# K241318: Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)

- Pathway: 510(k) (Traditional)
- Applicant: Adaptiiv Medical Technologies, Inc.
- Decided: Aug 30, 2024 after 112 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K971367 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213438: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory, Adaptiiv (2022) Summary page 4.

## Indications for use
Nova Surface Applicator is indicated for and intended to be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy. The device is for a single patient's use only and can be reused throughout the entirety of the treatment plan. The device is designed by radiation therapy professionals using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use. The device is restricted to sale by or on the order of a physician and is by prescription only.

Source page: https://510kreport.com/device/K241318
Methodology: https://510kreport.com/methodology