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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

March 19, 2018

Genicon, Inc Katlyn Kachman Regulatory Compliance 6869 Stapoint Court Suite 114 Winter Park, Florida 32792

Re: K180579

Trade/Device Name: EZee Retrieval Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 1, 2018 Received: March 5, 2018

Dear Ms. Kachman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Ms. Katlyn Kachman

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180579

Device Name EZee Retrieval

Indications for Use (Describe)

The GENICON EZee Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary per 21 CFR 807.92

1. Contact Information GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Kachman, Regulatory Compliance March 19, 2018
1. Device Name GENICON EZee Retrieval
Substantially Equivalent Device 3. GENICON EZEE Retrieval [K162059]
1. Description

1. Indications for Use The GENICON EZee Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
1. Technical Specifications

The GENICON EZee Retrieval is intended for Laparoscopic Surgery (GCJ) and contains a Bag, Biasing Arms, Introducer, Closure String, Handle and Actuation/Deployment Shaft. The shaft diameter is 10mm and is composed of PC while the Bag is Plastic and the Introducer is Stainless Steel. There are no FDA performance standards for these products. The sterilization is performed by Ethylene Oxide per ISO 11135:2014. This device is available by Prescription Only for use in a Hospital Operating Room. This device is compliant with FDA Class II requirements for ISO 10993.

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Image /page/4/Picture/2 description: The image contains the logo for Genicon. The word "GENICON" is written in large, bold, blue letters. Underneath the word is a curved line that is green on top and blue on the bottom. The registered trademark symbol is located to the right of the word.

Device	Genicon Ezee Retrieval 510 (k) K162059	Genicon Ezee Retrieval (with updated technology change) 510 (k) K180579
Intended use	Laparoscopic Surgery (GCJ)	Laparoscopic Surgery (GCJ)
Design	Bag, Biasing Arms, Introducer, Closure Suture/String, Handle, Actuation/Deployment Shaft	Same
Introducer diameter	10mm	10mm
Materials	Shaft - ABS/PCBag - TPU	Same
Performance	There are no FDA performance standards for these products. Bench testing and clinical evaluation performed.	SAMEAdditional performance bench testing for multiple deployment evaluation
Sterilization	Ethylene Oxide per ISO 11135-1:2014	SAME
Where used	Hospital operating room	SAME
Prescription only	YES	YES
Biocompatibility	Compliant with FDA class II requirements for ISO 10993	SAME

7. Nonclinical Tests

The GENICON EZee Retrieval has been evaluated by our Chief Technical Officer and Design Engineers through performance studies and bench testing which included Deployment Force, Seam Strength, and Puncture Force. In addition, testing was performed to simulate multiple specimen captures to see if there were any performance concerns. The test shows that affer there are no concerns of safety or effectiveness of the device after multiple uses.

In order to inspect for leaks after simulating multiple specimen captures, the sample pouch was removed from the device and the water-impregnated specimen was placed in the open bag. The sample was slowly rolled top down as the internal pressure continued to rise. The bag was visually inspected for bursts and tears during this process and found no water on the exterior of the bag.

8. Clinical Tests

There were no clinical trials performed on the GENICON EZee Retrieval.

9. Conclusions

Based on the indications for use and technological characteristics, the GENICON EZee Retrieval has shown to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.