(522 days)
Not Found
No
The description focuses on the hardware components of an RF coil for MRI and does not mention any software or algorithms that would utilize AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is an RF coil used for imaging with an MRI scanner, not for treating a disease or condition.
No.
The device is a chest coil used in conjunction with MRI scanners to obtain an image of hyperpolarized 129Xe in the lungs. It is a tool for image acquisition, not a diagnostic device itself. The diagnostic interpretation would be performed by a trained physician using the images generated.
No
The device description clearly states it is a physical RF coil constructed of circuit board material, electronic components, and padding, which are hardware components.
Based on the provided information, the Polarean XENOVIEW 3.0T Chest Coil is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Chest Coil is a medical device used in conjunction with an MRI scanner to image the distribution of inhaled hyperpolarized xenon gas within the patient's lungs. It does not analyze biological samples taken from the patient.
- The intended use is for imaging the lungs. The description clearly states the device is used to "obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs." This is an in-vivo imaging procedure, not an in-vitro diagnostic test.
- The device description focuses on the physical characteristics and function of an RF coil for MRI. The components and construction are typical of an MRI coil, not a device designed for analyzing biological specimens.
Therefore, the Polarean XENOVIEW 3.0T Chest Coil is a medical device used for in-vivo imaging, not an in-vitro diagnostic device.
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 129Xe 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
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)
Non-Clinical Testing:
- Performance – Bench testing performed in accordance with NEMA MS 6-2008 (R2014), NEMA MS 8-2016, and NEMA MS 14-2019.
- Electrical Safety and Electromagnetic Compatibility testing performed in accordance with IEC 60601-1, IEC 60601-2-33:2015, and IEC 60601-1-2:2014.
- Biocompatibility testing performed per ISO 10993-1:2018, specifically Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), and Irritation (ISO 10993-10:2010).
Key results: The testing demonstrates that the Polarean XENOVIEW 3.0T Chest Coil is substantially equivalent to the predicate device (K061952) and assures that the Polarean XENOVIEW 3.0T Chest Coil is as safe and effective as the predicate device.
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 contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2022
Polarean, Inc. % Rita King CEO MethodSense. Inc. 1 Copley Parkway. Suite 410 Morrisville, North Carolina 27560
Re: K212239
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: December 16, 2022 Received: December 19, 2022
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
FDA
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212239
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) |
|---|
| ------------------------------------------------- |
| X 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. K212239
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: | December 22, 2022 |
| 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. |
Predicate Device:
| Trade Name | Cardiovascular Array Coils, Models CAC-63-16, CAC-63-32, CAC-123-32, and CAC-127-16 |
|---|---|
| 510(k) Submitter / Holder | INVIVO |
| 510(k) Number | K061952 |
| Regulation 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 129Xe 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 1ª8%e 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 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.
Substantial Equivalence
The Polarean XENOVIEW 3.0T Chest Coil is substantially equivalent to its predicate device, Cardiovascular Array Coils, Models CAC-63-16, CAC-63-32, CAC-123-32, and CAC-127-16 (K061952).
The table below provides a detailed comparison of Polarean XENOVIEW 3.0T Chest Coil to the predicate device.
5
Detailed Comparison of the Subject and Predicate Devices
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T
Chest Coil | Predicate Device
Cardiovascular Array Coils
(K061952) | 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. | To be used in conjunction with a
Magnetic Resonance Scanner to
produce diagnostic images of the
cardiovascular, pulmonary, renal,
and abdominal systems that can
be interpreted by a trained
physician. | The intended use of the Polarean XENOVIEW
3.0T Chest Coil is identical to the predicate
device (K061952). Both devices are being used
to help produce diagnostic images in MRI
scanners interpreted by a trained physician. |
| Anatomical
Area | Chest | Chest | The anatomical area imaged by the Polarean
XENOVIEW 3.0T Chest Coil is identical to the
anatomical area imaged by the predicate device
(K061952). |
| Compatible
MRI Systems | Siemens 3T | Siemens 3T and 1.5T and GE 3T
and 1.5T | The Polarean XENOVIEW 3.0T Chest Coil is
equivalent to the predicate device (K061952), in
that both devices support 3T MRI Systems. The
difference between the Polarean XENOVIEW
3.0T Chest Coil and the predicate device
(K061952) is that the predicate device (K061952)
is additionally compatible with Siemens 1.5T and
