(42 days)
The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: · accurate and reproducible patient positioning. • a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively (aka 4DCT) gated imaging and reconstruction. The system cannot directly determine the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.
The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the CT. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. On this surface the user, a health care professional, virtually marks where on the patient the respiratory motion signal shall be measured and in the next step, when the 4DCT imaging starts, the signal is measured with a frequency of around 16Hz. In general, the system is capable of acquiring more than 50 contours per second. The acquired 3D surface can also be exported and used as a reference image in the treatment room. The Sentinel system for the CT room is used in radiation therapy clinics to perform prospective or retrospective gated imaging (4DCT) prior to treatment. The system provides information about a patient's respiratory motion during the localization of the tumour in CT imaging. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments. The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the diagnostic procedure. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow. The software is designed to integrate with existing CT systems at the clinic. The Sentinel system does not require any markers to be placed on the patient or the couch and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the CT room during the whole set up procedure. Sentinel for the CT room includes the cRespiration module for respiratory gating during diagnostic CT imaging, so called 4D CT studies.
Here's a breakdown of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) summary) does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics for the Sentinel system or its cRespiration module. It makes a general statement about safety and effectiveness.
-
Acceptance Criteria (Implied): The device Sentinel, in particular its cRespiration module, should:
- Provide "accurate and reproducible patient positioning."
- Deliver "a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction."
- Be substantially equivalent to its predicate device (Sentinel K120668) in terms of technological characteristics, safety, and efficacy.
- Not introduce new issues of safety or efficacy due to software update (64-bit architecture) and rephrasing of intended use.
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Reported Device Performance:
- "The system is capable of acquiring more than 50 contours per second."
- Respiratory signal measured with a frequency of around 16Hz.
- Allows for two detection points for thoracic and abdominal breathing motions.
- Functionality of the software with respect to 64-bit support is unchanged.
- "Performance data has been submitted to show that Sentinel achieves its intended use and that the software update and rephrasing of intended use raise no new issues of safety or efficacy." (This is a general statement, not specific quantitative performance data in the document itself).
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "re-verification has been performed to verify that the design outputs meets the design inputs after the change from 32-bit to 64-bit support."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide details on the number of experts, their qualifications, or how they were used to establish ground truth for testing. It states that "the actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID," implying that qualified personnel are involved in clinical use and verification but not necessarily for structured testing with ground truth establishment.
4. Adjudication Method
The document does not mention any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth in a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI vs. without AI assistance. The device in question is a positioning and respiratory gating system, not an AI-based diagnostic tool for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document focuses on the system's capabilities (acquiring contours, measuring respiratory signals) and its integration into the clinical workflow, which inherently involves human interaction. It does not present data relevant to a standalone algorithm-only performance study. The system provides signals and positioning information to human professionals and other diagnostic equipment.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for testing. For its intended use of patient positioning and respiratory signal provision, ground truth would likely involve highly accurate measurements from other, established systems (e.g., precise physical measurements, data from other high-accuracy imaging modalities or motion tracking systems) against which the Sentinel system's output is compared.
8. Sample Size for the Training Set
The document does not provide the sample size for the training set. Given that this is a premarket notification for a predicate device with a software update and rephrased intended use, it's possible that extensive de novo training data for a machine learning model, as would be required for a distinctly AI device, was not the primary focus of this submission. The "re-verification" mentioned suggests testing against design inputs rather than extensive new machine learning model training.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth was established for any training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
C-Rad Positioning AB % Mr. Thomas Matzen Director Quality and Regulatory Affairs Bredgränd 18 Uppsala, Uppsala 75320 SWEDEN
April 20, 2020
Re: K200600
Trade/Device Name: Sentinel Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: March 23, 2020 Received: March 23, 2020
Dear Mr. Matzen:
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
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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
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Indications for Use
510(k) Number (if known) K200600
Device Name Sentinel
Indications for Use (Describe)
The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: · accurate and reproducible patient positioning.
• a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively (aka 4DCT) gated imaging and reconstruction.
