(47 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of a specimen retrieval bag, with no mention of AI or ML technologies.
No
The device is used to retrieve organs or tissue during laparoscopic procedures, not to treat a disease or condition.
No
This device is used for capturing and retrieving organs or tissue during laparoscopic procedures. Its function is to facilitate the removal of tissue from the body, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly indicates it is a physical product (flexible plastic bag, deployment mechanism, push rod, handle) used for capturing tissue, not a software application.
No, 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 during a procedure to physically contain and remove tissue.
- Device Description: The description details a physical bag and a deployment mechanism. It's a mechanical device for handling tissue.
- Lack of Diagnostic Function: An IVD is a device used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device doesn't perform any analysis or testing of the tissue; it simply holds it for removal.
The device is a surgical instrument, not a diagnostic one.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing showed that the device performed equivalent or better and is therefore substantially equivalent in performance to the predicate devices.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
2
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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)
-
- Substantially Equivalent Device Legally Marketed (unmodified) Devices: The Espiner Tissue Retrieval System (K111845)
-
- Device Description
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.
-
- 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.
- Intended Use
-
Technological Characteristics of the Subject Device Compared to the Predicate Device 6.
| Device | The Espiner Tissue Retrieval System
(K111845) | GENICON SimplyStrong and SimplyEZee
Retrieval System |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Endoscope and Accessories (GCJ) | SAME |
| Component
Design | Image: Espiner Tissue Retrieval System Component Design
A. Closure Suture
B. Bag
C. Introduction Tab(s) | Image: GENICON SimplyStrong and SimplyEZee Retrieval System Component Design
A. Closure Suture
B. Bag
C. Introduction Tab(s) |
| Design | The Espiner Tissue Retrieval System consists of a family
of impervious sacs which are sterile single use device that
can be used alone of with a dedicated introducer system
for the encaptured and removal of an organ, tissue or fluid
from the body cavity during laparoscopic surgery.
The sac includes introduction tab(s) and a drawstring
(closure suture). The introduction tab(s) are used as a
contact points for the instrument or push rod for | The GENICON Simple Specimen Retrieval Bags consist of
a family of retrieval bags which are sterile single-use
devices that can be used alone or with a dedicated
introducer system for the capture and removal of organs or
tissue 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 the
instrument or push rod for introduction through an |
4
| | introduction through an appropriately sized cannula. The
drawstring facilitates mouth opening as well as secure
closure of the sac.
Devices are X-ray opaque. | appropriately sized cannula. The drawstring facilitates
mouth opening as well as secure closure of the sac.
Bags incorporates radiopaque markers allowing for x-ray
detection in case the bag is left inside the patient after the
surgical procedure. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volume | 50 to 6000 mL | 50 to 3000 mL |
| Cannula
Diameter | 5 to 15 mm | SAME |
| Performance/
Testing | There are no FDA performance standards for these
products. Bench Testing to demonstrate safety and
effectiveness to predicate device. | Performance testing showed that the device
performed equivalent or better and is therefore
substantially equivalent in performance to the
predicate 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.
-
- 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.
- Conclusions