(21 days)
The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. The Scope ProTech is intended for the protection of the distal tip and the bending rubber of endoscopes with a diameter of 2.7mm-8.0mm and 8.7mm-14.7mm. The Scope ProTech will aid in the protection of distal end, the lens and other delicate components from damage. It is not intended for use during sterilization.
The Scope ProTech is a single-use, sterile endoscopic tip protector which provides a simple, safe, and highly effective method of protecting the delicate optics of an endoscope, while allowing the tip to 'breath' and thus not allowing biofilm to form. The Scope ProTech is available in two models to fit a range of scopes: INOV8-028S (Scope ProTech Small) for scope sizes 2.7 to 8mm and INOV8-028L (Scope ProTech Large) for scope sizes 8.7 to 14.7mm. The Scope ProTech is manufactured using injection moulding using a soft polypropylene.
The provided text describes the Meditech Endoscopy Ltd Scope ProTech, a device intended for protecting endoscope tips during transport and storage. The submission is a 510(k) premarket notification, establishing substantial equivalence to a predicate device rather than independently proving safety and effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies is presented in the context of this 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state acceptance criteria with numerical targets in the way a clinical trial might, as it focuses on demonstrating substantial equivalence to a predicate device. Instead, it compares characteristics of the Scope ProTech to its predicate, the US Endoscopy Endo-Boot (K951104). The "Equivalence" column in the table below effectively serves as the acceptance criteria for a 510(k) submission.
| Characteristic | Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (Scope ProTech) |
|---|---|---|
| Device Name | n/a | Scope ProTech |
| Indications for Use | Substantially Equivalent | The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. It protects the distal tip and bending rubber of endoscopes with diameters of 2.7mm-8.0mm and 8.7mm-14.7mm. Aids in protection of distal end, lens, and other delicate components from damage. Not intended for use during sterilization. |
| Intended User/Location | Equivalent | Healthcare professionals/technicians and non-patient contacting; Healthcare facility |
| Storage and Transport | Equivalent | Intended for use immediately after processing in an AER and used during storage and transport to and from the location of the procedure. |
| Sterile | Substantially Equivalent (ProTech is sterile, predicate is non-sterile) | Yes, EtO sterilised |
| Re-use | Equivalent | Sterile single-use device, stated on packaging. |
| Scope Sizes Covered | Substantially Equivalent | 2.7 - 8 mm (Small), 8.8 - 14.7 mm (Large) |
| Materials | Substantially Equivalent (ProTech is polypropylene, predicate is sponge) | Injection moulding using soft polypropylene |
| Instructions for Use | Equivalent | Instructions for use included that include graphical instructions, text and relevant warnings and cautions. |
| Use on an Endoscope | Equivalent | Slides over the distal tip of an endoscope. |
| Distal Tip Protection | Substantially Equivalent (ProTech allows complete coverage and aeration, predicate leaves tip uncovered) | Intended to protect the entire distal end of the endoscope, covering the tip and delicate components. |
| Clean/Dirty Identification | (Not explicitly compared as an equivalence criterion, but highlighted as a difference) | Includes tabs that identify the status of the device and prevents re-use of a used device on a clean scope. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of human data. It states, "No clinical data was used in the submission." The testing described is non-clinical bench testing.
- Data Provenance: Not applicable, as no clinical human data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. No human experts were used to establish ground truth from clinical test sets, as no clinical data was used. The substantial equivalence argument relies on comparison of device characteristics and bench testing.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set requiring adjudication was used.
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. This device is a physical endoscopic tip protector and does not involve AI or human "readers" or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
- The "ground truth" for the substantial equivalence determination is primarily based on comparative characteristics with a legally marketed predicate device (Endo-Boot K951104) and bench testing results for mechanical performance, scope compatibility, retention performance, sterility, and shelf-life requirements. There is no "ground truth" derived from clinical outcomes or expert consensus on patient data.
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning or algorithm-based device, so there is no training set in that sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set.
§ 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.