(92 days)
Not Found
No
The document describes software enhancements focused on operating system updates, dose rate variability, and MLC leaf control, with no mention of AI or ML technologies.
No
The device is described as interface and control software for medical digital linear accelerators used for delivering radiation, which is a therapeutic treatment. However, the software itself is not a therapeutic device but rather a component that facilitates the delivery of therapeutic radiation by a separate medical device (the linear accelerator).
No.
The device description clearly states its purpose is to "assist a licensed practitioner in the delivery of radiation to defined target volumes" for cancer treatment, indicating a therapeutic rather than diagnostic function.
No
The device is described as "interface and control software for the Elekta range of medical digital linear accelerators," indicating it is software that controls a physical medical device (linear accelerator) and is not a standalone software-only device.
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 Integrity™ 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 delivering radiation treatment, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description focuses on software enhancements for controlling a linear accelerator, a device used for radiation therapy. It mentions features related to dose rate and MLC control, all relevant to radiation delivery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any other activities typically associated with in vitro diagnostics.
Therefore, Integrity™ is a therapeutic device used in radiation oncology, not an IVD.
N/A
Intended Use / Indications for Use
Integrity™ 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 turnours), 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
IYE
Device Description
This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the Elekta range of medical digital linear accelerators. Integrity R1.0 employs a new LynxOS operating system that has a proven track record in safety and security to replace RMX. The software introduces Continuously Variable Dose Rate (CVDR), which is an enhancement to standard dose rate for dynamic delivery techniques. This function increases the number of available dose rates which can make treatment delivery more efficient and provide smoother delivery of VMAT prescriptions. The software supports the ability for the MLCi2 leaves to interdigitate, supporting the creation of island fields for X-Ray treatment delivery techniques.
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)
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.
0
Image /page/0/Picture/0 description: The image shows the word "ELEKTA" in a bold, sans-serif font. To the left of the word is a circular logo with a broken outline at the top. Inside the circle are a few small dots and a short, curved line.
.
510(k) SUMMARY
NOV - 4 2010
Date of preparation of summary: 28th July 2010
Submitted by:
Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH20 9RR, United Kingdom Telephone: +44 (0) 1293 654201 Fax: +44 (0) 1293 654260
Contact name: Mr. Andrew Hedges
| Trade Name: | Integrity™ R1.0 |
|---|---|
| Common Name: | Control System, Medical Linear Accelerator |
| Classification Name: | Medical Linear Accelerator Accessory, IYE |
| Predicate Device: | Desktop Pro™ (K080585) |
Product Description:
This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the Elekta range of medical digital linear accelerators. Integrity R1.0 employs a new LynxOS operating system that has a proven track record in safety and security to replace RMX. The software introduces Continuously Variable Dose Rate (CVDR), which is an enhancement to standard dose rate for dynamic delivery techniques. This function increases the number of available dose rates which can make treatment delivery more efficient and provide smoother delivery of VMAT prescriptions. The software supports the ability for the MLCi2 leaves to interdigitate, supporting the creation of island fields for X-Ray treatment delivery techniques.
Intended Use Statement:
Integrity™ 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 turnours), 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:
Integrity™ 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 Integrity™ is equivalent to its predicate device the Elekta Desktop Pro™ (K080585) 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three tail feathers, representing the department's mission to protect the health of all Americans. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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
Mr. Andrew Hedges Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM
NOV - 4 2010
Re: K102200
Trade Name: Integrity Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 2, 2010 Received: August 4, 2010
Dear Mr. Hedges
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
2
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
3
1102200
Indications for Use
NOV - 4 2010
510(k) Number (if known):
Device Name:
Indications for Use
Indications for Use: Integrity™ 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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510K | K102200 |
|---|---|
| ------ | --------- |
| Page 1 of 1 | |
|---|---|
| -- | ------------- |
| 2010/05/12 | Elekta Integrity™ | Document 04 - 01 |
|---|---|---|
| ------------ | ------------------- | ------------------ |
© 2010 Elekta Limited, Crawley, UK. All rights reserved.