(389 days)
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No
The summary does not mention AI, ML, or related concepts, and the device description is a standard linear accelerator.
Yes
The device is explicitly described as a "mobile electron linear accelerator 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 its therapeutic purpose to treat diseases.
No
Explanation: The device is a mobile electron linear accelerator used for intra-operative radiotherapy (IORT) to deliver high doses of radiation directly aimed at tumors. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "mobile electron linear accelerator," which is a hardware device used for delivering radiation therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Liac is a "mobile electron linear accelerator for intra-operative radiotherapy (IORT)" used to deliver radiation directly to tumors on a patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
The Liac operates directly on the patient's body during surgery, not on specimens taken from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a pair of wings.
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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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