(258 days)
Not Found
No
The summary describes a mobile electron linear accelerator for intra-operative radiotherapy and does not mention any AI or ML components or functionalities.
Yes
The device is described as "mobile electron linear accelerators for intra-operative radiotherapy (IORT)" and its intended use is for "radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm," indicating it is used for treating a medical condition.
No
Explanation: The device is described as a mobile electron linear accelerator used for intra-operative radiotherapy (IORT) to deliver high doses of radiation directly to tumors. Its function is to treat, not to diagnose.
No
The device description explicitly states it consists of a STAND (irradiating unit), CONTROL UNIT, and APPLICATORS, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intra-operative radiotherapy (IORT), which involves delivering radiation directly to a patient's body during surgery. This is a therapeutic procedure performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device is an electron linear accelerator that emits an electron beam. This is a type of medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
In summary, the LIAC HWL is a therapeutic device used for delivering radiation treatment, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The LIAC HWL is a mobile electron linear accelerator for intra-operative radiotherapy (IORT). It consists of a mobile unit (LINAC), a control unit, and applicators. It has additional shielding system in the radiant head to reduce scattered radiation and lower length applicators to reduce SSD. It also has a higher dose rate and a modified remote control compared to its primary predicate device. The device is designed to deliver high doses of radiation directly aimed at tumors or other sites during surgical procedures in an operating room.
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
Operating theatre, physician
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.
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
§ 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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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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3
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 | |
| Galleria del Pozzo Rosso, 13, | ||
| 36100 Vicenza VI, Italy | ||
| Tel. +39 0444 233711 | ||
| Registration Number: 3010625741 | ||
| Owner/Operator Number: 10043521 | ||
| Consultant/ Contact: | Maurizio Pantaleoni | |
| ISEMED srl | ||
| Via P.Togliatti, 19/X | ||
| 40026 Imola (BO) - ITALY | ||
| Mob. +39 348 4435155 | ||
| Tel. +39 0542 683803 | ||
| Fax +39 0542 698456 | ||
| Email: regulatory@isemed.eu | ||
| 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 |
4
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:
-
- LIAC HWL has additional shielding system in the radiant head to reduce scattered radiation.
-
- LIAC HWL has lower length applicators to reduce SSD.
-
- LIAC HWL has a higher dose rate.
-
- 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:
5
SIT SORDINA IORT TECHNOLOGIES SP
TRADITIONAL 510(K)
PREMARKET NOTIFICATION
LIAC HWL
(10 MeV &12 MeV)
| Characteristic
| Device Name | PROPOSE DEVICE | PREDICATE DEVICE | Remote control | YES | YES | YES | |
|---|---|---|---|---|---|---|---|
| LIAC HWL | |||||||
| (MODELS: 10MEV AND 12MEV) | LIAC | ||||||
| (MODELS: 10MEV AND 12MEV) | NOVAC11 | Nominal energies | 4, 6, 8, 10 MeV (10 MeV) | ||||
| 6, 8, 10, 12 MeV (12 MeV) | 4, 6, 8, 10 MeV (10 MeV) | ||||||
| 6, 8, 10, 12 MeV (12 MeV) | 4, 6, 8, 10 MeV | ||||||
| Image: LIAC HWL | Image: LIAC | Image: NOVAC11 | Maximum operating | ||||
| temperature | 25°C | 25°C | 25°C | ||||
| Manufacture | SORDINA IORT TECHNOLOGIES SPA | ||||||
| S.I.T. - | SORDINA IORT TECHNOLOGIES SPA | ||||||
| K110840 | |||||||
| S.I.T. - | SORDINA IORT TECHNOLOGIES SPA | ||||||
| K112286 | |||||||
| S.I.T. - | Maximum power | ||||||
| dissipation | COMPONENTS -Mobile Unit | ||||||
| Length | 210 cm | 210 cm | 230 cm | ||||
| Width | 76 cm | 76 cm | 95 cm | ||||
| Height | 180 cm | 180 cm | 199 cm | ||||
| Weight | 570+ (COMPONENTS -Control unit | ||||||
| Control unit | |||||||
| dimensions | 80 cm x 60 cm x 120 cm | ||||||
| (width, depth, height) | 80 cm x 57 cm x 114 cm | ||||||
| (width, depth, height) | |||||||
| Control unit weight | 120 kg | 100 kg | |||||
| COMPONENTS -Applicator | |||||||
| Applicator length | 40 cm | 60 cm | 100 cm | ||||
| Applicator size | Ø: 3, 4, 5, 6, 7, 8, 9, 10 and 12 cm each | ||||||
| with bevel angels of 0°, 15°, 30°, 45° | Ø: 3, 4, 5, 6, 7, 8, 10 cm each with bevel | ||||||
| angels of 0°, 15°, 30°, 45° | Ø: 3, 4, 5, 6, 7, 8, 10 cm | ||||||
| Applicator Material | PMMA | PMMA | PMMA |