Ingenia 1.5T and Ingenia 1.5T S R5.2

• K Number: K153324
• Device Name: Ingenia 1.5T and Ingenia 1.5T S R5.2
• Manufacturer: PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
• Date Cleared: 2016-03-22 ( 125 days)
• Product Code: LNH , LNI
• Regulation Number: 892.1000
• Type: Abbreviated
• Panel: Radiology
• Reference & Predicate Devices: K110151
• Predicate For: N/A

Intended Use

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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician.

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 specific MR 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.

Device Description

The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature is provided with a 70 cm magnet. ScanWise Implant functionality enables MR technologists to implement an improved and controlled workflow for MR Conditional implants. The feature consists of an extension to the Patient Registration User Interface where the information relevant to MR Conditional device labeling can be assessed, controlled and reviewed. The ScanWise Implant feature allows the user at the examination level to define restrictions on the 'active fields' generated by the MR system.

The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature also consolidates separately-cleared novel functionalities, and minor hardware and software changes since the clearance of the currently marketed and predicate device, Ingenia R4 (K110151, 03/22/2011).

Following minor hardware and software changes are covered in this submission:

1. (Hardware) Enhanced Patient Communication User Interface Module, IEC/ISO compliant symbols.
2. (Hardware) New computing platform and peripherals for MR Spectrometer (DDAS).
3. (Software) User Interface layout modifications for scan preparation, sequence planning (geometries and parameters), and data processing and viewing.
4. (Software) Planning on cine images.
5. (Software) SAR related parameters (SED). Pregnancy status related to Normal Mode.
6. (Software) Parameter optimization for the reconstruction algorithms.
7. (Software) Partial NSA algorithm in reconstruction.
8. (Software) AutoVoice, using pre-recorded spoken instructions.
9. (Software) VCG, optimized electrode placement and enhanced algorithm.
10. (Software) ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise.
11. Enhanced sequences:
    a. AutoSpair.
    b. TSE flow compensation enhancement.
    c. Optimized 3D TSE flip angle sweeps per anatomy.
    d. ENCASE: 3D encoding.
    e. CardiacQuant: triggered T1 mapping sequence.
    f. pCASL.
    g. DTI enhancements.

AI/ML Overview

The provided text primarily focuses on demonstrating substantial equivalence of the Philips Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria.

However, based on the Summary of Non-Clinical Performance Data and Summary of Clinical Data sections, we can infer some information relevant to acceptance criteria and the "study" conducted.

Here's an attempt to structure the information as requested, drawing conclusions from the provided text where explicit details are not present.

Acceptance Criteria and Device Performance

The document doesn't provide a table of explicit, quantitative acceptance criteria for the device's performance (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). Instead, the acceptance criteria are implicitly tied to demonstrating safety and effectiveness compared to a predicate device, and compliance with various standards.

Acceptance Criterion (Inferred from text)	Reported Device Performance
Safety:
Patient protection against excessive RF exposures (SAR, B1+rms controls)	ScanWise Implant uses existing safety mechanisms to protect the patient against excessive RF exposures (Whole Body and Head SAR, local SAR controls, and display of B1+rms). No modifications relative to the implementation of safety mechanisms relative to the predicate device was required.
Prevention of peripheral nerve stimulation (dB/dt control)	ScanWise Implant extends existing software safety provisions to prevent peripheral nerve stimulation. dB/dt is controlled not to exceed a user-specified value (implying adherence to safety limits).
Compliance with international and FDA-recognized consensus standards (e.g., IEC60601 series, NEMA MS series, ISO 14971)	The proposed device complies with and meets the acceptance criteria of: IEC60601-1 Edition 3 Amendment 1, IEC60601-1-2 Edition 3, IEC60601-1-6 Edition 3 / IEC62366, IEC60601-1-8 Edition 2, IEC60601-2-33 Edition 3 Amendment 1, IEC 62304, NEMA MS-1 2008, NEMA MS-4 2008, NEMA MS-8 2008, ISO 14971 (2007), and the device-specific guidance "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14 1998".
Effectiveness:
Human Factors Engineering acceptance (for ScanWise Implant feature)	Human Factors Engineering testing was performed in line with FDA's guidance document "Applying Human Factors and Usability Engineering to Optimize Medical Device Design - June 22, 2011", indicating successful evaluation of usability and user interface for the ScanWise Implant feature.
Equivalent imaging capabilities and diagnostic information to predicate 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. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. (Stated as equivalent to predicate, and supported by non-clinical verification/validation).
Adequate for intended use	Non-clinical verification and/or validation tests demonstrate that the proposed device "Meets the acceptance criteria and is adequate for its intended use." (This is a general statement, not specific quantitative metrics).

