(79 days)
The FOS iView EPID, as with the predicate SKI 100, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
The iView EPID is an enhancement to the existing SRI 100 electronic portal imaging device which has previously been cleared for commercial distribution. The primary reason for the introduction of this device is to address obsolescence issues associated with the image acquisition components and the computer hardware/operating system.
This document is a 510(k) submission for the Elekta Oncology Systems iView Electronic Portal Imaging Device (EPID). It primarily focuses on demonstrating substantial equivalence to a predicate device (SRI 100 EPID) rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device.
Therefore, for many of your requested items, the information is not explicitly provided in the furnished text. The submission relies heavily on the established safety and effectiveness of the predicate device and the fact that the iView EPID addresses obsolescence issues without introducing new safety or effectiveness concerns.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided text. The submission focuses on demonstrating substantial equivalence to an existing device rather than presenting specific performance metrics against pre-defined acceptance criteria for the iView EPID itself. The "reported device performance" is implied to be equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined in the document for the new device) | (Implied to be equivalent to the predicate SRI 100 EPID) |
2. Sample sized used for the test set and the data provenance
Not applicable/Not provided. The document does not describe a new study with a test set of data for the iView EPID's performance. The basis for safety and effectiveness is primarily the predicate device's track record and the assertion that the iView EPID does not raise new issues.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No new test set data or ground truth establishment is described for the iView EPID's performance.
4. Adjudication method for the test set
Not applicable/Not provided. No new test set data or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not provided. This device is an Electronic Portal Imaging Device (EPID), which is a hardware and software system used in radiation therapy for imaging, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is not an algorithmic diagnostic device in the sense of AI; it's an imaging device. The document states that it's an enhancement to an existing device, implying its performance is comparable to the predicate.
7. The type of ground truth used
Not applicable/Not provided. No new ground truth is described for the iView EPID. The "ground truth" for its safety and effectiveness relies on the established use of the predicate device (SRI 100) in treating malignant neoplastic diseases, as determined by a licensed medical practitioner.
8. The sample size for the training set
Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device in the context of image analysis or diagnostics that requires a separate training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no mentioned training set, this question is not applicable.
Summary of what the document does provide regarding acceptance criteria and studies:
The document demonstrates that the Elekta Oncology Systems iView EPID meets acceptance criteria primarily through:
- Substantial Equivalence: The core argument is that the iView EPID is an "enhancement" to the existing SRI 100 EPID, which has already been cleared and has a "proven track record for safety." This implies the acceptance criteria for safety and effectiveness are met by virtue of being similar to or better than the predicate.
- Addressing Obsolescence: The primary reason for the new device is to update components and address obsolescence, not to fundamentally change its function or performance in a way that would require new clinical effectiveness studies.
- Compliance with Standards:
- Safety Standards: The iView EPID has been subject to compliance testing as defined in IEC 601-1 and IEC 601-2-1. Proprietary IT equipment complies with IEC 950 and/or UL 1950.
- Quality System Standards: Elekta Oncology Systems is a registered medical device manufacturer assessed against ISO 9001, EN 46001, and the Medical Device Directive, 93/42/EEC Annex II. Their software quality system meets ISO 9001, EN 46001, the Medical Device Directive, and US 21 CFR 820 GMP.
- Regulatory Compliance: The device bears the CE mark, affirming compliance with relevant European Directives (Medical Device Directive, Electromagnetic Compatibility Directive).
- Hazard Analysis: Elekta Oncology Systems conducted a hazard analysis and concluded that the device does not introduce new types of safety or effectiveness considerations.
- Audits: The quality system is subject to periodic internal quality audits and regular, planned, and documented GMP audits by external auditors (SGS Yarsley and FDA).
In essence, the "study" proving the device meets acceptance criteria is a documentation of substantial equivalence, compliance with established safety and quality standards, and internal hazard analysis, rather than a clinical performance study with explicit test sets and ground truth.
