(212 days)
Not Found
No
The summary describes a mechanical device for adjusting a treatment table and does not mention any AI or ML components or functions.
No.
The device is used to compensate for patient misalignment during radiation treatment, which is a therapeutic procedure, but the device itself does not directly treat the patient. It is an accessory to a treatment table.
No
The device is described as an "additional device for treatment tables" that "enables a motorized table tilt" to "compensate for patient rotation" during radiation treatment. Its function is to adjust patient positioning, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "powered patient support assembly" and enables "motorized tilt adjustment," indicating it is a hardware device with mechanical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Table Tilt Device is used during radiation treatment to adjust the position of the patient on the treatment table. It directly interacts with the patient's physical position, not with biological samples.
- Intended Use: The intended use clearly states it's for compensating patient misalignment during radiation treatment.
- Device Description: The description reinforces that it's a powered patient support assembly for use in radiotherapy and radiosurgery treatments.
The device is a therapeutic device used in conjunction with a radiation treatment system, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Table Tilt Device is an additional device for treatment tables used for radiation treatment. It enables a motorized table tilt around the lateral and longitudinal axis to compensate for patient rotation. In this fashion misalignments and shift of the patient can be precisely compensated.
The Table Tilt Device is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures.
Product codes
90 JAI
Device Description
The Table Tilt Device is a powered patient support assembly for use in radiotherapy and radiosurgery treatments. It allows the user to undertake motorized tilt adjustment of a patient misalignment to eliminate the need to manually move the patient on the table.
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 Table Tilt Device will be 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.
0
MAY 1 4 2004
510 (k) Summary of Safety and Effectiveness for Table Tilt Device
Image /page/0/Picture/2 description: The image shows a handwritten text string. The string appears to be "K033316". The text is written in a dark ink on a white background. The handwriting is somewhat stylized, with some of the characters slightly slanted or distorted.
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: | January 8, 2004 | |
| Device Name: | |
|---|---|
| Trade name: | Robotic Tilt Module |
| Common/Classification Name: | Table Tilt Device |
| Predicate Device: | Med-Tec 6 degree axis couch, model MT-6DAC (K031866) |
|---|---|
| Device Classification Name: | Powered radiation therapy patient support assembly |
| Regulatory Class: | Class II |
Intended Use:
The Table Tilt Device is an additional device for treatment tables used for radiation treatment. It enables a motorized table tilt around the lateral and longitudinal axis to compensate for patient rotation. In this fashion misalignments and shift of the patient can be precisely compensated.
Device Description:
The Table Tilt Device is a powered patient support assembly for use in radiotherapy and radiosurgery treatments. It allows the user to undertake motorized tilt adjustment of a patient misalignment to eliminate the need to manually move the patient on the table.
Substantial equivalence:
The Table Tilt Device will be 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 of Med-Tec: Med-Tec 6 degree axis couch, model MT-6DAC (K031866).
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three curved lines representing its body and wings, conveying a sense of motion and flight. The overall design is simple and recognizable, representing the HHS's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8 85551 Heimstetten GERMANY
Re: K033316 Trade/Device Name: Table Tilt Device Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI Dated: February 25, 2004 Received: March 9, 2004
Dear Mr. Birkenbach:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section > re(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regally including the Medical Device American be lo commerce private to May 20, 1770, the claculance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosment Act (Act) that do not reques of the general controls provisions of the Act. The Y ou may, therefore, market the detros, books of the courements for annual registration, listing of general controls provisions of the rice 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 If your device is classince (soo avoro) its . Existing major regulations affecting your device can may be subject to such additional controller. Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Cleg.
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 mall FUA has made a decemmance. Inc. Jour stered by other Federal agencies. You must comply of any Pederal Statures and regalations and but not limited to: registration and listing (21 CFR Part with an the Act s requirements, menumacturing practice requirements as set forth in the 807), laoching (21 CFR Part 820); and if applicable, the electronic product quality Systems (QB) regions (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) I has lotter will and work your 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. Brogden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Table Tilt Device Device Name:
Indications For Usc:
The Table Tilt Device is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033316