LIAC HWL

K172961 · Sit Sordina Iort Technologies Spa · IYE · Jun 11, 2018 · Radiology

Device Facts

• Record ID: K172961
• Device Name: LIAC HWL
• Applicant: Sit Sordina Iort Technologies Spa
• Product Code: IYE · Radiology
• Decision Date: Jun 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LIAC HWL are mobile electron linear accelerators 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 HWL are meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The devices must be sold by or on the order of a physician. They are by the general public or over-the-counter. LIAC HWL are electron accelerators that can work in an operating its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.

Device Story

Mobile electron linear accelerator (LINAC) for intra-operative radiotherapy (IORT); used in operating rooms immediately following surgical tumor resection. Device delivers high-dose electron radiation directly to tumor site while sparing surrounding healthy tissue. System comprises irradiating unit (stand), control unit, and applicators. Surgeon/physician operates device to target residual tumor beds. Modifications from predicate include additional shielding in radiant head to reduce scattered radiation, shorter applicators to reduce source-surface distance (SSD), higher dose rate, and modified remote control. Benefits include localized treatment without requiring patient transport to radiation oncology department.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including radiation performance metrics (surface dose, field symmetry, dose rate, stray X-radiation, stability) and compliance with applicable safety standards.

Technological Characteristics

Mobile electron linear accelerator; energy levels 10 MeV and 12 MeV. Materials: PMMA applicators. Energy source: electrical (230V, 50Hz). Connectivity: remote control. Standards: IEC 60601-1, IEC 60601-2-1, IEC 62304. Features: hard docking, electron beam emission, integrated shielding in radiant head, 40 cm applicator length.

Indications for Use

Indicated for intra-operative radiotherapy (IORT) in the operating theatre for patients who have just undergone surgical removal of a neoplasm (malignant or benign conditions).

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

• LIAC (K110840)
• NOVAC11 (K112286)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

SIT SORDINA IORT TECHNOLOGIES SPA % Maurizio Pantaleoni CEO Isemed Srl Via P. Togliatti, 19/X Imola, Bo 40026 ITALY

Re: K172961

Trade/Device Name: LIAC HWL Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 8, 2017 Received: May 10, 2017

Dear Maurizio Pantaleoni:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

June 11, 2018

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# Page 2 - Maurizio Pantaleoni

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K172961

Device Name LIAC HWL

Indications for Use (Describe)

LIAC HWL are mobile electron linear accelerators 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 HWL are meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm.

The devices must be sold by or on the order of a physician. They are by the general public or over-the-counter.

LIAC HWL are electron accelerators that can work in an operating its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# S.I.T. -SORDINA IORT TECHNOLOGIES S.p.A TRADITIONAL 510(K) PREMARKET NOTIFICATION

# Traditional 510(k) Summary

This Traditional 510(k) Summary is being submitted as required by 21 CFR 807.92.

| 1. | General Information | |
|----|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitter : | SIT SORDINA IORT TECHNOLOGIES SPA<br>Galleria del Pozzo Rosso, 13,<br>36100 Vicenza VI, Italy<br>Tel. [phone]<br>Registration Number: 3010625741<br>Owner/Operator Number: 10043521 |
| | Consultant/ Contact: | Maurizio Pantaleoni<br>ISEMED srl<br>Via P.Togliatti, 19/X<br>40026 Imola (BO) - ITALY<br>Mob. [phone]<br>Tel. [phone]<br>Fax [phone]<br>Email: [e-mail] |
| | Summary Prepared Date: | November 24, 2017. |

# 2. Names

| Device Name: | LIAC HWL |
|------------------|------------------------------------------------------------------|
| Common Name: | Radiosurgery/radiotherapy treatment planning and delivery system |
| Regulation Name: | Medical charged particle radiationtherapy system |
| Product Code: | IYE |
| Classification: | 21CFR 892.5050; Class II |

# 3. Predicate Devices

The LIAC HWL is substantially equivalent to the following predicate devices, which are legally marketed in the US.

| Applicant | Device name | 510(k) Number |
|-------------------|-------------|---------------|
| SIT SORDINA IORT | LIAC | K110840 |
| TECHNOLOGIES SPA. | NOVAC11 | K112286 |

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LIAC HWL (10 MeV &12 MeV)

# S.I.T. -SORDINA IORT TECHNOLOGIES S.p.A TRADITIONAL 510(K) PREMARKET NOTIFICATION

The primary predicate device is LIAC (K110840) and secondary predicate device is NOVAC11 (K112286). Both devices are manufactured by SIT SORDINA IORT TECHNOLOGIES SPA. And they have not been subject of any device recalls.

