(19 days)
Not Found
No
The device description and performance studies focus on mechanical properties and functionality, with no mention of AI or ML.
No.
The device's intended use is to capture organs or tissue for removal, not to treat or cure a disease or condition. It is a retrieval tool used during surgery.
No
The device is described as a specimen retrieval system used in laparoscopic procedures to capture organs or tissue for removal. Its function is to facilitate the physical removal of tissue, not to diagnose a condition or analyze patient data.
No
The device description explicitly details physical components like a flexible plastic bag, deployment mechanism, push-pull rod, introducer assembly, biasing arms, and a closure suture. The performance studies also focus on physical properties and mechanical performance.
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 tissue.
- Device Description: The description details a physical bag and deployment mechanism for collecting tissue during surgery. There is no mention of analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue samples) in vitro to provide information about a patient's health, diagnose conditions, or monitor treatment. This device does not perform any such analysis.
The device is a surgical instrument for specimen retrieval during a procedure, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The GENICON 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 Specimen Retrieval Bag System is comprised of a flexible plastic bag and deployment mechanism. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms. 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This device is available by Prescription Only for use in a 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The GENICON Specimen Retrieval line has been evaluated by our Chief Technical Officer and Design Engineers, through performance studies and bench testing which included determining and verifying appropriate introduction forces, seam strengths, puncture forces, tests for fluid permeability and transparency, open and closure forces of deployment and retraction of biasing arms.
For the upgraded biasing arms benchmarking of the introduction and retraction of the GeniStrong device was performed during initial development. The increased strength in the arms used this criterion as a limit of how much the arm geometry can be changed. This in turn was modified to increase holding forces of the bag when loaded without having any detriment on the overall safety and effectiveness of the device.
For multiple deployment, tests were performed to simulate multiple specimen captures to see if there were any performance concerns. In order to inspect for leaks after simulating multiple specimen captures, the sample pouch was removed from 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 baq was visually inspected for bursts and tears during this process and found no water on the exterior of the bag. The tests show that after multiple deployments there are no concerns of safety or effectiveness of the device after multiple uses.
The addition of gamma as a sterilization method has been evaluated for compatibility with materials being exposed and tested to ISO 10993, along with performance testing of the device. The performance of the critical features of the bags was done on product run up to minimum of 2 times maximum exposure. The critical performance features of the device passed all minimum acceptance currently applied to the product. From the testing, the FMEA and risks were updated and show that there are no additional concerns of safety or effectiveness of the device. The updated biocompatibility was completed to approve second source suppliers and any updated materials for many of the materials used in production including barium thread, PU, PU coated Nylon, PP Monofilament, and Heat Shrink.
Validation of the gamma sterilization process was accomplished according to ISO 11137-1:2006 to provide a SAL of 10-9. Validation of the Ethylene Oxide process remains unchanged from the original submission.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The overall design is clean and professional, reflecting the organization's role in public health and safety.
April 18, 2018
GENICON. Inc Katlyn Kachman Regulatory Compliance 6869 Stapoint Court, Suite 114 Winter Park, Florida 32792
Re: K180836
Trade/Device Name: GENICON Specimen Retrieval Bag (GeniStrong) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 27, 2018 Received: March 30, 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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);
1
Page 2 - 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 -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
510(k) Number (if known) K180836
Device Name Specimen Retrieval Bag (GeniStrong)
Indications for Use (Describe)
The GENICON Specimen 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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3
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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 April 11, 2018
-
- Device Name GENICON Specimen Retrieval Bag (GeniStrong)
- Substantially Equivalent Device 3. GENICON Specimen Retrieval Bag [K132375]
-
- Description
The Genicon Specimen Retrieval Bag System is comprised of a flexible plastic bag and deployment mechanism. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms. 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.
-
- Indications for Use
The GENICON Specimen 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 Specimen Retrieval Baq System is comprised of a flexible plastic bag and deployment mechanism.
- Technical Specifications
The bag is made from polvurethane and/or rip-stop nylon and consists of a large, easily accessible opening and a polyolefin closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The bags come in sizes from 50 to 3000 mL.
The deployment mechanism consists of a push-pull rod and introducer assembly. The push-pull rod consists of a handle, shaft and biasing arms and is made from a combination of Stainless Steel, Nitinol, ABS, and PC. The introducer assembly consists of a tube and handle and is made from ABS and/or PC. The deployment mechanism allows easy insertion through the cannula and full deployment the bag with the use of the metallic biasing arms. Introducers range from 5 to 15 mm in diameter.
