(22 days)
Not Found
No
The device description and performance studies focus on mechanical components and material properties, with no mention of AI or ML.
No.
The document describes the device as a tool for "encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery," which is a surgical tool/accessory, not a therapeutic device.
No
Explanation: The device is described as a "sterile disposable pouch used for the encapture and removal of an organ or tissue during laparoscopic surgery," which indicates it is a surgical tool for tissue retrieval, not for diagnosis.
No
The device description explicitly details physical components such as a pouch, stainless steel arms, a handle, an introducer, and a drawstring, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery." This is a surgical procedure performed on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical device (pouch, arms, introducer, handle, drawstring) used for physically manipulating and removing tissue during surgery. It does not describe reagents, analyzers, or other components typically associated with in vitro diagnostic testing.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze tissue for diagnostic purposes, measure biomarkers, or provide any information about a patient's health status based on testing of samples.
In vitro diagnostics are tests performed on samples (like blood, urine, tissue biopsies) outside of the body to diagnose diseases or conditions. This device is a surgical tool used within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Anchor Tissue Retrieval System™ by CONMED is a sterile, disposable retrieval pouch for use with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. The Anchor Tissue Retrieval System™ by CONMED consists of a rip stop nylon pouch, two stainless steel arms attached to internal pusher rod connected to a handle at the distal end to the patient. Around the internal pusher rod is the introducer and handle. The introducer handle incorporates a spring loaded button and stop mechanism is built into the pusher rod. There is a braided drawstring which enters the introducer with the pusher rod and loops through the rip stop nylon pouch.
Differences between the predicate device and the Anchor Tissue Retrieval System™ by CONMED are limited to the additional feature that the Anchor Tissue Retrieval System™™ by CONMED is able to be redeployed within a single patient procedure.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench and simulated use testing demonstrate the Anchor Tissue Retrieval System™ by CONMED is substantially equivalent to the predicate device with regard to indication for use, materials, technology, and performance. Design verification testing demonstrates devices comply with design specifications and applicable sections of ISO 11607-1:2006. ISO 11135:2014. ISO 10993-7:2008. Results from design validation testing performed demonstrate that the Anchor Tissue Retrieval System™ by CONMED conforms to user needs and the intended use. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Anchor Tissue Retrieval System™ by CONMED, including redeployment, are mitigated to an acceptable level. No new issues of safety of effectiveness were identified and redeployment has no impact on current device safety and effectiveness. Analyses of these activities conclude the benefits associated with the use of the Anchor Tissue Retrieval System™ by CONMED outweigh the residual risks. Material analysis and testing demonstrate the patient contacting materials are biocompatible and comply with the requirements of ISO 10993-1:2009. Redeployment verification testing determined that the Anchor Tissue Retrieval System™ by CONMED can be deployed more than once within a single patient procedure. Performance testing demonstrates that the performance of the Anchor Tissue Retrieval System™ by CONMED is substantially equivalent to the predicate device.
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 & 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.
October 18, 2017
ConMed Corporation Ms. Rachelle Fitzgerald Senior Specialist, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K172940
Trade/Device Name: ANCHOR Tissue Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 25, 2017 Received: September 26, 2017
Dear Ms. Fitzgerald:
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, 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 (DICE) 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 (DICE) 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, 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Anchor Tissue Retrieval System by CONMED
Indications for Use (Describe)
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.
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)
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510(k) Summary of Safety and Effectiveness
Anchor Tissue Retrieval System™ by CONMED
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 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
Rachelle Fitzgerald Senior Specialist, Regulatory Affairs T: (203) 799-2400 ext 8195 F: (203) 799-2401
C. Device Name
| Proprietary Name: | Anchor 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 |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k): | K091930 |
This predicate has not been subject to a design-related recall.
