. The safety and performance testing that was performed in the previous submission (K212239) was repeated to demonstrate that the Chest Coil is as safe and effective when used with the Philips 3T MRI scanners as when used with the Siemens 3T MRI scanners.
The table below provides a detailed comparison of Polarean XENOVIEW 3.0T Chest Coil to the predicate device (K212239).
5
Detailed Comparison of the Subject and Predicate Devices
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-03) | Primary Predicate Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-01) (K212239) | Comparison |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | The Polarean XENOVIEW 3.0T
Chest Coil is to be used in
conjunction with compatible 3.0T
Magnetic Resonance Imaging
(MRI) scanners and approved
xenon Xe 129 hyperpolarized for
oral inhalation for evaluation of
lung ventilation in adults and
pediatric patients aged 12 years
and older. | The Polarean XENOVIEW 3.0T
Chest Coil is to be used in
conjunction with compatible 3.0T
Magnetic Resonance Imaging
(MRI) scanners and approved
xenon Xe 129 hyperpolarized for
oral inhalation for evaluation of
lung ventilation in adults and
pediatric patients aged 12 years
and older. | Identical |
| Anatomical
Area | Chest | Chest | Identical |
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-03) | Primary Predicate Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-01) (K212239) | Comparison |
| Compatible
MRI Systems | Philips 3T | Siemens 3T | Equivalent. Subject device is
compatible with Philips 3T MRI
scanners and the predicate device
is compatible with Siemens 3T
MRI scanners. Both the subject
device and predicate device are
compatible with 3T MRI scanners.
Both devices use a connector that
is compatible with the respective
MRI scanner. The addition of the
new configuration with
compatibility with Philips 3T MRI
scanners does not affect the
intended use of the device and
safety and effectiveness of the
device has been confirmed with
testing. |
| Mode of
Operation | Transmit / Receive | Transmit / Receive | Identical |
| Flexible / Rigid | Flexible | Flexible | Identical |
| Nucleus | 129Xe (Multinuclear Channel) | 129Xe (Multinuclear Channel) | Identical |
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-03) | Primary Predicate Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-01) (K212239) | Comparison |
| Frequency of
Operation | 35.33 MHz | 34.07 MHz | Equivalent. Subject device is
compatible with Philips 3T MRI
scanners and the predicate device
is compatible with Siemens 3T
MRI scanners. Both the subject
device and predicate device
operate at the same frequency of
the respective compatible MRI
scanner. Both devices use a
connector that is compatible with
the respective MRI scanner. This
difference in frequency is a
function of the difference between
magnetic field strength between
different MRI manufacturers and
does not affect the intended use of
the device and safety and
effectiveness of the device has
been confirmed with testing. |
| Antenna
Configuration | Quadrature (co-rotating saddle
coil pairs) | Quadrature (co-rotating saddle
coil pairs) | Identical |
| Tuning /
Impedance
Matching | Fixed tuning and matching.
Factory set. | Fixed tuning and matching.
Factory set. | Identical |
| Method of
Decoupling | Passive decoupling for ¹H. | Passive decoupling for ¹H. | Identical |
| Materials | Foam and fabric. | Foam and fabric. | Identical |
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-03) | Primary Predicate Device
Polarean XENOVIEW 3.0T Chest
Coil (Model 44315-01) (K212239) | Comparison |
| # of receive
channels | 1 | 1 | Identical |
6
7
8
9
Non-Clinical Testing
The XENOVIEW 3.0T Chest Coil was verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed. Polarean has completed the following testing:
Performance - Bench
Bench testing was repeated by Polarean for the new model of the Chest Coil with compatible MRI scanners to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards:
- NEMA MS 6-2008 (R2014). Determination of Signal-to-Noise Ratio and Image . Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging
- NEMA MS 8-2016. Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
- . NEMA MS 14-2019. Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Electrical Safety and Electromagnetic Compatibility
Electrical Safety and Electromagnetic Compatibility testing was repeated for the new model of the Chest Coil to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards:
- Basic Safety and Essential Performance (IEC 60601-1:2005/(R)2012 and A1:2012)
- . Basic Safety and Essential Performance of MR Equipment (IEC 60601-2-33:2015)
- Electromagnetic Compatibility (IEC 60601-1-2:2020) .
Biocompatibility
Biocompatibility testing was performed per ISO 10993-1:2018 to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) .
- . Irritation (ISO 10993-10:2010)
Summary Clinical Testing
No clinical tests were required to demonstrate substantial equivalence.
Conclusion
The conclusions drawn from the nonclinical testing demonstrate that the subject device, XENOVIEW 3.0T Chest Coil is as safe, as effective, and performs as well as or better than the legally marketed predicate. XENOVIEW 3.0T Chest Coil (K212239).