(268 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as optical tracking of infrared reflecting markers, with no mention of AI/ML in the device description or intended use.
No
The device is described as a system for positioning patients during stereotactic radiosurgery or radiotherapy procedures, which are therapeutic, but the device itself is for placement, not therapy delivery.
No
The device is described as a system for patient positioning (locating the position of the patient) during radiosurgery or radiotherapy, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of infrared cameras, a computer workstation, reflective markers, and calibration tools, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device, the ExacTrac System, is used to position a patient for radiation therapy. It uses optical tracking of markers on the patient's body.
- Lack of Biological Sample Analysis: The system does not analyze any biological samples from the patient. It interacts with the patient externally to determine their physical position.
Therefore, based on the provided information, the ExacTrac System falls under the category of a medical device used for patient positioning during treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures.
Product codes
90-LNH
Device Description
The ExacTrac System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical tracking of infrared reflecting markers
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service 12 2022 2
100 11 2017 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUI 14 1999
Rainer Birkenbach BrainLAB USA, Inc. Building 4A, Mailstop E233 3100 Hanson Way Palo Alto, CA 94304
Re: K983660
Trade Name: ExacTrac (BrainLAB Patient Positioning System) Regulatory Class: II Product Code: 90-LNH/ 892.5050 Dated: April 7, 1999 Received: April 12, 1999
Dear Mr. Birkenbach:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP requiration may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known):
Device Name: ExacTrac (BrainLAB Patient Positioning System)
Indications For Use:
ExacTrac
This submission describes 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 System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
and Radiological I Prescription Use 510(k) Number (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format I-2-96)