(65 days)
The GENICON EZEE Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
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.
This document describes the regulatory submission for the "GENICON EZEE Retrieval" device, a specimen retrieval bag for laparoscopic procedures. The provided text outlines the device's technical specifications and a summary of testing conducted to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, many of the requested categories related to AI/ML device evaluation (like sample size, ground truth, experts, MRMC studies, standalone performance, and training set details) are not applicable to this document.
Here's the information that can be extracted or inferred from the provided text regarding the GENICON EZEE Retrieval device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity). Instead, it refers to "performance studies and bench testing" for specific physical attributes. The "reported device performance" is broadly stated as showing substantial equivalence to predicate devices based on these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Deployment Force | Evaluated through bench testing |
| Seam Strength | Evaluated through bench testing |
| Puncture Force | Evaluated through bench testing |
| Biocompatibility | Compliant with FDA Class II requirements for ISO 10993 |
| Sterilization | Ethylene Oxide per ISO 11135-1:2014 |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for the "performance studies and bench testing." Data provenance information (country of origin, retrospective/prospective) is not provided as these are not a clinical study involving patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of an AI/ML device. For the physical performance tests, the evaluation was conducted by the device manufacturer's internal team: "our Chief Technical Officer, Design Engineers, and Chief Medical Officer." Their specific qualifications beyond their titles are not detailed.
4. Adjudication method for the test set
Not applicable as this is not a study requiring adjudication of expert interpretations.
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
No MRMC study was done, as this is a medical device (a specimen retrieval bag) and not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used
For the specific performance characteristics (Deployment Force, Seam Strength, Puncture Force), the "ground truth" would be the measured physical properties of the device under test conditions. Biocompatibility and sterilization compliance are based on adherence to ISO standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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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 (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" (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 (800) 638-2041 or (301) 796-7100 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 407.657.4851 - WWW.GENICONENDO.COM - FAX 407.677.9773 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
-
- Contact Information GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Kachman, Regulatory Compliance September 20, 2016
-
- Device Name GENICON EZEE Retrieval
-
- 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.
- Indications for Use
-
- 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.
- Technical Specifications
| Area | Genicon 510K Number:K132375 | Covidien 510K Number:K922123 | EZEE Retrieval 510K Number:K162059 |
|---|---|---|---|
| Intended Use | Laparoscopic Surgery (GCJ) | Laparoscopic Surgery (GCJ) | Laparoscopic Surgery (GCJ) |
| Design | Bag, Biasing Arms, Introducer,Closure Suture/String, Handle,Actuation/Deployment Shaft | SAME | SAME |
| Introducer | 5 to 15 mm | 10 to 15 mm | 10 mm |
WWW.GENICONENDO.COM FAX 407 677 9773
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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 – PCBag – PU Coated Nylon(PA) | Shaft – Plastic and StainlessSteelBag – TPU | Shaft – ABSBag – TPU |
| Performance | There are no FDA performancestandards for these products.Bench Testing and ClinicalEvaluation performed. (ref.TR–12022-A and CLEV–032–A) | SAME | SAME |
| Sterilization | Ethylene Oxide per ISO11135–1:2014 | Ethylene Oxide | Ethylene Oxide per ISO 11135–1:2014 |
| Where Used | Hospital Operating Room | SAME | SAME |
| Prescription Only | Yes | Yes | Yes |
| Biocompatibility | Compliant with FDA Class IIrequirements for ISO 10993 | SAME | SAME |
-
- 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.
- Nonclinical Tests
-
- Clinical Tests
There were no clinical trials performed on the GENICON EZEE Retrieval.
- Clinical Tests
-
- Conclusions
(GENIFirst)
- Conclusions
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 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 2NW
§ 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.