(14 days)
Not Found
No
The device description and performance studies focus on mechanical properties and functionality, with no mention of AI/ML terms or data processing.
No
The device is used to retrieve organs or tissue during laparoscopic procedures; it does not treat or prevent a disease or condition.
No
The device is described as an EZee Retrieval system used in laparoscopic procedures to capture and remove organs or tissue. Its function is to facilitate the physical removal of specimens, not to diagnose conditions.
No
The device description explicitly details physical components such as a flexible plastic bag, actuation rod, thumb ring handle, finger rings, string, closure suture, introducer shaft, and a metallic rim. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "capture organs or tissue to be removed from the body cavity" during laparoscopic procedures. This is a surgical tool used in vivo (within the body) to facilitate the removal of specimens.
- Device Description: The description details a physical device (bag, rod, handle, etc.) designed for physical manipulation and containment of tissue. It does not describe any components or processes related to analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other typical characteristics of an IVD device.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the physical retrieval of tissue during surgery.
N/A
Intended Use / 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.
Product codes
GCJ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital Operating Room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
2
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
-
- 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
-
- Device Name GENICON EZee Retrieval
- Substantially Equivalent Device 3. GENICON EZEE Retrieval [K162059]
-
- 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.
-
- 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.
-
- 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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| 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/PC | |
| Bag - TPU | Same | |
| Performance | There are no FDA performance standards for these products. Bench testing and clinical evaluation performed. | SAME |
| Additional 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.