This device is packaged and sterilized for single use only. Do not re-use, reprocess, or resterilize. Discard after use.
There are no FDA performance standards for these products. The sterilization is performed by Ethylene Oxide per ISO 11135:2014 or Gamma Radiation per ISO11137:2006. 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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Image /page/4/Picture/2 description: The image shows the logo for Genicon. The logo is in blue and features the word "GENICON" in large, bold letters. A curved line in shades of green and yellow runs underneath the word. The logo is simple and modern.
| Device | Genicon 510k Number: K132375 | Genicon Re-Deployable Bag |
|---|---|---|
| Intended Use | Laparoscopic Surgery (GCJ) | Laparoscopic Surgery (GCJ) |
| Component Design | Bag, Biasing Arms, Introducer, Closure Suture, | |
| Handle, Actuation/Deployment Shaft | SAME | |
| Introducer Diameter | 5 to 15 mm | SAME |
| Materials | Introducer Assembly - PC, ABS, Silicone | |
| Bag – Polyolefin, PU Coated Nylon | ||
| Push-Pull Rod - Stainless Steel, Nitinol, ABS | Introducer Assembly - PC, ABS, Silicone | |
| Bag - Polyolefin, PU and/or Nylon | ||
| Push-Pull Rod - Stainless Steel, Nitinol, ABS, | ||
| PC | ||
| Performance | There are no FDA performance standards for | |
| these products. Bench Testing and Clinical | ||
| Evaluation performed, | SAME. | |
| Additional performance bench testing for | ||
| increased biasing arm strength, ability for | ||
| redeployment, and gamma sterilization | ||
| Sterilization | Ethylene Oxide per ISO 11135-1:2007 | Ethylene Oxide per ISO 11135-1:2007 or |
| Gamma to ISO 11137-1:2006 | ||
| Where Used | Hospital Operating Room | SAME |
| Prescription Only | YES | SAME |
| Biocompatibility | Compliant with FDA Class II requirements for | |
| ISO 10993 | SAME |
7. Nonclinical Tests
The GENICON Specimen Retrieval line has been evaluated by our Chief Technical Officer and Design Engineers, through performance studies and bench testing which included determining and verifying appropriate introduction forces, seam strengths, puncture forces, tests for fluid permeability and transparency, open and closure forces of deployment and retraction of biasing arms.
For the upgraded biasing arms benchmarking of the introduction and retraction of the GeniStrong device was performed during initial development. The increased strength in the arms used this criterion as a limit of how much the arm geometry can be changed. This in turn was modified to increase holding forces of the bag when loaded without having any detriment on the overall safety and effectiveness of the device.
For multiple deployment, tests were performed to simulate multiple specimen captures to see if there were any performance concerns. In order to inspect for leaks after simulating multiple specimen captures, the sample pouch was removed from 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 baq was visually inspected for bursts and tears during this process and found no water on the exterior of the bag. The tests show that after multiple deployments there are no concerns of safety or effectiveness of the device after multiple uses.
The addition of gamma as a sterilization method has been evaluated for compatibility with materials being exposed and tested to ISO 10993, along with performance testing of the device. The performance of the critical features of the bags was done on product run up to minimum of 2 times maximum exposure. The critical performance features of the device passed all minimum acceptance currently applied to the product. From the testing, the FMEA and risks were updated
5
Image /page/5/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 logo is simple and clean, and the colors are bright and eye-catching.
and show that there are no additional concerns of safety or effectiveness of the device. The updated biocompatibility was completed to approve second source suppliers and any updated materials for many of the materials used in production including barium thread, PU, PU coated Nylon, PP Monofilament, and Heat Shrink.
Validation of the gamma sterilization process was accomplished according to ISO 11137-1:2006 to provide a SAL of 10-9. Validation of the Ethylene Oxide process remains unchanged from the original submission.
8. Clinical Tests
There were no clinical trials performed on the GENICON Specimen Retrieval Bag (GeniStrong).
-
- Conclusions
Based on the indications for use and technological characteristics, the GENICON Specimen Retrieval (GeniStrong) has shown to be substantially equivalent to the predicate device.
- Conclusions