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document states that "Non-Clinical verification and or validation tests have been performed." and mentions "sample clinical images." However, no specific sample size for a test set (e.g., number of patients, number of images) is provided.
   • Data Provenance: Not specified. Given the lack of a clinical study, the "sample clinical images" were likely used for qualitative assessment during non-clinical validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No clinical study involving expert interpretation for ground truth establishment is described. The device's primary pathway to market is substantial equivalence to a predicate, relying on non-clinical testing and engineering validation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical study with expert adjudication is described.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness."
   • The device being cleared is an MR system, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate reader improvement. The "ScanWise Implant" feature is described as enabling an "improved and controlled workflow" for MR Conditional implants, acting as a control mechanism rather than an interpretive AI.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable in the typical sense of an AI algorithm. This is a hardware and software update to an MRI system. The performance evaluated was the system's ability to operate safely and effectively, and to manage parameters for MR Conditional implants, rather than an "algorithm only" diagnostic performance. The text mentions "Parameter optimization for the reconstruction algorithms" and "Partial NSA algorithm in reconstruction" which are standalone algorithms within the system, but their performance isn't quantified in terms of diagnostic metrics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the non-clinical validation, the "ground truth" was implicitly defined by engineering specifications, safety standards, and the performance characteristics of the predicate device. The text doesn't describe pathology-confirmed diagnoses or outcomes data as "ground truth."

7. The sample size for the training set:

   • Not applicable in the context of machine learning training data. This submission describes a new version of an MRI system, not an AI/ML device that requires a distinct training set. The various software enhancements and algorithms mentioned (e.g., parameter optimization for reconstruction, DTI enhancements, ComforTone) were developed and refined through engineering processes, not via a labelled "training set" like a typical AI application.

8. How the ground truth for the training set was established:

   • Not applicable. (See point 7).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2016

Philips Medical Systems, Nederlands B.V. % Mr. Henrie Daniels Regulatory Affairs Engineer Veenpluis 4-6 Best, 5684 PC THE NETHERLANDS

Re: K153324

Trade/Device Name: Ingenia 1.5T and Ingenia 1.5T S R5.2 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI Dated: February 16, 2016 Received: February 18, 2016

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'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

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Indications for Use

510(k) Number (if known) K153324

Device Name

Ingenia 1.5T and Ingenia 1.5T S R5.2

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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician.

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 specific MR 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)

