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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Polarean XENOVIEW 3.0T Chest Coil. It details the device's characteristics, its intended use, and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device performance study. The device in question is a chest coil, which is a hardware component used in MRI, not an AI algorithm.

Therefore, many of the requested elements (like MRMC studies, standalone algorithm performance, number of experts for ground truth, training set details) are not applicable to this type of device submission and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through:

Bench testing: Verifying the coil's physical and electrical performance (e.g., signal-to-noise ratio, SAR, RF coil heating).
Electrical Safety and Electromagnetic Compatibility (EMC) testing: Ensuring safety standards compliance.
Biocompatibility testing: Confirming the materials are safe for human contact.

Below, I'll address the applicable points based on the provided text, and explicitly state when information is not available or not relevant for this type of device.

Acceptance Criteria and Device Performance (for a hardware component)

The document specifies conformance to various standards as part of its verification and validation. These can be considered the "acceptance criteria" for a hardware device like an MRI coil.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Measured by Conformance to Standards)	Reported Device Performance (as stated in the document)
Performance – Bench Testing:	"Bench testing was performed... to confirm the safety and performance of various components of the Chest Coil in accordance with the following standards:" (Implicitly, the device met these standards)
- NEMA MS 6-2008 (R2014) for Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils	Conformance demonstrated
- NEMA MS 8-2016 for Characterization of the Specific Absorption Rate (SAR) for MRI Systems	Conformance demonstrated
- NEMA MS 14-2019 for Characterization of Radiofrequency (RF) Coil Heating in MRI Systems	Conformance demonstrated
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:" (Implicitly, the device met these standards)
- IEC 60601-1 (Basic Safety and Essential Performance)	Conformance demonstrated
- IEC 60601-2-33:2015 (Basic Safety and Essential Performance of MR Equipment)	Conformance demonstrated
- IEC 60601-1-2:2014 (Electromagnetic Compatibility)	Conformance demonstrated
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:" (Implicitly, the device met these standards)
- ISO 10993-5:2009 (Cytotoxicity)	Conformance demonstrated
- ISO 10993-10:2010 (Sensitization)	Conformance demonstrated
- ISO 10993-10:2010 (Irritation)	Conformance demonstrated

Regarding the study proving the device meets acceptance criteria:

The document broadly states that the device was "verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria." It lists the types of tests performed and the standards they conform to.

Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for hardware testing. This usually involves testing a certain number of manufactured units or prototypes to ensure reproducible performance.
- Data Provenance: Not applicable in the context of clinical image data. These are engineering and safety tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. For hardware testing, the "ground truth" is adherence to engineering specifications and safety standards, which is assessed by qualified engineers and testing facilities, not medical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for image interpretation or diagnosis consensus, not hardware testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The device is an MRI chest coil, a hardware component, not an AI algorithm intended to assist human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is hardware, not an algorithm. Bench testing mentioned would be "standalone" in the sense of testing the hardware component itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For hardware, the "ground truth" is defined by the technical specifications, performance limits, and safety standards (e.g., NEMA standards, IEC standards, ISO standards for biocompatibility). Test results are compared directly to these established limits.
The sample size for the training set:
- Not applicable. The device is a hardware component; there is no "training set" in the machine learning sense.
How the ground truth for the training set was established:
- Not applicable. There is no training set. Engineering specifications and regulatory standards serve as the basis for evaluation.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K212239

Device Name XENOVIEW 3.0T Chest Coil

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

Polarean, Inc. K212239

This 510(k) Summary is in conformance with 21CFR 807.92

Submitter:	Polarean, Inc.PO Box 14805Research Triangle Park, NC 27709-4805
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: (919) 313-3961Fax: (919) 313-3979
Company Contact:	Neil WadehraTitle: VP of OperationsEmail: nwadehra@polarean.comPhone: (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.

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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.

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.

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Detailed Comparison of the Subject and Predicate Devices