LIAC HWL is a modified model of its primary predicate device LIAC (K110840). Both have the same intended use and the same operation mode. LIAC HWL and its predicate devices are electron linear Accelerators used to perform radiation therapy during surgical procedures in an operating room. This technique is known as Intra-Operative Radiation Therapy (IORT) ant it is used for the treatment of malignant and benign conditions. IORT allows delivering of high doses of radiation directly to tumour site, while normal tissues are protected against dosage impact.

SIT SORDINA IORT TECHNOLOGIES SPA was written this Traditional 510(k) for the LIAC HWL in accordance to "Letter to Manufacturers of Linear Accelerators, Radiation Therapy Treatment Planning Systems, and Ancillary Devices" released in 2010 by CDRH.

LIAC HWL (10MeV & 12 MeV) and LIAC (10MeV & 12 MeV) (K110840) have the following technological differences:

- 5. LIAC HWL has additional shielding system in the radiant head to reduce scattered radiation.
- 6. LIAC HWL has lower length applicators to reduce SSD.
- 7. LIAC HWL has a higher dose rate.
- 8. LIAC HWL and predicate device LIAC (K110840) have a modified remote control.

SIT SORDINA IORT TECHNOLOGIES SPA has evaluated each modification of LIAC HWL to establish if the intended use or the technological features are different from those of predicate devices LIAC (K110840) and NOVAC 11 (K112286).

The differences between LIAC HWL and the predicate devices are summarized in the following comparison table:

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SIT SORDINA IORT TECHNOLOGIES SP
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

LIAC HWL
(10 MeV &12 MeV)

