(85 days)
The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.
Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.
The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and nearinfrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.
This report confirms that the ActivSight Intraoperative Imaging System (K231344) has been found substantially equivalent to its predicate device (K203550) by the FDA. This determination is primarily based on non-clinical testing related to a new sterilization method, as the device itself is identical in intended use and technology to the predicate. Therefore, detailed information regarding acceptance criteria and performance of an AI/human-in-the-loop system, as typically required for novel AI-powered medical devices, is largely not applicable to this specific submission.
However, based on the limited information provided, we can infer some aspects and highlight what is not present given the nature of the submission. Since the provided text is a 510(k) clearance letter and summary for a modification (specifically, a new sterilization method) to an existing device, it does not contain the detailed clinical study data typically found in original submissions for AI-powered devices.
Here's an analysis based on the context:
1. A table of acceptance criteria and the reported device performance
The provided documentation does not specify acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness, as this was a 510(k) submission for a modification (sterilization) rather than a de novo AI device.
The non-clinical testing performed focused on:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 10^-6 | Achieved SAL of 10^-6 with listed VHP cycles |
| Functional reliability/performance after reprocessing | No impact on functional reliability or performance over multiple reprocessing cycles |
2. Sample size used for the test set and the data provenance
For the sterilization efficacy testing:
- Sample Size: Not explicitly stated, but typically involves a sufficient number of test articles (e.g., medical devices or biological indicators) to statistically validate a SAL of 10^-6.
- Data Provenance: Not specified, but likely laboratory testing conducted under controlled conditions. This is not clinical data from patients.
For functional testing after reprocessing:
- Sample Size: Not explicitly stated, but usually involves testing multiple units through a predefined number of reprocessing cycles.
- Data Provenance: Not specified, but likely laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of submission. Ground truth, in the context of diagnostic accuracy, would involve expert radiologists or pathologists interpreting images or samples. The testing here is for sterility and functional reliability, not diagnostic performance.
4. Adjudication method for the test set
This is not applicable as there are no expert interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or required for this 510(k) submission, as it relates to a modification of an existing imaging system's sterilization method, not its diagnostic or assistive AI capabilities. The device is an intraoperative imaging system that provides fluorescence and near-infrared imaging for surgeons, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The ActivSight system is described as an "accessory to existing commercial surgical laparoscope systems" and "enables surgeons to visually assess," indicating it's a visualization tool used by surgeons, not a standalone AI algorithm producing interpretations.
7. The type of ground truth used
For sterilization testing, the ground truth is established by microbiological methods (e.g., culturing biological indicators after sterilization to confirm kill rates). For functional testing, the ground truth is the device's operational specifications and performance metrics (e.g., image quality, light output, mechanical integrity).
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set. Even if the original predicate device (K203550) involved some form of image processing or enhancement, the provided document does not indicate that it is an AI/ML-based device that would undergo a training phase.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
In summary:
This 510(k) clearance is for a change to an already cleared medical device (specifically, its sterilization method). Therefore, the detailed performance data, acceptance criteria, and study designs typically associated with new AI/ML-driven diagnostic or treatment devices are not present in this document. The "study" mentioned here refers to the non-clinical validation of the new sterilization processes and confirmation of the device's continued functional reliability after these processes.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.