(56 days)
The prompt states "Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text".
The text explicitly states "Reference Device(s) Not Found".
Therefore, there are no reference devices listed in the text.
No
The description focuses on traditional radiation treatment planning algorithms and user-driven plan creation, with no mention of AI or ML.
No.
The device is a radiation treatment planning system that calculates and displays radiation dose distributions; it does not directly treat patients.
No
The device is used to create treatment plans based on existing diagnostic imaging data, not to diagnose medical conditions itself. It processes data and calculates dose distributions for therapy rather than providing a diagnosis.
No
The device description explicitly states that the system accepts patient diagnostic imaging data from CT and MR scans, or from films, and "source" dosimetry data, typically from a linear accelerator. While the core function is software-based planning, it relies on and processes data from external hardware devices (imaging modalities and linear accelerators). The 510(k) summary does not indicate that the device itself is solely software without any associated hardware components or dependencies beyond a general-purpose computing platform.
Based on the provided information, the XiO RTP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- XiO RTP System Function: The XiO RTP System is a treatment planning system used to calculate and display radiation dose distributions within a patient based on imaging data and radiation source parameters. It helps clinical personnel design and optimize radiation therapy treatments.
- Lack of Specimen Analysis: The system does not involve the analysis of any biological specimens taken from the patient. Its inputs are imaging data and radiation source information.
Therefore, the XiO RTP System falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Product codes
MUJ, LHN
Device Description
The XiO Radiation Treatment Planning system accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume, which is the structure to be treated, and critical structures, or organs-atrisk, to which radiation dose must be limited.
Based on the dose prescribed, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The XiO system produces a display of radiation dose distribution within the patient, indicating doses to the target volume and critical structures. Appropriate clinical personnel select the plan that they believe most effectively maximizes dose to the target volume while minimizing dose to critical structures. The parameters of the plan are output in hard-copy format for later reference placed in the patient file.
This Premarket Notification addresses the addition of the Proton Spot Scanning. XiO provides the user with the ability to choose between multiple dose calculation algorithms, selecting the algorithm most appropriate for the given clinical scenario. More accurate dose computation increases the probability that disease will be effectively treated and decreases the probability of undesirable side effects. No algorithm produces a perfectly accurate description of dose distribution; all algorithms have limitations, which are generally well understood and documented in scientific literature.
CMS received 510(k) clearance for the addition of proton planning capability to XiO in 2002. This feature extends proton planning functionality, giving the user the ability to create proton treatment plans that involve a series of small proton beams for which dose and monitor units are calculated and displayed individually. This allows users to create intensity modulated radiation therapy (IMRT) plans with protons, as discussed in more detail in section 11 of this submission. The proton spot scanning feature includes a new pencil beam dose calculation algorithm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR scans, or from films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typically a Dosimetrist or Medical Physicist; Appropriate clinical personnel.
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
Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy. In addition, clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. The product was deemed fit for clinical use.
Summary of Performance Studies
Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy. In addition, clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. The product was deemed fit for clinical use.
Key Metrics
Not Found
Predicate Device(s)
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.
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August 4, 2010
XiO RTP System - Proton Spot Scanning Premarket Notification (510(k)) Summary of Safety and Effectiveness
OCT " 1 2010
INTRODUCTION
This document summarizes the safety and effectiveness information contained within the XiO RTP System - Proton Spot Scanning 510(k). The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution.
PREMARKET NOTIFICATION INFORMATION
-
- Product Information:
- a. Product Trade Name
- b. Release Version Number
-
- Classification Information:
- Classification Name a. system
- b. Common/Usual Name
- Product Classification C.
- d. Product Code
- e. Reference
- f. Review Panel
-
- Establishment Information:
- a. Submitter
- Submitter Address b.
C. Establishment Number
- Contact d.
- Contact Phone e.
- t. Contact Fax
XiO RTP System Proton Spot Scanning added in release 4.61
Medical charged-particle radiation therapy
Radiation Treatment Planning System Class II MUJ 21 CFR 892.5050 Radiology
Computerized Medical Systems, Inc. 13723 Riverport Dr. . Suite 100 Maryland Heights, MO 63043 1937649 Kathryn Stinson, RA Specialist 314-993-0003 314-993-1175
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PREDICATE DEVICE INFORMATION
The XiO RTP System with Proton Spot Scanning functionality is substantially equivalent to the following devices that the Food and Drug Administration (FDA) has cleared for distribution and are currently being actively marketed in the United States. XiO is substantially equivalent to these products in intended use and safety and effectiveness.
-
- XiO RTP System Computerized Medical Systems, Inc. K092132
-
- Eclipse Treatment Planning System Varian Medical Systems K091492
XIO INTENDED USE
The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will i calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
DESCRIPTION OF THE PRODUCT
The XiO Radiation Treatment Planning system accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume, which is the structure to be treated, and critical structures, or organs-atrisk, to which radiation dose must be limited.
Based on the dose prescribed, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The XiO system produces a display of radiation dose distribution within the patient, indicating doses to the target volume and critical structures. Appropriate clinical personnel select the plan that they believe most effectively maximizes dose to the target volume while minimizing dose to critical structures. The parameters of the plan are output in hard-copy format for later reference placed in the patient file.
This Premarket Notification addresses the addition of the Proton Spot Scanning. XiO provides the user with the ability to choose between multiple dose calculation algorithms, selecting the algorithm most appropriate for the given clinical scenario. More accurate
2
dose computation increases the probability that disease will be effectively treated and decreases the probability of undesirable side effects. No algorithm produces a perfectly accurate description of dose distribution; all algorithms have limitations, which are generally well understood and documented in scientific literature.
CMS received 510(k) clearance for the addition of proton planning capability to XiO in 2002. This feature extends proton planning functionality, giving the user the ability to create proton treatment plans that involve a series of small proton beams for which dose and monitor units are calculated and displayed individually. This allows users to create intensity modulated radiation therapy (IMRT) plans with protons, as discussed in more detail in section 11 of this submission. The proton spot scanning feature includes a new pencil beam dose calculation algorithm.
LEVEL OF CONCERN
Item 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices asks, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems ... " XiO does not directly control the linear accelerator that delivers the radiation. Once completed, plans are reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place. There is no automatic link between the XiO software and the linear accelerator. However, should a flaw in the treatment plan escape the notice of the qualified professionals using the XiO system, serious injury or death could result. Therefore, we believe XiO to be of major level of concern.
SUMMARY OF CLINICAL TESTING
Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy. In addition, clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. The product was deemed fit for clinical use.
5-3
3
SUMMARY OF NON-CLINICAL TESTING
Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in the XiO Verification Test Report, which is included in section 18 of this submission. XiO successfully passed verification testing.
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Image /page/4/Picture/0 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 entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol. The text is in all capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathryn Stinson Regulatory Affairs Specialist Computerized Medical Systems, Inc. 13723 Riverport Drive, Suite 100 MARYLAND HEIGHTS MO 63043
OCT 1 2010
Re: K102216
Trade/Device Name: XiO RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ and LHN Dated: August 4, 2010 Received: August 6, 2010
Dear Ms. Stinson:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K10 2216
Device Name: XiO RTP System
Indication For Use:
The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Hevice Evaluation (ODE) (2)
Muband D. Rhm for David G. Brown
Division Sign Off
Division Sign-Off
510(k): K102216
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