FDA grants 510(k) clearance to Ambu’s HD cystoscopy solution

The FDA has granted 510(k) clearance to Ambu’s HD cystoscopy solution, consisting of the company’s HD single-use cystoscope, the Ambu aScope 5 Cysto HD, and its 2 full-HD endoscopy systems, Ambu aView 2 Advance and Ambu aBox 2, the company announced in a news release.¹

The company offers 3 endoscopes: the the aScope 4 Cysto, the aScope 5 Cysto HD, and the Ambu aScope 5 Uretero.

In October 2023, the cystoscopy solution was granteda CE mark for regulatory clearance in Europe. In the United States, the company is planning an upcoming commercial launch of the solution, which is designed to support urologists performing both diagnostic and therapeutic ureteroscopy procedures.

This news follows the FDA clearance of Ambu’s single-use digital flexible ureteroscope, aScope 5 Uretero, and the full-HD endoscopy system, aBox 2, in June 2024.² The company’s ureteroscopy solution also received a CE mark for regulatory clearance in Europe in November 2023.

“Our expanded urology portfolio underscores our commitment to meeting the evolving needs of urologists and nurses, ensuring they have the best solutions at their disposal for unlocking workflow efficiency and enhancing patient outcomes,” said Britt Meelby Jensen, CEO of Ambu, in the news release.¹ “Our expanded urology portfolio targets a wide range of needs, and I am excited about the potential it holds for transforming patient care in the field.”

According to the company, the Ambu aScope 5 Cysto HD includes a high-resolution camera chip and advanced image enhancement technology to aid urologists during procedures requiring superior imaging, such as select bladder cancer screenings and bladder tumor removals.

In addition to the aScope 5 Cysto HD and the Ambu aScope 5 Uretero, Ambu also offers an additional single-use endoscope: the aScope 4 Cysto.

The company noted, “The Ambu aScope 4 Cysto will continue to serve a wide range of standard cystoscopy procedures across outpatient clinics and hospitals, while the Ambu aScope 5 Cysto HD will target specific procedures requiring superior image quality. It will be priced at a premium, compared to the Ambu aScope 4 Cysto.”¹

Data on the Ambu aScope 4 Cysto

The clinical utility of the single-use Ambu aScope 4 Cysto was demonstrated in a noninferiority trial published in the Journal of Endourology.³

Overall, data from the study showed that the single-use cystoscope was noninferior to a standard reusable cystoscope regarding effective procedure completion rate, image quality, light quality, and maneuverability.

Specifically, the effective procedure completion rate was 100% with the single-use cystoscope vs 98% with the reusable cystoscope (CI, -0.059 to 0.019). Image quality, light quality, and maneuverability between the single-use scope compared with the reusable scope were 96% and 100% (CI, -0.014 to 0.092); 98% and 100% (CI, -0.018 to 0.058); and 98% and 100% (CI, -0.018 to 0.058), respectively.

The data also showed no difference between the 2 scopes in operation time (P = .415) or total theater use time (P = .441). Regarding safety, 4.08% of patients in the single-use scope arm and 4.16% in the reusable scope arm experienced an adverse event.

In total, the trial enrolled 101 patients who were randomly assigned 1:1 to have their cystoscopy performed with a single-use scope (n = 50) or a reusable scope (n = 51). The primary outcome measures were the noninferiority of the single-use cystoscope vs a reusable cystoscope regarding effective procedure completion rate, image quality, light quality, and maneuverability. Secondary outcome measures were operative and perioperative time and safety.

Based on these findings, the authors concluded, “Single-use flexible cystoscopes are an effective and safe alternative to reusable flexible cystoscopes and may act as a suitable alternative or adjunct in the urologist's armamentarium.”

References

1. Ambu launches HD cystoscopy solution in the U.S. News release. Ambu. October 17, 2024. Accessed October 23, 2024. https://www.ambu.com/Files/Files/Ambu/Investor/News/English/2024/Ambu-launches-HD-cystoscopy-solution-in-the-US.pdf

2. Ambu obtains FDA clearance for new ureteroscopy endoscopy solution. News release. Ambu. June 26, 2024. Accessed October 23, 2024. https://www.ambu.com/Files/Files/Ambu/Investor/News/English/2024/Ambu-obtains-FDA-clearance-for-new-ureteroscopy-endoscopy-solution.pdf

3. Holmes A, O’Kane D, Wombwell A, Grills R. Clinical utility of a single-use flexible cystoscope compared with a standard reusable device: A randomized noninferiority study. J Endourol. 2023;37(1):80-84.doi:10.1089/end.2022.0210