The system cannot directly determine the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for C-RAD. The logo consists of a stylized letter "N" in orange, followed by the text "C-RAD". The "C" is also in orange, while the "RAD" is in gray. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
Owner:
C-Rad Positioning Ab Bredgränd 18 753 20 Uppsala Phone no. +46 (0)18 66 69 30 Fax no. +46 (0)18 12 69 30
Establishment registration no: 3006621300
500021500
Contact person:
Ellinor Nami Regulatory Affairs Specialist Phone no: +46 (0)18 410 82 36
Date of preparation:
February 24, 2020
Trade name of device:
Sentinel Sentinel 4DCT
Common name:
Radiotherapy positioning system
Classification name:
Medical charged-particle radiation therapy system Regulation: 21 CFR 892.5050
Product code: IYE
Predicate marketed device(s):
Sentinel (K120668)
Device description:
The Sentinel hardware consists of a single scanner unit containing the laser and camera. mounted in the ceiling in front of the CT. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. On this surface the user, a health care professional, virtually marks where on the patient the respiratory motion signal shall be measured and in the next step, when the 4DCT imaging starts, the signal is measured with a frequency of around 16Hz. In general, the system is capable of acquiring more than 50 contours per second. The acquired 3D surface can also be exported and used as a reference image in the treatment room.
The Sentinel system for the CT room is used in radiation therapy clinics to perform prospective or retrospective gated imaging (4DCT) prior to treatment. The system Sentinel 510(k) application Vol 006 510(k) Summary Page 1 (3)
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Image /page/4/Picture/0 description: The image shows the logo for C-RAD. The logo consists of an orange geometric shape resembling an abstract letter "N" or a stylized mountain range. To the right of the shape is the text "C-RAD," with the "C" in orange and the "RAD" in gray. The logo has a clean and modern design.
provides information about a patient's respiratory motion during the localization of the tumour in CT imaging. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.
The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the diagnostic procedure. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow. The software is designed to integrate with existing CT systems at the clinic. The Sentinel system does not require any markers to be placed on the patient or the couch and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the CT room during the whole set up procedure.
Sentinel for the CT room includes the cRespiration module for respiratory gating during diagnostic CT imaging, so called 4D CT studies.
cRespiration
The Sentinel system allows you to perform prospectively or retrospectively gated imaging (4DCT) and with an interface to the CT system the user can easily integrate cRespiration to the clinical work flow with improved accuracy in the CT room. cRespiration allows you to have two detection points which enables both thoracic and abdominal breathing motions to be detected in parallel.
Intended use:
The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides:
- accurate and reproducible patient positioning.
- a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) . for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction.
The system cannot directly determine the location of the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.
Technological comparison:
The Sentinel system is substantially equivalent to its predicate device Sentinel (K120668) in terms of their technological characteristics and its safety and efficacy profile.
The Sentinel system has been used in both treatment room and CT room in radiotherapy clinics. However, since 2017 it has only been used and supported in the CT room. The change we made to the intended use reflects the actual usage of the system to show that we no longer support patient motion supervision in treatment rooms. Based on a business decision this feature has been withdrawn for new sales and hence the intended use has been updated by removing the option of patient motion supervision in treatment room. This change does not have any effect on the validation and verification activities performed on the system.
The c4D software version 6.0.0 is supporting 64-bit architecture. In earlier versions the software was only supporting 32-bit architecture. In c4D 6.0.0 all program components have been compiled for 64-bit architecture. The functionality of the software with respect to the 64-bit support is unchanged. Complete re-verification has been performed to verify that the design outputs meets the design inputs after the change from 32-bit to 64-bit support.
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Image /page/5/Picture/0 description: The image shows the logo for C-RAD. The logo consists of an orange geometric shape on the left, followed by the text "C-RAD" in gray. The "C" is orange, while the "RAD" is in a lighter shade of gray.
Safety and effectiveness:
Performance data has been submitted to show that Sentinel achieves its intended use and that the software update and rephrasing of intended use raise no new issues of safety or efficacy.
§ 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.