(79 days)
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No
The description focuses on a physical device (Dental Tray) used for positioning, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, a Dental Tray, is described as holding a dental impression to allow repeat positioning of a stereotactic frame for radiotherapy treatments. It is an accessory used in the delivery of treatment, but it does not directly treat or diagnose a disease itself.
No
The device is described as holding an impression of the upper teeth to allow repeat positioning of a stereotactic frame for radiotherapy treatments. It is a physical accessory for positioning and does not gather or analyze data to determine the presence or nature of a medical condition.
No
The device is a physical dental tray, a hardware component used to hold an impression of teeth for positioning in a medical system. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold a dental impression for repeat positioning of a stereotactic frame during radiotherapy treatment. This is a mechanical function related to patient positioning for a therapeutic procedure.
- Device Description: The description reinforces the mechanical function of holding a dental impression for positioning.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to analyze blood, urine, tissue, etc.
The device is clearly intended for use in a therapeutic setting (radiotherapy) and its function is purely mechanical for patient positioning.
N/A
Intended Use / Indications for Use
The Dental Tray holds an impression of the upper teeth, and is part of the GTC Relocatable Head Holder in stereotactic collimated beam, computer planned, LINAC (linear accelerator) based treatment. The Dental Tray holds the dental impression. The dental impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments.
Product codes
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Device Description
The Dental Tray holds an impression of the upper teeth and is part of the GTC Relocatable Head Holder System. This impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments. The material of the GTC Dental Tray has been modified from that described in K934523.
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
Upper teeth (impression)
Indicated Patient Age Range
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Intended User / Care Setting
Physician
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.
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
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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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Appendix A:
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Summary of Safety and Effectiveness
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I. General Information
Dental Tray for use with the Gill-Thomas-Device Name: Cosman Relocatable Head Holder, a stereotactic head holder (for LINAC-based stereotactic radiotherapy) Proprietary Trade Name Gill-Thomas-Cosman (GTC) Dental Tray 1222895 Establishment Registration Number: Classification: Class II / Radiology No applicable performance standards or special Performance Standard: controls have been issued under section 514 of the Food, Drug, and Cosmetic Act. The Dental Tray holds an impression of the Intended Use: upper teeth, and is part of the GTC Relocatable Head Holder in stereotactic collimated beam, computer planned, LINAC (linear accelerator) based treatment. The Dental Tray holds the dental impression. The dental impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments. Dental Tray included in the Gill-Thomas-Predicate Device: Cosman Relocatable Head Holder System K934523 Manufacturing Facility: Radionics Software Applications 22 Terry Avenue Burlington, MA 01803 (617) 272-1233 Contact Name: Amy LaForte, Ph.D.
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II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
A summary of the information contained in this 510(k) PMN that addresses safety and effectiveness follows.
General Safety and Effectiveness Concerns
RSA GTC Dental Tray labeling contains instructions for the proper use of this product. It includes a description of the product, directions for use, and applicable safety information. The testing provided in this 510(k) PMN, along with the instructions for use, ensure safe and effective use of the device when followed by the physician.
Description of the Device and Basis for Substantial Equivalence
The material of the GTC Dental Tray has been modified from that described in (K934523). The GTC Dental Tray addressed in this 510(k) PMN has the same intended use, design, and technological characteristics as the Dental Tray included in the commercially available GTC Relocatable Head Holder System (K934523). The Dental Tray holds an impression of the upper teeth as part of the predicate system. This impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments.