(134 days)
This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images.
Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.
MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
The proposed Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications The proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). The following modifications are covered compared to legally marketed predicate device: 1. Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10); 2. PerformanceBridge Protocol Manager Release 1.0; 3. Introduction of new gradient system hardware with new qradient specifications: 4. Introduction of new product name and covers. The proposed Ingenia Elition S and Ingenia Elition X R5.4 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: 1. mDIXON K102344 2. SWIp K131241 3. mDIXON-Quant K133526 4. MRE K140666 5. mDIXON XD K143128 6. O-MAR K143253 7. MultiBand SENSE K143606 8. Ingenia Coils See Appendix 004
The provided text is a 510(k) summary for the Philips Ingenia Elition S and Ingenia Elition X R5.4 Magnetic Resonance Diagnostic Devices. This document does not describe acceptance criteria or a specific study proving the device meets acceptance criteria in the way typically expected for an AI/algorithm-based device's performance.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3, K163116) through non-clinical performance data and compliance with recognized standards. The "acceptance criteria" referred to in the document are general statements about meeting regulatory and safety standards for an MRDD, rather than specific performance metrics (e.g., sensitivity, specificity, AUC) for an AI algorithm.
Therefore, many sections of your requested output cannot be fulfilled from the provided text.
Here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with international and FDA-recognized consensus standards (e.g., IEC, NEMA, ISO) | The device complies with the listed standards. |
| Meets acceptance criteria and is adequate for its intended use | Non-Clinical verification and validation tests demonstrate that the device meets acceptance criteria and is adequate for its intended use. |
| Substantial equivalence to predicate device in terms of safety and effectiveness | Demonstrated through non-clinical performance (verification and validation) tests. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The document explicitly states: "The proposed Ingenia Elition S and Ingenia Elition X R5.4 did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
- The "test set" in this context refers to non-clinical verification and validation tests, not a dataset of patient images for an algorithm's performance evaluation. No information on sample size or data provenance (country of origin, retrospective/prospective) for such tests is provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. As no clinical study was performed for AI algorithm performance, there's no mention of experts establishing a ground truth for a test set.
4. Adjudication Method for the Test Set:
- Not Applicable. No clinical study or performance evaluation with a test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states no clinical study was required. Therefore, an MRMC study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This submission is for an MRI system, not a standalone AI algorithm. The performance evaluation focuses on the safety and effectiveness of the MRI system, not an AI component's standalone diagnostic capabilities.
7. The Type of Ground Truth Used:
- Not Applicable. For the non-clinical verification and validation tests, the "ground truth" would be established by engineering specifications, regulatory standards, and expected physical performance parameters of the MRI system, rather than expert consensus, pathology, or outcomes data related to an algorithm's diagnostic output. The document doesn't detail the specifics of these non-clinical ground truths.
8. The Sample Size for the Training Set:
- Not Applicable. This is not a submission for an AI/ML algorithm that requires a training set. The "software changes" mentioned are minor updates to the operating system and existing functionalities, not the development of a new AI model requiring training data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No AI/ML algorithm requiring a training set is described.
In summary:
This 510(k) submission primarily details the device (an MRI system) modifications and demonstrates substantial equivalence to a previously cleared predicate device through compliance with various non-clinical standards and tests. It does not involve the evaluation of an AI algorithm's diagnostic performance against specific acceptance criteria using patient data, and thus, many of the requested details are not present in this type of regulatory filing.
{0}------------------------------------------------
March 20, 2018
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue and white.
Philips Medical Systems Nederland B.V. % Mr. Henrie Daniels Regulatory Affairs Specialist Veenpluis 4-6 5684 PC, Best THE NETHERLANDS
Re: K173451
Trade/Device Name: Ingenia Elition S and Ingenia Elition X Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI Dated: February 7, 2018 Received: February 12, 2018
Dear Mr. Daniels:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K173451
Device Name Ingenia Elition S and Ingenia Elition X
Indications for Use (Describe)
This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images.
Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.
MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
| 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) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.
Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Abbreviated 510(k)
Ingenia Elition S and Ingenia Elition X R5.4
Section 5
510(k) Summary
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | October 20, 2017 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277 |
| Primary Contact Person: | Jan van de KerkhofSr. Manager Regulatory AffairsPhone: +31 613300542E-mail: jan.van.de.kerkhof@philips.com |
| Secondary Contact Person | Henrie DanielsRegulatory Affairs SpecialistTelephone: +31 643837374E-mail: henrie.daniels@philips.com |
| Device Name: | Ingenia Elition S and Ingenia Elition X R5.4 |
| Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Regulation: 21CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: 90LNH90LNI |
| Primary Predicate Device: | Trade name: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K163116Classification Regulation: 21CFR 892.1000Classification name: Magnetic Resonance Diagnostic Device (MRDD)Classification Panel: RadiologyDevice class: Class IIProduct Code: 90LNH90LNI |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill the majority of the frame. The background is plain white, which makes the blue letters stand out.
The proposed Ingenia Elition S and Ingenia Elition X R5.4 with Device Description: new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications The proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). The following modifications are covered compared to legally marketed predicate device: 1. Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10); 2. PerformanceBridge Protocol Manager Release 1.0; 3. Introduction of new gradient system hardware with new qradient specifications: 4. Introduction of new product name and covers. The proposed Ingenia Elition S and Ingenia Elition X R5.4 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: 1. mDIXON K102344 2. SWIp K131241 3. mDIXON-Quant K133526 4. MRE K140666 5. mDIXON XD K143128 6. O-MAR K143253 7. MultiBand SENSE K143606 8. Ingenia Coils See Appendix 004
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.
| Indications for Use: | This system is a Magnetic Resonance Medical Electrical Systems |
|---|---|
| indicated for use as a diagnostic device. The system can producecross-sectional images, spectroscopic images and/or spectra inany orientation of the internal structure of the head, body orextremities. | |
| Magnetic Resonance images represent the spatial distribution ofprotons or other nuclei with spin. Image appearance is determinedby many different physical properties of the tissue and theanatomy, and the MR scan technique applied. The imageacquisition process can be synchronized with the patient'sbreathing or cardiac cycle. The systems can use combinations ofimages to produce physical parameters, and related derivedimages. | |
| Images, spectra, and measurements of physical parameters,when interpreted by a trained physician, provide information thatmay assist the diagnosis and therapy planning. The accuracy ofdetermined physical parameters depends on system and scanparameters, and must be controlled and validated by the clinicaluser. The use of contrast agents for diagnostic imagingapplications should be performed consistent with the approvedlabeling for the contrast agent. | |
| In addition the Philips MR systems provide imaging capabilities,such as MR fluoroscopy, to guide and evaluate interventional andminimally invasive procedures in the head, body and extremities. | |
| MR Interventional procedures, performed inside or adjacent to thePhilips MR system, must be performed with MR Conditional or MRSafe instrumentation as selected and evaluated by the clinicaluser for use with the specific MR system configuration in thehospital. The appropriateness and use of information from aPhilips MR system for a specific interventional procedure andspecific MR system configuration must be validated by the clinicaluser. |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and colored in a bright blue. The background is white, providing a strong contrast that makes the word stand out.
| Design Features/Fundamental ScientificTechnology: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 arebased on the principle that certain atomic nuclei present in thehuman body will emit a weak relaxation signal when placed in astrong magnetic field and excited by a radio signal at theprecession frequency. The emitted relaxation signals are analyzedby the system and a computed image reconstruction is displayedon a video screen.The principal technological components (magnet, receive coilsand patient support) of the proposed Ingenia Elition S andIngenia Elition X R5.4 are identical to those used in the legallymarketed predicate device, Ingenia 1.5T, Ingenia 1.5T S andIngenia 3.0T R5.3 (K163116, 01/06/2017), except for the transmitbody coil and the gradient coil, which have been changed to adaptto the changed voltage levels of the gradient amplifier.Based on the information provided above, the proposed IngeniaElition S and Ingenia Elition X R5.4 does not raise differentquestions of safety and effectiveness compared to the legallymarketed predicate device Ingenia 1.5T, Ingenia 1.5T S andIngenia 3.0T R5.3 (K163116, 01/06/2017). |
|---|---|
| ----------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue letters.
