XENOVIEW 3.0T Chest Coil

{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) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-family: Arial;"> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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K212239 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: ritaking@methodsense.com<br>Phone: (919) 313-3961<br>Fax: (919) 313-3979 | | Company Contact: | Neil Wadehra<br>Title: VP of Operations<br>Email: nwadehra@polarean.com<br>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<br>Polarean XENOVIEW 3.0T<br>Chest Coil | Predicate Device<br>Cardiovascular Array Coils<br>(K061952) | Comparison | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use/Indications<br>for Use | The Polarean XENOVIEW<br>3.0T Chest Coil is to be<br>used in conjunction with<br>compatible 3.0T Magnetic<br>Resonance Imaging (MRI)<br>scanners and approved<br>xenon Xe 129<br>hyperpolarized for oral<br>inhalation for evaluation of<br>lung ventilation in adults<br>and pediatric patients aged<br>12 years and older. | To be used in conjunction with a<br>Magnetic Resonance Scanner to<br>produce diagnostic images of the<br>cardiovascular, pulmonary, renal,<br>and abdominal systems that can<br>be interpreted by a trained<br>physician. | The intended use of the Polarean XENOVIEW<br>3.0T Chest Coil is identical to the predicate<br>device (K061952). Both devices are being used<br>to help produce diagnostic images in MRI<br>scanners interpreted by a trained physician. | | Anatomical<br>Area | Chest | Chest | The anatomical area imaged by the Polarean<br>XENOVIEW 3.0T Chest Coil is identical to the<br>anatomical area imaged by the predicate device<br>(K061952). | | Compatible<br>MRI Systems | Siemens 3T | Siemens 3T and 1.5T and GE 3T<br>and 1.5T | The Polarean XENOVIEW 3.0T Chest Coil is<br>equivalent to the predicate device (K061952), in<br>that both devices support 3T MRI Systems. The<br>difference between the Polarean XENOVIEW<br>3.0T Chest Coil and the predicate device<br>(K061952) is that the predicate device (K061952)<br>is additionally compatible with Siemens 1.5T and<br>GE 3T and 1.5T MRI scanners. This difference<br>does not affect the intended use or the safety<br>and effectiveness of the device. | | Characteristic | Subject Device<br>Polarean XENOVIEW 3.0T<br>Chest Coil | Predicate Device<br>Cardiovascular Array Coils<br>(K061952) | Comparison | | Mode of<br>Operation | Transmit / Receive | Receive Only | The mode of operation of the Polarean<br>XENOVIEW 3.0T Chest Coil is equivalent to that<br>of the predicate device (K061952) as the both<br>have a receive mode of operation. The Polarean<br>XENOVIEW 3.0T Chest Coil additionally has a<br>transmit mode of operation which the predicate<br>device (K061952) does not. This difference does<br>not affect the intended use of the device and<br>safety and effectiveness of the device has been<br>confirmed with testing. | | Flexible / Rigid | Flexible | Flexible with rigid sections | The flexibility of the Polarean XENOVIEW 3.0T<br>Chest Coil compared to the predicate device<br>(K061952) is equivalent. | | Nucleus | 129Xe (Multinuclear<br>Channel) | 1H (Proton Channel) | The Polarean XENOVIEW 3.0T Chest Coil is<br>different to the predicate device (K061952) as the<br>Polarean XENOVIEW 3.0T Chest Coil uses the<br>MRI multinuclear channel to image 129Xe and the<br>predicate device (K061952) uses the MRI proton<br>channel to image 1H. This difference does not<br>affect the intended use of the device and safety<br>and effectiveness of the device has been<br>confirmed with testing. | | Frequency of<br>Operation | 34.07 MHz | 63.6, 63.86, 123.2, 127.72 MHz | The frequency of operation of the Polarean<br>XENOVIEW 3.0T Chest Coil is different than the<br>frequencies of operation of the predicate device<br>(K061952) as the subject device is intended to<br>image 129Xe. This difference does not affect the<br>intended use of the device and safety and<br>effectiveness of the device has been confirmed<br>with testing. | | Characteristic | Subject Device<br>Polarean XENOVIEW 3.0T<br>Chest Coil | Predicate Device<br>Cardiovascular Array Coils<br>(K061952) | Comparison | | Antenna<br>Configuration | Quadrature (co-rotating<br>saddle coil pairs) | Flat array of loops | The antenna configuration of the Polarean<br>XENOVIEW 3.0T Chest Coil is different from the<br>predicate device (K061952) as the Polarean<br>XENOVIEW 3.0T Chest Coil uses a quadrature<br>configuration while the predicate device<br>(K061952) uses a flat array of loops. This<br>difference does not affect the intended use of the<br>device and safety and effectiveness of the device<br>has been confirmed with testing. | | Tuning /<br>Impedance<br>Matching | Fixed tuning and matching.<br>Factory set. | Fixed tuning and matching.<br>Factory set. | The tuning / impedance matching mode of the<br>Polarean XENOVIEW 3.0T Chest Coil is identical<br>to the predicate device (K061952). | | Method of<br>Decoupling | Passive decoupling for 1H. | Active and passive decoupling. | The method of decoupling of the Polarean<br>XENOVIEW 3.0T Chest Coil is equivalent to the<br>method of predicate device (K061952). Both<br>devices use passive decoupling. The predicate<br>device (K061952) also uses active decoupling.<br>This difference does not affect the intended use<br>of the device and safety and effectiveness of the<br>device has been confirmed with testing. | | Materials | Foam and fabric. | Foam and fabric. | The materials of the Polarean XENOVIEW 3.0T<br>Chest Coil are equivalent to the material of the<br>predicate device (K061952). | | Characteristic | Subject Device<br>Polarean XENOVIEW 3.0T<br>Chest Coil | Predicate Device<br>Cardiovascular Array Coils<br>(K061952) | Comparison | | # of receive<br>channels | 1 | 16 or 32 | The number of receive channels of the Polarean<br>XENOVIEW 3.0T Chest Coil is different than the<br>predicate device (K061952) as the Polarean<br>XENOVIEW 3.0T Chest Coil has one receive<br>channel while the predicate device (K061952)<br>has 16 or 32 receive channels. This difference<br>does not affect the intended use of the device or<br>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.