(50 days)
ExacTrac is a system that is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac system uses optical tracking of infrared markers and x-ray registration to determine and correct the position of the patient. With the additional ExacTrac gating module, the treatment beam is gated in accordance with the patient's breathing level.
ExacTrac 5.5 is an Image Processing System for patient positioning with the ability of a gated treatment. It is based on an imported isocenter from a planning system or on an isocenter imported from a simulator. It allows verification and, if necessary, correction of the patient's position.
The correction of the patient's position is based on a comparison of digital reconstructed radiographs (DRR) calculated from a corresponding CT data set (reference image). Alternatively implanted radioopaque markers may be used for localization by comparing their position in the x-ray with their original position in the reference CT data set. Within the Gating module the 3D position of the implanted markers is compared, for at least one breathing level of the patient, to their expected position based on the CT data With the resultant correction values and target movement information the patient is repositioned and the system generates a signal to gate the linear accelerator depending on the patients breathing.
A scientific study to validate accuracy was performed.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | The ExacTrac 5.5 system has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. |
2. Sample size used for the test set and the data provenance
The sample size for the test set and the data provenance (e.g., country of origin, retrospective or prospective) are not specified in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The number and qualifications of experts used to establish ground truth for the test set are not specified in the provided 510(k) summary.
4. Adjudication method for the test set
The adjudication method for the test set is not specified in the provided 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study and any effect size related to human reader improvement with or without AI assistance are not described in the provided 510(k) summary. The ExacTrac 5.5 system is intended for patient positioning and correction, not for diagnostic interpretation by human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The provided text states: "ExacTrac 5.5 is an Image Processing System for patient positioning with the ability of a gated treatment... It allows verification and, if necessary, correction of the patient's position." The system operates by comparing images (DRRs or x-rays of markers) to a reference CT data set to determine and correct patient position. This implies a standalone algorithmic function to derive the correction values. However, the exact methodology of a "standalone" performance study as a separate entity is not explicitly detailed as such in the provided text, but the system's core function is an automated process.
7. The type of ground truth used
The ground truth used for localization is based on:
- "a comparison of digital reconstructed radiographs (DRR) calculated from a corresponding CT data set (reference image)."
- "Alternatively implanted radioopaque markers may be used for localization by comparing their position in the x-ray with their original position in the reference CT data set."
- "Within the Gating module the 3D position of the implanted markers is compared, for at least one breathing level of the patient, to their expected position based on the CT data."
This indicates that the ground truth relies on reference CT data sets and the known positions of implanted radioopaque markers as established during planning or simulation.
8. The sample size for the training set
The sample size for the training set is not specified in the provided 510(k) summary. The document describes a validation of the system after development, not a detailed account of the AI/algorithm training process.
9. How the ground truth for the training set was established
The method for establishing ground truth for a training set is not specified in the provided 510(k) summary. The document focuses on the validation of the system's performance for patient positioning against defined reference points.
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77506 510 (k) Summary of Safety and Effectiveness for ExacTrac 5.5
Manufacturer
Address
| BrainLAB AG |
|---|
| Kapellenstr. 12 |
| 85622 Feldkirchen |
| Germany |
| Phone: +49 89 99 15 68 0 |
| Fax: +49 89 99 15 68 33 |
| Mr. Rainer Birkenbach |
| July, 2007 |
OCT 26 2007
Device Name
Contact Person Summary Date
Device Name
Common Name
Classification Name Classification Number Regulatory Class FDA Establishment Registration Number
ExacTrac 5.5, will also be marketed under the name ExacTrac X-Ray 6D or Novalis Body Patient Positioning System with respiratory Gating, Radiation Therapy, Charged-Particle, Medical System, Radiation Therapy, Charged-Particle, Medical 892.5050 Class II 804 39 33
Predicate Device
ExacTrac 4.0(K040585) ExacTrac Gating (K033287)
X-ray Generator Device Classification Name: Generator, High Voltage X-Ray, Diagnostic Regulatory Class: Class I Exempt Accession Number: 0110172-00
X-ray Tubes Device Classification Name: Assembly, Tube Housing, X-Ray, Diagnostic Regulatory Class: Class | Exempt Accession Number: 7410266-15
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Intended Use
ExacTrac is a system that is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac system uses optical tracking of infrared markers and xray registration to determine and correct the position of the patient. With the additional ExacTrac gating module, the treatment beam is gated in accordance with the patient's breathing level.
Device Description
ExacTrac 5.5 is an Image Processing System for patient positioning with the ability of a gated treatment. It is based on an imported isocenter from a planning system or on an isocenter imported from a simulator. It allows verification and, if necessary, correction of the patient's position.
The correction of the patient's position is based on a comparison of digital reconstructed radiographs (DRR) calculated from a corresponding CT data set (reference image). Alternatively implanted radioopaque markers may be used for localization by comparing their position in the x-ray with their original position in the reference CT data set. Within the Gating module the 3D position of the implanted markers is compared, for at least one breathing level of the patient, to their expected position based on the CT data With the resultant correction values and target movement information the patient is repositioned and the system generates a signal to gate the linear accelerator depending on the patients breathing.
Substantial Equivalence
ExacTrac 5.5 has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device ExacTrac 4.0 (K040585) combined with ExacTraction (K033287).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 2007
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12 85622 Feldkirchen GERMANY
Re: K072506
Trade/Device Name: ExacTrac 5.5 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 31, 2007 Received: September 6, 2007
Dear Mr. Birkenbach:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072506
Device Name: ExacTrac 5.5
Indications For Use:
ExacTrac is a system that is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac system uses optical tracking of infrared markers and x-ray registration to determine and correct the position of the patient. With the additional ExacTrac gating module, the treatment beam is gated in accordance with the patient's breathing level.
Amyu Th Thx
(Division Sián-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.