The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

Device Description

The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

AI/ML Overview

The provided document is a 510(k) summary for the GENICON Specimen Retrieval Bag. It details the device's description, indications for use, and a statement about nonclinical tests supporting substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or a detailed study report that proves the device meets those criteria, as typically found in a clinical trial or performance study report. The document mentions "Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A)," but the details of these tests are not provided in this regulatory submission.

Therefore, for aspects requiring detailed study information, the answer will reflect that the information is "Not Available in the provided text."

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly list quantitative acceptance criteria or detailed device performance metrics from a study. It only states that "Successful results support a determination of substantial equivalence" for general operation, seal strength peel, and puncture resistance. Without access to TR-12022-A and CLEV-032-A, specific criteria and performance values cannot be extracted.

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not available in the provided text. The document states "Successful results support a determination of substantial equivalence" for bench testing related to seal strength, puncture resistance, and general operation.	Not available in the provided text. The document refers to internal reports (TR-12022-A and CLEV-032-A) for specifics, which are not included here.

2. Sample Size for the Test Set and Data Provenance

Sample size used for the test set: Not available in the provided text. The document mentions "Bench Testing and Clinical Evaluation," but no sample sizes are given for either.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of experts: Not available in the provided text.
Qualifications of those experts: Not available in the provided text.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication method: Not available in the provided text.

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

MRMC comparative effectiveness study: Not applicable. This device is a physical specimen retrieval bag, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone performance study: Not applicable. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: Not available in the provided text. For bench testing, ground truth would likely be established by objective physical measurements according to specified test methods. For clinical evaluation, it would typically relate to the device's ability to safely and effectively retrieve specimens in a surgical setting, which could involve surgical observations, successful specimen retrieval without complications, and potentially pathology results of retrieved specimens. However, the document does not specify.

8. The Sample Size for the Training Set

Sample size for the training set: Not applicable/Not available. This device is a physical specimen retrieval bag, and the concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here. Even if a design verification/validation process involved iterative testing, the term "training set" as used in AI contexts does not apply.

9. How the Ground Truth for the Training Set Was Established

How the ground truth for the training set was established: Not applicable/Not available, as the concept of a "training set" for a physical device is not relevant in the context of this summary.

Summary

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N 1_2 2014 K132375

Page 1 of 1

Section 2 510(k) Summary per 21 CFR 807.92

Contact Information GENICON LLC 6869 Stapoint Court Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Tissue, Quality Supervisor July 24, 2013

2. Device Name

Trade Name: GENICON Specimen Retrieval Bag Common Name: Single Use Specimen Retrieval Bag including sterile packaged Single-Use Specimen Retrieval Bag and Introducer Classification: 21 CFR 876.1500 GCJ

3. Substantially Equivalent Device

Anchor Tissue Retrieval Bag 100, 10mm introducer, K061555, K091930

4. Description

5. Indications for Use

The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to caplure and remove organs or tissue from the body cavity.

6. Technical Specifications

The GENICON Single-Use Specimen Retrieval Bag is intended for Laparoscopic Surgery (GCJ) and contains a Bag, Biasing Arms, Introducer, Closure Suture/String, Handle and Actuation/Deployment Shaft. The shaft diameter ranges from 5-15 mm and is composed of PC while the Bag is PU Coated Nylon (PA) and the Introducer is Stainless Steel. There are no FDA performance standards for these products; however Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A). The sterlization is performed by Ethylene Oxide per ISO 11135-1:2007. 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.

7. Nonclinical Tests

The GENICON Specimen Retrieval Bag has been evaluated with seal strength peel, puncture resistance, and general operation testing. Successful results support a determination of substantial equivalence

8. Conclusions

Based on the indications for use and technological characteristics, the GENCON Specimen Retrieval Bag has shown to be safe and effective for its intended use and substantially equivalent to the predicate devices.

WWW.GENICONENDO.COM FAX 407.677.9773 TEL 407.657.4851 ----US OFFICE - 6869 Stapoint Court # 114, Winter Park, Florida USA 32792 - EU OFFICE - 44 Airedale Avenue, Chiswick, London U.K. W4 ZNN

FASHING (FRANT) CARDE S (FRIE) (GHErp) (Graca)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

GENICON LLC Ms. Katlyn Tissue Quality Supervisor 6869 Stapoint Court, Suite 114 Winter Park, Florida 32792

June 12, 2014

Re: K132375

Trade/Device Name: GENICON Specimen Retrieval Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 27, 2014 Received: March 28, 2014

Dear Ms. Tissue:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Katlyn Tissue

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Neil R Oaden -S 2014.06.12 16:09:43 -04'00'

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) K132375

Device Name GENICON Specimen Retrieval Bag

Indications for Use (Describe)

The GENICON Single-Use Specimen Retrieval Bag 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FREE OF FOR FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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.