(22 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-driven devices.
No
The device is a treatment planning system (software), not a device that directly delivers therapy to a patient. Its function is to plan treatments, not to provide them.
No
This device is described as a "radiosurgery and radiotherapy treatment planning system" used for treatment, not for diagnosing conditions.
Yes
The device is described as a "stereotactic treatment planning software" and its description focuses solely on its software capabilities and the platform it runs on (Linux workstation). There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, the XKnife RT 4 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "radiosurgery and radiotherapy treatment planning system." This involves planning medical treatments based on imaging data, not performing tests on biological samples in vitro (outside the body).
- Device Description: The description confirms it's "stereotactic treatment planning software." This reinforces its role in treatment planning, not diagnostic testing.
- Lack of IVD Characteristics: The description doesn't mention any activities related to analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro tests.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The XKnife RT 4's function is entirely focused on planning radiation therapy based on medical images.
N/A
Intended Use / Indications for Use
XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment.
Product codes (comma separated list FDA assigned to the subject device)
IYE, MUJ
Device Description
The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET scans
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.
Not Found
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
KD6/893
Section 6: 510(k) Summary
JUL 25 2006
Integra Radionics XKnife RT 4 510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.
1.0 The submitter of this premarket notification is:
Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: (781) 565-1227 Fax: (781) 238-0645
This summary was prepared on June 30, 2006.
- 2.0 The name of the device is the Integra Radionics XKnife RT 4. The common name is Stereotactic Radiation Treatment Planning System and Accessories, and its classification name is X-ray radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics XK.nife RT 3 with Non Stereotactic Module 510(k), K041997.
- 4.0 The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.
- 5.0 The device like its predicates is intended for use in stereotactic, conformal, computer planned, LINAC (linear accelerator) based radiation. The indications for use are: XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment .
- 6.0 The technological characteristics are the same or similar to those found with the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the left side of the logo.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 25 2006
Mr. Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue BURLINGTON MA 01803-2516
Re: K061893
Trade/Device Name: Integra Radionics XKnife RT 4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: June 30, 2006 Received: July 3, 2006
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" written below. Three stars are arranged beneath the word "Centennial". The logo is surrounded by a circular border with additional text, though the specific words are not clear due to the image quality.
Protecting and Promoting Public Health
2
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 (OS) 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 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/edrh/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _ Ko 6 1 8 9 3
Device Name: Integra Radionics XKnife RT 4
Indications For use: XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment
PRESCRIPTION USE XX (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)
Y. Alvarez Garcia
(Division Sign n
Division of Reproducere andominal,
and Radiological Devices
510(k) Number