# K170023: SPiN Thoracic Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Veran Medical Technologies, Inc.
- Decided: May 15, 2017 after 132 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K926514 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122106: Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle, Veran Medical Technologies, Inc. (2012) Summary page 4.
- K081379: Modification to Inreach System, Superdimension, Ltd. (2008) Summary page 4.

## Recalls of this device
- Aug 10, 2023 · Class II · Z-2663-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2660-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2661-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2659-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2662-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2664-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- May 15, 2023 · Class II · Z-2263-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2269-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2267-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2268-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2266-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2264-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2265-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2262-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- Dec 13, 2022 · Class II · Z-1103-2023: A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolong

## Indications for use
The SPiN Thoracic Navigation System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The SPiN Thoracic Navigation System is indicated for displaying; + An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s). * Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract, The SPiN Thoracic Navigation System compensates for the patient's respiratory phases. The SPiN Thoracic Navigation System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures. The SPiN Thoracic Navigation System enables marker placement in soft lung tissue.

Source page: https://510kreport.com/device/K170023
Methodology: https://510kreport.com/methodology