| Characteristic<br>Device Name | PROPOSE DEVICE | PREDICATE DEVICE | Remote control | YES | YES | YES | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------|
| | LIAC HWL<br>(MODELS: 10MEV AND 12MEV) | LIAC<br>(MODELS: 10MEV AND 12MEV) | NOVAC11 | Nominal energies | 4, 6, 8, 10 MeV (10 MeV)<br>6, 8, 10, 12 MeV (12 MeV) | 4, 6, 8, 10 MeV (10 MeV)<br>6, 8, 10, 12 MeV (12 MeV) | 4, 6, 8, 10 MeV |
| | Image: LIAC HWL | Image: LIAC | Image: NOVAC11 | Maximum operating<br>temperature | 25°C | 25°C | 25°C |
| Manufacture | SORDINA IORT TECHNOLOGIES SPA<br>S.I.T. - | SORDINA IORT TECHNOLOGIES SPA<br>K110840<br>S.I.T. - | SORDINA IORT TECHNOLOGIES SPA<br>K112286<br>S.I.T. - | Maximum power<br>dissipation | < 2.5 kW | < 2.5 kW | < 1 kW |
| GENERAL FEATURES | | | | Electrical power<br>requirement | 230 V, 50 Hz, 3 kVA | 230 V, 50 Hz, 3 kVA | 230 V, 50 Hz, 2.5 kVA |
| Classification | II | II | II | Applied Standards | IEC 60601-1 IEC 60601-2-1 IEC 62304 | IEC 60601-1 IEC 60601-1 Rev.2nd (IEC 60601-1-4 ) IEC 60601-1-2 IEC 62304 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-4 IEC 62304 EN60601-2-1 |
| Regulation number | 892.5050 | 892.5050 | 892.5050 | DEVICE DESIGN – RADIATION PERFORMANCE | | | |
| Product code | IYE | IYE | IYE | Surface dose | ≥ 88 % (10 MeV)<br>≥ 90 % (12 MeV) | ≥ 85 % (10 MeV)<br>≥ 87 %(12 MeV) | ≥ 80-85% |
| Product Code description | Accelerator, linear, medical<br>Medical charged-particle radiation<br>Therapy system | Accelerator, linear, medical<br>Medical charged-particle radiation<br>Therapy system | Accelerator, linear, medical<br>Medical charged-particle radiation<br>Therapy system | Field symmetry | ≤ 3 % | ≤ 3 % | ≤ 2 % |
| Indications for Use | | | | Pulse repetition<br>frequency | 5 - 50 Hz (depended on the selected<br>energy) | 5 - 50 Hz (depended on the selected<br>energy) | 9 Hz |
| | LIAC (MODELS: 10MEV AND 12MEV) IS A MOBILE<br>ELECTRON LINEAR ACCELERATOR FOR INTRA-<br>OPERATIVE RADIOTHERAPY (IORT).<br>KNOWN AS INTRAOPERATIVE RADIATION<br>THERAPY (IORT), THIS TECHNIQUE ALLOWS<br>DELIVERY OF HIGH DOSES OF RADIATION DIRECTLY<br>AIMED AT TUMORS OR OTHER SITES.<br>THE LIAC IS MEANT TO BE USED FOR<br>RADIOTHERAPY IN THE OPERATING THEATRE ON A<br>PATIENT TO WHICH THE SURGEON HAS JUST<br>REMOVED A NEOPLASM.<br>THE DEVICE MUST BE SOLD BY OR ON THE ORDER<br>OF A PHYSICIAN. IT IS NOT FOR USE BY THE<br>GENERAL PUBLIC OR OVER-THE-COUNTER. | NOVAC11 IS AN ELECTRON LINEAR<br>ACCELERATOR USED FOR RADIATION THERAPY<br>DURING SURGICAL PROCEDURES IN AN<br>OPERATING ROOM FOR THE TREATMENT OF<br>MALIGNANT AND BENIGN CONDITIONS.<br>KNOWN AS INTRAOPERATIVE RADIATION<br>THERAPY (IORT), THIS TECHNIQUE<br>ALLOWS DELIVERY OF HIGH DOSES OF<br>RADIATION DIRECTLY AIMED AT TUMORS OR<br>OTHER SITES WHILE AVOIDING DOSAGE TO<br>SURGICALLY MOBILIZED NORMAL TISSUES.<br>NOVAC11 IS A MOBILE AND<br>ARTICULATED MACHINE THAT CAN BE<br>MOVED TOWARDS THE PATIENT AN PUT IN<br>THE APPROPRIATE POSITION TO CARRY OUT<br>THE NECESSARY RADIOTHERAPY.<br>APPLICATORS LEAD THE ELECTRON BEAM TO<br>THE SURGICAL AREA OF INTEREST. | | Beam current | ≤ 1.5 mA | ≤ 1.5 mA | ≤ 1.5 mA |
| LIAC HWL ARE MOBILE ELECTRON LINEAR<br>ACCELERATORS FOR INTRA-OPERATIVE<br>RADIOTHERAPY (IORT). KNOWN AS<br>INTRAOPERATIVE RADIATION THERAPY<br>(IORT), THIS TECHNIQUE ALLOWS DELIVERY<br>OF HIGH DOSES OF RADIATION DIRECTLY<br>AIMED AT TUMORS OR OTHER SITES.<br>THE LIAC HWL ARE MEANT TO BE USED FOR<br>RADIOTHERAPY IN THE OPERATING THEATRE<br>ON A PATIENT TO WHICH THE SURGEON HAS<br>JUST REMOVED A NEOPLASM.<br>THE DEVICES MUST BE SOLD BY OR ON THE<br>ORDER OF A PHYSICIAN. THEY ARE NOT FOR<br>USE BY THE GENERAL PUBLIC OR OVER-THE-<br>COUNTER. | | | LIAC HWL ARE ELECTRON ACCELERATORS<br>THAT CAN WORK IN AN OPERATING<br>THEATER RESPECTING ITS SPECIFIC<br>CHARACTERISTICS IN TERMS OF CLEANING<br>POSSIBILITY, NOISE AND HEAT DISSIPATION; IN<br>PARTICULAR, THEY DO NOT REQUIRE TO<br>MOVE THE PATIENT. | Long term stability | ≤ 3% | ≤ 3% | ≤ 2 % |
| DEVICE DESIGN – TECHNICAL FEATURES | | | | Short term stability | ≤ 1% | ≤ 1% | ≤ 1 % |
| Design structure | STAND (irradiating unit) CONTROL UNIT APPLICATORS | STAND (irradiating unit) CONTROL UNIT APPLICATORS(ACCESSORY) | STAND (irradiating unit) CONTROL PANEL APPLICATORS PROTECTION DISC (ACCESSORY) | Dosimetric system<br>linearity | ≤ 1 % | ≤ 1 % | ≤ 1 % |
| Emission | ELECTRON BEAM | ELECTRON BEAM | ELECTRON BEAM | Dose rate (applicator<br>∅ 10 cm) | 10 - 30 Gy/min | 3 - 20 Gy/min | According to applicator<br>From 6 to 39 Gy/min |
| Type of structure | LINAC | LINAC | LINAC | Stray X-radiation<br>(PDD Bremsstrahlung<br>tail) | ≤ 0.4 % | ≤ 0.7 % | ≤ 0.2 % |
| Docking | HARD DOCKING | HARD DOCKING | HARD DOCKING | | | | |

