K230727 is an FDA 510(k) clearance for the SPY Portable Handheld Imaging (SPY-PHI) System. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.
Submitted by Novadaq Technologies Ulc (A Part of Stryker) (Burnaby, CA). The FDA issued a Cleared decision on June 5, 2023 after a review of 81 days - a notably fast clearance cycle.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1600 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.
View all Novadaq Technologies Ulc (A Part of Stryker) devices
NCT03200704
Completed
Interventional
Industry-sponsored
A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
| Condition studied |
Breast Cancer; Lymph Node Mapping; Sentinel Lymph Node Biopsy |
| Study design |
Single group |
| Eligibility |
Female only
· 18 Years+
|
| Principal investigator |
David Weintritt, MD, FACS |
| Sponsor |
Novadaq Technologies ULC, now a part of Stryker
(industry)
|
Started 2019-01-04
→
Primary completion 2020-08-27
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Completed 2020-09-28
Primary outcome
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
Secondary outcome
Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe
View full study on ClinicalTrials.gov