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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Intended Use	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.	Meets criteria; same as predicate.
Where Used	Operating room	Meets criteria; same as predicate.
Prescription Only	Yes	Meets criteria; same as predicate.
Design	Specimen bag and a delivery system consisting of an introducer shaft deployment handle.	Meets criteria; same as predicate.
Materials	Nylon, stainless steel, polycarbonate	Meets criteria; same as predicate.
Mechanism to deploy bag	Automatic with compression of pusher rod	Meets criteria; same as predicate.
Mechanism to separate bag from introducer	Push button	Meets criteria; same as predicate.
Performance	Adequately tested through bench testing methodologies; no FDA performance standards.	Meets criteria; adequately tested, substantially equivalent to predicate.
Sterilization	Ethylene Oxide per ISO 11135:2014	Meets criteria; same as predicate.
Biocompatibility	According to ISO 10993-1:2009	Meets criteria; patient contacting materials compliant.
Redeployment Capability (New Feature)	Can be deployed more than once within a single patient procedure.	Meets criteria; redeployment verification testing performed.
Safety and Effectiveness (Overall)	No new issues of safety or effectiveness identified, and redeployment has no impact on current device safety and effectiveness. Benefits outweigh residual risks.	Meets criteria; concluded through risk management activities in accordance with ISO 14971.
Compliance with Standards	Design specifications and applicable sections of ISO 11607-1:2006, ISO 11135:2014, ISO 10993-7:2008.	Meets criteria; compliance demonstrated through design verification testing.
User Needs and Intended Use	Conforms to user needs and the intended use.	Meets criteria; demonstrated through design validation testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" with a particular sample size from a patient population, nor does it mention data provenance in terms of country of origin or retrospective/prospective nature. The studies conducted were primarily targeted performance and design verification/validation testing.

Sample Size for performance testing: The document mentions "bench and simulated use testing" and "redeployment verification testing." It doesn't specify the exact number of devices or trials for these tests.
Data Provenance: The studies are "non-clinical bench and simulated use testing," implying laboratory-based testing rather than patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described is primarily engineering and performance-based validation rather than clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve a process of adjudication by experts for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted. This device is a surgical tissue retrieval system, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Design Specifications: The device is tested against its established design specifications.
Performance Standards (Industry/Regulatory): Compliance with relevant ISO standards (e.g., ISO 11607-1:2006 for packaging, ISO 11135:2014 for sterilization, ISO 10993-1:2009 & ISO 10993-7:2008 for biocompatibility).
User Needs: Demonstrated conformance to user needs and intended use from design validation.
Substantial Equivalence to Predicate: Performance is compared to a legally marketed predicate device (K091930) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this traditional medical device. This term is typically used for machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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)

K172940

Device Name

Anchor Tissue Retrieval System by CONMED

Indications for Use (Describe)

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

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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

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™ byCONMED	Predicate DeviceK091930
Intended Use	The Anchor Tissue retrieval system byCONMED is a sterile disposable pouch usedwith a dedicated introducer for the encaptureand removal of an organ or tissue from thebody cavity during laparoscopic surgery.	Same
	Where Used	Operating room	Same
	Prescription Only	Yes	Same
	Design	Specimen bag and a delivery systemconsisting of an introducer shaft deploymenthandle	Same
		Materials	Nylon, stainless steel, polycarbonate
Mechanism to deploy bag		Automatic with compression of pusher rod	Same
Mechanism to separate bagfrom introducer	Push button	Same

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Characteristic	Anchor Tissue Retrieval System™ byCONMED	Predicate DeviceK091930
Performance	There are no FDA performance standards forthis device. Device performance wasadequately tested through bench testingmethodologies.	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.

Regulation Number and Section

§ 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.