(77 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a tissue retrieval pouch, with no mention of AI or ML technologies.
No.
The device is used for the retrieval of tissue, not for treating a disease or condition.
No
The device is described as a "Tissue Retrieval System" used for the "encapture and removal of an organ or tissue" during surgery. Its function is to physically retrieve tissue, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description clearly states it is a sterile, disposable pouch made of physical materials (ripstop nylon, polyurethane laminate, braided drawstring) used for the physical retrieval of tissue. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- Device Function: The description clearly states the device is used for the "encapture and removal of an organ or tissue from the body cavity during laparoscopic or minimally invasive surgery." This is a surgical tool used within the body (in vivo) to facilitate the removal of tissue.
- Lack of Diagnostic Testing: The device itself does not perform any diagnostic tests on the tissue. It is solely a retrieval mechanism.
Therefore, based on the provided information, the Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a sterile disposable pouch used for the encapture and removal of an organ or tissue from the body cavity during laparoscopic or minimally invasive surgery.
Product codes
GCJ
Device Description
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a sterile, disposable retrieval pouch for the encapture and removal of an orqan or tissue from the body cavity during laparoscopic surgery. The Anchor Bag-Alone® Tissue Retrieval System"" by CONMED consists of a ripstop nylon pouch with polyurethane laminate and a braided drawstring that loops through the ripstop nylon pouch.
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
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
Non-clinical bench and simulated use testing demonstrated the Anchor Bag-Alone® by CONMED is substantially equivalent to the Anchor Tissue Retrieval System™ by CONMED with regard to intended use, materials, technology, and performance. Design verification testing demonstrates the devices comply with the applicable sections of ISO 11607-1:2006, ISO 11135:2014, ISO 10993-7:2008. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Anchor Bag-Alone® Tissue Retrieval System™ by CONMED are mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the Anchor Bag-Alone® Tissue Retrieval System™ by CONMED outweigh the residual risks.
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.
0
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March 13, 3019
ConMed Corporation Jessica Swafford Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K183600
Trade/Device Name: Anchor Bag-Alone Tissue Retrieval System by CONMED Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: December 20, 2018 Received: December 26, 2018
Dear Jessica Swafford:
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/cfpmn/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.
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
1
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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
Long H. Chen Chen -S Digitally signed by Long H. Date: 2019.03.13 06:58:00 -5 -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
2
Indications for Use
510(k) Number (if known) K183600
Device Name
Anchor Bag-Alone® Tissue Retrieval System™ by CONMED
Indications for Use (Describe)
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a sterile disposable pouch used for the encapture and removal of an organ or tissue from the body cavity during laparoscopic or minimally invasive surgery.
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
510(k) Summary of Safety and Effectiveness
Anchor Bag-Alone® by CONMED
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Registration: 1320894
B. Company Contact
Jessica Swafford Specialist. Requlatory Affairs T: (303) 699-7600 ext. 5086 F: (303)-699-9854
C. Device Name
| Proprietary Name: | Anchor Bag-Alone® Tissue Retrieval System™ by
CONMED |
|--------------------|---------------------------------------------------------|
| Common Name: | Laparoscope, General & Plastic Surgery |
| Panel: | Gastroenterology/Urology |
| Product Code: | GCJ |
| Device Class: | II |
| Regulation Number: | 876.1500 |
D. Predicate Device
| Primary Device Name: | Anchor Tissue Retrieval System™ by CONMED |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k): | K172940 |
This predicate has not been the subject of a design-related recall.
E. Device Description
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a sterile, disposable retrieval pouch for the encapture and removal of an orqan or tissue from the body cavity during laparoscopic surgery. The Anchor Bag-Alone® Tissue Retrieval System"" by CONMED consists of a ripstop nylon pouch with polyurethane laminate and a braided drawstring that loops through the ripstop nylon pouch.
4
Differences between the predicate device and the subject device designs are limited to the following:
- -The subject device design does not incorporate the introducer with handle, pusher rod, and stainless-steel arms present in the predicate;
- -The subject device is designed with nominal bag volumes of 175, 250, and 1200mL compared to the predicate device nominal bag volumes of 125, 175, 250, 1200, and 1800mL;
- -The subject device is intended to be used with 10mm or larger trocar/port compared to the predicate device compatible trocar/port range which includes 8mm or larger.
- -The subject device is inserted into a cannula using laparoscopic instruments compared to the predicate devices which are inserted via a dedicated introducer.
F. Intended Use / Indications for Use
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is a sterile disposable pouch used for the encapture and removal of an organ or tissue from the body cavity during laparoscopic or minimally invasive surgery.
G. Technological Characteristics
The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is similar to the predicate device in that the pouch and drawstring materials and designs are the same as the predicate. As with the predicate, the Anchor Tissue Retrieval System™ by CONMED continues to function as a single patient/procedure use pouch for the encapture and removal of the organ or tissue from the body cavity during laparoscopic surgery. The difference in the subject device from the predicate device is the removal of the introducer components. The Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is safe and effective and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.
| Characteristic | Anchor Bag-Alone™ Tissue
Retrieval System™ by CONMED | Predicate Device K172940 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Anchor Bag-Alone® Tissue
Retrieval System™ by CONMED is
a sterile disposable pouch used for
the encapture and removal of an
organ or tissue from the body cavity
during laparoscopic or minimally
invasive surgery. | The Anchor Tissue Retrieval
System™ by CONMED is a
sterile disposable pouch used
with a dedicated introducer for
the encapture and removal of
an organ or tissue from the
body cavity during laparoscopic
surgery. |
| Where Used | Operating room | Identical |
| Prescription Only | Yes | Identical |
5
| Characteristic | Anchor Bag-Alone™ Tissue
Retrieval System™ by CONMED | Predicate Device K172940 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Design | Specimen bag and drawstring | Specimen bag and drawstring
with a delivery system
consisting of an introducer shaft
and deployment handle and
latch |
| Materials | Ripstop Nylon with Polyurethane
Laminate, polyester yarn | Stainless-steel, polycarbonate
Identical nylon, and polyester
yarn |
| Performance | There are no FDA performance
standards for this device. Device
performance was adequately tested
through bench testing
methodologies. | Identical |
| Sterilization | Ethylene Oxide per ISO
11135:2014 | Identical |
| Biocompatibility | According to ISO 10993-1:2009 | Identical |
H. Performance Testing
Non-clinical bench and simulated use testing demonstrated the Anchor Bag-Alone® by CONMED is substantially equivalent to the Anchor Tissue Retrieval System™ by CONMED with regard to intended use, materials, technology, and performance. Design verification testing demonstrates the devices comply with the applicable sections of ISO 11607-1:2006, ISO 11135:2014, ISO 10993-7:2008. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Anchor Bag-Alone® Tissue Retrieval System™ by CONMED are mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the Anchor Bag-Alone® Tissue Retrieval System™ by CONMED outweigh the residual risks.
Substantial Equivalence .
The differences between the predicate device and the proposed device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the Anchor Bag-Alone® Tissue Retrieval System™ by CONMED is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the predicate Anchor Tissue Retrieval System™ by CONMED.