(61 days)
Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when intraoperative cholangiography.
The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables 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 duct, common bile duct or common hepatic duct), using nearinfrared imaging.
Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymphatic vessels and lymph nodes.
The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9104, SC9134, SC9144, SC9504, SC9534, SC9544, SC9101 and SC9131. These are the major components of the PINPOINT System.
During surgical procedures. PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.
To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.
When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.
The provided text focuses on the 510(k) submission for the PINPOINT Endoscopic Fluorescence Imaging System, particularly emphasizing its substantial equivalence to a predicate device and expanded indications for use. While it mentions performance testing and a clinical trial, it does not explicitly detail acceptance criteria or the study's findings in a quantitative manner. Therefore, I cannot fully complete the requested table and answer all questions with the provided information.
However, I can extract and infer some information.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated. The submission focuses on demonstrating substantial equivalence.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not Explicitly Stated for this 510(k | The device demonstrated conformance to various IEC standards (60601-1, 60601-1-2, 60601-2-18) and IEC 60825 (Class 3R laser device). A Phase III, randomized controlled clinical trial supported the new proposed lymphatic indications for use. Specific performance metrics are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- The text mentions a "Phase III, randomized controlled clinical trial" to support the new lymphatic indications.
- Sample Size: The sample size for this clinical trial is not provided in the given document.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a Phase III trial, it would be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- The document mentions a "Phase III, randomized controlled clinical trial" but does not explicitly state if it was an MRMC study or if it measured the comparative effectiveness of human readers with vs. without AI assistance. The device description suggests an imaging system for surgeons, implying human-in-the-loop use, but the study described is for new indications rather than comparative effectiveness for human readers.
- Effect Size: Not provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The PINPOINT Endoscopic Fluorescence Imaging System is described as enabling surgeons to perform minimally invasive surgery and visual assessment. The "device is not intended for standalone use for biliary duct visualization." This strongly suggests the device is an assistive tool for human use, not a standalone AI algorithm. Therefore, a standalone performance study without human-in-the-loop is unlikely for the core device function, though specific aspects of its internal processing might have been validated. The text does not describe a standalone study for an AI algorithm.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For the "Phase III, randomized controlled clinical trial" supporting the lymphatic indications, the type of ground truth used is not specified. For a clinical trial of this nature, it would typically involve clinical outcomes, pathology/histology, or established clinical standards as ground truth.
8. Sample Size for the Training Set
- The device being cleared is an imaging system, not an AI algorithm that would typically require a training set in the conventional sense (e.g., for machine learning model development). While the system likely has internal algorithms for image processing, the submission focuses on its hardware and its use with an imaging agent.
- If "training set" refers to data used to develop any internal algorithms, this information is not provided. The text emphasizes substantial equivalence to a predicate device, implying similar underlying technology.
9. How the Ground Truth for the Training Set Was Established
- As the device is an imaging system and not explicitly an AI/ML product developed with a training set for a specific diagnostic task, this information is not applicable or provided in the context of this 510(k) summary.
§ 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.