E. Device Description
The Anchor Tissue Retrieval System™ by CONMED is a sterile, disposable retrieval pouch for use with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. The Anchor Tissue Retrieval System™ by CONMED consists of a rip stop nylon pouch, two stainless steel arms attached to internal pusher rod connected to a handle at the distal end to the patient. Around the internal pusher rod is the introducer and handle. The introducer handle
4
incorporates a spring loaded button and stop mechanism is built into the pusher rod. There is a braided drawstring which enters the introducer with the pusher rod and loops through the rip stop nylon pouch.
Differences between the predicate device and the Anchor Tissue Retrieval System™ by CONMED are limited to the additional feature that the Anchor Tissue Retrieval System™™ by CONMED is able to be redeployed within a single patient procedure.
F. Intended Use / Indications for Use
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.
G. Technological Characteristics
The Anchor Tissue Retrieval System™ by CONMED has the same technological characteristics as the predicate device in that the Anchor Tissue Retrieval System™ by CONMED has the same design, same deployment mechanism, and utilizes the same rip stop nylon pouch, introducer components, and external introducer as the predicate. As with the predicate, the Anchor Tissue Retrieval System™ by CONMED continues to function as a single patient/procedure use pouch with a dedicated introducer 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 that the subject device has a new feature where, if the surgeon deems it appropriate, the Anchor Tissue Retrieval System™ by CONMED can be redeployed in the same single patient procedure. The Anchor Tissue Retrieval System™ by CONMED is safe and effective and substantially equivalent to the predicate as demonstrated by non-clinical performance testing for the same indications for use, target population, principles of operation, performance specifications, and standards for sterilization, packaging, and biocompatibility.
| Characteristic | Anchor Tissue Retrieval System™ by
CONMED | Predicate Device
K091930 | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | 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. | Same | |
| | Where Used | Operating room | Same |
| | Prescription Only | Yes | Same |
| | Design | Specimen bag and a delivery system
consisting of an introducer shaft deployment
handle | Same |
| | | Materials | Nylon, stainless steel, polycarbonate |
| Mechanism to deploy bag | | Automatic with compression of pusher rod | Same |
| Mechanism to separate bag
from introducer | Push button | Same | |
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| Characteristic | Anchor Tissue Retrieval System™ by
CONMED | Predicate Device
K091930 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Performance | There are no FDA performance standards for
this device. Device performance was
adequately tested through bench testing
methodologies. | Same |
| Sterilization | Ethylene Oxide per ISO 11135:2014 | Same |
| Biocompatibility | According to ISO 10993-1:2009 | Same |
H. Performance Testing
Non-clinical bench and simulated use testing demonstrate the Anchor Tissue Retrieval System™ by CONMED is substantially equivalent to the predicate device with regard to indication for use, materials, technology, and performance. Design verification testing demonstrates devices comply with design specifications and applicable sections of ISO 11607-1:2006. ISO 11135:2014. ISO 10993-7:2008. Results from design validation testing performed demonstrate that the Anchor Tissue Retrieval System™ by CONMED conforms to user needs and the intended use. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Anchor Tissue Retrieval System™ by CONMED, including redeployment, are mitigated to an acceptable level. No new issues of safety of effectiveness were identified and redeployment has no impact on current device safety and effectiveness. Analyses of these activities conclude the benefits associated with the use of the Anchor Tissue Retrieval System™ by CONMED outweigh the residual risks. Material analysis and testing demonstrate the patient contacting materials are biocompatible and comply with the requirements of ISO 10993-1:2009. Redeployment verification testing determined that the Anchor Tissue Retrieval System™ by CONMED can be deployed more than once within a single patient procedure. Performance testing demonstrates that the performance of the Anchor Tissue Retrieval System™ by CONMED is substantially equivalent to the predicate device.
Substantial Equivalence -
There are no differences between the predicate device and the proposed device regarding design, intended use, principals of operation and technical characteristics. Supporting information per this premarket submission confirms that the Anchor Tissue Retrieval System™ by CONMED does not raise any new risks of safety or effectiveness.