(100 days)
Not Found
No
The document describes software enhancements for controlling a linear accelerator, focusing on continuous variation of treatment parameters (VMAT). There is no mention of AI, ML, or related concepts in the provided text.
Yes
Explanation: The device is intended to assist in the delivery of radiation for therapeutic purposes, such as treating tumors.
No
The device is described as "interface and control software" for linear accelerators used in radiation delivery/therapy, not for diagnosis. Its purpose is to assist in delivering radiation treatment, not to identify or characterize diseases.
No
The device description explicitly states that the software is executed on a "dedicated control cabinet," indicating the presence of associated hardware.
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 device is "intended to assist a licensed practitioner in the delivery of radiation to defined target volumes... whilst sparing surrounding normal tissue and critical organs from excess radiation." This describes a therapeutic device used for treating patients directly, not a device used to examine specimens taken from the body to diagnose diseases or conditions.
- Device Description: The description focuses on the software's role in controlling a medical linear accelerator for radiation therapy delivery. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Desktop Pro™ (VMAT) software, as described, is a component of a therapeutic radiation delivery system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all areas of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed practitioner
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.
Elekta Synergy® (K051932)
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
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 | CA
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