(26 days)
The Cranial 4Pi Immobilization is a device used for immobilization of the patient's •cranial area •head and neck area in a CT- and linear accelerator environment.
The Cranial 4Pi Immobilization device is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.
The Cranial 4Pi Immobilization group of devices is used for fixation and repositioning of the patient's head and neck in a CT- and linear accelerator environment.
The SRS 4Pi CT Table Overlay (43430) is a medical device used for fixation and repositioning of the patient's head and neck in a CT- environment.
The mask sets Cranial 4Pi Stereotactic Mask (43450) / Cranial 4Pi Basic Mask (43451) / Cranial 4Pi Openface Mask (43452) are medical devices used for producing custom-made masks for patient fixation to the Overlay Board in a CT- and linear accelerator environment.
The device is portable. The system consists of two Overlays, three types of thermoplastic mask sets with the corresponding rear head support and a Target Pointer. The system fixates a patient mechanically to hold them still during CT scanning and again during Treatment. The Overlays (one for Linac room) are used to rigidly attach to multiple Table top/Couch Top types and to provide an interface to the Mask sets. The Target Pointer is used for performance of isocenter quality assurance procedures in a linear accelerator environment.
The provided text describes a medical device, Cranial 4Pi Immobilization, which is used for patient immobilization during radiotherapy and radiosurgery. The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device and details verification activities related to mechanical stability, usability, and biocompatibility.
However, the provided document does NOT contain information about any study that proves the device meets specific acceptance criteria related to its performance in terms of patient immobilization accuracy or any AI/imaging-related performance metrics. The text outlines the device's function (immobilization) and general safety/effectiveness verification, but it does not present a table of acceptance criteria with reported device performance outcomes for areas like:
- Accuracy of immobilization (e.g., maximum displacement allowed vs. measured displacement)
- Repeatability of patient positioning
- Performance compared to human readers (MRMC study)
- Standalone algorithm performance
- Details on test set or training set characteristics (sample size, provenance, ground truth establishment, expert adjudication).
The document is a regulatory submission for a physical immobilization device, not a software-driven AI diagnostic or therapeutic device. Therefore, questions 2 through 9 regarding study design, sample size, expert involvement, and AI performance are not applicable to the content provided.
Based on the provided text, I can only address the general nature of the "acceptance criteria" through the lens of safety and effectiveness for a physical device, and the "study" as the verification activities performed for regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of physical immobilization device are largely focused on mechanical stability, usability, and biocompatibility, rather than diagnostic accuracy or AI performance metrics. The document lists "Key Performance Specifications/Characteristics" as "Immobilization of patient's head or head and neck." However, it doesn't quantify this performance.
Here's an interpretation based on the provided text, focusing on the types of verification activities performed, which imply the acceptance criteria were related to meeting harmonized standards and ensuring user safety and device function.
| Acceptance Criteria Category | Report Device Performance (Based on Verification Activities) |
|---|---|
| Mechanical Stability | Acceptance Criteria: Device withstands forces and operational stresses without failure, ensuring patient stability and safety. Meets applicable paragraphs of IEC 60601-1:2005 AMD 2012. Reported Performance: "Mechanical stability tests (according to applicable paragraphs of IEC 60601-1:2005 AMD 2012)" were carried out. (Details of specific pass/fail results or quantitative data are not provided in this summary). |
| Usability | Acceptance Criteria: Device is safe and effective for use by intended users, minimizing use errors. Meets EN 62366:2008. Reported Performance: "Usability evaluations (according to EN 62366:2008)" were performed to ensure safe and effective user interaction (e.g., attachment of Overlay, patient immobilization with mask). (Specific findings or metrics of usability are not detailed). |
| Biocompatibility | Acceptance Criteria: Materials used in patient contact are non-toxic and do not cause adverse biological reactions. Meets ISO 10993-1: 2010. Reported Performance: "Biocompatibility testing acc. to ISO 10993-1: 2010" was conducted. (Specific results are not provided). |
| Dosimetry (Radiation Interaction) | Acceptance Criteria: Device does not unduly attenuate or build up radiation dose, ensuring accurate treatment delivery. Reported Performance: "Dosimetry testing (dose build-up, dose attenuation)" was performed. (Specific values or ranges are not provided). |
| Compatibility/Interface | Acceptance Criteria: Device interfaces correctly and safely with other specified equipment (CT- and linear accelerator environment, couch tops). Reported Performance: "Compatibility / interface testing" was performed. (Specific outcomes not detailed). |
| General Safety & Effectiveness | Acceptance Criteria: No new issues of safety and effectiveness are presented compared to the predicate device. Reported Performance: "The Subject Device do not present any new issues of safety and effectiveness when compared to the predicate device." This is a conclusion of the review, indicating these general criteria were met. |
The following points (2-9) are not applicable or cannot be answered based on the provided document, as it pertains to a physical immobilization device and not an AI/imaging diagnostic tool.
