MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)

K012289 · Elekta Oncology Systems, Ltd. · IYE · Aug 14, 2001 · Radiology

Device Facts

• Record ID: K012289
• Device Name: MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
• Applicant: Elekta Oncology Systems, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Device Story

The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device. It utilizes solid-state detectors for image acquisition during radiation therapy. The device captures images of the radiation field to assist in treatment verification. It is intended for use in clinical settings by trained medical professionals. The output is used by clinicians to verify patient positioning and treatment delivery accuracy, potentially improving the precision of radiation therapy for malignant neoplastic diseases. The device does not introduce new safety or effectiveness considerations compared to the predicate.

Clinical Evidence

No clinical data provided. The device relies on bench testing and compliance with international safety standards (IEC 60601-1, IEC 60601-2-1, IEC 60950/UL 1950) to demonstrate safety and effectiveness.

Technological Characteristics

The device utilizes solid-state detector technology for image acquisition. It is designed to comply with IEC 60601-1 and IEC 60601-2-1 safety standards. IT equipment complies with IEC 60950 and UL 1950. The device is CE marked under the European Medical Device Directive and Electromagnetic Compatibility Directive.

Indications for Use

Indicated for patients undergoing radiation therapy for malignant neoplastic diseases, as determined by a licensed medical practitioner.

Regulatory Classification

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.

Predicate Devices

• iView Electronic Portal Imaging Device (K981790)

Submission Summary (Full Text)

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## KO12289 SUMMARY OF SAFETY & EFFECTIVENESS

- 7) Elekta Oncology Systems is a registered medical device manufacturer of assessed capability against the requirements of ISO 9001. EN 46001. ISO 13485 and the Medical Device Directive 93/42/EEC Annex II.
- 8) In accordance with the above requirements all parts of the Quality 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.
- 9) The quality system is subject to regular, planned and 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 10) iViewGT™ EPID and has concluded that it does not introduce hazards that raise new types of safety or effectiveness considerations. After considering the Guidance for the Content of Pre-Market Nøtification Submissions of Medical Devices Containing Software EOS has concluded the level of concern appropriate to the device is "Higher".

Signature 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Vice President Research & Development

Signature ...

Director Product Management

Signature ..

Vice President Quality and Regulatory Affairs Manager

| REF.: MO1RA011 | Summary of Safety & Effectiveness Information<br>for the Elekta Oncology Systems iViewGTTM<br>Electronic Portal Imaging Device (EPID) | N.C. 4513 341 2200<br>Attachment No: 6 | |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------|
| | | Page 2 of 2 | 17/07/01 |
| © 2001 Elekta Oncology Systems Ltd. All rights reserved | | | |
| ELEKTA ONCOLOGY SYSTEMS LTD. CRAWLEY, UK | | | |

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## SUMMARY OF SAFETY & EFFECTIVENESS

Elekta Oncology Systems Ltd hereby provide the following material summarising safety and effectiveness information for the Elekta Oncology Systems iViewGT™ Electronic Portal Imaging Device(EPID). This information is summarised as follows :-

- The iViewGT™ EPID is an enhancement to the existing iView Electronic 1) Portal Imaging Device which has previously been cleared for commercial distribution under D.C. K981790. These devices have an established and proven track record for safety. The primary reason for this modification to support solid state detectors for image acquisition. The iViewGTTM EPID does not raise additional types of safety or effectiveness considerations.
- It is our opinion that the iViewGT™ EPID does not have technological 2) characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing iView Electronic Portal Imaging Device.
- The accompanying documents provided for the user contain 3) 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.
- The iViewGT™ EPID is subject to compliance testing as defined in the 4) internationally recognised safety standards IEC 60601-1 and IEC 60601-2-1. As appropriate, proprietary information technology equipment is procured to the internationally recognised standards IEC 60950 and/or UL 1950.
- The iViewGT™ EPID is designed to bear the CE mark affirming 5) compliance with all relevant European Directives in force, in particular 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 Software Quality System has been established to 6) satisfy the requirements of ISO 9001, EN 46001, ISO 13485, the Medical Device Directive 93/42/EEC Annex II and the US 21 CFR 820 GMP. Elekta Oncology Systems has developed the iViewGT™ EPID using an established and documented Quality Management System.

| REF.: MO1RA011 | Summary of Safety & Effectiveness Information<br>for the Elekta Oncology Systems iViewGTTM<br>Electronic Portal Imaging Device (EPID) | N.C. 4513 341 2200<br>Attachment No: 6<br>Page 1 of 2<br>17/07/01 |
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| © 2001 Elekta Oncology Systems Ltd. All rights reserved | | |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation. The birds are depicted with curved lines, giving them a sense of movement.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elekta Oncology Systems (EOS), Ltd. % Mr. Peter Stegagno Director, Regulatory Affairs & Quality Assurance Elekta Instruments, Inc. 3155 Northwoods Parkway NORCROSS GA 30071

Re: K012289

iView GT Electronic Portal Imaging Device Dated: July 19, 2001 Received: July 20, 2001 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE

## Dear Mr. Stegagno:

We have reviewed your Section 510(k) notification of intent to market to the marketed above and we bave decemined the interstant We have reviewed your Section 310(K) notification of the connects on the devices maketed in interstate device is substantially equivalent (to the use success to receive) to to devices that have been been been commerce prior to May 28, 1976, in eliacinent uac or the Federal Food, Drug, and Cosmetic Act (Act.). You may, therefore, narke reclassified in acordance with the provisions of the Act. The general provisions of the Act indude requirements the device, subject to the general colludis provisions of the river seating and prohibitions against misbranding and adulteration.

AUG 1 4 2001

If your device is classified (see above) into either class II (grecial Controls) or class III (provaries Approval), it may be subjicon If your device is classified (see above) into entrely of the Coast on to for the Code of Feed in the Code of Feed Meeplations, to such additional controls. Existing major regulations areculiance with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalent determination Title 21, Parts 800 to 895. A substanted minutes and on included by incerc Central regulation (21 CFR Partice Practice requirements, as Set lotti in the Quality of the Manistration (FDA) will verify such assumptions. Failure 820) and that, through periodic QS inspection. In e rood and Drug Tournal publish further announcements.
to comply with the GMP regulation may result in regulatory action. I to comply with the GMP regulation may result inis response to your prematic notification submission does not
concerning your device in the Federal Register. Please not of th concerning your device in the Federal Register. Prease note for your possible of the Electronic Product affect any outgation , as other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarker notification for your device ond This letter will allow you to begily marketed predicated in your 3 to (pressure 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 809.00 for in vitte If you desire specific advice for your device of [phone]. Additionally, for questions on the promotions on the promotion diagnosite devices), please contact the Office of Compliance at [phone]. Also, please not the regulation and advertising of your device, please contribution on Complance at (197) - noor personalistical integral discussion in the pumber entitled, "Misfranding by reterence notification" (216) in and Consumer Assistance at its toll-free number Act may be obtained from the DVVsloll of Sthan Mandrass http://www.da.gov/odrh/dsmaldsmamain.html.

Sincerely Yours

Percy Brogdon

Nancy C. rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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N.C. 4513 341 2200

K0/2289

510(k) Number (if known):

EOS iViewGT™ EPID

Device Name:

Indication for Use:

The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, 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 THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy Skogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012289

(Optional Format 1-2-96)