(81 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is used for radiotherapy treatments of cancerous tumors and other medical conditions, which falls under therapeutic applications.
No
The "Intended Use / Indications for Use" section specifies that the device is "intended for superficial cases and lesions" and for "radiotherapy treatments of cancerous tumors and research," with "typical treatments include treatment for basal cell carcinoma, squamous cell carcinoma, Karposi's Sarcoma, rectal adenocarcinoma and other intracavital sites." This indicates a therapeutic, not a diagnostic, purpose.
No
The device description explicitly states it is a "variable low energy x-ray system," which is a hardware device.
Based on the provided information, the Therapax SXT 150 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the Therapax SXT 150 is for radiotherapy treatments of cancerous tumors and lesions directly on the patient's body using x-rays.
- The device description and intended use clearly indicate a therapeutic function, not a diagnostic one involving in vitro analysis of samples.
Therefore, the Therapax SXT 150 is a therapeutic medical device, specifically an x-ray system for radiotherapy, and not an IVD.
N/A
Intended Use / Indications for Use
The Therapax SXT 150 is a variable low energy x-ray system intended for superficial radiotherapy treatments of cancerous tumours and lesions. Typical applications include treatment for basal cell carcinoma, squamous cell carcinoma, Karposi's Sarcoma, rectal adenocarcinoma and other intracavital sites.
Product codes
90 JAD
Device Description
The Therapax SXT 150 is a variable low energy x-ray system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
Superficial cancerous tumours and lesions, intracavital sites (basal cell carcinoma, squamous cell carcinoma, Kaposi's Sarcoma, rectal adenocarcinoma).
Indicated Patient Age Range
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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.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.
0
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 caduceus symbol, which features three lines representing snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Greg Moreau Pantak, Inc. 31 Business Park Drive P.O. Box 865 JUN 1 3 1997 Branford, CT 06405
Re: K971074
Therapax SXT 150 X-Ray Therapy Device Dated: March 14, 1997 Received: March 24, 1997 Regulatory class: II 21 CFR 892.5900/Procode: 90 JAD
Dear Mr. Moreau: 会
We have reviewed your Secuon 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 and prohibitions gainst misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device and in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substanially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket southeation. The FDA finding of . substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please ontact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Indications for Use Section 3:
参
The Therapax SXT 150 is a variable low energy x-ray system intended for superficial The Therapax SX1 150 is a variable tow cases and lesions. Typical applications include radiotherapy treatments of cancerous tumous and resears. " years of "
treatment for basal cell carcinoma, squamous cell carcinoma, Karposi's Sarcoma, rectal adenocarcinoma and other intracavital sites.
David A. Kepner
(Division Sign-Off)
(Person of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use _ (Per 21 CFR 801.109)