(100 days)
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
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
The provided 510(k) summary for Integrity™ R1.1 discusses a software enhancement to an existing medical linear accelerator control system. This submission does not describe a study in the traditional sense with acceptance criteria, sample sizes, expert ground truth, or an MRMC study related to diagnostic accuracy. Instead, it focuses on verifying the software's functionality and safety and establishing substantial equivalence to a predicate device.
The "acceptance criteria" here are essentially the successful completion of various engineering and validation tests, ensuring the new software features and changes do not negatively impact safety or effectiveness.
Here's a breakdown of the requested information based on the provided text, recognizing that many categories are not applicable to this type of submission which focuses on software changes to a control system, rather than a diagnostic AI device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) (software update for a control system), the "acceptance criteria" are implied to be the successful execution and verification of functional and safety requirements, and demonstrating substantial equivalence to the predicate device. The "reported device performance" refers to the system meeting these established criteria.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Verification | All new and existing features perform as specified in the requirement specification. | "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." |
| Safety and Effectiveness | The device maintains safety and effectiveness equivalent to the predicate device and complies with relevant safety standards. | "Results from verification and validation testing demonstrate that conformance to applicable technical design specification and assured safety & effectiveness have been met." "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." |
| Substantial Equivalence | Demonstrated equivalence in intended use, principles of operation, technological characteristics, and labeling to the predicate device (Integrity™ R1.0, K102200). | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or clinical images, as this is a software update for a control system. Testing was performed on "production equivalent systems at Elekta and at customer sites." There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because the testing is related to the functionality of the control system software, not analysis of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a software control system update, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
N/A. Not applicable for this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device (a linear accelerator control system software update). The device's primary function is to control radiation delivery, not to interpret diagnostic images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone algorithm (a control system software). Its performance was evaluated through verification and validation testing, as described in the "Summary of non clinical performance testing." This is effectively "standalone" performance testing for the software's functionality.
7. The Type of Ground Truth Used
N/A. For a control system, "ground truth" is defined by the technical specifications and desired operational parameters. Successful operation according to these specifications (e.g., accurate beam delivery, proper system responses) constitutes meeting the "ground truth." There is no patient-level ground truth (like pathology or outcomes data) involved for this type of submission.
8. The Sample Size for the Training Set
N/A. This 510(k) is for a software update to a control system. It does not involve machine learning or AI in the sense of being "trained" on a dataset like an image analysis algorithm would be.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no "training set" in the context of an AI/ML algorithm that learns from data, this question is not applicable.
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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
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| Functionality | NEW DEVICEIntegrity R1.1 | PREDICATE DEVICEIntegrityR1.0 | ||
|---|---|---|---|---|
| MLCi2 | BM | MLCi2 | BM | |
| MLC move duringirradiation | No change | No change | YES | YES |
| Max. speed of MLCmovement | 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 diaphragmsmove during | No change | No change | Track lastleaf forlower leakage | N/A |
| Gantry move duringirradiation | No change | No change | YES | YES |
| Variable gantry speed | No change | No change | YES | YES |
| Collimator rotatesduring irradiation | No change | No change | YES | YES |
| Variable Doserates(available dose rates) | No change | No change | ( 255 ) | ( 255 ) |
| Treatment DeliveryTime ≈ | 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
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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
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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
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Indications for Use
510(k) Number (if known): (< l ( 26 13
Device Name: Integrity R1.1
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)
..
(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. K112613
Page 1 of 1
| 2011/07/12 | Elekta Integrity TM | Document 04 - 01 |
|---|---|---|
| © 2011 Elekta Limited, Crawley, UK. All rights reserved. | Page 1 of 1 |
§ 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.