(82 days)
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 ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared 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.
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 quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. 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, indocvanine 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 does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria in the format requested. The document is a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which primarily focuses on demonstrating substantial equivalence to a predicate device.
However, based on the non-clinical performance testing section, we can infer some general acceptance criteria related to safety and performance through adherence to standards.
Here's an attempt to extract and present the information, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Specific Standard/Requirement Met (Reported Device Performance) |
|---|---|
| Basic Safety and Essential Performance | IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance conformance demonstrated. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests conformance demonstrated. |
| Safety of Endoscopic Equipment | IEC 60601-2-18:2009 Medical Electrical Equipment – Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment conformance demonstrated. |
| Laser Safety | IEC 60825:2007 Safety of laser products – Part 1: Equipment classification and requirements conformance assessed by UL, classified as a Class 3R laser device with internal maximum Class 4 laser radiation. |
| In Vivo Fluorescence Imaging Capability | Animal testing using a porcine model validated the in vivo fluorescence imaging capability of the PINPOINT System. |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (PINPOINT Endoscopic Fluorescence Imaging System K150956) in terms of safety, effectiveness, and performance based on identical indications for use, technological characteristics, and principle of operation. |
Regarding the study proving the device meets acceptance criteria:
The document describes "Non-Clinical Performance Testing" which includes adherence to various IEC standards and animal testing. This is the "study" demonstrating performance against safety and basic functional criteria. However, it's not a typical clinical study with patient outcomes or a reader study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the in vivo fluorescence imaging capability, the "test set" was a porcine model. The exact number of animals is not specified.
- For the other performance tests (IEC standards), these are typically performed on hardware and software and do not involve a "test set" in the sense of patient data.
- Data Provenance:
- The animal testing (porcine model) appears to be prospective and conducted by NOVADAQ.
- The standards conformance testing was conducted by NOVADAQ and accredited third-party laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The animal model study used to validate in vivo fluorescence imaging would likely have involved veterinarians or surgical experts, but their number and qualifications are not detailed. For the standards testing, "ground truth" is typically defined by the standard itself rather than expert consensus on a test set.
4. Adjudication Method for the Test Set
- This information is not provided. Given the nature of the tests described (animal model and standards conformance), a formal adjudication method like 2+1 or 3+1 is unlikely to have been used, as these are typically reserved for image interpretation studies.
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 comparative effectiveness study is mentioned. This device is an imaging system, not an AI-powered diagnostic tool, so such a study would not be directly applicable in the sense of "human readers improve with AI." The document focuses on the system's ability to provide visual assessment of vessels, blood flow, and bile ducts using near-infrared imaging alongside visible light.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is an imaging system used in real-time by surgeons; it is not an algorithm that performs a standalone diagnostic function. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The device's "performance" is its ability to acquire and display images.
7. The type of ground truth used
- For the in vivo fluorescence imaging validation, the ground truth was likely physiological observation within the porcine model by trained personnel, confirming the system's ability to visualize expected fluorescence in living tissue after ICG administration.
- For the standards conformance tests, the "ground truth" is the requirements outlined in the respective IEC and UL standards.
8. The sample size for the training set
- This device is an imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set sample size is not applicable and not provided.
9. How the ground truth for the training set was established
- As there is no mention of a training set, this information is 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.