(29 days)
The Stryker AIM Light Source and SafeLight Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The Stryker AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the Stryker AIM Light Source and SafeLight Cable are intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
This is a Special 510(k) submission for a proposed labeling change that impacts the Stryker® IRF Light Source and SafeLight Cable (referred to as Stryker AIM Light Source hereafter) which was cleared under K142310.
The Stryker AIM Light Source is part of the Stryker® Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared dye fluorescence imaging of indocvanine green (ICG) during minimally invasive surgery. The Stryker® Infrared Fluorescence (IRF) Imaging System consists of the following main components:
- A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum (focus of this submission).
- A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and a camera head (cleared under K132785).
- A laparoscope for visible light and near-infrared light illumination and imaging (cleared under K142310)
- An imaging agent kit containing ICG (Kit containing IC-Green® drug and Aqueous Solvents, manufactured by Akorn (NDA 011525), cleared under K142310)
There are no proposed changes to any other components of the Stryker® Infrared Fluorescence (IRF) system.
The Stryker AIM Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Upon the absorption of laser light, the ICG in the vessels is excited and emits infrared light at a different wave length. The camera system captures the infrared emission, processes the image and displays it on a surgical display.
The proposed labeling change is to allow the Stryker AIM Light Source to work with two additional kit configurations of the same imaging agent (ICG). Specifically, both device user manual and ICG kit Instruction for Use are updated to adequately cross-label and cross-reference the compatible device/ICG kit(s) per FDA guidance. It is to be noted that Stryker Endoscopy is not the manufacturer of the Imaging agent kits or the ICG drug; the proposed change in labeling does not necessitate any change in the imaging drug formulation, dosage, rate, or route of administration,
This 510(k) premarket notification describes a labeling change for the Stryker AIM Light Source and SafeLight Cable (originally cleared under K142310) to confirm its compatibility with two additional Indocyanine Green (ICG) kits. Therefore, the information provided primarily focuses on demonstrating the substantial equivalence of the modified device (with updated labeling) to its predicate device, rather than presenting a new study for the core performance of the device itself.
Based on the provided text, a detailed answer to your request is limited:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the modification is primarily a labeling change to allow compatibility with two additional ICG kits. It explicitly mentions: "The modification proposed within this submission for the Stryker AIM Light source does not impact the performance characteristics that were cleared in the previous submissions." Therefore, no new acceptance criteria or device performance metrics for the current submission are detailed, as the core performance of the device was accepted under K142310.
However, the document does state that "Bench testing was conducted to demonstrate the compatibility of the Stryker AIM Light Source with the PINPOINT PAQ® AIM." The specific acceptance criteria for this compatibility testing are not explicitly described in the provided text. It can be inferred that the acceptance criteria would involve successful functional operation of the light source with the new ICG kits without adverse effects or changes in imaging quality, consistent with the performance previously established.
| Acceptance Criteria (Inferred from "compatibility" testing) | Reported Device Performance |
|---|---|
| Successful functional operation with PINPOINT PAQ® AIM | Demonstrated compatibility |
| No adverse impact on current performance characteristics | Confirmed no impact |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The "bench testing" mentioned for compatibility generally doesn't involve a "test set" in the sense of patient data. It would likely involve a limited number of physical devices and the specified ICG kits.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this specific modification as it involves bench testing for compatibility rather than clinical data. Previous clinical studies for the original device (K142310) are mentioned but not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This submission focuses on a labeling change and bench testing for compatibility, not on establishing ground truth for a clinical test set.
4. Adjudication Method for the Test Set:
Not applicable.
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:
Not applicable. The device is a light source and cable for fluorescence imaging, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is hardware (light source and cable), not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
Not applicable for this submission. The "ground truth" for the compatibility testing would be the successful functional output of the integrated system.
8. The Sample Size for the Training Set:
Not applicable. This is a hardware device with a labeling change, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 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.