The Genicon Simple Specimen Retrieval Bags are comprised of a flexible plastic bag with and without a deployment mechanism. The deployment mechanism consists of a push rod and handle. The deployment mechanism allows for easy insertion through the cannula to deploy the bag within the body cavity. Bags without a deployment mechanism may be introduced using a standard atraumatic grasper or dissector. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

AI/ML Overview

This is a medical device submission for the GENICON Simple Specimen Retrieval Bag (SimplyStrong and SimplyEZee) and therefore does not include information about AI/ML algorithm performance. The document describes the substantial equivalence of the device to a predicate device based on non-clinical testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Test/Characteristic	Acceptance Criteria (Bench Test Outcome)	Reported Device Performance (GENICON Simple Specimen Retrieval Bag)
Introduction Forces	Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device.	Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for introduction forces.
Seam Strengths	Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device.	Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for seam strengths.
Puncture Forces	Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device.	Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for puncture forces.
Fluid Permeability	Not explicitly stated as a numerical criterion, but implied to be "appropriate" (likely non-permeable for fluid containment) and equivalent to the predicate device.	Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for fluid permeability.
Transparency	Not explicitly stated as a numerical criterion, but implied to be "appropriate" (likely transparent enough for visualization) and equivalent to the predicate device.	Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for transparency.
Open/Closure Forces	Not explicitly stated as a numerical criterion, but implied to be "appropriate" for ease of use and secure closure, and equivalent to the predicate device.	Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for open/closure forces.
Packaging Validation	Not explicitly stated, but implies meeting established standards for medical device packaging integrity.	Validation was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence).
Visual Inspection	Not explicitly stated, but implies conforming to manufacturing specifications and absence of defects.	Inspection was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence).
Biocompatibility	Conforms to ISO 10993.	Conforms to ISO 10993.
Sterilization Validation	Not explicitly stated, but implies meeting established standards for medical device sterilization.	Validation was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence).
Radiopaque Markers	The predicate device (Espiner Tissue Retrieval System) is X-ray opaque, implying the ability for detection. For the GENICON device, it's the incorporation of radiopaque markers allowing for x-ray detection in case the bag is left inside the patient after the surgical procedure.	Bags incorporate radiopaque markers allowing for x-ray detection in case the bag is left inside the patient after the surgical procedure. (This isn't a direct performance-based "acceptance criterion" in the same way as forces, but a design feature that meets a safety requirement).
Intended Use	Endoscope and Accessories (GCJ) for capturing organs or tissue to be removed from the body cavity during laparoscopic surgery.	SAME – Indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
Volume	50 to 6000 mL (Predicate)	50 to 3000 mL (GENICON) - Note: Reduced volume range compared to predicate, but still deemed substantially equivalent for its intended use.
Cannula Diameter	5 to 15 mm (Predicate)	SAME – 5 to 15 mm.
Sterilization	Sterile/Single-Use.	SAME – Sterile/Single-Use.
Prescription Only	Yes.	SAME – Yes.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily discusses "bench testing" and "performance studies" for non-clinical evaluation. It does not specify sample sizes for these tests, nor does it explicitly mention data provenance (country of origin, retrospective/prospective). These are typically internal corporate tests supporting substantial equivalence claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as the submission is for a physical medical device (specimen retrieval bag) and relies on technical bench testing and comparison to a predicate, not clinical "ground truth" established by experts in the context of diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or adjudication.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the predicate device's established performance and the generally accepted engineering and material standards for medical devices (e.g., ISO 10993 for biocompatibility, sterility standards). The new device's performance is compared against these established benchmarks through non-clinical bench testing.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML algorithm requiring a training set.

Summary

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August 21, 2018

GENICON, Inc Katlyn Kachman Regulatory Complaince 6869 Stapoint Court Suite 114 Winter Park, Florida 32792

Re: K181791

Trade/Device Name: GENICON Simple Specimen Retrieval Bag (SimplyStrong and SimplyEZee) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 29, 2018 Received: July 5, 2018

Dear Katlyn 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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 -S3

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181791

Device Name

GENICON SIMPLE SPECIMEN RETRIEVAL BAG (SIMPLYSTRONG AND SIMPLYEZEE)

Indications for Use (Describe) THE GENICON SIMPLE SPECIMEN RETRIEVAL IS INDICATED FOR USE IN LAPAROSCOPIC PROCEDURES TO CAPTURE ORGANS OR TISSUE TO BE REMOVED FROM THE BODY CAVITY.

