APEX

K111676 · Elekta Limited · IXI · Sep 30, 2011 · Radiology

Device Facts

• Record ID: K111676
• Device Name: APEX
• Applicant: Elekta Limited
• Product Code: IXI · Radiology
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Apex™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

Device Story

Apex is an add-on micro-multileaf collimator (microMLC) accessory for digital linear accelerators; used in radiation therapy. Device shapes X-ray fields in static or dynamic modes; adjusts based on gantry angle. System comprises 112 individually controlled and monitored leaves; 2.5mm leaf width at isocenter; 120mm x 140mm field size. Operated by radiation oncology staff in clinical settings. Assists oncologists in delivering precise radiation doses to target tissues while sparing surrounding healthy anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Add-on microMLC system; 112 individually controlled/monitored leaves; 2.5mm leaf thickness at isocenter; 120mm x 140mm field size. Accessory to digital linear accelerators.

Indications for Use

Indicated for use as an accessory to a linear accelerator in radiation therapy to shape X-ray fields in static or dynamic modes for patients requiring targeted radiation therapy while sparing surrounding normal tissues.

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Predicate Devices

• DMLC IV (K001163)

Submission Summary (Full Text)

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# 510(k) SUMMARY

SEP 3 0 2011

Date of preparation of summary: May 10th 2011

Submitted by:

Trade Name:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Fax: [phone] Telephone: [phone]

Contact name:

Mr Patrick Hull Apex TM

Common Name: Add-on microMLC

Classification Name:

5710, Product Code IXI)

Predicate Device: DMLC IV (K001163)

#### Product Description:

This Traditional 510(k) describes modifications made to the add-on DMLC accessory for the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the leaf resolution - Apex 11 has a reduced leaf width of 2.5mm and increased field size.

BLOCK, BEAM-SHAPING, RADIATION THERAPY (21CFR 892

### Intended Use Statement:

Apex™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

### Indication for Use Statement:

Apex ™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

Summary of Technological Characteristics:
The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.

There has been no substantial change made to the underlying technological characteristics of the product.

## Substantial Equivalence

The functionality for the Apex™ is equivalent to its predicate device DMLC IV (K001163) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device and differences in operation are described in the comparison as and discussion provided elsewhere in this 510(k) submission.

| 2011/05/10 | Apex | Document 05-01 |
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| © 2011 Elekta Limited, Crawley, UK. All rights reserved. | | Page 1 of 1 |

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue text. To the left of the text is an emblem featuring a stylized human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JUL 2 4 2012

Mr. Patrick Hull Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way CRAWLEY, WEST SUSSEX RH10 9RR UNITED KINGDOM

Re: K111676

Trade/Device Name: Apex Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation Therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: May 10, 2011 Received: June 15, 2011

Dear Mr. Hull:

This letter corrects our substantially equivalent letter of September 30. 2011. 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. Iisting 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting 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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Section 4 - Indications for Use Statement and Technical Description of Apex

Apex

510(k) Number (if known): _ KII I676

Device Name:

Indications for Use:

Apex is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)
Mary S Potts

Concurrence of CDRH, Office of Device Evaluation of

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