GILL-THOMAS-COSMAN(GTC) DENTAL TRAY

K962155 · Radionics Software Applications, Inc. · IYE · Aug 22, 1996 · Radiology

Device Facts

• Record ID: K962155
• Device Name: GILL-THOMAS-COSMAN(GTC) DENTAL TRAY
• Applicant: Radionics Software Applications, Inc.
• Product Code: IYE · Radiology
• Decision Date: Aug 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Device: GTC Dental Tray; component of GTC Relocatable Head Holder system. Input: dental impression of patient's upper teeth. Function: secures dental impression to stereotactic frame; enables precise, repeatable patient positioning for multiple fractionated LINAC-based stereotactic radiotherapy treatments. Usage: clinical setting; operated by medical staff/physicians. Benefit: ensures accurate frame relocation across multiple treatment sessions; facilitates consistent dose delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical dental tray; modified material composition compared to predicate. Used as a physical interface for stereotactic frame positioning.

Indications for Use

Indicated for patients undergoing LINAC-based stereotactic radiotherapy requiring repeat positioning of a stereotactic frame for fractionated treatment sessions.

Regulatory Classification

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.

Predicate Devices

• Dental Tray included in the Gill-Thomas-Cosman Relocatable Head Holder System (K934523)

Submission Summary (Full Text)

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AUG 22 1996
K962155

## Appendix A:

Summary of Safety and Effectiveness

GTC Dental Tray 510(k)
June 3, 1996
A-1

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# I. General Information

| Device Name: | Dental Tray for use with the Gill-Thomas-Cosman Relocatable Head Holder, a stereotactic head holder (for LINAC-based stereotactic radiotherapy) |
| --- | --- |
| Proprietary Trade Name | Gill-Thomas-Cosman (GTC) Dental Tray |
| Establishment Registration Number: | 1222895 |
| Classification: | Class II / Radiology |
| Performance Standard: | No applicable performance standards or special controls have been issued under section 514 of the Food, Drug, and Cosmetic Act. |
| Intended 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. |
| Predicate Device: | Dental Tray included in the Gill-Thomas-Cosman Relocatable Head Holder System K934523 |
| Manufacturing Facility: | Radionics Software Applications
22 Terry Avenue
Burlington, MA 01803
[phone] |
| Contact Name: | Amy LaForte, Ph.D. |

GTC Dental Tray 510(k)
June 3, 1996
A-2

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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.

GTC Dental Tray 510(k)
June 3, 1996
A-3