(14 days)
The GENICON EZee Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The GENICON EZee Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial or a performance study with specific metrics and statistical analysis. Instead, it describes a substantial equivalence determination based on non-clinical bench testing.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the GENICON EZee Retrieval (K180579) indicates that there are "no FDA performance standards for these products." Therefore, the acceptance criteria are based on internal performance studies and bench testing to demonstrate the device performs as intended and is substantially equivalent to a predicate device (GENICON EZEE Retrieval [K162059]).
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Deployment Force | Evaluated and deemed acceptable |
| Seam Strength | Evaluated and deemed acceptable |
| Puncture Force | Evaluated and deemed acceptable |
| Performance after multiple specimen captures (simulated) | No concerns of safety or effectiveness after multiple uses |
| Leak inspection after multiple specimen captures | No bursts or tears observed; no water on the exterior of the bag |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text mentions "the sample pouch" in reference to the leak inspection, suggesting a small number of units were tested, but no specific count is given.
- Data Provenance: The testing was conducted internally by Genicon. The text does not specify the country of origin of data or whether it was retrospective or prospective, but it implies prospective bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two, "our Chief Technical Officer and Design Engineers."
- Qualifications: "Chief Technical Officer and Design Engineers." Specific years of experience or specialized certifications are not provided, but their titles suggest expertise in medical device design and engineering.
4. Adjudication Method for the Test Set
Not applicable. The "experts" (CTO and Design Engineers) appear to have directly conducted and/or reviewed the performance studies and bench testing results. There is no mention of a separate adjudication process for subjective assessments, as the tests described (force, strength, leaks) are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical retrieval bag for laparoscopic procedures, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. If a Standalone Performance Study Was Done
Yes, a "standalone" performance evaluation in the form of bench testing was done. This testing assessed the device's physical properties and performance characteristics (Deployment Force, Seam Strength, Puncture Force, and performance after simulating multiple specimen captures) independent of human interaction beyond operating the test equipment.
7. Type of Ground Truth Used
The "ground truth" for the bench testing was based on engineering specifications and direct observation of physical properties. For example, seam strength would be compared against a defined engineering requirement or industry standard for adequate strength, and leak inspection relied on visual confirmation of no water egress.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" for the algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.