(209 days)
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No
The provided text describes a radiation therapy planning software and does not mention AI or ML capabilities.
No
The device is planning software used to create treatment plans for radiation therapy; it does not directly treat the patient.
No
The device is described as a "software-based planning system intended for the creation of treatment plans for radiation therapy." It is used after a medical diagnosis to plan treatment, not to make a diagnosis itself.
Yes
The device is described as "software-based planning system" and its intended use is solely focused on the creation of treatment plans, which is a software function. There is no mention of any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for the creation of treatment plans for radiation therapy. This is a therapeutic application, not a diagnostic one.
- Nature of the Device: The device is described as "software-based planning system." IVDs are typically reagents, instruments, or systems used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This software does not perform such examinations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information based on biological markers, or any other activity typically associated with IVDs.
The software is a tool for planning medical treatment based on existing medical diagnoses, not for making those diagnoses itself.
N/A
Intended Use / Indications for Use
The RadioSystem/NT stereotactic planning software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-energetic photons. It is used for patients which are selected for a precise radiation therapeutical treatment of arbitrary parts of the human body according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers. In addition the planning of interstitial radiosurgery by implanting radioactive seeds inside of the target volume (Brachytherapy) and the planning of stereotactic approaches (Stereotaxy) will be supported.
Product codes
90 IYE, KXK
Device Description
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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
arbitrary parts of the human body
Indicated Patient Age Range
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Intended User / Care Setting
radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.
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): 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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Re: K020320
Trade/Device Name: RadioSystem/NT V1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 IYE and KXK Dated: May 29, 2002 Received: May 30, 2002
Dear Ms. Bitterburg:
Ms. Kelli Bitterburg
Stryker Leibinger
Regulatory Affairs Associate
4100 East Milham Avenue
KALAMAZOO MI 49001
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
RadioSystem/NT Device Name:
Indications For Use:
1 :
The RadioSystem/NT stereotactic planning software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-energetic photons. It is used for patients which are selected for a precise radiation therapeutical treatment of arbitrary parts of the human body according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.
Kozo320
In addition the planning of interstitial radiosurgery by implanting radioactive seeds inside of the target volume (Brachytherapy) and the planning of stereotactic approaches (Stereotaxy) will be supported.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The- Counter Use
(Optional Format 1-2-96)
Nancy L. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number.