(50 days)
0110172-00, 7410266-15
No
The description focuses on traditional image processing techniques (comparison of DRRs, marker localization) and optical tracking, with no mention of AI or ML algorithms.
No
The device is described as an "Image Processing System for patient positioning" that helps to accurately place patients for radiotherapy and radiosurgery, which are therapeutic procedures, but the device itself does not perform the therapy. It is an accessory to a therapeutic device (medical accelerator).
No
This device is used for patient positioning and correction during radiotherapy procedures, not for diagnosing a medical condition. While it uses imaging for verification, its primary purpose is therapeutic positioning.
No
The device description explicitly mentions the use of "optical tracking of infrared markers and x-ray registration" and "implanted radioopaque markers," which are hardware components used for patient positioning and localization. It also mentions generating a signal to gate the linear accelerator, implying interaction with external hardware. While it includes image processing software, it is part of a larger system that incorporates hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- ExacTrac's Intended Use: The intended use of ExacTrac is to accurately position patients for radiotherapy and radiosurgery procedures. It uses imaging and tracking to ensure the patient is correctly aligned with the treatment beam.
- ExacTrac's Mechanism: The system works by tracking infrared markers and using x-ray imaging to determine and correct the patient's position. It compares images (DRRs or marker positions) to a reference CT dataset. The gating module uses marker positions and breathing levels to control the treatment beam.
- No Specimen Examination: There is no mention of ExacTrac examining any biological specimens (blood, tissue, urine, etc.) from the patient. Its function is entirely focused on external patient positioning and alignment for treatment delivery.
Therefore, ExacTrac falls under the category of a medical device used for treatment delivery and patient positioning, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical tracking of infrared markers, x-ray, CT data set
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
0110172-00, 7410266-15
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is black against a white background. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.
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.
3
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
4
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)