(100 days)
Desktop Pro™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the range of medical digital linear accelerators. These enhancements enable existing control functions to be continuously varied during the delivery of radiation therapy. Thus gantry rotation and speed of rotation, multi-leaf collimator - leaf position and head rotation, back-up diaphragms and dose rate can be continuously and simultaneously varied during treatment delivery. The suffix (VMAT) is used commercially to differentiate this version of the software.
Desktop Pro™ (VMAT) is an integrated digital control system, providing interface and machine control functions for the Elekta range of digital accelerators. It comprises a dedicated control cabinet on which the interface and machine control software is executed.
The provided document is a 510(k) summary for the Elekta Desktop Pro™ (VMAT) device. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance rather than presenting a study demonstrating performance against specific acceptance criteria in the context of AI/ML device evaluation.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, is not available within this document. The document primarily describes the device, its intended use, and argues for its substantial equivalence to an existing, legally marketed predicate device (Elekta Synergy® K051932) based on technological characteristics and functional similarity. It does not detail a study designed to quantify and prove the device's performance against predefined acceptance criteria using clinical data.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on feature equivalence rather than performance metrics.
- Sample size used for the test set and the data provenance: Not applicable, as there's no performance study described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a control system for linear accelerators, not an AI-powered diagnostic or assistive tool for human readers in the sense of image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an integral control system for a linear accelerator, not a standalone algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in that context.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Elekta. The logo is a black circle with a white line extending from the center to the edge, resembling a clock hand. The word "ELEKTA" is written in capital letters below the circle.
JUN 1 1 2008
510(k) SUMMARY
Date of preparation of summary: 12th February 2008
Submitted by: Elekta Limited
Linac House, Fleming Way, Crawley, West Sussex RH20 9RR, United Kingdom Telephone: +44 (0) 1293 544422 Fax: +44 (0) 1293 654260
Contact name: Mr. Patrick Hull
| Trade Name: | Desktop Pro™ |
|---|---|
| Common Name: | Control System, Medical Linear Accelerator |
| Classification Name: | Medical Linear Accelerator Accessory, IYE |
| Predicate Device: | Elekta Synergy® (K051932) |
Product Description:
This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the range of medical digital linear accelerators. These enhancements enable existing control functions to be continuously varied during the delivery of radiation therapy. Thus gantry rotation and speed of rotation, multi-leaf collimator - leaf position and head rotation, back-up diaphragms and dose rate can be continuously and simultaneously varied during treatment delivery. The suffix (VMAT) is used commercially to differentiate this version of the software.
Intended Use Statement:
Desktop Pro™ (VMAT) is the interface for the Elekta range of digital medical linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours). whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Summary of Technological Characteristics:
Desktop Pro™ (VMAT) is an integrated digital control system, providing interface and machine control functions for the Elekta range of digital accelerators. It comprises a dedicated control cabinet on which the interface and machine control software is executed. There has been no change made to the underlying technological characteristics of the product from the predicate device.
Substantial Equivalence
The functionality for the Desktop Pro™ (VMAT) is equivalent to its predicate device the Elekta Synergy (K051932) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device and differences in operation are described in the comparison chart and discussion provided elsewhere in this 510(k) submission.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the figure. The figure is composed of three curved lines that resemble a person with their arms raised.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 2008
Mr. Patrick T M Hull Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM
Re: K080585
Trade/Device Name: Desktop ProTM Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 15, 2008 Received: May 19, 2008
Dear Mr. Hull:
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.
{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 (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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 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/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Burgdon
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):
Device Name ..................... Desktop Pro™
Indication for Use:
Desktop Pro™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Prescription Use - YES (Per 21 CFR 801.109 Subpart D) AND/OR
- NO 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)
Arni M. Whang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
| 2008/02/12 | Jesktop Pro | CA11DocumentI |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | iektaLimited.Crawley. | CageD |
§ 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.