(90 days)
The Therapax DXT 300 is a variable high energy X-Ray system intended for superficial to The Therapy radiotherapy treatments of cancerous tumours and lesions. Typical suboutineous include treatment for basal and squamous cell carcinoma, cancerous lung, breast, ribs, rectal adenocarcinoma and other intracavital sites.
Therapax DXT 300 X-Ray Therapy Device - Model HF-300
This document is a 510(k) clearance letter from the FDA for an X-ray therapy device, the Therapax DXT 300. It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance using the requested metrics.
Therefore, I cannot provide the requested information from this document. The document primarily states that the device is substantially equivalent to previously marketed devices and outlines regulatory responsibilities.
Here's why the requested information is absent:
- Acceptance Criteria & Performance Table: This type of detail is typically found in a clinical study report or a technical performance validation document, not a 510(k) clearance letter. The letter confirms regulatory equivalence, not specific performance metrics.
- Sample Size & Data Provenance: Not mentioned.
- Number & Qualifications of Experts for Ground Truth: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned as this is a therapy device, not an AI diagnostic tool where MRMC studies are common.
- Standalone Performance Study: Not mentioned.
- Type of Ground Truth: Not mentioned.
- Training Set Sample Size: Not applicable as this is not an AI/ML device.
- Ground Truth for Training Set: Not applicable.
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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Greg Moreau Director, Quality Assurance Pantak, Inc. 231 Silver Sands Rd. East Haven, CT 06512-4140 Re: K973315
Therapax DXT 300 X-Ray Therapy Device - Model HF-300 Dated: August 27, 1997 Received: September 3, 1997 Regulatory class: II 21 CFR 892.5900/Procode: 90 JAD
Dear Mr. Moreau:
We have reviewed your Section 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 110(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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (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
h.J.Liau Yu
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
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Enclosure
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Indications for Use Section 3-4:
The Therapax DXT 300 is a variable high energy X-Ray system intended for superficial to The Therapy radiotherapy treatments of cancerous tumours and lesions. Typical suboutineous include treatment for basal and squamous cell carcinoma, cancerous lung, breast, ribs, rectal adenocarcinoma and other intracavital sites.
David C. Seymour
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 973315 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
二十二期
§ 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.