| Summary of Non-Clinical PerformanceData: | The proposed Ingenia Elition S and Ingenia Elition X R5.4comply with the following international and FDA-recognizedconsensus standards: |
|---|---|
| • IEC60601-1 Edition 3 | |
| • IEC60601-1-2 Edition 3 | |
| • IEC60601-1-6 Edition 3 | |
| • IEC62366 Edition 1 | |
| • IEC60601-1-8 Edition 2 | |
| • IEC60601-2-33 Edition 3 | |
| • IEC 62304 Edition 1 | |
| • NEMA MS-1 2008 | |
| • NEMA MS-4 2010 | |
| • NEMA MS-8 2008 | |
| • NEMA PS 3.1-PS 3.20 | |
| • ISO 14971 Edition 2 | |
| • Device specific guidance document, entitled "Guidance for theSubmission Of Premarket Notifications for Magnetic ResonanceDiagnostic Devices – November 18, 2016" | |
| • Guidance for Industry and FDA Staff - Guidance for the Contentof Premarket Submissions for Software Contained in MedicalDevices (issued May 11, 2005) | |
| • Guidance for Industry and FDA Staff - Applying Human Factorsand Usability Engineering to Medical Devices 9 issued February3, 2016) | |
| • Guidance for Industry and FDA Staff - Content of PremarketSubmissions for Management of Cybersecurity in MedicalDevices issued October 2, 2014 | |
| • Guidance for Industry and FDA Staff – Use of InternationalStandard ISO 10993-1, "Biological evaluation of medicaldevices – Part 1: Evaluation and testing within a riskmanagement process" (issued June 16, 2016) | |
| • Guidance for Industry and FDA Staff – Information to Support aClaim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016) | |
| Non-Clinical verification and or validation tests have beenperformed with regards to the intended use, the technical claims,the requirement specifications and the risk management results. | |
| The verification and/or validation test results demonstrate that the |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue letters.
| • Complies with the aforementioned international and FDArecognized consensus standards and Device specificguidance document, entitled "Guidance for the Submission OfPremarket Notifications for Magnetic Resonance DiagnosticDevices - November 18, 2016"• Meets the acceptance criteria and is adequate for its intendeduse. | |
|---|---|
| Therefore, the proposed Ingenia Elition S and Ingenia Elition XR5.4 are substantially equivalent to the legally marketed predicatedevice Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3(K163116, 01/06/2017) in terms of safety and effectiveness. | |
| Summary of ClinicalData: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 didnot require a clinical study since substantial equivalence to thelegally marketed predicate device was proven with theverification/validation testing. |
| SubstantialEquivalence: | The proposed Ingenia Elition S and Ingenia Elition X R5.4 andthe legally marketed predicate device Ingenia 1.5T, Ingenia 1.5TS and Ingenia 3.0T R5.3 (K163116, 01/06/2017) have the sameindications for use with respect to the following:• Providing cross-sectional images based on the magneticresonance phenomenon• Interpretation of the images is the responsibility of trainedphysicians• Images can be used for interventional and treatment planningpurposesThe proposed Ingenia Elition S and Ingenia Elition X R5.4 aresubstantially equivalent to the legally marketed predicate deviceIngenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116,01/06/2017) in terms of design features, fundamental scientific |
| technology, indications for use, and safety and effectiveness.Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, whichcomplied with the requirements specified in the international andFDA-recognized consensus standards and device-specificguidance. | |
| Conclusion: | The results of these tests demonstrate that the proposed IngeniaElition S and Ingenia Elition X R5.4 meet the acceptance criteriaand is adequate for its intended use. |
§ 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.