(85 days)
Not Found
No
The description focuses on mechanical support, fixation, and interfacing with existing robotic arms and accessories. There is no mention of any computational or analytical functions that would typically involve AI/ML.
No
The device is described as a support and fixation device for patients undergoing radiotherapy treatment, not as a device that delivers therapy itself.
No
The device is described as a "support and fixation device for patients undergoing radiotherapy treatment(s)" and assists in "fixation of the patient during said treatment(s)". It does not mention any diagnostic functions such as detection, diagnosis, or monitoring of a disease or condition.
No
The device description clearly outlines a physical chair with mechanical adjustments and interfaces for other physical components (robotic arm, couchtop inserts, bite block system, masks). There is no mention of software being the primary or sole component of the device.
Based on the provided information, the Qfix Radiotherapy Chair is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the Qfix Radiotherapy Chair is a "support and fixation device for patients undergoing radiotherapy treatment(s)." Its purpose is to position and stabilize the patient during treatment, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to sample collection, analysis, reagents, or any other typical components of an IVD device.
Therefore, the Qfix Radiotherapy Chair falls under the category of a medical device used for patient support and positioning during treatment, not an IVD.
N/A
Intended Use / Indications for Use
The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes.
It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles.
The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).
Product codes
JAI
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
Not Found
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Timothy Wade Quality Systems Manager WFR/Aquaplast Corp 440 Church Road AVONDALE PA 19311
JUN 2 0 2012
Re: K120916
Trade/Device Name: Qfix Radiotherapy Chair Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: February 29, 2012 Received: March 27, 2012
Dear Mr. Wade:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
` Enclosure
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PREMARKET NOTIFICATION
INDICATION FOR USE
The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes.
It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles.
The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).
Signature:
Date: 4/23/2012
Premarket Notification 510(k) Number K 20091
Prescription Use (Part 21 CFR 801 Subpart D)
(Division Sign-Off)
Division of Radiological Dev
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120916
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