(100 days)
Not Found
No
The summary describes software enhancements for linear accelerators focused on interface, control, beam delivery, compatibility, and diagnostic tools. There is no mention of AI, ML, or related concepts, nor is there a description of training or test sets for such algorithms.
Yes
Explanation: The device, Integrity™, is software for medical digital linear accelerators intended to assist in the delivery of radiation to treat defined target volumes like lesions, tumors, and malformations, which aligns with the definition of a therapeutic device.
No
The device is described as interface and control software for medical digital linear accelerators used for delivering radiation therapy, not for diagnosing conditions. While it provides "diagnostic tools to assist service engineers," these tools are for the device itself, not for patient diagnosis.
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 hardware medical device (linear accelerator), not a standalone software-only medical 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 the device is "intended to assist a licensed practitioner in the delivery of radiation to defined target volumes...". This describes a therapeutic device used for treating patients directly, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on software for controlling medical linear accelerators, which are used for radiation therapy. It mentions improvements to beam delivery and compatibility with other Elekta products, all related to the operation of a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the device described is a therapeutic device used in radiation oncology, not an in vitro diagnostic device.
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.q. 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 interface and machine control functions for the Elekta Limited range of medical digital linear accelerators. These modifications provide improvements to beam delivery, compatibility with a wider range of Elekta products and the provision of diagnostic tools to assist service engineers
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)
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against the requirement specification. Regression testing has been performed successfully to verify the integrity of any changes. Validation of the system under actual use conditions have been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specification and assured safety & effectiveness have been met. Testing has been undertaken on both production equivalent systems at Elekta and at customer sites. The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in the Standard Data Report in section 9 which includes but not limited to IEC 60601-1, IEC 60601-2-1, IEC 60601-1-4, IEC 62304, IEC 60601-1-6, IEC 62366 and ISO 14971.
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.
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
510(k) SUMMARY
Date of preparation of summary: 1st September 2011
Submitted by:
Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR. United Kingdom Telephone: +44 (0) 1293 654201 Fax: +44 (0) 1293 654260
Contact name: Mr. Andrew Hedges
| Trade Name: | Integrity™ R1.1 |
|---|---|
| Common Name: | Control System, Medical Linear Accelerator |
| Classification Name: | Medical charged-particle radiation therapy system, 21CFR 892.5050 |
| Product Code: | IYE |
| Predicate Device: | Integrity™ R1.0 (K102200) |
Product Description:
This Traditional 510(k) describes enhancements to the integral software performing the interface and machine control functions for the Elekta Limited range of medical digital linear accelerators. These modifications provide improvements to beam delivery, compatibility with a wider range of Elekta products and the provision of diagnostic tools to assist service engineers
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.q. 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:
Integrity™ is an integrated digital control system, providing interface and machine control functions for the Elekta Limited 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 substantially equivalent to its predicate device, Integrity™ R1.0 (K102200) in safety and effectiveness. The intended use, principles of operation, technological characteristics and labelling are the same or equivalent to the predicate device.
The primary difference between the predicate device and the modified device is the improved consistency of VMAT beam delivery and added flexibility for fault diagnosis. It does not introduce additional clinical functionality or performance.
Elekta Ltd., Linac House, Fleming Way, Crawley, West Sussex RH10 9RR UK Tel:+44 (0)1293 544422 Fax:+44 (0)1293 654321 www.elekta.com Registered in England No. 324454 DEC 1 6 2011
1
| Functionality | NEW DEVICE
Integrity R1.1 | | PREDICATE DEVICE
IntegrityR1.0 | |
|----------------------------------------------|------------------------------|-----------|-----------------------------------------|---------|
| | MLCi2 | BM | MLCi2 | BM |
| MLC move during
irradiation | No change | No change | YES | YES |
| Max. speed of MLC
movement | No change | No change | 2cm/s | 2.5cm/s |
| Variable leaf speed | No change | No change | YES | YES |
| Interdigitation | No change | No change | YES | YES |
| Back up diaphragms | No change | No change | YES | NO |
| Back up diaphragms
move during | No change | No change | Track last
leaf for
lower leakage | N/A |
| Gantry move during
irradiation | No change | No change | YES | YES |
| Variable gantry speed | No change | No change | YES | YES |
| Collimator rotates
during irradiation | No change | No change | YES | YES |
| Variable Doserates
(available dose rates) | No change | No change | ( 255 ) | ( 255 ) |
| Treatment Delivery
Time ≈ | No change | No change | 1.4 min | 1.4 min |
Summary of non clinical performance testing
Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against the requirement specification.
Regression testing has been performed successfully to verify the integrity of any changes.
Validation of the system under actual use conditions have been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specification and assured safety & effectiveness have been met.
Testing has been undertaken on both production equivalent systems at Elekta and at · customer sites.
The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in the Standard Data Report in section 9 which includes but not limited to IEC 60601-1, IEC 60601-2-1, IEC 60601-1-4, IEC 62304, IEC 60601-1-6, IEC 62366 and ISO 14971.
Elekta Ltd., Linac House, Fleming Way, Crawley, West Sussex RH10 9RR UK Tel:+44 (0)1293 544422 Fax:+44 (0)1293 654321 www.elekta.com Registered in England No. 3244454
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ 1
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of an eagle.
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 Crawley, West Sussex RH10 9RR UNITED KINGDOM
DEC 1 6 2011
Re: K112613
Trade/Device Name: Integrity R1.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 7, 2011 Received: November 9, 2011
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
3
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,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): (TM | Document 04 - 01 |
|----------------------------------------------------------|--------------------------------|------------------|
| © 2011 Elekta Limited, Crawley, UK. All rights reserved. | | Page 1 of 1 |