(53 days)
The LLICS™ is indicated for use in laparoscopic surgeries to clean the laparoscope lens within the surgical cavity, preventing temperature changes associated with lens fogging.
The LLICS sterile system is intended for single-procedure use. Each LLICS package includes two cleaning swabs that can be introduced through an existing surgical trocar or cannula and one bottle of surfactant.
Each cleaning swab consists of a foam tip mounted on a plastic rod, an outer cannula, and an actuator handle.
The surfactant is applied to the foam tip on the cleaning swab. The tip is then retracted into the LLICS cannula before it is introduced through the surgical trocar/cannula. The LLICS cannula helps to keep the foam tip clean while it passes through the existing surgical trocar/cannula.
Once the LLICS device has passed through the surgical trocar/cannula, the surgeon visualizes the end of the LLICS cannula and uses the actuator handle to deploy the surfactant-moistened foam tip. The actuator handle remains outside the body and can be operated with one hand. The surgeon uses the foam tip to clean the endoscope lens and then retracts the tip into the LLICS cannula. The retracted device can be left in the surgical trocar/cannula for additional cleaning cycles or removed to make the trocar/cannula available for introducing other endoscope accessories.
This device is the LLICS™ Laparoscopic Lens Internal Cleaning System. The provided text is a 510(k) summary, which describes the device and its equivalence to legally marketed devices, rather than a detailed study report that establishes novel acceptance criteria and proves the device meets them through clinical or large-scale non-clinical studies for new indications.
The document primarily focuses on demonstrating substantial equivalence to existing devices (D.H.E.L.P. heated endoscope lens protector and Clear Field Sterile Wipes, and other laparoscopic accessories regarding trocar insertion). Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device.
Given this context, the acceptance criteria and study information are presented differently than for a brand new, high-risk device where a comparative effectiveness study or large standalone study might be expected. The "acceptance criteria" here are largely based on the performance of the predicate devices and general safety/effectiveness principles for similar instruments.
Here's an attempt to extract and synthesize the requested information, acknowledging the limitations inherent in a 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity, sensitization, or irritation. | Passed all tests for cytotoxicity, sensitization, and irritation after E-Beam sterilization. |
| Cleaning Performance | Ability to restore specified level of visibility in a soiled endoscope over multiple cleaning cycles. | "Able to restore the specified level of visibility over multiple cleaning cycles" on endoscopes soiled with bacon fat and/or tissue. |
| Durability | Insertion portion remains intact, no foam shed after multiple cleaning cycles. | Insertion portion remained intact, and no foam was shed after an average of 29 cycles during simulated cleaning. |
| Usability | Healthcare professionals (nurses, scrub technicians) can prepare the device without contamination. Surgeons can complete cleaning without device/endoscope damage. Nurses can detect non-intact foam tip. | Nurses and scrub technicians could prepare the device without use errors. Surgeons could complete cleaning without damage in simulated conditions. Nurses were able to detect when a foam tip was not intact. |
| Sterility Testing | No information provided in the summary. Implies standard sterility assurance levels for medical devices. | Product sterilized with E-Beam radiation at higher than maximum dose prior to biocompatibility testing. |
| Intended Use Equivalence | Same general intended use as predicate devices: preserve/restore visibility by removing soil and preventing fogging. | "Same general intended use" as predicate devices. Differences in terminology (lens cleaning vs. defogging) do not create a new intended use or new safety concerns. |
| Safety of Trocar Insertion | Safe introduction into surgical cavity via trocar/cannula, similar to other laparoscopic accessories. | Similar to other laparoscopic instruments (e.g., PMC Laparoscopic Instruments) that are introduced via trocar/cannula. No specific adverse events reported. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The summary does not specify the number of devices or experimental units used for each biocompatibility test (cytotoxicity, sensitization, irritation).
- Data Provenance: Not specified, but generally performed by accredited testing laboratories as part of pre-market submissions. Retrospective in relation to the submission date, but the tests were performed specifically for this device.
- Cleaning Performance: The specific number of endoscopes, cleaning cycles, or repetitions is not specified.
- Data Provenance: Bench testing, likely in a controlled laboratory setting. Retrospective.
- Durability Testing: "Average of 29 cycles" for foam shedding suggests multiple devices or tests were performed, but the exact sample size is not provided.
- Data Provenance: Bench testing, likely in a controlled laboratory setting. Retrospective.
- Usability Testing: Involved "surgical nurses, scrub technicians, and laparoscopic surgeons." The number of participants for each group is not specified.
- Data Provenance: Simulated use testing in a surgical suite. Retrospective.
- Training Set Sample Size:
- Biocompatibility: No specific training set for this type of test; it's a direct pass/fail assessment against established biological response criteria.
- Cleaning/Durability/Usability: Not applicable for these non-clinical tests in the context of a "training set" as one would consider for an AI/ML algorithm. These are direct performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The summary does not detail the use of "experts" in the traditional sense for establishing ground truth for the test set beyond the general implication that the tests simulate real-world conditions and are evaluated by technical personnel.
- For Cleaning Performance, a "standardized visual reference" was used to assess visibility, which would imply a pre-defined objective standard rather than direct expert consensus on each individual test.
- For Usability Testing, the participants (surgical nurses, scrub technicians, laparoscopic surgeons) were the "users" being observed, and their ability to perform tasks correctly indicated usability, rather than them establishing a separate "ground truth" for the device's performance. The "ground truth" for usability here would be the successful completion of tasks as defined by the study protocol.
- The document does not mention any formal "expert consensus" process or specific expert qualifications for establishing ground truth in the way one might for diagnostic accuracy studies (e.g., radiologists reviewing images).
4. Adjudication Method for the Test Set
- No formal adjudication method (e.g., 2+1, 3+1) is described. The tests appear to be direct performance evaluations against pre-defined criteria (e.g., visual reference for cleaning, integrity for durability, successful task completion for usability, biological response for biocompatibility).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This type of study is typically conducted for diagnostic AI devices comparing human performance with and without AI assistance. The LLICS™ is a surgical tool, not a diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable in the context of this device. The LLICS™ is a mechanical cleaning system and does not involve an algorithm. Its performance is standalone in the sense that its physical function is evaluated, but it is always used by a human surgeon.
7. The Type of Ground Truth Used
- Biocompatibility: Established biological response criteria (e.g., ISO 10993 standards for cytotoxicity, sensitization, irritation).
- Cleaning Performance: "Standardized visual reference" for visibility, and objective assessment of removal of bacon fat/tissue. This is an objective measurement against a defined standard.
- Durability Testing: Objective assessment of material integrity (e.g., "insertion portion remained intact," "no foam shed").
- Usability Testing: Observational data of task completion and absence of use errors by trained medical professionals, against predefined successful completion criteria.
- No pathology, outcomes data, or expert consensus (in the diagnostic sense) was used as ground truth for proving performance. The ground truth is primarily based on objective physical performance and user interaction.
8. The Sample Size for the Training Set
- Not applicable. The LLICS™ is a mechanical device, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The device developers would have designed and prototyped the device, and tested various iterations, but this is part of engineering development, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an algorithm.
§ 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.