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510(k) Data Aggregation

    K Number
    K210894
    Device Name
    SIDDHARTH-II; IMPACT
    Date Cleared
    2021-09-28

    (187 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Panacea Medical Technologies Pvt.Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lessons, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients. The indication for use of Immobilization & Patient positioning devices (IMPACT) is to immobilize the patient during treatment by providing appropriate support and comfort which in turn leads to precise treatment delivery.
    Device Description
    SIDDHARTH-II is an external beam radiotherapy equipment using a linear accelerator with the treatment modalities such as 3D-Coventional radiotherapy, Intensity modulated radiotherapy, Volumetric modulated Arc therapy & Stereotactic body radiotherapy by delivering 6 MV photons with Flattening Filter & Free Flattening Filter. The Intended Use is achieved under the supervision of the qualified personnel in a shielded room with a patient support system and a control console outside the treatment room. These treatment modalities are delivered with Image Guided Radiation technique using on-board orthogonal kV imaging for generating CBCT and stereotactic images. SIDDHARTH-II provides an intuitive and simplified workflow for the user to enter, plan, edit and execute patient treatment swiftly. Software functionalities such as patient schedule and patient alignment has been taken care by frontend software & acquiring volumetric imaging is performed by implementing IGRT technology. Image processing functionalities such as 3D reconstruction and Image registration by calculating couch shift corrections are performed by Online R&V Software (Image Processing) to ensure patient positioning for accurate treatment which is the supporting software for SIDDHARTH-II frontend software. In order to fulfill the Intended use and to enhance functionality of SIDDHARTH-II, some of the accessories are integrated along with the system as listed below. - a) Closed Circuit Television System (CCTV) - b) Mike and Speaker - c) Virtual Isocenter Laser - d) Immobilization & Patient Positioning devices (IMPACT) IMPACT Head base plate is designed to deliver firm support & comfortable positioning for patient's head, neck, and shoulder. Tilting Head Base Plate is designed to provide perfect angulation from 5° to 25° with 5° increments. A standard indexing bar is present which helps in fixing the base plate on couch top. Head rests made up of Carbon Fibre with six different dimensions (A-F) headrest which provides support to the head & neck region & maintains the maximum reproducibility in every treatment. Prone head support is intended to deliver the best patient positioning in prone position of head & neck during the treatment. This is indexable on Tilting base plate, head & shoulder base plate which provides an accurate treatment delivery. Breast board is designed to provide complete, reproducible support for the patients by creating perfect angle required while treatment is in breast region. Breast board can be placed on couch top featured with different tilting angulations to the upper body parts & comfortable armrests with rigid locking mechanism, head support can be placed into the baseplate and ergonomic and rigid body stopper is made available for patient comfort & support. Wing Board is designed for easy positioning, precise repositioning & high patient comfort during breast & thorax treatments in supine position. Wing board are placed on couch top by using standard indexing bar which comfortably positions and supports the arms when the patient is in supine position. Wing board does not have tilting possibility. Hip Fix base plate is a comprehensive system which facilitates consistent positioning of hip & pelvic regions by affixing the hip fix base pate on couch top by using standard indexing bar. It has an ergonomic central aperture enabling comfortable supine positioning to patient during the entire screening & treatment. Belly Board is intended to provide the comfortable positioning for the bowel region when patient is in prone position during the treatment. Lower part of the board supports legs and there are 2 different cushions for resting forehead. Sigma Pelvic Board is intended to provide a comfortable prone positioning for the patients getting treatment in pelvic and abdomen region. The base plate is light weight, indexable on any couch top and comfortable for the patient. IMPACT Sigma board System is designed to position the patient for delivering "One for All" treatments to provide support & exact positioning of the patient for all body parts which can fix & detach the sigma board on couch top based on need for base plates. Thermoplastic immobilization is intended to immobilize patient to increase precision during treatment delivery. These thermoplastic masks are non-sticky, perforated, smooth & durable. The uniform perforation & uniform thickness of these masks are ideal to customise on patient's anatomy to reproduce in the next fraction of treatment. SBRT System is intended for limiting the patient motion (intrafraction motion) during treatment, to ensure patient is close to the intended treatment site thus avoiding errors, and to hold patient close to the original simulation geometry. It is intended to use for immobilizing the patient for lungs and moving organ treatments. This system consists of couch top made of carbon fibre, bridge rail, Indexing bar, Wing Board, Head Rest, Bridge with Respiratory Plate or Respiratory belt. The patient set-up is similar to all the boards like supine position with the arms mainly positioned above the patient's head. Knees, and feet positioned in indexed positions. The mechanical pressure system consists of a bridge with a respiratory plate. Abdominal compression can also be created with respiratory belt which is inflatable. IMPACT SRS System immobilizes the patient by confining the head and provide corrective tilting of the head for treatment and simulation. IMPACT SRS system consists of couch top, Head Base plate, Head Rest and SRS mask. These SRS thermoplastic masks are non-sticky, perforated, smooth & durable. The uniform perforation & uniform thickness of these masks are ideal to customise on patient's anatomy to reproduce in the next fraction of treatment.
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