(90 days)
Not Found
None
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is used in radiation therapy to deliver a prescribed dose to the skin surface and underlying tissue, which is a therapeutic intervention.
No
This device is used to deliver prescribed radiation doses to tissue, which is a treatment function, not a diagnostic one. It corrects for anatomical irregularities during therapy delivery.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue." This describes a therapeutic device used directly on the patient for treatment, not a device used to examine specimens (like blood, urine, or tissue) outside the body to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any activities typical of IVDs, such as analyzing biological samples, providing diagnostic results, or being used in a laboratory setting.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue.
Product codes
90 IYE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin surface and underlying tissue
Indicated Patient Age Range
Adult, Child, and Infant
Intended User / Care Setting
physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "Department of Health & Human Services".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2000 FEB
I.Z.I. Corporation E.J. Smith C/O Smith Associates P.O. Box 4341 Crofton, MD 21114
K993742 Re:
Super Tissue Dated: October 29, 1999 Received: November 4, 1999 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Smith:
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 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 (Ad). 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 III (Special Controls) or dass III (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 requirements, 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 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 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 requiation 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
K99374/2
Page 1 of 1
510(K) Number (if known):
Product Name: Super Tissue
Indications for Use.
For use in high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue.
Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.
Target Population: Adult, Child, and Infant
Daniel G. Seymour
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
L
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Over the Counter Use_