(97 days)
The EES Slotted Anoscope is intended for physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures.
The Ethicon Endo Surgery® Slotted Anoscope consists of a transparent plastic disposable anoscope in sterile condition. The Slotted Anoscope comprises a cylindrical body, with a closed end conical-shaped distal tip and a longitudinal open channel that accommodates a removable slide. The removable slide comprises a longitudinal open channel of 11mm in width. The body of the Slotted Anoscope has an outer diameter (OD) of 34mm. The Slotted Anoscope is a single patient use device.
The transparent characteristics of the material used in the Slotted Anoscope allows for visualization of the tissue in contact with the device in the anal canal. The opening in the removable slide provides access to tissue in the canal. The removal of the slide provides a wider margin of access to the targeted area.
The provided 510(k) summary for the Ethicon Endo-Surgery® Slotted Anoscope (K093896) indicates that it is a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria (such as sample size for test set, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable in this context.
The device is a simple, transparent plastic anoscope with a removable slide for physician use to examine the anal sphincter and anus. Its clearance is based on substantial equivalence to a predicate device (Sapimed Self Light Disposable Anoscope, model A.4083, K070913).
Here's a breakdown of the applicable information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on substantiating that the new device has "the same technological characteristics" as the predicate, with only "minor difference" in the width of the open channel. The acceptance criteria are implicitly that these minor differences do not affect safety or performance.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material & Design | Transparent plastic, cylindrical body, closed-end conical tip. | Device is a transparent plastic disposable anoscope with a cylindrical body and a closed-end conical-shaped distal tip. |
| Functionality | Accommodates a removable slide. | Comprises a cylindrical body... with a longitudinal open channel that accommodates a removable slide. |
| Access to tissue | Removable slide provides access to tissue. | The removable slide comprises a longitudinal open channel of 11mm in width; removal of the slide provides a wider margin of access. |
| Visualization of tissue | Transparent material allows for visualization in the anal canal. | Transparent characteristics of the material allow for visualization of tissue in contact with the device in the anal canal. |
| Impact of Channel Width | Width of open channel does not affect safety or performance. | The new EES device contains a removable slide that provides the user with the choice of two different widths for the open channel. This difference does not affect the safety or performance characteristics of the new EES device compared to the predicate. |
| Intended Use | Same indications for use as the predicate device. | The Ethicon Endo-Surgery® Slotted Anoscope has the same indication statement as the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of medical device clearance. The evaluation was based on bench testing and preclinical laboratory evaluations, not a clinical study with a human test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth in the sense of expert consensus on clinical data was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. The device is not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" equivalent would be engineering specifications and functional performance metrics confirmed through bench testing and preclinical laboratory evaluations to ensure the device performs as intended and is substantially equivalent to the predicate. This is based on physical and functional characteristics, not clinical outcomes data or expert interpretation of images.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm, and thus no training set was used.
9. 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.