(118 days)
The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.
The Minimally Invasive Defogging and Cleaning Solution is a biocompatible surfactant (Docusate Sodium) when used as indicated. It functions in the same manner as the predicate devices. It is intended to be used to prevent fogging of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries. Additionally, the solution can be used to clean the end of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries (i.e. to rinse lens intra-operatively by rinsing any debris from the lens which becomes attached to the lens as a result of the procedure.)
The provided text describes the Minimally Invasive Devices Defogging and Cleaning Solution (Flo-X) and its equivalence to predicate devices. It includes a summary of performance testing, which serves as the data to prove the device meets certain criteria.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets in a formal table like sensitivity/specificity. Instead, it describes performance goals as "effectiveness" and "equivalence" to predicate devices. Since specific criteria are not quantified, I will present the test title as the implicit criterion and the summarized results as the reported performance.
| Acceptance Criteria (Implicit from Test Title) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Syringe Extractable Study | Testing in compliance with ISO 10993-18 was performed to demonstrate that the container did not have any extractable compound that would leach into the Defogging and Cleaning solution. |
| - Evaluation of acute systemic toxicity (single intra-peritoneal injection into mice) | There was no mortality or evidence of systemic toxicity from the test article injected into mice. |
| Defogging Effectiveness: | |
| - Effectiveness in defogging a laparoscope lens | This testing demonstrated that the Defogging and Cleaning Solution was effective as a defogging agent when the solution was applied to the laparoscope lens with no mechanical action such as blotting or use of a saturated sponge. |
| - Ability to Defog the Laparoscope Lens: Comparison with a Predicate Device | The Defogging and Cleaning Solution and the predicate device both demonstrated that they were effective and equivalent in defogging the laparoscope lens. |
| - Animal Testing: Effectiveness in keeping laparoscope lens defogged (Porcine Peritoneal Cavity) | The Defogging and Cleaning Solution was effective in keeping the laparoscope lens defogged when applied externally and was found to be equivalent to the predicate devices in keeping the laparoscope lens defogged when applied externally. The Minimally Invasive Device Defogging and Cleaning Solution did not interfere with the function of the FloShield™ Plus System, worked in conjunction with the FloShield™ Plus System and was effective in removing/cleaning debris/blood/fat from the lens in situ when applied in 1-2 cc aliquots through the FloShield™ Plus System. |
| Cleaning Effectiveness: | |
| - Ability to Clean the Laparoscope Lens: Comparison with Water and Saline | The results demonstrate that the Defogging and Cleaning Solution effectively removed the grease from the laparoscope lens when applied with flushing via the FloShield™ Plus System. In comparison with water and saline, the water was the least effective at cleaning the lens, saline was slightly better, but the Defogging and Cleaning Solution was superior to water and saline in clearing grease from the lens. The Minimally Invasive Device Defogging and Cleaning Solution did not interfere with the function of the FloShield™ Plus System, worked in conjunction with the FloShield™ Plus System and was effective in removing/cleaning debris/blood/fat from the lens in situ when applied in 1-2 cc aliquots through the FloShield™ Plus System. (This benefit is also mentioned in the animal testing result). |
| Stability/Sterilization Compatibility: | |
| - Effects of Irradiation on the Defogging and Cleaning Solution (E-Beam 25-40 kGy) | Analysis of the Defogging and Cleaning Solution pre and post E-Beam irradiation to 25-40 kiloGray (kGy) demonstrates that the solution is not affected by irradiation. The Docusate component is stable and the solution properties are unchanged. pH, concentration and analysis by HPLC were used to make the assessments. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact numerical sample sizes for most tests.
- For the acute systemic toxicity test, it mentions "mice" but not the number of mice.
- For other bench and animal (porcine peritoneal cavity) studies, the sample sizes are not explicitly stated.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but the descriptions of "testing performed" and "studies" imply these were prospective studies designed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The tests seem to be primarily objective (e.g., measuring defogging, cleaning efficacy against a known contaminant like grease, stability analysis) rather than relying on expert subjective evaluation for "ground truth."
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the tests (bench and animal, with objective metrics like clearing grease or defogging), it's unlikely that a human adjudication method in the context of clinical image assessment would be relevant or used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
An MRMC study is not applicable and was not done. The device is a "Defogging and Cleaning Solution" for a laparoscope lens, not an AI or diagnostic imaging tool that would assist human readers interpreting medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable. The device is a physical solution, not an algorithm. Its performance is inherent to its physical and chemical properties and is evaluated in its intended use environment.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests appears to be:
- Objective measures of function: E.g., the visible absence of fog, the visible removal of grease, the stability of chemical properties (pH, concentration, HPLC).
- Comparison to controls/predicates: Water, saline, and legally marketed predicate defogging devices serve as benchmarks for effectiveness and equivalence.
- Biological outcomes: For the toxicity study, "no mortality or evidence of systemic toxicity" in mice served as the outcome/ground truth for safety.
8. The Sample Size for the Training Set:
This question is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as #8.
§ 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.