XENOVIEW 3.0T Chest Coil

K231647 · Polarean, Inc. · MOS · Jun 29, 2023 · Radiology

Device Facts

• Record ID: K231647
• Device Name: XENOVIEW 3.0T Chest Coil
• Applicant: Polarean, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jun 29, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Flexible, single-channel, transmit-receive RF coil; worn by patient during MRI scan. Input: hyperpolarized 129Xe gas inhaled by patient; MRI scanner signals. Operation: coil detects 129Xe nuclei distribution in lungs; fixed tuning/matching; passive decoupling for 1H. Output: MR image of regional lung ventilation. Used in clinical MRI suites; operated by MRI technicians/radiologists. Output used by clinicians to evaluate lung ventilation; aids in clinical decision-making regarding pulmonary function. Benefits: enables non-invasive visualization of lung ventilation using hyperpolarized gas.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, electrical safety, electromagnetic compatibility, and biocompatibility testing.

Technological Characteristics

Flexible, single-channel transmit-receive RF coil; foam and fabric construction. Fixed tuning/matching; quadrature antenna configuration (saddle coil pairs). Passive decoupling for 1H. Operates at 35.33 MHz (Philips 3T compatible). Standards: NEMA MS 6-2008, MS 8-2016, MS 14-2019; IEC 60601-1, 60601-2-33, 60601-1-2; ISO 10993-1, 10993-5, 10993-10.

Indications for Use

Indicated for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older using hyperpolarized xenon Xe 129 gas with compatible 3.0T MRI scanners.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Polarean XENOVIEW 3.0T Chest Coil (K212239)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

# Polarean, Inc. K231647

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

| Submitter: | Polarean, Inc.<br>PO Box 14805<br>Research Triangle Park, NC 27709-4805 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Company Contact: | Neil Wadehra<br>Title: VP of Operations<br>Email: [e-mail]<br>Phone: [phone] |
| 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<br>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.

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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 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).

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# Detailed Comparison of the Subject and Predicate Devices

| Characteristic | Subject Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-03) | Primary Predicate Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-01) (K212239) | Comparison |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications<br>for Use | The Polarean XENOVIEW 3.0T<br>Chest Coil is to be used in<br>conjunction with compatible 3.0T<br>Magnetic Resonance Imaging<br>(MRI) scanners and approved<br>xenon Xe 129 hyperpolarized for<br>oral inhalation for evaluation of<br>lung ventilation in adults and<br>pediatric patients aged 12 years<br>and older. | The Polarean XENOVIEW 3.0T<br>Chest Coil is to be used in<br>conjunction with compatible 3.0T<br>Magnetic Resonance Imaging<br>(MRI) scanners and approved<br>xenon Xe 129 hyperpolarized for<br>oral inhalation for evaluation of<br>lung ventilation in adults and<br>pediatric patients aged 12 years<br>and older. | Identical |
| Anatomical<br>Area | Chest | Chest | Identical |
| Characteristic | Subject Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-03) | Primary Predicate Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-01) (K212239) | Comparison |
| Compatible<br>MRI Systems | Philips 3T | Siemens 3T | Equivalent. Subject device is<br>compatible with Philips 3T MRI<br>scanners and the predicate device<br>is compatible with Siemens 3T<br>MRI scanners. Both the subject<br>device and predicate device are<br>compatible with 3T MRI scanners.<br>Both devices use a connector that<br>is compatible with the respective<br>MRI scanner. The addition of the<br>new configuration with<br>compatibility with Philips 3T MRI<br>scanners does not affect the<br>intended use of the device and<br>safety and effectiveness of the<br>device has been confirmed with<br>testing. |
| Mode of<br>Operation | Transmit / Receive | Transmit / Receive | Identical |
| Flexible / Rigid | Flexible | Flexible | Identical |
| Nucleus | 129Xe (Multinuclear Channel) | 129Xe (Multinuclear Channel) | Identical |
| Characteristic | Subject Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-03) | Primary Predicate Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-01) (K212239) | Comparison |
| Frequency of<br>Operation | 35.33 MHz | 34.07 MHz | Equivalent. Subject device is<br>compatible with Philips 3T MRI<br>scanners and the predicate device<br>is compatible with Siemens 3T<br>MRI scanners. Both the subject<br>device and predicate device<br>operate at the same frequency of<br>the respective compatible MRI<br>scanner. Both devices use a<br>connector that is compatible with<br>the respective MRI scanner. This<br>difference in frequency is a<br>function of the difference between<br>magnetic field strength between<br>different MRI manufacturers and<br>does not affect the intended use of<br>the device and safety and<br>effectiveness of the device has<br>been confirmed with testing. |
| Antenna<br>Configuration | Quadrature (co-rotating saddle<br>coil pairs) | Quadrature (co-rotating saddle<br>coil pairs) | Identical |
| Tuning /<br>Impedance<br>Matching | Fixed tuning and matching.<br>Factory set. | Fixed tuning and matching.<br>Factory set. | Identical |
| Method of<br>Decoupling | Passive decoupling for ¹H. | Passive decoupling for ¹H. | Identical |
| Materials | Foam and fabric. | Foam and fabric. | Identical |
| Characteristic | Subject Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-03) | Primary Predicate Device<br>Polarean XENOVIEW 3.0T Chest<br>Coil (Model 44315-01) (K212239) | Comparison |
| # of receive<br>channels | 1 | 1 | Identical |

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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 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).