(90 days)
Not Found
No
The device description and intended use clearly describe a mechanical positioning device. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for patient positioning prior to radiotherapy/radiosurgery; it does not directly treat the patient.
No
This device is a positioning tool for stereotactic radiotherapy/radiosurgery. Its purpose is to physically position the patient for treatment, not to diagnose a condition or disease.
No
The device description explicitly states it is a "non-invasive mechanical device that consists of an aluminum frame and four Target Positioner Carrier Plates made of transparent plastics," indicating it is a physical hardware device.
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 a patient for stereotactic radiotherapy/radiosurgery. This is a therapeutic procedure performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device is described as a non-invasive mechanical device used for patient positioning. It does not involve the analysis of biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on biological markers.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical positioning for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Target Positioner is used to position the patient for the stereotactic radiotherapy/ radiosurgery.
The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the Target Positioner after its removal.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Target Positioner is a non-invasive mechanical device that consists of an aluminum frame and four Target Positioner Carrier Plates made of transparent plastics.
In order to ensure a rigid fixation to different types of Headring respectively to the BrainLAB Mask System, various Target Positioners with adapted interface specifications are provided. The Target Positioner enables alignment of the planned patient's treatment isocenter with the LINAC Isocenter.
Prior to the treatment the Target Positioner has to be removed.
The usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The Target Positioner 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.
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
Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a document identifier or page number. The text includes "K073018" on the first line, followed by "pg. 10 of 2" on the second line. The handwriting is somewhat stylized, with the numbers and letters clearly distinguishable.
JAN 23 2008
510 (k) Summary of Safety and Effectiveness for Target Positioner
Manufacturer:
| Address: | BrainLAB AG
Kapellenstrasse 12
85622 Feldkirchen
Germany |
|-----------------|-------------------------------------------------------------------|
| | Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | October 23, 2007 |
Device Name:
Trade name:
Common Name:
Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight
Target Positioner, Counterweight
Predicate Device: BrainLAB LINAC Hardware (K934657)
Device Classification Name: Medical charged-particle radiation therapy system (892/6050) Requlatory Class; Class II
Intended Use:
The Target Positioner is used to position the patient for the stereotactic radiotherapy/ radiosurgery.
The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the Target Positioner after its removal.
Device Description:
The Target Positioner is a non-invasive mechanical device that consists of an aluminum frame and four Target Positioner Carrier Plates made of transparent plastics.
In order to ensure a rigid fixation to different types of Headring respectively to the BrainLAB Mask System, various Target Positioners with adapted interface specifications are provided. The Target Positioner enables alignment of the planned patient's treatment isocenter with the LINAC Isocenter.
Prior to the treatment the Target Positioner has to be removed.
1
K073018
pg. 2 of 2
The usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.
Substantial equivalence:
The Target Positioner 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 BrainLAB LINAC Hardware (K934657).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three horizontal lines curving downwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A
3 2018
Mr.Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12 85622 Feldkirchen GERMANY
Re: K073018
Trade/Device Name: Target Positioner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 23, 2007 Received: October 25, 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" (21 CFR 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 yours,
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):
Device Name: Target Positioner
Indications For Use:
The Target Positioner (TaPo) is used to position the patient for the stereotactic radiotherapy/radiosurgery.
The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -------------------------------------------------------------------------------- |
Division of Reproductive, Abdominal, and
Radiological Devices Concurrence of CDRH, Office of Device Evaluation (ODE)
| 510(k) Number | K073018 |
|---|---|
| --------------- | --------- |
Page __ 1 _ of __ 1 __ 1