(213 days)
MapRT is indicated for assisting with planning of radiation therapy by:
- Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and
- Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures
MapRT is used by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation.
MapRT uses two lateral wide-field cameras in simulation to deliver a full 3D model of patients and accessories. This model is then used to calculate a clearance map for every couch (x-axis) and gantry (y-axis) angles. Radiotherapy treatment plans can then be imported automatically to check beams, arcs, and the transition clearance.
The provided document is a 510(k) clearance letter for a software device called MapRT, which assists in radiation therapy planning by predicting collisions. However, the document explicitly states: "As with the predicate device, no clinical investigations were performed for MapRT. Verification tests were performed to ensure that the module works as intended and pass/fail criteria were used to verify requirements. Validation testing was performed using summative evaluation techniques per 62366-1:2015/A1:2020. Verification and validation testing passed in all test cases."
This means the submission did not include a study design or performance data in the typical sense of a clinical trial or a multi-reader multi-case (MRMC) study to prove the device meets acceptance criteria related to clinical performance metrics like sensitivity, specificity, accuracy, or reader improvement. Instead, the clearance relies on:
- Substantial Equivalence: The primary argument for clearance is that MapRT v1.2 is substantially equivalent to its predicate device (MapRT v1.0, K231185). The document highlights that the indications for use, functionality, technological characteristics, and intended users are the same as the predicate.
- Verification and Validation (V&V) Testing: The document mentions that "Verification and validation testing passed in all test cases," indicating that the software meets its design specifications and functions as intended, primarily in terms of software functionality and accuracy of collision prediction within its defined operational parameters.
Given this information, it's not possible to fill out all aspects of your requested response, particularly those related to clinical studies, ground truth establishment, expert consensus, and MRMC studies, as they were explicitly not performed.
Here's an attempt to answer based on the provided document, noting where information is not available:
Device Acceptance Criteria and Study Performance for MapRT
The FDA 510(k) clearance for MapRT v1.2 is primarily based on demonstrating substantial equivalence to a legally marketed predicate device (MapRT v1.0, K231185) and successful completion of software verification and validation activities. The submission explicitly states that "no clinical investigations were performed for MapRT." Therefore, the acceptance criteria and performance proof are framed in the context of software verification and validation, and functional accuracy rather than clinical efficacy studies.
1. Acceptance Criteria and Reported Device Performance
The core functional acceptance criterion is the accuracy of collision prediction.
| Acceptance Criterion (Functional/Technical, as per document) | Reported Device Performance |
|---|---|
| Accuracy of Gantry Clearance Calculation | Calculates gantry clearance with an accuracy of ± 2cm. |
| Verification & Validation (V&V) Testing | "Verification and validation testing passed in all test cases." This implies meeting all internal design specifications and functional requirements as per 62366-1:2015/A1:2020 for summative evaluation techniques. The device "continues to meet the design specifications and performs as intended." |
| Substantial Equivalence | Demonstrated substantial equivalence to predicate device (MapRT v1.0, K231185) in Indications for Use, Intended Users, Contraindications, Functionality, Technology, Input/Output, and Design (with minor non-safety impacting GUI differences). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "test set" in the context of patient data or clinical cases. The performance data mentioned refer to software verification and validation tests, which would involve a set of test cases designed to cover various scenarios and functional requirements. The specific number or nature of these test cases is not detailed.
- Data Provenance: Not applicable for a clinical test set, as no clinical investigations were performed. The V&V testing would likely involve simulated data, synthetic models, or potentially anonymized patient models used for testing collision detection scenarios. The provenance (country of origin, retrospective/prospective) of such test data is not provided.
