(317 days)
Not Found
No
The device description and performance studies focus on mechanical properties and clinical evaluation of a physical retrieval bag, with no mention of AI/ML terms or functionalities.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is used to retrieve tissue and organs during laparoscopic procedures, but it does not have any therapeutic function.
No
The device is described as a bag used during laparoscopic procedures to retrieve organs or tissue from the bodycavity. Its function is to capture and remove specimens, not to diagnose conditions or diseases.
No
The device description clearly outlines physical components such as a flexible plastic bag, push-pull rod, thumb ring handle, finger rings, string, introducer shaft, and metallic rim, indicating it is a hardware device.
Based on the provided information, the GENICON Single-Use Specimen Retrieval Bag 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 device used within the body to facilitate the removal of tissue.
- Device Description: The description details a physical bag and associated components for retrieving tissue. It does not mention any components or processes related to analyzing biological samples outside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical retrieval.
Therefore, the GENICON Single-Use Specimen Retrieval Bag is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The GENICON Single-Use Specimen Retrieval Bag 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 Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized 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
Prescription Use (Part 21 CFR 801 Subpart D), 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
Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The GENICON Specimen Retrieval Bag has been evaluated with seal strength peel, puncture resistance, and general operation testing. Successful results support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image shows the word "GENICON" in a bold, sans-serif font. The word is black and appears to be the logo for a company or product. Underneath the word, there are two curved lines that add a design element to the logo.
N 1_2 2014 K132375
Page 1 of 1
Section 2 510(k) Summary per 21 CFR 807.92
- Contact Information GENICON LLC 6869 Stapoint Court Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Tissue, Quality Supervisor July 24, 2013
2. Device Name
Trade Name: GENICON Specimen Retrieval Bag Common Name: Single Use Specimen Retrieval Bag including sterile packaged Single-Use Specimen Retrieval Bag and Introducer Classification: 21 CFR 876.1500 GCJ
3. Substantially Equivalent Device
Anchor Tissue Retrieval Bag 100, 10mm introducer, K061555, K091930
4. Description
The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
5. Indications for Use
The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to caplure and remove organs or tissue from the body cavity.
6. Technical Specifications
The GENICON Single-Use Specimen Retrieval Bag is intended for Laparoscopic Surgery (GCJ) and contains a Bag, Biasing Arms, Introducer, Closure Suture/String, Handle and Actuation/Deployment Shaft. The shaft diameter ranges from 5-15 mm and is composed of PC while the Bag is PU Coated Nylon (PA) and the Introducer is Stainless Steel. There are no FDA performance standards for these products; however Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A). The sterlization is performed by Ethylene Oxide per ISO 11135-1:2007. 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.
7. Nonclinical Tests
The GENICON Specimen Retrieval Bag has been evaluated with seal strength peel, puncture resistance, and general operation testing. Successful results support a determination of substantial equivalence
8. Conclusions
Based on the indications for use and technological characteristics, the GENCON Specimen Retrieval Bag has shown to be safe and effective for its intended use and substantially equivalent to the predicate devices.
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 ZNN
FASHING (FRANT) CARDE S (FRIE) (GHErp) (Graca)
1
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
GENICON LLC Ms. Katlyn Tissue Quality Supervisor 6869 Stapoint Court, Suite 114 Winter Park, Florida 32792
June 12, 2014
Re: K132375
Trade/Device Name: GENICON Specimen Retrieval Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 27, 2014 Received: March 28, 2014
Dear Ms. Tissue:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 – Ms. Katlyn Tissue
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 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" (21CFR 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
1 - 19
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Neil R Oaden -S 2014.06.12 16:09:43 -04'00'
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
3
Indications for Use
510(k) Number (if known) K132375
Device Name GENICON Specimen Retrieval Bag
Indications for Use (Describe)
The GENICON Single-Use Specimen Retrieval Bag 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FREE OF FOR FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-FOR-
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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