(49 days)
Not Found
No
The device description explicitly states it includes only mechanical devices for patient fixation and repositioning, with no mention of AI or ML technologies.
No
The device is used for patient fixation, localization, and repositioning during radiosurgery/radiotherapy procedures, which are therapeutic, but the device itself does not directly treat a medical condition.
No
Explanation: The device is used for patient fixation, localization, and repositioning during stereotactic radiosurgery/radiotherapy procedures. While it can be used for "repeated diagnostic tomographic scanning," its primary stated purpose and function are to hold the patient in position, not to diagnose. It is a mechanical positioning device.
No
The device description explicitly states that the Frameless Radiosurgery Components "only include mechanical devices," indicating it is a hardware-based system for patient fixation and positioning, not software.
Based on the provided information, 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 description clearly states that the Frameless Radiosurgery Components are "mechanical devices" used for "fixation, localization and repositioning of the patient's head and neck... in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures."
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely mechanical and related to patient positioning for treatment.
Therefore, the device falls under the category of a medical device used for treatment support, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's
- head and neck
- head, neck, and shoulders
in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures,
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Frameless Radiosurgery Components only include mechanical devices, which can be repeatedly attached to the patient to keep his/her head and neck (head, neck and shoulders) in the same position for radiotherapy/radiosurgery. All components are intended to be non-invasive. The Frameless Radiosurgery Components are indicated for any medical condition in which the use of stereotactic radiotherapy may be considered to be safe and effective. They may be used also for repeated diagnostic tomographic scanning, The Frameless Radiosurgery Components can be used with other devices, which have already been cleared by the FDA (e.g. BrainLAB Robotics, BrainLAB Brainscan).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
- head and neck
- head, neck, and shoulders
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)
The Frameless Radiosurgery Components have 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.
Not Found
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
053500
FEB 3 2006
510(k) Summary of Safety and Effectiveness for Frameless Radiosurgery Components
| Manufacturer: | BrainLAB AG |
|---|---|
| Address: | 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: | January 12, 2006 |
| Device Name: | |
| Trade name: | Frameless Radiosurgery System |
| Common/Classification Name: | Frameless Radiosurgery Components |
| Predicate Device: | BrainLAB Mask System (K945903) |
| BrainLAB CT/X-Ray Localizer (K954861) | |
| Device Classification Name: | Medical charged-particle radiation therapy system (892.5050) |
| Regulatory Class: | Class II |
Intended Use:
The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's
- head and neck ເ
- ﺳ head, neck, and shoulders
in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures,
Device Description:
The Frameless Radiosurgery Components only include mechanical devices, which can be repeatedly attached to the patient to keep his/her head and neck (head, neck and shoulders) in the same position for radiotherapy/radiosurgery. All components are intended to be non-invasive. The Frameless Radiosurgery Components are indicated for any medical condition in which the use of stereotactic radiotherapy may be considered to be safe and effective. They may be used also for repeated diagnostic tomographic scanning, The Frameless Radiosurgery Components can be used with other devices, which have already been cleared by the FDA (e.g. BrainLAB Robotics, BrainLAB Brainscan).
Substantial equivalence:
The Frameless Radiosurgery Components have 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 BrainLAB Mask System (K945903) and BrainLAB CT/X-Ray Localizer (K954861).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2006
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8 85551 Heimstetten GERMANY
Re: K053500 Trade/Device Name: Frameless Radiosurgery Components Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 7, 2005 Received: December 16, 2005
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 (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 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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 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" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Nancy C. Bugdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
KOS3500
Device Name:
Frameless Radiosurgery Components
Indications For Use:
The Frameless Radiosurgery Components are a device used for fixation and reposition and repositioning of the patient´s
- head and neck
- head, neck, and shoulders -
in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
Mansel C. Bringdon
(Division Sign-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)