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AUG - 7 1988
SUMMARY OF SAFETY & EFFECTIVENESS
Elekta Oncology Systems Ltd hereby provide the following material summarising safety and effectiveness information for the Elekta Oncology Systems iView Electronic Portal Imaging Device(EPID). This information is summarised as follows:-
- The iView EPID is an enhancement to the existing SRI 100 electronic 1) portal imaging device which has previously been cleared for commercial distribution. These devices have an established and proven track record for safety. The primary reason for the introduction of this device is to address obsolescence issues associated with the image acquisition components and the computer hardware/operating system. The iView EPID does not raise additional types of safety or effectiveness considerations.
- The accompanying documents provided for the user contain 2) comprehensive information to ensure safe and effective use. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed by the accompanying documents provided for the user.
- It is our opinion that the iView EPID does not have technological 3) characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing SRI 100 electronic portal imaging device.
- The iView EPID has been subject to compliance testing as defined in the 4) internationally recognised safety standards IEC 601-1 and IEC 601-2-1. As appropriate, proprietary information technology equipment is procured to the internationally recognised standards IEC 950 and/or UL 1950.
- ર) All products bear the CE mark affirming compliance with all relevant European Directives in force. In particular compliance has been assured to the European Medical Device Directive and the European Electromagnetic Compatibility Directive. As a result of this products may be sold freely without restriction throughout the entire European Union.
- Elekta Oncology Systems is a registered medical device manufacturer of 6) assessed capability against the requirements of ISO 9001, EN 46001, and the Medical Device Directive, 93/42/EEC Annex II.
| REF: 804/PC52MA07795MO7QA078 | Summary of Safety & Effectiveness Informationfor the Elekta Oncology Systems iViewElectronic Portal Imaging Device (EPID) | N.C. 4513 364 1878Attachment No: 9 | |
|---|---|---|---|
| Page 1 of 2 | 27/03/98 | ||
| © 1998 Elekta Oncology Systems Ltd. All rights reserved | |||
| ELEKTA ONCOLOGY SYSTEMS LTD, CRAWLEY. UK. |
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- Elekta Oncology Systems Software Quality System has been established 7) to satisfy the requirements of ISO 9001, EN 46001, the Medical Device Directive, 93/42/EEC Annex II, and the US 21 CFR 820 GMP. Elekta Oncology Systems has developed the iView EPID using an established and documented Software Quality Management System.
- In accordance with the above requirements all parts of the Quality 8) System are subject to periodic and systematic internal Quality Audits. These audits are performed by trained personnel not having direct responsibilities in the functions being audited.
- Additionally the quality system is subject to regular, planned and 9) documented GMP audits conducted by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
- Elekta Oncology Systems has conducted hazard analysis on the iView 10) EPID and has concluded that it does not introduce hazards that raise new type of safety or effectiveness considerations and that the level of concern appropriate to the device is high.
Signature ...................................................................
Development Director
Signature
Field Support Director the provided text is not related to the image. I am unable to perform the requested task. Please provide an image that contains text.
Signature CkReelt 3/3/18.
Quality and Regulatory Affairs Manager
| REF: 804/PC52MA07795MO7QA078 | Summary of Safety & Effectiveness Informationfor the Elekta Oncology Systems iViewElectronic Portal Imaging Device (EPID) | N.C. 4513 364 1878Attachment No: 9 | |
|---|---|---|---|
| Page 2 of 2 | 27/03/98 | ||
| © 1998 Elekta Oncology Systems Ltd. All rights reserved | |||
| ELEKTA ONCOLOGY SYSTEMS LTD, CRAWLEY. UK. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head composed of three profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 1998
Paul L. Sumner Director, Regulatory Affairs & Quality Assurance Elekta Instruments, Inc. 8 Executive Park West Atlanta, GA 30329
Dear Mr. Sumner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Re:
Dated: May 19, 1998
Regulatory class: II
Received: May 20, 1998
21 CFR 892.5050/Procode: 90 IYE
iView Electronic Portal Imaging Device (EPID)
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N 981790 510(k) Number (if known): __
EOS iView Electronic Portal Imaging Device (EPID)
Device Name:
Indication For Use:
The FOS ?View EPID, as with the predicate SKI 100, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
(PLEASE DO NOT WRITE BELOW TIMS LINE - CONTINUL ON ANOTIVIER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
William
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use X
( Per 21 CFR 801.109
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.