2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a patient image test set. The verification activities are related to device testing (e.g., mechanical, electrical, material).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the context of diagnostic imaging or AI performance is established or discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
August 19, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration".
Brainlab AG % Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Bavaria 81829 GERMANY
Re: K202050
Trade/Device Name: Cranial 4Pi Immobilization Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 21, 2020 Received: July 24, 2020
Dear Chiara Cunico:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K202050
Device Name Cranial 4Pi Immobilization
Indications for Use (Describe) The Cranial 4Pi Immobilization is a device used for immobilization of the patient's •cranial area •head and neck area in a CT- and linear accelerator environment.
The Cranial 4Pi Immobilization device is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.
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 PRAStaff@fda.hhs.gov
"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}------------------------------------------------
510(k) SUBMISSION
Image /page/3/Picture/1 description: The image shows the word "BRAINLAB" in a bold, sans-serif font. To the left of the word is a stylized logo that appears to be three abstract shapes stacked on top of each other. The logo and the word are both in black, and the background is white.
Image /page/3/Picture/2 description: The image is an abstract design featuring a series of interconnected triangles. The triangles vary in size and shade, transitioning from a darker blue on the left to a lighter blue and almost white on the right. White lines separate the triangles, creating a fragmented, geometric pattern across the image.
Image /page/3/Picture/3 description: The image shows the word "BRAINLAB" in a bold, sans-serif font. To the left of the word is a stylized logo that appears to be three curved lines stacked on top of each other. The logo and the word are both in black, and the background is white.
510(k) Summary
July 21, 2020
| General Information | |
|---|---|
| Manufacturer | Brainlab AG |
| Establishment Registration | 8043933 |
| Device Name | Accelerator, Linear, Medical |
| Trade Name | Cranial 4Pi Immobilization |
| Classification Name | Medical charged-particle radiation therapy system |
| Product Code | IYE |
| Regulation Number | 892.5050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Device and K Number | Frameless Radiosurgery Components - K053500 |
| Contact Information | |
|---|---|
| Primary Contact | Alternate Contact |
| Chiara Cunico | Regulatory Affairs Brainlab |
| Manager RA | Phone: +49 89 99 15 68 0 |
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 |
| Email: chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com |
1. Intended Use
The Cranial 4Pi Immobilization is a device used for immobilization of the patient's
- Cranial area
- Head and neck area
in a CT- and linear accelerator environment.
The Cranial 4Pi Immobilization device is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.
2. Device Description
{4}------------------------------------------------
510(k) SUBMISSION
Image /page/4/Picture/1 description: The image shows the logo for Brainlab. The logo consists of a stylized caduceus symbol on the left, followed by the word "BRAINLAB" in bold, sans-serif font. The caduceus symbol is a medical emblem featuring a staff with two snakes coiled around it.
The Cranial 4Pi Immobilization device is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments. Cranial 4Pi is an accessory to medical device ExacTrac Dynamic.
The Cranial 4Pi Immobilization group of devices is used for fixation and repositioning of the patient's head and neck in a CT- and linear accelerator environment.
The SRS 4Pi CT Table Overlay (43430) is a medical device used for fixation and repositioning of the patient's head and neck in a CT- environment.
