EZEE RETRIEVAL

K162059 · Genicon, Inc. · GCJ · Sep 29, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162059
• Device Name: EZEE RETRIEVAL
• Applicant: Genicon, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 29, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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

Device Story

The GENICON EZEE Retrieval is a single-use, disposable laparoscopic instrument used to capture and retrieve tissue or organs during surgery. The device consists of a flexible plastic specimen bag, a metallic rim for opening, an actuation rod with a thumb ring handle, and a closure string. Operated by a surgeon in a hospital operating room, the device is inserted through a 10mm trocar. The surgeon uses the handle to deploy the bag within the body cavity; once the specimen is captured, the surgeon pulls the closure string to secure the bag before removal. This process facilitates the safe extraction of tissue through small incisions, minimizing trauma and improving surgical efficiency.

Clinical Evidence

No clinical trials were performed. Substantial equivalence is supported by bench testing, including deployment force, seam strength, and puncture force evaluations (TR–12022-A and CLEV–032–A).

Technological Characteristics

Shaft: ABS; Bag: TPU. 10mm diameter. Manual actuation via thumb ring handle and deployment shaft. Sterilization: Ethylene Oxide per ISO 11135:2014. Biocompatibility: ISO 10993 compliant. Single-use, disposable.

Indications for Use

Indicated for use in laparoscopic procedures to capture organs or tissue for removal from the body cavity. Intended for use in hospital operating rooms by trained clinicians.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Covidien Endo Catch Gold Specimen Pouch, 10mm, 173050G (K922123)
• GeniStrong Single Use Specimen Retrieval Bag, 10mm, 550-000-003 (K132375)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.

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

September 29, 2016

GENICON, Inc. Ms. Katlyn Kachman Regulatory Compliance 6869 Stapoint Court, Suite 114 Winter Park, Florida 32792

Re: K162059

Trade/Device Name: Ezee Retrieval Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 13, 2016 Received: September 16, 2016

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 adultera K162059tion. 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

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related adverse events) (21 CFR Part 803); good manufacturing practice requirements as set 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 Parts 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 [phone] or [phone] 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" (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.

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 [phone] or [phone] or at its Internet address

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

Sincerely.

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

## Section 1 Indications for Use

K162059 510(k) Number (if known)

Device Name GENICON EZEE Retrieval

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

TEL [phone] - WWW.GENICONENDO.COM - FAX [phone] US OFFICE · 6869 Stapoint Court #114, Winter Park, Florida USA 32792 - EU OFFICE · 44 Airedale Avenue, Chiswick, London U.K W4 2NW

(GENIFirst)

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Image /page/3/Picture/0 description: The image shows the word "GENICON" in large, bold, blue letters. Underneath the word is a curved line that is blue on top and green on the bottom. The word "GENICON" is the main focus of the image and is likely a logo or brand name.

## Section 2 510(k) Summary per 21 CFR 807.92

- 1. Contact Information GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone [phone] Fax [phone] Katlyn Kachman, Regulatory Compliance September 20, 2016
- 2. Device Name GENICON EZEE Retrieval
- 3. Substantially Equivalent Device Covidien Endo Catch Gold Specimen Pouch, 10mm, 173050G [K922123] Legally Marketed (unmodified) Device: GeniStrong Single Use Specimen Retrieval Bag, 10mm, 550-000-003 [K132375]
- 4. Description

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.

- 5. 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.

- 6. 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 Baq 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.

| Area | Genicon 510K Number:<br>K132375 | Covidien 510K Number:<br>K922123 | EZEE Retrieval 510K Number:<br>K162059 |
|--------------|------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------|
| Intended Use | Laparoscopic Surgery (GCJ) | Laparoscopic Surgery (GCJ) | Laparoscopic Surgery (GCJ) |
| Design | Bag, Biasing Arms, Introducer,<br>Closure Suture/String, Handle,<br>Actuation/Deployment Shaft | SAME | SAME |
| Introducer | 5 to 15 mm | 10 to 15 mm | 10 mm |

WWW.GENICONENDO.COM FAX [phone]

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Image /page/4/Picture/0 description: The image shows the word "GENICON" in large, bold, blue letters. Underneath the word is a green and blue swoosh design. The registered trademark symbol is located to the right of the word.

| Diameter | | | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------|
| Materials | Shaft – PC<br>Bag – PU Coated Nylon(PA) | Shaft – Plastic and Stainless<br>Steel<br>Bag – TPU | Shaft – ABS<br>Bag – TPU |
| Performance | There are no FDA performance<br>standards for these products.<br>Bench Testing and Clinical<br>Evaluation performed. (ref.<br>TR–12022-A and CLEV–032–<br>A) | SAME | SAME |
| Sterilization | Ethylene Oxide per ISO<br>11135–1:2014 | Ethylene Oxide | Ethylene Oxide per ISO 11135–<br>1:2014 |
| Where Used | Hospital Operating Room | SAME | SAME |
| Prescription Only | Yes | Yes | Yes |
| Biocompatibility | Compliant with FDA Class II<br>requirements for ISO 10993 | SAME | SAME |

- 7. Nonclinical Tests
The GENICON EZEE Retrieval has been evaluated by our Chief Technical Officer, Design Engineers, and Chief Medical Officer through performance studies and bench testing which included Deployment Force, Seam Strength, and Puncture Force.

- 8. Clinical Tests
There were no clinical trials performed on the GENICON EZEE Retrieval.

- 9. Conclusions
(GENIFirst)

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

— WWW.GENICONENDO.COM — FAX [phone] TEL [phone] US OFFICE • 6869 Stapoint Court #114, Winter Park, Florida USA 32792 — EU OFFICE • 44 Airedale Avenue, Chiswick, London U.K W4 2NW