(30 days)
Not Found
No
The document describes improvements to existing hardware and software for efficiency, image quality, and connectivity, but does not mention AI or ML. While image processing is mentioned, it's not explicitly linked to AI/ML techniques.
No
The device is a radiation therapy system used for treating malignant neoplastic diseases, which is a form of therapy. Therefore, it is a therapeutic device.
No
Explanation: The device is described as a radiation therapy treatment system for malignant neoplastic diseases, not for diagnosing them. While it performs imaging (kV imaging), it is for the purpose of guiding treatment, not for making a diagnosis.
No
The device description explicitly states it is a "combination of the specially prepared Elekta medical linear accelerator, Elekta Synergy® Platform, with the XVI on-board kV imaging accessory," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "radiation therapy treatment of malignant neoplastic diseases." This is a therapeutic application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description focuses on a medical linear accelerator and an on-board kV imaging accessory used for radiation therapy. While it mentions "image processing," this is in the context of setting up and managing the radiation treatment, not for diagnosing a condition from a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a therapeutic medical device used for radiation treatment.
N/A
Intended Use / Indications for Use
The Elekta Synergy®, Elekta Synergy® S, and XVI R3.5 are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
This Premarket Notification Special 510(k) describes modifications to the Elekta Synergy® System; a combination of the specially prepared Elekta medical linear accelerator, Elekta Synergy® Platform, with the XVI on-board kV imaging accessory. The primary reasons for the modifications to this product are to provide:
- Hardware & software support for increased patient throughput
- Easier selection of parameters & provision of clinical presets to improve efficiency
- Improved image quality and image management
- Improved tools for device set-up and image processing
- Improved connectivity with other systems through DICOM
Mentions image processing
Improved tools for device set-up and image processing
Mentions AI, DNN, or ML
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Input Imaging Modality
kV imaging system
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical 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
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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.
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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).
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§ 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
KOS/932
510(k) SUMMARY
Date of preparation of summary:
4th July 2005
Submitted by:
Elekta Limited Linac House, Fleming Way Crawley, West Sussex RH20 9RR United Kingdom
Contact name, (application correspondent):
Peter Stegagno, Director, Regulatory Affairs & Quality Assurance 4775 Peachtree Industrial Boulevard, Building 300, Suite 300 Norcross, Georgia, 30092 USA
| Email: | peter.stegagno@elekta.com | |
|---|---|---|
| Telephone: (770) 300 9725 x2548 | Fax: (770) 448 6338 |
| Trade Name: | Elekta Synergy®, Elekta Synergy® S, and XVI R3.5 |
|---|---|
| Common Name: | Medical Linear Accelerator (with Patient Imaging) |
| Classification Name: | Medical Linear Accelerator Accessory 90 IYE |
| Predicate Device: | Elekta Synergy® System (K032996) |
Product Description:
This Premarket Notification Special 510(k) describes modifications to the Elekta Synergy® System; a combination of the specially prepared Elekta medical linear accelerator, Elekta Synergy® Platform, with the XVI on-board kV imaging accessory. The primary reasons for the modifications to this product are to provide:
- Hardware & software support for increased patient throughput �
- Easier selection of parameters & provision of clinical presets to improve efficiency �
- Improved image quality and image management �
- Improved tools for device set-up and image processing �
- Improved connectivity with other systems through DICOM �
Intended Use Statement:
This is unchanged from the predicate device and is defined as;
The Elekta Synergy®, Elekta Synergy® S, and XVI R3.5
are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner."
Summary of Technological Characteristics:
The Elekta Synergy® and Elekta Synergy® S comprise a standard Elekta medical linear accelerator, modified to accept the fitting of a kV imaging system (XVI R3.5), with a common MV and kV isocentre and orthogonal beam paths, all as previously cleared under Control Number K032996.
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There has been no change made to the underlying technological characteristics of the product.
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines emanating from its head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
AUG 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elekta Limited % Mr. Peter Stegagno Director, Regulatory Affairs & Quality Assurance Elekta, Inc. 4775 Peachtree Industrial Boulevard Building 300, Suite 300 NORCROSS GA 30092
Re: K051932 Trade/Device Name: Elekta Synergy®, Elekta Synergy® S and XVI R3.5 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 8, 2005 Received: July 13, 2005
Dear Mr. Stegagno:
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.
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manusing of substantial equivalence of your device to a legally premarket nothcation. The I DA Intentig or our 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 if you desire spective advice for your do 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" (21 CFR Also, please note the regulation entired, for responsibilities under the Act from the 807.97). You may obtain other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon 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
| 510(k) Number (if known): | K051932 |
|---|---|
| Device Name | Elekta Synergy ® , Elekta Synergy ® S, and XVI R3.5 |
| Indication for Use: | The Elekta Synergy ® , Elekta Synergy ® S, and XVI R3.5 are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed physician. |
| Prescription Use | |
| (Per 21 CFR 801.109 Subpart D) | - YES AND/OR Over-The-Counter Use - NO |
| (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)
David R. Lignon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _