(24 days)
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.
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.
This document describes the XENOVIEW 3.0T Chest Coil (Model 44315-03) and its substantial equivalence to a previously cleared predicate device (Model 44315-01, K212239). The primary difference is the expanded compatibility to include Philips 3T MRI scanners, in addition to the Siemens 3T MRI scanners supported by the predicate.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it refers to conformance with established performance criteria and specific industry standards. The reported "performance" aligns with meeting the requirements of these standards.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Bench Testing | Signal-to-Noise Ratio and Image Uniformity (NEMA MS 6-2008 (R2014)) | Conforms to standard for a flexible, single channel T/R RF coil. |
| Specific Absorption Rate (SAR) (NEMA MS 8-2016) | Conforms to standard for SAR characterization. | |
| RF Coil Heating (NEMA MS 14-2019) | Conforms to standard for RF coil heating characterization. | |
| Electrical Safety | Basic Safety & Essential Performance (IEC 60601-1:2005/(R)2012 and A1:2012) | Conforms to standard. |
| Basic Safety & Essential Performance of MR Equipment (IEC 60601-2-33:2015) | Conforms to standard. | |
| EMC | Electromagnetic Compatibility (IEC 60601-1-2:2020) | Conforms to standard. |
| Biocompatibility | General Biological Evaluation (ISO 10993-1:2018) | Conforms to standard. |
| Cytotoxicity (ISO 10993-5:2009) | Conforms to standard. | |
| Sensitization (ISO 10993-10:2010) | Conforms to standard. | |
| Irritation (ISO 10993-10:2010) | Conforms to standard. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical testing performed on the device itself. Therefore, there is no "test set" in the context of patient data. The testing involves physical devices (XENOVIEW 3.0T Chest Coil) and MRI scanners.
- Sample Size for Test Set: Not applicable as it's not a clinical study involving patient data. The testing was conducted on "the new model of the Chest Coil."
- Data Provenance: Not applicable. The testing was non-clinical (bench testing, electrical safety, EMC, biocompatibility).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a clinical study or a study relying on expert interpretation of diagnostic images. The ground truth for the non-clinical tests is based on the specifications of the standards (e.g., NEMA, IEC, ISO) and the physical properties of the device and MRI systems.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication for non-clinical performance and safety testing against engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This indicates that no MRMC comparative effectiveness study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a medical accessory (an RF coil for MRI), not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by:
- Established industry standards: NEMA MS, IEC 60601 series, ISO 10993 series. The device's performance against these standards constitutes the "truth" that it is safe and performs as intended.
- Physical and electrical characteristics: The fundamental properties and measurements of the coil (e.g., frequency of operation, SNR, SAR, heating) as measured in a controlled laboratory environment.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for it.
In summary, the provided document describes the safety and performance verification of an MRI chest coil through non-clinical laboratory testing against established engineering and safety standards, rather than through clinical trials or AI performance evaluations.
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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 (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
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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) |
|---|
| ☑ 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. K231647
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: | 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 previouslycleared 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 DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-03) | Primary Predicate DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-01) (K212239) | Comparison |
|---|---|---|---|
| IntendedUse/Indicationsfor Use | The Polarean XENOVIEW 3.0TChest Coil is to be used inconjunction with compatible 3.0TMagnetic Resonance Imaging(MRI) scanners and approvedxenon Xe 129 hyperpolarized fororal inhalation for evaluation oflung ventilation in adults andpediatric patients aged 12 yearsand older. | The Polarean XENOVIEW 3.0TChest Coil is to be used inconjunction with compatible 3.0TMagnetic Resonance Imaging(MRI) scanners and approvedxenon Xe 129 hyperpolarized fororal inhalation for evaluation oflung ventilation in adults andpediatric patients aged 12 yearsand older. | Identical |
| AnatomicalArea | Chest | Chest | Identical |
| Characteristic | Subject DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-03) | Primary Predicate DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-01) (K212239) | Comparison |
| CompatibleMRI Systems | Philips 3T | Siemens 3T | Equivalent. Subject device iscompatible with Philips 3T MRIscanners and the predicate deviceis compatible with Siemens 3TMRI scanners. Both the subjectdevice and predicate device arecompatible with 3T MRI scanners.Both devices use a connector thatis compatible with the respectiveMRI scanner. The addition of thenew configuration withcompatibility with Philips 3T MRIscanners does not affect theintended use of the device andsafety and effectiveness of thedevice has been confirmed withtesting. |
| Mode ofOperation | Transmit / Receive | Transmit / Receive | Identical |
| Flexible / Rigid | Flexible | Flexible | Identical |
| Nucleus | 129Xe (Multinuclear Channel) | 129Xe (Multinuclear Channel) | Identical |
| Characteristic | Subject DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-03) | Primary Predicate DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-01) (K212239) | Comparison |
| Frequency ofOperation | 35.33 MHz | 34.07 MHz | Equivalent. Subject device iscompatible with Philips 3T MRIscanners and the predicate deviceis compatible with Siemens 3TMRI scanners. Both the subjectdevice and predicate deviceoperate at the same frequency ofthe respective compatible MRIscanner. Both devices use aconnector that is compatible withthe respective MRI scanner. Thisdifference in frequency is afunction of the difference betweenmagnetic field strength betweendifferent MRI manufacturers anddoes not affect the intended use ofthe device and safety andeffectiveness of the device hasbeen confirmed with testing. |
| AntennaConfiguration | Quadrature (co-rotating saddlecoil pairs) | Quadrature (co-rotating saddlecoil pairs) | Identical |
| Tuning /ImpedanceMatching | Fixed tuning and matching.Factory set. | Fixed tuning and matching.Factory set. | Identical |
| Method ofDecoupling | Passive decoupling for ¹H. | Passive decoupling for ¹H. | Identical |
| Materials | Foam and fabric. | Foam and fabric. | Identical |
| Characteristic | Subject DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-03) | Primary Predicate DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-01) (K212239) | Comparison |
| # of receivechannels | 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).
§ 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.