Intracavitary/Interstitial System
Varian Medical SystemsThe Intracavitary/Interstitial System by Varian Medical Systems is a medical device used in cancer treatment for the uterus, cervix, and vagina. It employs HDR or PDR brachytherapy, guiding radioactive sources via hollow catheters and needles for precise radiation delivery, helping clinicians target tumors effectively while minimizing exposure to surrounding tissues.
Intended Use
The Intracavitary/Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.
Technology
The device consists of hollow, open-ended guide tubes that connect to applicator sets with ovoids, ring caps, or templates to guide interstitial needles for brachytherapy. It includes a fixation mechanism for needle insertion depth. It is compatible with accessories like plastic needles and leak stop channel markers, is MR Safe, and made of biocompatible materials such as FEP/PEEK.
Performance
Performance testing included biocompatibility, cleaning, sterilization, human factors, mechanical and acoustic testing, MR compatibility, and electromagnetic compatibility, demonstrating the device performs safely and effectively as intended.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/31/2025
2 months - 2
FDA Approval
4/25/2025
Other devices from Varian Medical Systems
- Mobius3D (4.1)2025 • 510K
- CT/ MR Tandem and Ovoid Set2025 • 510K
- Identify (4.0)2025 • 510K
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