3. Number of Experts Used to Establish Ground Truth for Test Set and Their Qualifications
Not applicable. Since no clinical investigations were performed, there was no clinical "ground truth" established by experts in the context of patient outcomes or image interpretation. The ground truth for functional testing of collision prediction would be derived from precise engineering specifications and physical measurements, likely validated internally by the manufacturer's engineering team.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "As with the predicate device, no clinical investigations were performed for MapRT." Therefore, no MRMC study was conducted to compare human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, in essence. The stated "accuracy of ± 2cm" for gantry clearance calculation and the passing of "all test cases" in verification and validation testing refer to the isolated performance of the MapRT algorithm in predicting collisions and calculating clearance. This implies an evaluation of the algorithm's functional accuracy independent of human interaction beyond inputting treatment plans. However, the details of how this accuracy was measured (e.g., against a gold standard derived from physical models or high-precision simulations) are not provided in this summary.
7. The Type of Ground Truth Used
For the accuracy of gantry clearance calculation (± 2cm), the ground truth would typically be established through:
- Precise engineering specifications and measurements of physical models of the treatment machine, patient, and support structures.
- High-fidelity simulation data where collision events and clearances can be precisely calculated geometrically.
It is not based on expert consensus, pathology, or outcomes data, as these are typically associated with clinical diagnostic or prognostic devices.
8. Sample Size for the Training Set
Not applicable. MapRT is a software device that simulates radiation treatment plans and predicts collisions based on geometric models and calculations. There is no indication that it is an AI/Machine Learning model that requires a "training set" of data in the conventional sense (e.g., for image classification or pattern recognition). Its "knowledge" of collision mechanics and geometries comes from programmed rules and pre-loaded models (e.g., LiDAR scans or 3D CAD models of equipment), not from learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI/ML model for MapRT based on the provided information.
FDA 510(k) Clearance Letter - MapRT
Page 1
May 19, 2025
Vision RT Ltd
Watheq Al-Hakam
Senior Regulatory Affairs Specialist
Dove House, Arcadia Avenue
London, N3 2JU
United Kingdom
Re: K243301
Trade/Device Name: MapRT
Regulation Number: 21 CFR 892.5050
Regulation Name: Medical Charged-Particle Radiation Therapy System
Regulatory Class: Class II
Product Code: IYE
Dated: April 24, 2025
Received: April 24, 2025
Dear Watheq Al-Hakam:
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.
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"
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K243301 - Watheq Al-Hakam Page 2
(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 (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-reporting-combination-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 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243301 - Watheq Al-Hakam Page 3
assistance/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,
Lora D. Weidner, Ph.D.
Assistant Director
Radiation Therapy Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243301
Device Name
MapRT
Indications for Use (Describe)
MapRT is indicated for assisting with planning of radiation therapy by:
- Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and
- Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures
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
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"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."
Page 5
MapRT 1.2 – 510(k) Summary Page 1 of 9
MapRT 1.2 510(k) notification
510(k) Summary
The information below is provided for modifications to MapRT following the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR 807.92.
Submitter's information
Submitter's name: Watheq Al-Hakam
Company: Vision RT Ltd.
Address: Dove House
Arcadia Avenue
London, N3 2JU
United Kingdom
Contact person: Watheq Al-Hakam
Senior Regulatory Affairs Specialist
Phone: +44 (0)20 8346 4300
Fax: N/A
Email: regulatory@visionrt.com
Date summary was prepared: 18-Oct-2024
Primary Predicate device information
Device name: MapRT
Premarket notification: K231185
Manufacturer: Vision RT Limited
Common name: Surface-guided clearance mapping system
Classification: Class II
Classification name: Medical charged-particle radiation therapy system
Regulation number: 892.5050
Device information
Trade name: MapRT
Common name: Surface-guided clearance mapping system
Classification: Class II
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MapRT 1.2 – 510(k) Summary Page 2 of 9
MapRT 1.2 510(k) notification
Classification name: Medical charged-particle radiation therapy system
Regulation number: 892.5050
Product code: IYE
Classification panel: Radiology
Device description
MapRT is used by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation.
MapRT uses two lateral wide-field cameras in simulation to deliver a full 3D model of patients and accessories. This model is then used to calculate a clearance map for every couch (x-axis) and gantry (y-axis) angles. Radiotherapy treatment plans can then be imported automatically to check beams, arcs, and the transition clearance.