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SIT SORDINA IORT TECHNOLOGIES SP
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

# LIAC HWL LIAC HWL
(10 MeV &12 MeV)

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SIT SORDINA IORT TECHNOLOGIES SP
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

LIAC HWL LIAC HWL
(10 MeV &12 MeV)

Vol001-27

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SIT SORDINA IORT TECHNOLOGIES SP.
TRADITIONAL 510(K)
PREMARKET NOTIFICATION

LIAC HWL
(10 MeV &12 MeV)

| Source Surface<br>Distance (SSD) | 64.5 cm | 71.3 cm | 65-80 cm |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------|
| Uniformity or Field<br>Flatness (value at the<br>maximum energy<br>level angle 0°) | ≤3% Ø 8,7,6 [cm]<br>≤7% Ø 10 [cm] (60601-2-1 conformity)<br>≤9% Ø 4,5 [cm]<br>≤12% Ø 3, 12 [cm]<br>≤4% Ø 9[cm] | ≤3% Ø 10, 8, 7, 6 [cm]<br>≤9% Ø 4,5 [cm]<br>≤12% Ø 3 [cm] | ≤5% |
| <b>COMPONENTS -Mobile Unit</b> | | | |
| Length | 210 cm | 210 cm | 230 cm |
| Width | 76 cm | 76 cm | 95 cm |
| Height | 180 cm | 180 cm | 199 cm |
| Weight | 570+ (< 230, shield) kg | 400+ (< 230, shield) kg | 630 kg |
| Focusing &<br>Collimation | Linac + applicators | Linac + applicators | Linac + applicators |
| <b>COMPONENTS -Control unit</b> | | | |
| Control unit<br>dimensions | 80 cm x 60 cm x 120 cm<br>(width, depth, height) | 80 cm x 57 cm x 114 cm<br>(width, depth, height) | |
| Control unit weight | 120 kg | 100 kg | |
| <b>COMPONENTS -Applicator</b> | | | |
| Applicator length | 40 cm | 60 cm | 100 cm |
| Applicator size | Ø: 3, 4, 5, 6, 7, 8, 9, 10 and 12 cm each<br>with bevel angels of 0°, 15°, 30°, 45° | Ø: 3, 4, 5, 6, 7, 8, 10 cm each with bevel<br>angels of 0°, 15°, 30°, 45° | Ø: 3, 4, 5, 6, 7, 8, 10 cm |
| Applicator Material | PMMA | PMMA | PMMA |