SERVICE LABOR.	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the rine to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

Contact Information GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Kachman, Regulatory Compliance August 21, 2018

2. Device Name

Trade Name - GENICON SimplyStrong and SimplyEZee
Common Name Simple Specimen Retrieval Bag ●
Classification Name - Endoscope and Accessories (21 CFR 876.1500, Product Code GCJ)
1. Substantially Equivalent Device Legally Marketed (unmodified) Devices: The Espiner Tissue Retrieval System (K111845)
1. Device Description

1. Intended Use
  The GENICON Simple Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
Technological Characteristics of the Subject Device Compared to the Predicate Device 6.

Device	The Espiner Tissue Retrieval System(K111845)	GENICON SimplyStrong and SimplyEZeeRetrieval System
Intended Use	Endoscope and Accessories (GCJ)	SAME
ComponentDesign	Image: Espiner Tissue Retrieval System Component DesignA. Closure SutureB. BagC. Introduction Tab(s)	Image: GENICON SimplyStrong and SimplyEZee Retrieval System Component DesignA. Closure SutureB. BagC. Introduction Tab(s)
Design	The Espiner Tissue Retrieval System consists of a familyof impervious sacs which are sterile single use device thatcan be used alone of with a dedicated introducer systemfor the encaptured and removal of an organ, tissue or fluidfrom the body cavity during laparoscopic surgery.The sac includes introduction tab(s) and a drawstring(closure suture). The introduction tab(s) are used as acontact points for the instrument or push rod for	The GENICON Simple Specimen Retrieval Bags consist ofa family of retrieval bags which are sterile single-usedevices that can be used alone or with a dedicatedintroducer system for the capture and removal of organs ortissue from the body cavity during laparoscopic surgery.The bag includes an introduction tab and a closure suture.The introduction tab is used as a contact point for theinstrument or push rod for introduction through an

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	introduction through an appropriately sized cannula. Thedrawstring facilitates mouth opening as well as secureclosure of the sac.Devices are X-ray opaque.	appropriately sized cannula. The drawstring facilitatesmouth opening as well as secure closure of the sac.Bags incorporates radiopaque markers allowing for x-raydetection in case the bag is left inside the patient after thesurgical procedure.
Volume	50 to 6000 mL	50 to 3000 mL
CannulaDiameter	5 to 15 mm	SAME
Performance/Testing	There are no FDA performance standards for theseproducts. Bench Testing to demonstrate safety andeffectiveness to predicate device.	Performance testing showed that the deviceperformed equivalent or better and is thereforesubstantially equivalent in performance to thepredicate devices
Sterilization	Sterile/Single-Use	SAME
Prescription Only	Yes	SAME
Biocompatibility	Unknown	Conforms to ISO 10993

There are no new technologies being added to the device from the predicate in terms of finished device functions. The device has the same intended use and application as the predicate device.

7. Non-Clinical Tests

The GENICON Simple Specimen Retrieval Bags have been determined to be substantially equivalent to the Espiner Tissue Retrieval System through performance studies and bench testing which included determining and verifying appropriate introduction forces, seam strengths, puncture forces, tests for fluid permeability and transparency, and open/closure forces. Testing showed that the same requirements as the predicate device. Additionally, the following tests were also conducted: packaging validation, visual inspection, biocompatibility testing, and sterilization validation.

8. Clinical Tests

There were no clinical trials performed on the GENICON Simple Specimen Retrieval Bags.

1. Conclusions
  The subject device has equivalent indications for use as the predicate device. The technological characteristics, non-clinical testing and performance and bench testing of the GENICON Simple Specimen Retrieval Bags show that the device is as safe, as effective, and meets the same performance standard. Therefore, the proposed GENICON Simple Specimen Retrieval Bags are substantially equivalent to the predicate.

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.