(71 days)
The Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.
The Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) is a confocal microscope with a fiber optic probe which allows in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure. The F-600 system has been designed to allow real-time observations of tissues. The device is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers and is thus composed of several elements: a Laser Scanning Unit, proprietary software running on a remote computer, a flat panel display and Miniaturized Fiber Optic Probes. The F-600 system can be used with any legally marketed endoscope with a working channel of 2.8 mm or greater.
The provided text describes the Mauna Kea Technologies F-600 System, a special 510(k) submission for the Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex). However, it does not contain details about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a Premarket Notification 510(k) Summary, which primarily focuses on:
- Submitter information
- Device name and classification
- Predicate devices
- Device description
- Intended use
- Comparison to predicate devices (specifically comparing it to their previously marketed F-400 system, which itself was based on predicate devices)
- FDA's substantial equivalence determination letter.
The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, rather than conducting new performance studies that establish acceptance criteria and device performance in the same way a PMA (Premarket Approval) might require.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the regulatory decision was based on substantial equivalence, not on specific performance data against predefined acceptance criteria for the new device.
§ 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.