Characteristic	Subject DevicePolarean XENOVIEW 3.0TChest Coil	Predicate DeviceCardiovascular Array Coils(K061952)	Comparison
IntendedUse/Indicationsfor Use	The Polarean XENOVIEW3.0T Chest Coil is to beused in conjunction withcompatible 3.0T MagneticResonance Imaging (MRI)scanners and approvedxenon Xe 129hyperpolarized for oralinhalation for evaluation oflung ventilation in adultsand pediatric patients aged12 years and older.	To be used in conjunction with aMagnetic Resonance Scanner toproduce diagnostic images of thecardiovascular, pulmonary, renal,and abdominal systems that canbe interpreted by a trainedphysician.	The intended use of the Polarean XENOVIEW3.0T Chest Coil is identical to the predicatedevice (K061952). Both devices are being usedto help produce diagnostic images in MRIscanners interpreted by a trained physician.
AnatomicalArea	Chest	Chest	The anatomical area imaged by the PolareanXENOVIEW 3.0T Chest Coil is identical to theanatomical area imaged by the predicate device(K061952).
CompatibleMRI Systems	Siemens 3T	Siemens 3T and 1.5T and GE 3Tand 1.5T	The Polarean XENOVIEW 3.0T Chest Coil isequivalent to the predicate device (K061952), inthat both devices support 3T MRI Systems. Thedifference between the Polarean XENOVIEW3.0T Chest Coil and the predicate device(K061952) is that the predicate device (K061952)is additionally compatible with Siemens 1.5T andGE 3T and 1.5T MRI scanners. This differencedoes not affect the intended use or the safetyand effectiveness of the device.
Characteristic	Subject DevicePolarean XENOVIEW 3.0TChest Coil	Predicate DeviceCardiovascular Array Coils(K061952)	Comparison
Mode ofOperation	Transmit / Receive	Receive Only	The mode of operation of the PolareanXENOVIEW 3.0T Chest Coil is equivalent to thatof the predicate device (K061952) as the bothhave a receive mode of operation. The PolareanXENOVIEW 3.0T Chest Coil additionally has atransmit mode of operation which the predicatedevice (K061952) does not. This difference doesnot affect the intended use of the device andsafety and effectiveness of the device has beenconfirmed with testing.
Flexible / Rigid	Flexible	Flexible with rigid sections	The flexibility of the Polarean XENOVIEW 3.0TChest Coil compared to the predicate device(K061952) is equivalent.
Nucleus	129Xe (MultinuclearChannel)	1H (Proton Channel)	The Polarean XENOVIEW 3.0T Chest Coil isdifferent to the predicate device (K061952) as thePolarean XENOVIEW 3.0T Chest Coil uses theMRI multinuclear channel to image 129Xe and thepredicate device (K061952) uses the MRI protonchannel to image 1H. This difference does notaffect the intended use of the device and safetyand effectiveness of the device has beenconfirmed with testing.
Frequency ofOperation	34.07 MHz	63.6, 63.86, 123.2, 127.72 MHz	The frequency of operation of the PolareanXENOVIEW 3.0T Chest Coil is different than thefrequencies of operation of the predicate device(K061952) as the subject device is intended toimage 129Xe. This difference does not affect theintended use of the device and safety andeffectiveness of the device has been confirmedwith testing.
Characteristic	Subject DevicePolarean XENOVIEW 3.0TChest Coil	Predicate DeviceCardiovascular Array Coils(K061952)	Comparison
AntennaConfiguration	Quadrature (co-rotatingsaddle coil pairs)	Flat array of loops	The antenna configuration of the PolareanXENOVIEW 3.0T Chest Coil is different from thepredicate device (K061952) as the PolareanXENOVIEW 3.0T Chest Coil uses a quadratureconfiguration while the predicate device(K061952) uses a flat array of loops. Thisdifference does not affect the intended use of thedevice and safety and effectiveness of the devicehas been confirmed with testing.
Tuning /ImpedanceMatching	Fixed tuning and matching.Factory set.	Fixed tuning and matching.Factory set.	The tuning / impedance matching mode of thePolarean XENOVIEW 3.0T Chest Coil is identicalto the predicate device (K061952).
Method ofDecoupling	Passive decoupling for 1H.	Active and passive decoupling.	The method of decoupling of the PolareanXENOVIEW 3.0T Chest Coil is equivalent to themethod of predicate device (K061952). Bothdevices use passive decoupling. The predicatedevice (K061952) also uses active decoupling.This difference does not affect the intended useof the device and safety and effectiveness of thedevice has been confirmed with testing.
Materials	Foam and fabric.	Foam and fabric.	The materials of the Polarean XENOVIEW 3.0TChest Coil are equivalent to the material of thepredicate device (K061952).
Characteristic	Subject DevicePolarean XENOVIEW 3.0TChest Coil	Predicate DeviceCardiovascular Array Coils(K061952)	Comparison
# of receivechannels	1	16 or 32	The number of receive channels of the PolareanXENOVIEW 3.0T Chest Coil is different than thepredicate device (K061952) as the PolareanXENOVIEW 3.0T Chest Coil has one receivechannel while the predicate device (K061952)has 16 or 32 receive channels. This differencedoes not affect the intended use of the device orthe safety and effectiveness of the device.

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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.

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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.

Regulation Number and Section

§ 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.