(48 days)
The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens.
The Scope Antifogging System is a single use, sterile device that is designed to apply an antifogging solution (surfactant) and warm the scope at or above the human body temperature when used prior to and during procedures that utilize an endoscope or laparoscope. The Scope Antifogging System provides antifogging of the lens of the endoscope and laparoscope when inserted into the Scope Antifogging System for use in a laparoscopic procedure. The Scope Antifogging System is controlled by an on switch to activate the circuit containing battery power source to indicate the activation of the antifogging solution warming circuit. The activation of the warming circuit life expectancy is 5 hours. The antifogging solution is retained in the device and warmed when the device is activated in the "on" position. Subsequently, the endoscope/laparoscope is inserted into the device port for application of the warmed antifogging solution. The device's single scope insertion port of the endoscope/laparoscope accepts scopes up to 12mm in diameter. The antifogging solution is included in with the Scope Antifogging System as fluid contained in two separate bottles. The solution is dispensed into the single port opening of the housing of the Scope Antifogging System prior to use. Included with the Scope Antifogging System in the same packaging is a pair of sponge-tipped, trocar wipes. Also included with the Scope Antifogging System in the same packaging is a single-use, microfiber cloth.
This document describes the Xodus Medical Scope Antifogging System and its substantial equivalence to a predicate device, the Covidien Clearify Visualization System. The information provided focuses on performance testing to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting specific performance metrics for antifogging and other functions.
| Acceptance Criteria (Implied) | Reported Device Performance (Xodus Medical Scope Antifogging System) |
|---|---|
| Antifogging Effectiveness | Bench Testing: Demonstrated effectiveness in preventing fogging on simulated equipment (laparoscope and glass mirror plate) consistently, comparable to the predicate device, when subjected to a high humidity source. |
| Animal Testing: Demonstrated effectiveness in preventing fogging of laparoscopes consistently in a live, anesthetized pig model, comparable to the predicate device, through a series of exploratory procedures with different Storz laparoscope types. | |
| Warming Circuit Duration | Bench Testing: Activation period determined to be a minimum of five (5) hours. Thermal characteristics were observed during this period. |
| Trocar Wiping Effectiveness | Bench Testing: Successfully wiped away blood and tissue (general smudging) from the scope interior of the trocar in three test cases, leaving no visible debris, comparable to the predicate device's trocar wipes. |
| Scope Lens Wiping of Debris | Animal Testing: Successfully wiped away bile, blood, and tissue from the scope lens on all occasions using the microfiber cloth and the foam pad on the Antifogging System. |
| Biocompatibility | Successfully conducted to ISO 10993-1 standard. Product category determined as "External Communicating Device" with "Tissue/Bone/Dentin" contact for "A-limited, ≤24hr". Met requirements for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Pyrogenicity. |
| Sterilization | Sterilized by gamma radiation based on ISO 11137-2 standard, validated to ensure 10^-6 Sterility Assurance Level (SAL) or better. Follows same processes as other FDA 510(k) cleared sterile products from Xodus Medical. |
| Electrical Safety / EMC | Successfully conducted, complying with IEC 60601-1-2 for EMC and shall be tested to IEC 60601-1 for electrical safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Antifogging Validation (Bench): Not explicitly stated, but implies multiple applications and comparisons.
- Life Expectancy Validation: Not explicitly stated; "The Scope Antifogging System was activated and observed" implies at least one device, likely more for statistical relevance.
- Trocar Wiping Validation: "three test cases" were conducted.
- Antifogging Validation (Animal): "several instances" and "series of exploratory procedures with four different Storz laparoscope types" were used in "a live, anesthetized pig."
- Scope Lens Wiping of Debris (Animal): "all occasions" when matter was applied and wiped.
- Biocompatibility, Sterilization, Electrical Safety/EMC: Standardized tests typically use specific sample sizes dictated by the standards themselves.
Data Provenance: The studies were conducted internally ("Performance Testing - Bench" and "Performance Testing - Animal") by Xodus Medical, Inc. The data is prospective, generated specifically for this 510(k) submission. No information on country of origin of data beyond "Xodus Medical, Inc."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not specify the number or qualifications of experts used to establish the ground truth for any of the performance tests. The conclusions for antifogging efficacy ("demonstrated the effectiveness... consistently, as with the predicate device") and wiping effectiveness ("successfully wiped away... no visible signs of any debris") appear to be based on direct observation during the tests.
4. Adjudication Method
Not applicable/not specified. The performance testing described suggests direct observation and comparison to the predicate device's performance, rather than an adjudication process involving multiple human reviewers to establish a consensus ground truth.
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 an antifogging system, not an AI-powered diagnostic or assistive tool for human readers/clinicians, therefore, no MRMC study or AI-related effect size data is presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As this device is a physical system for preventing fogging, the concept of a "standalone algorithm" is not relevant. The performance tests ("Bench" and "Animal") are essentially standalone evaluations of the device's physical function.
7. The Type of Ground Truth Used
- Antifogging: Direct observation of the presence or absence of fogging on the simulated equipment or laparoscope lens. The "ground truth" for effectiveness was the visual clear state of the lens, and the comparison was against the identical function of the predicate device.
- Warming Circuit Duration: Measurement of the duration the circuit remained activated and thermal characteristics were maintained.
- Wiping Effectiveness: Direct visual observation of the absence of debris (blood, tissue, bile, smudging) after wiping.
- Biocompatibility, Sterilization, Electrical Safety/EMC: Ground truth is established by adherence to and successful completion of specified international standards (ISO 10993-1, ISO 11137-2, IEC 60601-1-2, IEC 60601-1).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is 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.