(104 days)
No
The description focuses on image comparison and calculation of adjustments based on that comparison, which is standard image processing and not explicitly AI/ML. There is no mention of learning, training data, or AI/ML algorithms.
No
The device aids in positioning patients for radiotherapy but does not itself provide therapy. Its function is to ensure accurate patient alignment immediately prior to the therapeutic procedure.
No
The device is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy, and it specifies patient adjustment data based on image comparison; it does not provide a diagnosis.
No
The device description explicitly states that the system obtains images from "Varian Trilogy Linear Accelerators which incorporate CBCT devices." This indicates the system relies on and integrates with hardware components (linear accelerators and CBCT devices) for its function, making it more than just software.
Based on the provided information, the Radionics XKnife HDRT System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to aid in the positioning of patients immediately prior to therapy." This is a function related to patient treatment and positioning, not the analysis of biological samples or the diagnosis of disease.
- Device Description: The description focuses on comparing medical images (3D, CBCT, DICOM) to determine patient positioning adjustments for radiotherapy. This is a medical device used in a clinical setting for treatment delivery, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In summary, the Radionics XKnife HDRT System is a medical device used in radiotherapy for patient positioning, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
HDRT software is based on Integra Radionics ImageFusion 3 software (K063230) in that it compares multiple 3D images. In the case of HDRT the images compared are: the pretreatment planning images obtained immediately before treatment. The images immediately before treatment are obtained from Varian Trilogy Linear Accelerators which incorporate CBCT devices capable of exporting DICOM images to shared drives. Based on the comparison of the images, HDRT specifies patient adjustment data, to insure that the patient is appropriately positioned for treatment. This functionality allows for slight errors in positioning of the patient to be compensated for, it also compensates for movement of internal organs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CBCT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): 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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR - 2 2009
Radionics XKnife HDRT System 510(k) Summary
Submitter's Name and Address:
Integra Radionics 22 Terry Avenue Burlington, MA 01803 Tel: (781) 565-1227 Fax: (781) 238-0645
Contact Person and Telephone Number:
Kevin J. O'Connell Director Regulatory Affairs and Quality Assurance Integra Radionics, Inc. kevin.oconnell(@Integra-ls.com Tel .: (781) 565-1227 Fax: (781) 238-0645
Date Summary was Prepared: November 17, 2008
Name of the Device:
Trade Name: | Radionics XKnife HDRT System |
---|---|
Common Name: | Radiation Therapy Treatment Planning System |
Classification Name: | Medical charged-particle radiation therapy system |
Products Code 90 IYE / 90 MUJ | |
Classification Panel: | Radiology |
Substantial Equivalence:
The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.
The technological characteristics are similar to those found in the:
Varian Medical Systems Trilogy Radio Therapy System 510(k) K081188
HDRT software is based on Integra Radionics ImageFusion 3 software (K063230) in that it compares multiple 3D images. In the case of HDRT the images compared are: the pretreatment planning images obtained immediately before treatment. The images immediately before treatment are obtained from Varian Trilogy Linear
1
Accelerators which incorporate CBCT devices capable of exporting DICOM images to shared drives. Based on the comparison of the images, HDRT specifies patient adjustment data, to insure that the patient is appropriately positioned for treatment. This functionality allows for slight errors in positioning of the patient to be compensated for, it also compensates for movement of internal organs.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or abstract human figure with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 . . .
MAR - 2 2009
Mr. Kevin J. O'Connell
Director Regulatory Affairs and Quality Assurance
Integra Radionics, Inc.
22 Terry Avenue
BURLINGTON MA 01803-2516
Re: K083414
Trade/Device Name: Radionics XKnife HDRT System
Regulation Number: 21 CFR 892.5050
Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II
Product Code: MUJ
Dated: January 20, 2009
Received: January 21, 2009
Dear Mr. O'Connell:
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 such 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,
3
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.
21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
---|---|---|
21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: Radionics XKnife HDRT System
Indications For Use:
The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.
PRESCRIPTION USE (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Numbér
XKnife HDRT System 510(k)
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