(90 days)
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.
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.
The provided documentation is a 510(k) summary for the BrainLAB Target Positioner. It describes the device, its intended use, and states that its safety and effectiveness have been "verified and validated according to BrainLAB's procedures for product design and development." It concludes that the device is "substantially equivalent" to a predicate device.
However, the document does not include specific acceptance criteria, detailed study results, or the other specific pieces of information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, details of standalone or MRMC studies, training set information, or ground truth establishment). Instead, it makes a general statement about validation and substantial equivalence.
Therefore, I cannot extract the specific information you requested from the provided text.
Based on the information provided, here's what can be stated:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: The document generally states, "The validation proves the safety and effectiveness of the system." No specific performance metrics (e.g., accuracy, precision) or numerical results are provided.
2. Sample size used for the test set and the data provenance:
- Not specified. The document only mentions "validation" without detailing the study methodology or the data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document does not describe the use of experts for ground truth establishment.
4. Adjudication method for the test set:
- Not applicable/Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical positioning device, not an AI-assisted diagnostic or interpretation tool. The concept of "human readers improving with AI" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- Not specified. The document only refers to "validation" in general terms.
8. The sample size for the training set:
- Not applicable/Not specified. (This would typically apply to machine learning algorithms, which this device is not).
9. How the ground truth for the training set was established:
- Not applicable/Not specified.
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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 AGKapellenstrasse 1285622 FeldkirchenGermany |
|---|---|
| Phone: +49 89 99 15 68 0Fax: +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.
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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).
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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.
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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
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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 |
|---|---|
| --------------- | --------- |
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§ 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.