(140 days)
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No
The summary describes a purely mechanical system for patient positioning and collimation, with no mention of AI, ML, image processing, or data-driven decision making.
No
The device is a positioning and fixation system for a linear accelerator used in radiosurgery/radiotherapy; it does not directly treat a disease or condition.
No
The device is a floorstand based coordinate and fixation system for patient positioning during stereotactic radiosurgery or radiotherapy, and it provides secondary collimation and a fixed isocenter for the linear accelerator. It does not gather information to determine the presence, absence, or nature of a medical condition.
No
The device description explicitly details a "mechanical structure" and "gimbal bearing," indicating it is a hardware-based device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a "floorstand based coordinate and fixation system" used to position patients for radiotherapy procedures. It interacts with a linear accelerator and the patient's physical position, not with biological specimens.
Therefore, based on the provided information, the Linac Scalpel™ Floorstand is a medical device used in the delivery of radiation therapy, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"...This submission describes a floorstand based coordinate and fixation system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The Linac Scalpel™ Floorstand is designed to provide secondary collimation and a fixed isocenter for Radiosurgery or Radiotherapy when used in conjunction with a commercially available Linear Accelerator."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"The Linac Scalpel™ Floorstand consists of a mechanical structure which is located on the floor at predetermined points and attaches via a gimbal bearing to the head of a linear accelerator. The floorstand is designed to precisely control the accuracy of the collimation during the arcing of the radiation beam from the linear accelerator and the accuracy of the patient position during couch repositioning between arcs."
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
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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): 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.
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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.
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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).
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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.
0
APR
- 1 1997
Summary of Safety and Effectiveness
Linac Scalpel™ Floorstand System
I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
Product Name: Linac Scalpel™ Floorstand System II.
- III. This submission describes a floorstand based coordinate and fixation system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The Linac Scalpel™ Floorstand is designed to provide secondary collimation and a fixed isocenter for Radiosurgery or Radiotherapy when used in conjunction with a commercially available Linear Accelerator. The Linac Scalpel™ Floorstand consists of a mechanical structure which is located on the floor at predetermined points and attaches via a gimbal bearing to the head of a linear accelerator. The floorstand is designed to precisely control the accuracy of the collimation during the arcing of the radiation beam from the linear accelerator and the accuracy of the patient position during couch repositioning between arcs.
- I V. The Linac Scalpel™ Floorstand System was shown to be substantially equivalent to to other commercially avalaible patient positioning systems for use in conjunction with linear accelerator -based stereotactic radiosurgery/radiotherapy treatments.