(17 days)
DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
The Defogging Endoscopic Lens Protector (D.E.L.P.) is a small, sterile, disposable, multi-function device. It is designed to store and apply anti-fog surfactant solutions to the distal lens of endoscopes. This is intended to reduce fogging on endoscopes by applying anti-fog solution to the distal lens.
The provided document describes two devices, D.H.E.L.P. (Defogging Heated Endoscopic Lens Protector) and D.E.L.P. (Defogging Endoscopic Lens Protector). The initial section primarily focuses on D.H.E.L.P. and its performance assessment, while later sections introduce D.E.L.P. and state that its functionality and compatibility were tested in trials conducted with the D.H.E.L.P. device. The performance criteria and study details are primarily related to D.H.E.L.P.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with specific performance thresholds. Instead, the performance assessment aims to demonstrate "equivalence to any other conventional method evaluated." The implicit acceptance criterion is that the DHELP device performs at least as well as, or equivalently to, other conventionally used anti-fogging methods for endoscopes.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Prevention of fogging during endoscopic/laparoscopic procedures | "DHELP's performance was equivalent to any other conventional method evaluated." |
| Functional compatibility with various scopes and camera systems | DHELP was "used with 4 different laparoscope types and on Olympus, Stryker and Storz camera systems to make sure that it was functionally compatible with the most common scopes and systems." |
| Maintaining solution above body temperature (for D.H.E.L.P.) | "DHELP maintains this solution above body temperature for over 4 hours." (This is stated as a feature intended to reduce fogging better, implying it contributes to the overall performance.) |
| Biocompatibility standards met | "Meets Biocompatibility standards: Yes" for D.H.E.L.P. and predicate devices. |
| No new issues of safety and effectiveness | "Our evaluation concluded that D.H.E.L.P raises no new issues of Safety and effectiveness." and "Our evaluation concluded that D.E.L.P raises no new issues of Safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that DHELP testing was conducted "with a live anesthetized pig."
- It also states that DHELP was used with "4 different laparoscope types" (which could refer to the number of types used in the test, not necessarily the count of individual scopes) and "on Olympus, Stryker and Storz camera systems."
- The specific number of times the device was used on the pig, or the number of trials conducted to establish "equivalent" performance, is not specified.
- Data Provenance: The study was conducted in a laboratory setting ("live anesthetized pig"). There's no indication of country of origin for the data beyond the applicant's address in the USA. The study appears to be prospective in nature, as it describes a specific testing methodology for the DHELP device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth for the performance assessment. The conclusion of "equivalence" seems to be based on the internal evaluation of the manufacturer.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Decisions on "equivalence" appear to be made internally by the evaluators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described involves a device comparison against "current defogging methods" rather than assessing human reader performance with and without AI assistance. The device itself is an anti-fogging tool, not an AI diagnostic aid for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
The concept of "standalone (algorithm only)" is not applicable here as the device is a physical medical tool designed to prevent fogging, not a software algorithm. The performance assessment describes the functional performance of the physical device.
7. The Type of Ground Truth Used
The ground truth or reference standard for "equivalence to any other conventional method evaluated" and "prevent fogging" is implicitly expert observation and assessment during the live anesthetized pig study and potentially comparative qualitative assessment against predicate devices. There is no mention of pathology, outcomes data, or a formal expert consensus process.
8. The Sample Size for the Training Set
This question is not applicable. The DHELP and DELP devices are physical tools, not AI algorithms that require a training set. The descriptions relate to the testing of the final physical product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical medical 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.