Indications for use
MapRT is indicated for assisting with planning of radiation therapy by:
- Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and
- Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
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MapRT 1.2 – 510(k) Summary Page 3 of 9
MapRT 1.2 510(k) notification
Technological characteristics
The substantial equivalence comparison table below provides a comparison of the technological characteristics of MapRT to those of the predicate device MapRT.
| Predicate device (K231185 MapRT v1.0) | Subject device (K243301 MapRT v1.2) | Comments | |
|---|---|---|---|
| Manufacturer | Vision RT Ltd. | Vision RT Ltd. | Equivalent to the predicate device. |
| Indications for use | MapRT is indicated for assisting with planning of radiation therapy by:- Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and- Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures. | MapRT is indicated for assisting with planning of radiation therapy by:- Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and- Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures. | Equivalent to the predicate device. |
| Contra-indications | None. | None. | Equivalent to the predicate device. |
| Intended users | Trained clinically qualified | MapRT is intended to be used | Equivalent to the predicate |
MapRT 1.2 – 510(k) Summary Page 3 of 9
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MapRT 1.2 – 510(k) Summary Page 4 of 9
MapRT 1.2 510(k) notification
| Predicate device (K231185 MapRT v1.0) | Subject device (K243301 MapRT v1.2) | Comments | |
|---|---|---|---|
| radiation oncology personnel. | by radiotherapy professionals. | device. | |
| OTC/Rx | Rx | Rx | Equivalent to the predicate device. |
| Functionality | Simulates Radiation Treatment Plans to check static and arc beams, and transition clearance in between fields, predict collisions between the gantry and patient, couch and accessories and facilitate dose optimisation.- reconstruction of patient and treatment accessory surfaces acquired during simulation;- modelling the geometry and movement of equipment within the radiotherapy environment to check for collisions in the designed plan;- and facilitating treatment plan optimisation. | Simulates Radiation Treatment Plans to check static and arc beams, and transition clearance in between fields, predict collisions between the gantry and patient, couch and accessories and facilitate dose optimisation.- reconstruction of patient and treatment accessory surfaces acquired during simulation;- modelling the geometry and movement of equipment within the radiotherapy environment to check for collisions in the designed plan;- and facilitating treatment plan optimisation. | Equivalent to the predicate device. |
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MapRT 1.2 – 510(k) Summary Page 5 of 9
MapRT 1.2 510(k) notification
| Predicate device (K231185 MapRT v1.0) | Subject device (K243301 MapRT v1.2) | Comments | |
|---|---|---|---|
| Energy used and/or delivered | None - software-only application. The software application does not deliver or depend on energy delivered to or from patients. | None - the software application and couch markers do not deliver or depend on energy delivered to or from patients. | Equivalent to the predicate device. |
| Design: Graphical User Interface | Contains a Data Visualisation / Graphical User Interface | Contains a Data Visualisation / Graphical User Interface | Minor differences to the predicate device, the changes that have been made are visual only and do not impact the clinical workflow.This minor difference does not affect the safety or effectiveness of the device. MapRT works as intended and sufficient verification & validation testing has been conducted which show the software functions effectively to achieve its intended use. |
| Design: supported files | Files exported from the Treatment Planning System containing Treatment Plan (including treatment field) | Files exported from the Treatment Planning System containing Treatment Plan (including treatment field) | Equivalent to the predicate device. |
MapRT 1.2 – 510(k) Summary Page 5 of 9
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MapRT 1.2 – 510(k) Summary Page 6 of 9
MapRT 1.2 510(k) notification
| Predicate device (K231185 MapRT v1.0) | Subject device (K243301 MapRT v1.2) | Comments | |
|---|---|---|---|
| parameters. | parameters. | ||
| Design: calculation requirements | Uses local hardware and couch markers. | Uses local hardware and couch markers. | Equivalent to the predicate device. |
| Design: reporting | Reporting built-in and user has ability to customise. | Reporting built-in and user has ability to customise. | Equivalent to the predicate device. |
| Pure software | Uses both software and hardware (5x adhesive couch markers). | Uses both software and hardware (5x adhesive couch markers). | Equivalent to the predicate device. |
| Operating system | Windows. | Windows. | Equivalent to the predicate device. |
| Input | Treatment data obtained from supporting Treatment Planning System. | Treatment data obtained from supporting Treatment Planning System. | Equivalent to the predicate device. |
| Simulation details | Simulates the plan and predicts whether any gantry collisions occur with patient or support structures.Calculates gantry clearance by modelling the patient and accessory surfaces acquired during CT simulation, along with pre-loaded models of the couch and gantry created from LiDAR scans or 3D CAD models. Clearance is calculated with an | Simulates the plan and predicts whether any gantry collisions occur with patient or support structures.Calculates gantry clearance by modelling the patient and accessory surfaces acquired during CT simulation, along with pre-loaded models of the couch and gantry created from LiDAR scans or 3D CAD models. Clearance is calculated with an | Equivalent to the predicate device. |
MapRT 1.2 – 510(k) Summary Page 6 of 9
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MapRT 1.2 – 510(k) Summary Page 7 of 9
MapRT 1.2 510(k) notification
| Predicate device (K231185 MapRT v1.0) | Subject device (K243301 MapRT v1.2) | Comments | |
|---|---|---|---|
| accuracy of ± 2cm. | accuracy of ± 2cm. | ||
| Collision check output | MapRT presents a Clearance Map to the user using the couch (x axis) and gantry (y axis) to show collision-free angles and angles resulting in a collision at any given isocentre. MapRT also displays these angles visually using the acquired patient and accessory surfaces and pre-loaded models of the couch and gantry. The user can interact with the Clearance Map to inspect clearance at any couch / gantry angle and isocentre. | MapRT presents a Clearance Map to the user using the couch (x axis) and gantry (y axis) to show collision-free angles and angles resulting in a collision at any given isocentre. MapRT also displays these angles visually using the acquired patient and accessory surfaces and pre-loaded models of the couch and gantry. The user can interact with the Clearance Map to inspect clearance at any couch / gantry angle and isocentre. | Equivalent to the predicate device. |
| Dose optimisation | MapRT presents a Clearance Map to the user This map displays which couch / gantry angles and isocentres would result in a collision during treatment, and which are available to enhance the dose distribution. | MapRT presents a Clearance Map to the user This map displays which couch / gantry angles and isocentres would result in a collision during treatment, and which are available to enhance the dose distribution. | Equivalent to the predicate device. |
| Materials | couch/index bar markers: | couch/index bar markers: | Materials used are substantially equivalent to |
MapRT 1.2 – 510(k) Summary Page 7 of 9
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MapRT 1.2 – 510(k) Summary Page 8 of 9
MapRT 1.2 510(k) notification
| Predicate device (K231185 MapRT v1.0) | Subject device (K243301 MapRT v1.2) | Comments | |
|---|---|---|---|
| High-durability paper stickers with permanent adhesive acrylic. | High-tack vinyl markers overlayed with clear matt over-laminating film. | the predicate device.As per Appendix A of Evaluating Substantial Equivalence in Premarket Notifications 510(k), the materials do not impact the technological characteristics of the device. The materials do not have any biocompatibility concerns or introduce any new safety and effectiveness concerns. |
Table 1 - Substantial Equivalence table
MapRT 1.2 – 510(k) Summary Page 8 of 9
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MapRT 1.2 – 510(k) Summary Page 9 of 9
MapRT 1.2 510(k) notification
Performance data
As with the predicate device, no clinical investigations were performed for MapRT. Verification tests were performed to ensure that the module works as intended and pass/fail criteria were used to verify requirements. Validation testing was performed using summative evaluation techniques per 62366-1:2015/A1:2020. Verification and validation testing passed in all test cases.
Conclusion
MapRT is substantially equivalent to the predicate device. The minor technological change to the graphical user interface between MapRT and the predicate device does not raise any questions on the safety and effectiveness of MapRT.
Verification and validation activities have been performed following the same methods as the cleared device. Results of verification and validation activities confirm that the device continues to meet the design specifications and performs as intended. There are no changes to the indications or intended use of the device.
MapRT 1.2 – 510(k) Summary Page 9 of 9
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.