(28 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 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 100%e gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 199xe 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.
The provided document describes the Polarean XENOVIEW 3.0T Chest Coil (subject device) and its substantial equivalence to a predicate device (K231647). The submission focuses on adding compatibility with General Electric Healthcare (GEHC) 3T MR750 and Premier MRI scanners.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format with corresponding reported device performance for a diagnostic measurement. Instead, it outlines performance and safety standards against which the device was tested. The "performance" here refers to the device's functional integrity and safety within an MRI environment, rather than a diagnostic accuracy performance (e.g., sensitivity, specificity).
Implicit Acceptance Criteria and Demonstrated Performance:
| Acceptance Criteria Category | Specific Standard/Test Adhered To | Reported Device Performance |
|---|---|---|
| Performance - Bench Tests | NEMA MS 6-2008 (R2014): Signal-to-Noise Ratio & Image Uniformity | Testing repeated; "confirm the safety and performance" |
| NEMA MS 8-2016: Specific Absorption Rate (SAR) | Testing repeated; "confirm the safety and performance" | |
| NEMA MS 14-2019: RF Coil Heating | Testing repeated; "confirm the safety and performance" | |
| Electrical Safety & Electromagnetic Compatibility | IEC 60601-1:2005/(R)2012 and A1:2012: Basic Safety & Essential Performance | Testing repeated; "confirm the safety and performance" |
| IEC 60601-2-33:2015: Basic Safety & Essential Performance of MR Equipment | Testing repeated; "confirm the safety and performance" | |
| IEC 60601-1-2:2020: Electromagnetic Compatibility | Testing repeated; "confirm the safety and performance" | |
| Biocompatibility | ISO 10993-1:2018: Biocompatibility (general) | Testing performed; "confirm the safety and performance" |
| ISO 10993-5:2009: Cytotoxicity | Testing performed; "confirm the safety and performance" | |
| ISO 10993-10:2010: Sensitization | Testing performed; "confirm the safety and performance" | |
| ISO 10993-10:2010: Irritation | Testing performed; "confirm the safety and performance" |
Note: The document states "confirm the safety and performance" for each category, but does not provide specific numerical outcomes or thresholds that were met. The acceptance is implied by the statement that the device was "verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria" and the conclusion that it is "as safe, as effective, and performs as well as or better than" the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This means there was no patient-based test set for evaluating diagnostic or clinical performance. The testing was non-clinical (bench testing) and therefore, concepts of sample size, data provenance (country of origin, retrospective/prospective) are not applicable in the context of clinical studies for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as no clinical studies were performed, and thus no ground truth derived from expert review or clinical outcomes was established for a test set. The validation was based on engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies were performed, and thus no expert adjudication of clinical data was needed.
5. 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
This information is not applicable. The device is a physical MRI coil, not an AI-powered diagnostic tool, and no clinical studies were required or conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical MRI coil, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" was adherence to established international and national standards for medical device safety and performance, specifically related to MRI coils (e.g., NEMA, IEC, ISO standards). There was no clinical ground truth established from patient data.
8. The sample size for the training set
This information is not applicable as no algorithmic training was involved. The device is a physical MRI coil.
9. How the ground truth for the training set was established
This information is not applicable as no algorithmic training was involved.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
November 19, 2024
Polarean, Inc. % Rita King CEO MethodSense, Inc. 1 Copley Pkwy. Ste. 130 Morrisville, NC 27560
Re: K243316
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: October 18, 2024 Received: October 22, 2024
Dear Neil Wadehra:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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. K.
Daniel M. Krainak, Ph.D. Assistant Director 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) K243316
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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510(k) Summary
Polarean, Inc.
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: | October 17, 2024 |
| 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: | K231647 |
Predicate Device:
| Trade Name | Polarean XENOVIEW 3.0T Chest Coil |
|---|---|
| 510(k) Submitter / Holder | Polarean |
| 510(k) Number | K231647 |
| 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 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 100%e gas (XENOVIEW) to obtain an MR image of the regional distribution of hyperpolarized 199xe 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, Polarean XENOVIEW 3.0T Chest Coil (K231647). This submission adds compatibility of the Chest Coil with General Electric Healthcare (GEHC) 3T MR750 and Premier MRI scanners. The safety and performance testing that was performed in the previous submission (K231647) was repeated to demonstrate that the Chest Coil is as safe and effective when used with GEHC 3T MR750 and Premier MRI scanners as when used with Philips 3T MRI scanners.
The table below provides a detailed comparison of Polarean XENOVIEW 3.0T Chest Coil to the predicate device (K231647).
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Detailed Comparison of the Subject and Predicate Devices
| Characteristic | Subject DevicePolarean XENOVIEW 3.0T ChestCoil (Models 44315-02 and44315-04) | Primary Predicate DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-03) (K231647) | 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 (Models 44315-02 and44315-04) | Primary Predicate DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-03) (K231647) | Comparison |
| CompatibleMRI Systems | GEHC MR750 (44315-02) andPremier (44315-04) 3T | Philips 3T | Equivalent. Subject devices arecompatible with GEHC MR750and Premier 3T MRI scanners andthe predicate device is compatiblewith Philips 3T MRI scanners.Both the subject devices andpredicate device are compatiblewith 3T MRI scanners. Bothdevices use a connector that iscompatible with the respectiveMRI scanner. The addition of thenew configurations withcompatibility with GEHC MR750and Premier 3T MRI scannersdoes not affect the intended use ofthe device and safety andeffectiveness of the device hasbeen confirmed with testing. |
| Mode ofOperation | Transmit / Receive | Transmit / Receive | Identical |
| Flexible / Rigid | Flexible | Flexible | Identical |
| Nucleus | 129Xe (Multinuclear Channel) | 129Xe (Multinuclear Channel) | Identical |
| Frequency ofOperation | 35.33 MHz | 35.33 MHz | Identical |
| Characteristic | Subject DevicePolarean XENOVIEW 3.0T ChestCoil (Models 44315-02 and44315-04) | Primary Predicate DevicePolarean XENOVIEW 3.0T ChestCoil (Model 44315-03) (K231647) | Comparison |
| 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 |
| # 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 followina testina:
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 Sinqle-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance lmaqinq
- . 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 (K231647).
§ 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.