MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)

• K Number: K012289
• Device Name: MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
• Manufacturer: ELEKTA ONCOLOGY SYSTEMS, LTD.
• Date Cleared: 2001-08-14 ( 25 days)
• Product Code: IYE
• Regulation Number: 892.5050

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 Description

The iViewGT™ EPID is an enhancement to the existing iView Electronic 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.

Predicate Devices

K981790

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware enhancements (solid state detectors) and comparison to a predicate device without mentioning AI/ML capabilities.

Therapeutic

No.
The device is described as an Electronic Portal Imaging Device (EPID) used with radiation therapy treatments. Its purpose is for imaging and image acquisition, not for treating the disease directly.

Diagnostic

No

Explanation: The device is an Electronic Portal Imaging Device (EPID) used with radiation therapy treatments. It is not described as diagnosing diseases but rather as an imaging device for treatment.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "Electronic Portal Imaging Device (EPID)" and mentions supporting "solid state detectors for image acquisition," indicating it includes hardware components for image capture.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states it's for use with radiation therapy treatments of malignant neoplastic diseases. This is a therapeutic application, not a diagnostic one performed in vitro (outside the body).
• Device Description: The description focuses on image acquisition for radiation therapy, not on analyzing biological samples.
• Input Imaging Modality: Electronic Portal Imaging is a method of imaging the patient during radiation treatment, not a method for analyzing biological samples.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) during a treatment procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

90 IYE

Device Description

The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device which has previously been cleared for commercial distribution under D.C. K981790. The primary reason for this modification to support solid state detectors for image acquisition.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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): 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.

K981790

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

Regulation Number and Section

§ 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.

Summary

0

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
for the Elekta Oncology Systems iViewGTTM
Electronic Portal Imaging Device (EPID) | N.C. 4513 341 2200
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
for the Elekta Oncology Systems iViewGTTM
Electronic Portal Imaging Device (EPID) | N.C. 4513 341 2200
Attachment No: 6
Page 1 of 2
17/07/01 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| © 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)

3

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)