(35 days)
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
The Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device designed to maintain the intra-operative view during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids. The device was deemed substantially equivalent to a previously cleared predicate device (K160172).
Here's an analysis of the acceptance criteria and supporting studies, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly define quantitative acceptance criteria for device performance as would be expected for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and showing that design modifications do not negatively impact safety or effectiveness.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on substantial equivalence to K160172) | Reported Device Performance (LENS - K170103) |
|---|---|---|
| Intended Use | Maintain intra-operative view by shielding laparoscope lens from debris, grease, blood, and bodily fluids. | Same as predicate device. |
| Target Patient Population | Patients undergoing laparoscopic surgery. | Same as predicate device. |
| Target User Population | Clinicians qualified to perform laparoscopic surgery. | Same as predicate device. |
| Anatomical Site | Abdominopelvic cavity. | Same as predicate device. |
| Where Used | Hospital O.R. room. | Same as predicate device. |
| Contraindications | No known contraindications. | Same as predicate device. |
| Method of Introduction | Introduced into abdominopelvic cavity via a trocar. | Same as predicate device. |
| Performance (Functional) | Enable to maintain the intra-operative view when it gets soiled by debris. | Same as predicate device (demonstrated in animal model). |
| Biocompatibility | Limited exposure, external communication device of tissue contact. Pass cytotoxicity, sensitization, irritation, and acute systemic toxicity tests. | Passed cytotoxicity, sensitization, irritation, and acute systemic toxicity tests as per ISO 10993 standards. |
| Sterilization Method | Ethylene Oxide sterilization, SAL of 10-6. | Same as predicate device. |
| Energy Source | No energy source. | Same as predicate device. |
| Compatibility (Laparoscope) | 10mm/0°/30cm (standard) | 10mm/0°/30cm (standard) and 10mm/0°/42cm (bariatric). |
| Compatibility (Trocar) | 12mm | 12mm |
| Mechanical Integrity | Design specifications fulfilled, and design modifications do not affect safety and function. | Demonstrated through mechanical testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes performance testing which can be likened to a "test set" for evaluation.
- Biocompatibility Testing: The sample size for biocompatibility testing is not explicitly stated in terms of number of devices or test repetitions. The provenance is implied to be laboratory testing conducted according to recognized international standards (ISO 10993).
- Mechanical Testing: The sample size for mechanical testing is not explicitly stated. This would involve specific numbers of devices or components undergoing various mechanical stresses. The provenance is implied to be laboratory testing.
- Functional Testing: "Device functionality was tested in the animal model." The document does not specify the number of animals used, the species, or other details of the animal model. The provenance is an animal study.
Given the nature of the device (a physical accessory, not an AI/ML system), the concept of "country of origin of the data" and "retrospective or prospective" as typically applied to clinical data or AI training/test sets is not directly applicable here. The testing described is primarily in-vitro (biocompatibility, mechanical) and pre-clinical (animal model functional).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable in the context of this device and the provided document. The ground truth for biocompatibility is established by the results of standardized assays against ISO 10993 criteria, not expert consensus. The "ground truth" for mechanical integrity is adherence to design specifications verified through engineering tests. The "ground truth" for functional testing in the animal model would be the observable ability of the device to shield the lens and maintain the intra-operative view, likely assessed by the surgical team performing the animal procedure, but explicit expert involvement and qualifications for establishing this "ground truth" are not detailed.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for AI/ML devices to resolve discrepancies in expert interpretation of medical images or data. The testing described for this physical device does not involve such expert review or adjudication processes for its performance metrics.
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
This question is not applicable. The device is a physical laparoscopic accessory, not an AI/ML system, and therefore does not involve "human readers" or "AI assistance" in the sense of an MRMC study for diagnostic or prognostic AI.
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 laparoscopic accessory, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is implicitly derived from:
- Biocompatibility: Adherence to established biological safety standards (ISO 10993) based on laboratory assays.
- Mechanical Integrity: Compliance with engineering design specifications validated through mechanical testing.
- Functional Performance: Observable effectiveness in maintaining intra-operative view in an animal model. This would likely be clinical observation by the surgical team in the animal study.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an AI/ML system, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as it relates to AI/ML systems which this device is not.
§ 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.