(114 days)
The INTRABEAM® System is a system for radiotherapy treatment.
Indications for Use: INTRABEAM Flat Applicator
The INTRABEAM® Flat Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System.
- During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
- During treatment of tumors on the body surface.
The INTRABEAM® Flat Applicator is designed to deliver a flat radiation field at a distance of 5 mm from its circular application surface in water.
Indications for Use: INTRABEAM Surface Applicator
The INTRABEAM® Surface Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System.
- During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
- During treatment of tumors on the body surface.
The INTRABEAM® Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.
The INTRABEAM System is a miniature, high-dose rate, low energy X-ray source that emits Xray radiation intraoperatively for the treatment of cancer at the turnor cavity. The INTRABEAM Flat Applicator and INTRABEAM Surface Applicator are accessories to the INTRABEAM System that have been developed to provide radiotherapy to cancer lesions at or near the tissue surface. There are six sizes of INTRABEAM Flat Applicators in a set. The sizes are 1.0 cm, 2.0 cm, 3.0 cm, 4.0 cm, 5.0 cm and 6.0 cm in diameter. The INTRABEAM Surface Applicators are available in the four sizes. These sizes are 1.0 cm, 2.0 cm and 4.0 cm. The four smaller sizes of INTRABEAM Flat Applicators (size 1.0 to 4.0 cm) have the same dimensions and appearance as the INTRABEAM Surface Applicators (sizes 1.0 to 4.0 cm).
The INTRABEAM System has a maximum voltage of 50 kV and a maximum current of 40 µA. The INTRABEAM Flat Applicator and the INTRABEAM Surface Applicator provide a uniform dose of radiotherapy distributed across a flat surface. The applicators are made from the same materials. From a technical point of view, the INTRABEAM Flat and Surface Applicators are basically the same, but are optimized for treating different tissue depths.
The provided text describes a 510(k) premarket notification for the INTRABEAM Flat Applicator and INTRABEAM Surface Applicator. This documentation aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for a test set.
- Information on experts, adjudication methods, or MRMC studies.
- Data on standalone algorithm performance.
- Training set sample size or how its ground truth was established.
Instead, the document focuses on regulatory approval based on demonstrating substantial equivalence to an already legally marketed device.
Here's the relevant information that can be extracted:
1. Acceptance Criteria and Device Performance:
The document does not explicitly state acceptance criteria in terms of performance metrics for the device itself or a dedicated study's results table. The acceptance is based on demonstrating "substantial equivalence" to a predicate device.
Table: Acceptance (Substantial Equivalence) and Device Description
| Acceptance Criterion (Implicit) | Reported Device Description / Claim |
|---|---|
| Substantial Equivalence to Predicate Device (K083734) | The INTRABEAM Flat Applicator and INTRABEAM Surface Applicator are similar to the Axxent® Surface Applicator (K083734) in: |
- Target site: During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed; or during treatment of tumors on the body surface.
- Clinical use: Radiotherapy treatment, delivering a specified radiation dose.
- Principles of operation: Miniature, high-dose rate, low energy X-ray source that emits X-ray radiation. Delivers 50 kVp x-ray radiation to shallow tissue depths over small targeted areas. Provides a uniform dose of radiotherapy distributed across a flat surface.
- Indications for use: Intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed; treatment of tumors on the body surface.
- Design: Applicators for delivering X-ray radiation.
- Application: Used with the INTRABEAM System.
- Maximum voltage of 50 kV and a maximum current of 40 µA.
- INTRABEAM Flat Applicator designed to deliver a flat radiation field at a distance of 5 mm from its circular application surface in water.
- INTRABEAM Surface Applicator designed to deliver a flat radiation field directly at the applicator's surface. |
| Safety and Effectiveness for Intended Use | "Based on the information provided in the 510(k) and the comparison to the currently marketed predicate, the INTRABEAM Flat Applicator and INTRABEAM Surface Applicator are safe and effective with regards to the intended use." |
2. Sample size used for the test set and the data provenance:
This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device primarily through comparative analysis of technical specifications, intended use, and operational principles, rather than a clinical "test set" in the context of device performance metrics. Therefore, there is no information provided regarding a specific sample size for a test set or data provenance from human subjects in a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this document does not describe a clinical study for establishing ground truth.
4. Adjudication method for the test set:
Not applicable as this document does not describe a clinical study.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study is not mentioned in this document. The submission focuses on device equivalence, not human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical device (X-ray applicators) and not an algorithm.
7. The type of ground truth used:
Not applicable. The submission relies on technical verification and comparison to a predicate device's established safety and effectiveness.
8. The sample size for the training set:
Not applicable as this document does not describe an AI/algorithm-based device or a clinical training set.
9. How the ground truth for the training set was established:
Not applicable as this document does not describe an AI/algorithm-based device or a clinical training set.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.