The mask sets Cranial 4Pi Stereotactic Mask (43450) / Cranial 4Pi Basic Mask (43451) / Cranial 4Pi Openface Mask (43452) are medical devices used for producing custom-made masks for patient fixation to the Overlay Board in a CT- and linear accelerator environment.
The device is portable. The system consists of two Overlays, three types of thermoplastic mask sets with the corresponding rear head support and a Target Pointer. The system fixates a patient mechanically to hold them still during CT scanning and again during Treatment. The Overlays (one for Linac room) are used to rigidly attach to multiple Table top/Couch Top types and to provide an interface to the Mask sets. The Target Pointer is used for performance of isocenter quality assurance procedures in a linear accelerator environment.
Key Performance Specifications/Characteristics of the Device:
Primary Operating Function: Immobilization of patient's head or head and neck.
Series of tasks and user interactions that are frequently used and risk related
- Task: Attachment of Treatment Overlay to treatment couch top -
- User Interaction: Place Overlav on couch top ।
- User Interaction: Fixate Overlay to couch top with indexing brackets and locking latch mechanism
- Task: Immobilization of patient with mask -
- User Interaction: Attach rear mask to Overlav
- । User Interaction: Attach top mask to Overlay
Use Scenario
The following scenario describes the frequent use scenario and reflects already the worst case/ hazard related scenario.
An oncologist sends a patient with head or neck tumor for radiotherapy treatment. The patient will receive certain dose fractions according to a previously defined treatment plan. Therefore the patient lies on a couch with an Overlay during the CT imaging and for the treatment procedure. To immobilize the patient , thermoplastic mask sets (Stereotactic mask or Openface mask) in combination with the rear head support, are individually molded for each patient. A radiographer attaches the Mask set to the Overlay. Depending on the treatment indication the device is used for single-fraction treatments (radiosurgery) as well as for multi-fraction treatments (radiotherapy). If multi-fraction radiotherapy is applied the individually molded thermoplastic mask set ensures that for each fraction the patient is repositioned with the same position as in the initial setup.
3. Substantial Equivalence
{5}------------------------------------------------
510(k) SUBMISSION
Image /page/5/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in bold, sans-serif font on the right. The symbol appears to be an abstract representation of the brain.
When compared to its predicate device, the subject device remains same in terms of indications for use, the clinical condition, target user group, performance and safety characteristics, the principle of operation and the materials used.
Cranial patient immobilization via customized thermoplastic masks, which become flexible when heated up and are molded individually to the patient's head, is the technological principle for both the subject and predicate devices.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Masks made from thermoplastic material -
- -Mask adjustment
- -Fixation to CT/ treatment couch via an carbon-foam sandwich Overlay
The following technological differences exist between the subject and predicate devices:
- Subject offers additionally Open Face Mask and Basic Mask -
- Mask attachment and adjustment via integrated clipping mechanism and spacers (subject device) vs. separate clips and spacers (predicate device)
The only change is that new mask sheet cuts are available which enable a wider scope of application and that the integrated mask attachment and height adjustment unit improve the usability by eliminating loose separate parts of the predicate device.
Conclusion
The changes described above do not alter intended use or the fundamental scientific technology of the device because they do not change the operating principle. The Subject Device do not present any new issues of safety and effectiveness when compared to the predicate device. Therefore, we believe that Subject Device and the predicate device is substantially equivalent, as demonstrated above.
4. Verification Activities
The following verification activities were carried out to ensure the safety and efficacy of the device.
- Tests according to applicable harmonized standards (methods as specified)
- Mechanical stability tests (according to applicable paragraphs of IEC 60601-1:2005 AMD 2012) ●
- Usability evaluations (according to EN 62366:2008) ●
- Reviews of Procedures (E-TAPs and Service manuals)
- Reviews of Documents, Drawings and Datasheets ●
- Tests according to applicable paragraphs of IEC 60601-1:2005 AMD 2012
- Compatibility / interface testing ●
- Dosimetry testing (dose build-up, dose attenuation) ●
- Biocompatibility testing acc. to ISO 10993-1: 2010 ●
§ 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.