(67 days)
No
The description focuses on optical tracking, x-ray registration, and image comparison (DRR vs. x-ray, CT vs. ultrasound) for patient positioning, without mentioning any AI or ML algorithms for these processes.
No
The device is a patient positioning system used in radiotherapy procedures, not a device that directly treats or provides therapy to a patient.
No
The device is described as a "Patient Positioning System" that uses imaging and other methods to locate and correct a patient's position for radiotherapy procedures. Its purpose is to ensure accurate patient setup, not to diagnose a disease or condition. While it uses medical imaging, it does so for positional verification, not diagnostic interpretation.
No
The device description explicitly mentions the use of optical tracking of infrared reflecting markers, x-ray registration, and an ultrasound module, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to position patients for stereotactic radiosurgery or radiotherapy procedures. This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "Patient Positioning System" that uses optical tracking and x-ray/ultrasound imaging for patient alignment. This aligns with a system used for guiding treatment delivery, not for diagnosing a condition.
- Mechanism: The system compares images (CT, X-ray, Ultrasound) to a reference to ensure accurate patient positioning relative to a linear accelerator. This is a process of image-guided therapy, not in vitro analysis of biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such analysis.
N/A
Intended Use / Indications for Use
ExacTrac 4.0 is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.
Product codes
90 IYE
Device Description
ExacTrac 4.0 is a Patient Positioning System. 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.
Correction of patient's position is based on a comparison of digital reconstructed images (DRR) calculated from a corresponding CT set (reference image) and x-ray images). Structures on the images to be compared can be either anatomical landmarks or implanted internal markers.
For some applications (e.g. prostate tumors) the correction can alternatively be performed by using the ultrasound module. Here the correction of patient's position is based on a comparison of an outlined structure in the CT set (reference image) and perpendicular ultrasound images).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray images, CT set, ultrasound images
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
ExacTrac (K003285)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 11 2004
510 (k) Summary of Safety and Effectiveness K84058 for ExacTrac 4.0®
Manufacturer:
| Address: | BrainLAB AG
Ammerthalstrasse 8
85551 Heimstetten
Germany
Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | March 03, 2004 |
| Device Name: | |
| Trade name: | ExacTrac4.0, will also be marketed under the name |
| | ExacTrac X-ray 6D |
| Common/Classification Name: | Patient Positioning System / System, Radiation Therapy, Charged-
Particle, Medical |
Predicate Device: ExacTrac (K003285)
Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical Regulatory Class: Class II
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 I Exempt Accession Number: 7410266-15
1
Intended Use:
ExacTrac 4.0 is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.
Device Description:
ExacTrac 4.0 is a Patient Positioning System. 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.
Correction of patient's position is based on a comparison of digital reconstructed images (DRR) calculated from a corresponding CT set (reference image) and x-ray images) . Structures on the images to be compared can be either anatomical landmarks or implanted internal markers.
For some applications (e.g. prostate tumors) the correction can alternatively be performed by using the ultrasound module. Here the correction of patient's position is based on a comparison of an outlined structure in the CT set (reference image) and perpendicular ultrasound images) .
Substantial equivalence:
ExacTrac 4.0 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 2.0 (K003285)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2004
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten GERMANY
Re: K040585 Trade/Device Name: ExacTrac 4.0 Patient Positioning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: March 4, 2004 Received: March 5, 2004
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.
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
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Page 2
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
ExacTrac 4.0
Device Name: (BrainLAB's Patient Positioning System)
Indications For Use:
ExacTrac 4.0
ExacTrac 4.0 is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The Exact on 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as that nethod of locating the position of the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division Sign Division of Reprodu and Radiological D 510(k) Number