LIAC

K110840 · Sordina S.P.A. · IYE · Apr 17, 2012 · Radiology

Device Facts

• Record ID: K110840
• Device Name: LIAC
• Applicant: Sordina S.P.A.
• Product Code: IYE · Radiology
• Decision Date: Apr 17, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Liac (Models: 10MeV and 12MeV) is a mobile electron linear accelerator for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites. The LIAC is meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The device must be sold by or on the order of a physician. It is not for use by the general public or over-the-counter.

Device Story

LIAC (10MeV and 12MeV) is a mobile electron linear accelerator designed for intra-operative radiotherapy (IORT). Device operates in an operating theatre environment; used by physicians to deliver high-dose radiation directly to tumor sites immediately following surgical resection of neoplasms. System provides localized radiation therapy to improve treatment outcomes for patients undergoing cancer surgery.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Mobile electron linear accelerator; energy levels 10MeV and 12MeV; intended for intra-operative radiotherapy (IORT). Class II device (21 CFR 892.5050).

Indications for Use

Indicated for intra-operative radiotherapy (IORT) in patients following surgical removal of a neoplasm. For use by physicians in an operating theatre setting. Prescription only.

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.

Submission Summary (Full Text)

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## 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

APR 1 7 2012

SORDIN S.p.A. % Mr. Berthoin Claude President Denterprise International, Inc. 110E Granada Blvd. ORMOND BEACH FL 32176

Re: K110840

Trade/Device Name: LIAC (Models: 10MeV and 12MeV) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 23, 2012 Received: March 30, 2012

Dear Mr. Claude:

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 [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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## INDICATION FOR USE

## 510(k) Number (if known): K110840

Device Name: LIAC (Models: 10MeV and 12MeV)

Indications for Use:

Liac (Models: 10MeV and 12MeV) is a mobile electron linear accelerator for intra-operative radiotherapy (IORT).

Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites.

The LIAC is meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm.

The device must be sold by or on the order of a physician. It is not for use by the general public or over-the-counter.

Prescription Use __ × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ais Dókh

ivision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110840

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