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

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:	March 16, 2016
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-6, 5684 PC, Best, The NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Henrie DanielsRegulatory Affairs EngineerPhone: [phone]E-mail: [e-mail]
Secondary ContactPerson	Ruojuan ZhangRegulatory Affairs engineerPhone: [phone]E-mail: [e-mail]
Device Name:	Ingenia 1.5T and Ingenia 1.5T S R5.2
Classification:	Classification Name:	Magnetic Resonance DiagnosticDevice (MRDD)
	Classification Regulation:	21CFR §892.1000
	Classification Panel:	Radiology
	Device Class:	Class II
	Primary Product code:	90LNH90LNI
Primary PredicateDevice:	Trade Name:	ACHIEVA R4 1.5T and ACHIEVAR4 3.0T (aka Ingenia)
	Manufacturer:	Philips Medical Systems NederlandB.V.
	510(k) Clearance:	K110151 (March 22, 2011)
	Classification Regulation:	21 CFR, Part 892.1000
	Classification Name:	Magnetic Resonance DiagnosticDevice (MRDD)
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	90LNH
	90LNI
Device description:	The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 withScanWise Implant feature is provided with a 70 cm magnet.ScanWise Implant functionality enables MR technologists toimplement an improved and controlled workflow for MRConditional implants. The feature consists of an extension to thePatient Registration User Interface where the information relevantto MR Conditional device labeling can be assessed, controlled andreviewed. The ScanWise Implant feature allows the user at theexamination level to define restrictions on the 'active fields'generated by the MR system.The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 withScanWise Implant feature also consolidates separately-cleared novelfunctionalities, and minor hardware and software changes since theclearance of the currently marketed and predicate device, IngeniaR4 (K110151, 03/22/2011).Following minor hardware and software changes are covered in thissubmission:1. (Hardware) Enhanced Patient Communication User InterfaceModule, IEC/ISO compliant symbols.2. (Hardware) New computing platform and peripherals for MRSpectrometer (DDAS).3. (Software) User Interface layout modifications for scanpreparation, sequence planning (geometries and parameters), anddata processing and viewing.4. (Software) Planning on cine images.5. (Software) SAR related parameters (SED). Pregnancy statusrelated to Normal Mode.6. (Software) Parameter optimization for the reconstructionalgorithms.7. (Software) Partial NSA algorithm in reconstruction.8. (Software) AutoVoice, using pre-recorded spoken instructions.9. (Software) VCG, optimized electrode placement and enhancedalgorithm.10. (Software) ComforTone: mechanical resonance frequencydependent timing adjustments of sequences for lower acousticnoise.11. Enhanced sequences:a. AutoSpair.b. TSE flow compensation enhancement.c. Optimized 3D TSE flip angle sweeps per anatomy.
		d. ENCASE: 3D encoding.
		e. CardiacQuant: triggered T1 mapping sequence.
		f. pCASL.
		g. DTI enhancements.
Indications for Use:	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 anatomy, 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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician.
	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 specific MR 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.
FundamentalScientific Technology:	The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature is based on the principle that certain atomic nuclei present in the human body will emit a weak relaxation signal when placed in a strong magnetic field and excited by a radio signal at the precession frequency
Summary of Non-Clinical PerformanceData:	The emitted relaxation signals are analyzed by the system and a computed image reconstruction is displayed on a video screen.The principal technological components (magnet, transmit body coil, gradient coil, receive coils and patient support) of the proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature is identical to those used in the currently marketed and predicate device, Ingenia R4( K110151, 03/22/2011).ScanWise Implant uses existing safety mechanisms to protect the patient against excessive RF exposures. This includes Whole Body and Head SAR, local SAR controls, and display of B1+rms. No modifications relative to the implementation of safety mechanisms relative to the predicate device was required.ScanWise Implant extends existing software safety provisions to prevent peripheral nerve stimulation. In previous products, dB/dt was evaluated (at the compliance volume defined in IEC60601-2-33) and displayed for informational purposes. In this software, dB/dt is controlled not to exceed a user-specified value.Based on the information provided above, the proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature does not raise different questions of safety and effectiveness compared to the marketed and predicate device, Ingenia R4(K110151,03/22/2011).The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature comply with the following international and FDA-recognized consensus standards:IEC60601-1 Edition 3 Amendment 1 IEC60601-1-2 Edition 3 IEC60601-1-6 Edition 3 / IEC62366 IEC60601-1-8 Edition 2 IEC60601-2-33 Edition 3 Amendment 1 IEC 62304 NEMA MS-1 2008 NEMA MS-4 2008 NEMA MS-8 2008 ISO 14971 Application of risk management to medical devices (2007) Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14 1998"
	Non-Clinical verification and or validation tests have been performedwith regards to the intended use, the technical claims, the requirementspecifications and the risk management results.
	Specifically for ScanWise Implant, Human Factors Engineeringtesting was performed in line with FDA's guidance document entitled"Applying Human Factors and Usability Engineering to OptimizeMedical Device Design - June 22, 2011".
	The verification, validation test results and sample clinical imagesdemonstrate that the proposed Ingenia 1.5T and Ingenia 1.5T SR5.2 with ScanWise Implant feature:
	Complies with the aforementioned international and FDA-recognized consensus standards and Device specificguidance document, entitled "Guidance for the SubmissionOf Premarket Notifications for Magnetic ResonanceDiagnostic Devices – November 14, 1998" Meets the acceptance criteria and is adequate for its intendeduse.
	Therefore, the proposed Ingenia 1.5T and Ingenia 1.5T S R5.2with ScanWise Implant feature is substantially equivalent to thecurrently marketed and predicate device, Ingenia R4( K110151,03/22/2011) in terms of safety and effectiveness.
Summary of ClinicalData:	The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 withScanWise Implant feature did not require clinical study sincesubstantial equivalence to the primary currently marketed andpredicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness.
SubstantialEquivalenceConclusion:	The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 withScanWise Implant feature and the currently marketed and predicatedevice, Ingenia R4( K110151, 03/22/2011) have the same primaryindications 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 treatmentplanning purposes

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The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature and control software are substantially equivalent to the currently marketed and predicate device, Ingenia R4 (K110151, 03/22/2011) in terms of improving the user control of safety related parameters in MR Conditional workflows.

The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature are substantially equivalent to the currently marketed and predicate device, Ingenia R4,(K110151, 03/22/2011), 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, which complied with the requirements specified in the international and FDA-recognized consensus standards and device-specific guidance. The results of these tests demonstrate that the proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature met the acceptance criteria and is adequate for its intended use.

Regulation Number and Section

§ 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.