(96 days)
LaparoVue is a single-use, sterile device to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
The Laparo Vue is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile (radiation) and intended for single-use only in a healthcare facility / hospital. The LaparoVue is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by LEDs which are illuminated at each port. The LaparoVue has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 12mm in diameter. The horizontal port is the main warming port, primarily used prior to the surgical case to warm the scope before the insertion into a body cavity. A small scope stand is part of the LaparoVue, designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. The vertical port contains a sponge that is saturated with the surfactant solution and warmed when the device is active. This port allows for the user to apply the warmed surfactant prior to and during the case. The LaparoVue is powered by alkaline batteries and has a single-use surgical life of a minimum of 5 hours. A small piece of microfiber is attached to the main housing of the unit that would allow the user to physically wipe the lens to remove any debris throughout the surgical procedure. The VueTip trocar swabs are an accessory that is provided in the same package with the LaparoVue. They are each a sterile, single-use accessory to be used to physically clean debris from the trocar/cannula to minimize any smudging of the scope lens when it is inserted. The trocar swabs are constructed using foam attached to a handle, where the foam is used for the mechanical wiping of the port of the trocar/cannula. Two different configurations are provided, one with a foam diameter intended for use with trocar/cannulas up to 7mm, and the other for trocar/cannula with a diameter from 7mm up to 12mm. The handle material for the VueTip trocar swab is constructed to be radiopaque for the surgical setting. A microfiber cloth is an accessory that is provided in the same package with the Laparo Vue. The cloth is a sterile, single-use accessory to be used as an alternate method to physically wipe debris from the lens of scope during the case. The construction of the microfiber cloth is radiopaque for the surgical setting.
This FDA 510(k) summary for the LaparoVue device primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for the LaparoVue itself. The document describes types of performance tests conducted but does not provide specific acceptance criteria or reported device performance values from those tests in a way that allows for a direct comparison as requested.
Therefore, many of the requested sections cannot be fully populated from the provided text.
Here is an attempt to address your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes types of performance tests but does not explicitly state numerical acceptance criteria or provide quantitative reported device performance values for the LaparoVue device for fogging prevention. The "Lens Fogging Validation" section notes that "digital images were recorded to demonstrate the effectiveness of preventing the fog from forming on the lens when the Laparo Vue was utilized," implying a qualitative assessment rather than a specific numerical metric.
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1 for biological evaluation; passing results for Cytotoxicity, Systemic Toxicity, Maximization Sensitization, and Intracutaneous Sensitization. (As an external device with limited contact duration |
§ 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.