GE 3T and 1.5T MRI scanners. This difference
does not affect the intended use or the safety
and effectiveness of the device. |
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T
Chest Coil | Predicate Device
Cardiovascular Array Coils
(K061952) | Comparison |
| Mode of
Operation | Transmit / Receive | Receive Only | The mode of operation of the Polarean
XENOVIEW 3.0T Chest Coil is equivalent to that
of the predicate device (K061952) as the both
have a receive mode of operation. The Polarean
XENOVIEW 3.0T Chest Coil additionally has a
transmit mode of operation which the predicate
device (K061952) does not. This difference does
not affect the intended use of the device and
safety and effectiveness of the device has been
confirmed with testing. |
| Flexible / Rigid | Flexible | Flexible with rigid sections | The flexibility of the Polarean XENOVIEW 3.0T
Chest Coil compared to the predicate device
(K061952) is equivalent. |
| Nucleus | 129Xe (Multinuclear
Channel) | 1H (Proton Channel) | The Polarean XENOVIEW 3.0T Chest Coil is
different to the predicate device (K061952) as the
Polarean XENOVIEW 3.0T Chest Coil uses the
MRI multinuclear channel to image 129Xe and the
predicate device (K061952) uses the MRI proton
channel to image 1H. This difference does not
affect the intended use of the device and safety
and effectiveness of the device has been
confirmed with testing. |
| Frequency of
Operation | 34.07 MHz | 63.6, 63.86, 123.2, 127.72 MHz | The frequency of operation of the Polarean
XENOVIEW 3.0T Chest Coil is different than the
frequencies of operation of the predicate device
(K061952) as the subject device is intended to
image 129Xe. This difference does not affect the
intended use of the device and safety and
effectiveness of the device has been confirmed
with testing. |
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T
Chest Coil | Predicate Device
Cardiovascular Array Coils
(K061952) | Comparison |
| Antenna
Configuration | Quadrature (co-rotating
saddle coil pairs) | Flat array of loops | The antenna configuration of the Polarean
XENOVIEW 3.0T Chest Coil is different from the
predicate device (K061952) as the Polarean
XENOVIEW 3.0T Chest Coil uses a quadrature
configuration while the predicate device
(K061952) uses a flat array of loops. This
difference does not affect the intended use of the
device and safety and effectiveness of the device
has been confirmed with testing. |
| Tuning /
Impedance
Matching | Fixed tuning and matching.
Factory set. | Fixed tuning and matching.
Factory set. | The tuning / impedance matching mode of the
Polarean XENOVIEW 3.0T Chest Coil is identical
to the predicate device (K061952). |
| Method of
Decoupling | Passive decoupling for 1H. | Active and passive decoupling. | The method of decoupling of the Polarean
XENOVIEW 3.0T Chest Coil is equivalent to the
method of predicate device (K061952). Both
devices use passive decoupling. The predicate
device (K061952) also uses active decoupling.
This difference does not affect the intended use
of the device and safety and effectiveness of the
device has been confirmed with testing. |
| Materials | Foam and fabric. | Foam and fabric. | The materials of the Polarean XENOVIEW 3.0T
Chest Coil are equivalent to the material of the
predicate device (K061952). |
| Characteristic | Subject Device
Polarean XENOVIEW 3.0T
Chest Coil | Predicate Device
Cardiovascular Array Coils
(K061952) | Comparison |
| # of receive
channels | 1 | 16 or 32 | The number of receive channels of the Polarean
XENOVIEW 3.0T Chest Coil is different than the
predicate device (K061952) as the Polarean
XENOVIEW 3.0T Chest Coil has one receive
channel while the predicate device (K061952)
has 16 or 32 receive channels. This difference
does not affect the intended use of the device or
the safety and effectiveness of the device. |
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 performed by Polarean 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 Maqnetic Resonance Imaging Systems
Electrical Safety and Electromagnetic Compatibility
Electrical Safety and Electromagnetic Compatibility testing was performed 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) ●
- Basic Safety and Essential Performance of MR Equipment (IEC 60601-2-33:2015) .
- . Electromagnetic Compatibility (IEC 60601-1-2:2014)
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) .
Substantial Equivalence Conclusions
In conclusion, the intended use/indications for use of the Polarean XENOVIEW 3.0T Chest Coil is identical to the intended use/indications for use of the predicate device (K061952) as both devices are used to help produce diagnostic images in MRI scanners and are being interpreted by a trained physician. The technological characteristics demonstrate that the Polarean XENOVIEW 3.0T Chest Coil is substantially equivalent to the predicate device (K061952). The testing demonstrates that the Polarean XENOVIEW 3.0T Chest Coil is substantially equivalent to the predicate device (K061952) and assures that the Polarean XENOVIEW 3.0T Chest Coil is as safe and effective as the predicate device.
10
Conclusion
The 510(k) Premarket Notification for the XENOVIEW 3.0T Chest Coil contains adequate information and data to determine that XENOVIEW 3.0T Chest Coil is as safe and effective as the legally marketed predicate device.