(15 days)
The Essex Dissection Cannula is intended for use in dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures.
The Essex Dissection Cannula is indicated for dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures including percutaneous thoracic and pericardial surgery.
The Essex Dissection Cannula is a reusable device designed for dissection of tissue and introduction of instruments for visualization and manipulation during endoscopic surgical procedures. The device consists of two tubular cannulae for introduction of instrumentation into the surgical site. One lumen allows insertion of an endoscope for illumination and visualization of the procedure. Another lumen provides access for surgical instruments. A disposable Dissection Tip may be attached to the end of the cannula for dissection of tissue.
The provided text is a 510(k) summary for the Essex Dissection Cannula. It outlines the device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) submission would for novel, high-risk devices. For lower-risk devices like this cannula, the "proof" often lies in the argument that the new device is fundamentally similar to a device already deemed safe and effective.
Therefore, I cannot provide the requested information from the given text.
This document does not contain the information required to populate the following sections:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented.
- Sample size used for the test set and the data provenance: No test set information is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method for the test set: No test set or adjudication method is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm, so this concept is not applicable.
- The type of ground truth used: No ground truth is mentioned.
- The sample size for the training set: This is a physical medical device, not a machine learning model, so no training set is relevant.
- 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.