The Anchor™ Tissue Retrieval System™ by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue during laparoscopic hysterectomy.

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 transvaginal removal of an organ or tissue during laparoscopic hysterectomy. The Anchor™ Tissue Retrieval System™ by CONMED consists of a rip stop nylon with polyurethane laminate pouch and two stainless steel arms attached to internal pusher rod, which is connected to a handle at the end distal to the patient. Around the internal pusher rod is the introducer with handle. The introducer handle incorporates a spring-loaded button and a 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 with polyurethane laminate.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Anchor™ Tissue Retrieval System™ by CONMED. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new device's performance.

Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth methodologies) is not explicitly detailed in the provided text, as these are typically part of a full study report or design validation documentation, not a 510(k) summary.

However, I can extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Design verification activities demonstrate the device meets design specifications" and lists the types of tests conducted. It does not provide specific numerical acceptance criteria or the reported performance values for each criterion. It only states that the results were "acceptable."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Bag volume meets specifications	Acceptable (Specific volume: 6000mL)
Drawstring length meets specifications	Acceptable
Puncture resistance meets specifications	Acceptable
Multiple deployments meet specifications	Acceptable
Insertion/removal force meets specifications	Acceptable
Bag burst pressure meets specifications	Acceptable
User performance during simulated use (insertion, multiple deployments, device/specimen removal, clarity of IFU, overall reliability and quality)	Acceptable

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

The document states: "Design validation activities consisted of simulated use in a cadaver model."

Sample Size for Test Set: Not explicitly stated.
Data Provenance: Cadaver model (simulated use). Country of origin is not specified, but the submission is to the U.S. FDA, implying U.S. standards or studies. It is a prospective simulation study.

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

The document mentions "Users performance including insertion, multiple assessed device deployments, device/specimen removal, clarity of instructions for use and overall reliability and quality of the device."

Number of Experts: Not explicitly stated. The term "Users" suggests multiple individuals participated.
Qualifications of Experts: Not explicitly stated. However, given the context of a surgical device and "user performance," it is highly probable these "users" were surgeons or other medical professionals with relevant experience in laparoscopic hysterectomy.

4. Adjudication Method for the Test Set

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this type of study is not described. The device is a tissue retrieval system, not an AI diagnostic tool that would typically involve a multi-reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical device (a tissue retrieval system), not an algorithm or AI.

7. The Type of Ground Truth Used

For the simulated use in the cadaver model, the "ground truth" was likely subjective user assessment of performance, reliability, and clarity of instructions, potentially with objective measures of device functionality during the simulation (e.g., successful deployment, retrieval without tearing). It is based on expert assessment/observation in a simulated environment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set. The "design verification activities" and "design validation activities" constitute the testing phases for the device.

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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September 11, 2018

ConMed Corporation Lisa Anderson Manager, Regulatory Affairs 525 French Road Utica, NY 13502

Re: K173822

Trade/Device Name: Anchor™ Tissue Retrieval System™ by CONMED Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: August 9, 2018 Received: August 10, 2018

Dear Lisa Anderson:

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 mav, 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 avare 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 mediation-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,

Sharon M. Andrews -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173822

Device Name

AnchorTM Tissue Retrieval System™ by CONMED

Indications for Use (Describe)

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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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 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K173822 as of September 11, 2018.

A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502

Establishment Registration: 1320894

B. Company Contact

Lisa Anderson Manager, Regulatory Affairs T: (941) 713-2035 F: (315) 624-3225

C. Device Name

Proprietary Name: Anchor™ Tissue Retrieval System™ by CONMED Common Name: Specimen Retrieval Baq Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Product Code: GCJ (laparoscope, general & plastic surgery) Device Class: .

D. Predicate Device

Primary Device Name:	Anchor Tissue Retrieval System
Company Name:	CONMED Corporation
510(k):	K172940

This predicate has not been the subject to a design-related recall.

E. Device Description

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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 with polyurethane laminate.

If the surgeon deems it appropriate, the Anchor™ Tissue Retrieval System™ by CONMED can be redeployed in the same single patient procedure.

F. Indications for Use

The Anchor™ Tissue Retrieval System™ by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and transvaginal removal of an organ or tissue laparoscopic hysterectomy.

In comparison with the predicate device, the subject device is designed for the same intended use of encapture and removal of an organ and tissue from the body cavity. The devices differ in the mode of insertion and surgical procedure. The predicate is intended to be inserted into the body cavity via a laparoscopic access port and indicated for use during laparoscopic surgery. The subject device is intended to be inserted through the vaginal canal and indicated for use during laparoscopic hysterectomy.

G. Technological Characteristics

The Anchor™ Tissue Retrieval System™ by CONMED has similar 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 materials including the rip stop nylon with polyurethane laminate, 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 pouch with a dedicated introducer for the encapture and removal of the organ or tissue during laparoscopic surgery. The differences in the subject device from the predicate device is that the subject device has larger dimensions than the predicate device, the shape of the introducer is different, the stainless steel used is different and the subject device will be inserted into the patient directly through a natural body orifice.

Characteristic	Anchor™ Tissue Retrieval System™ byCONMED	Predicate DeviceK172940
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	Same
Introducer Shape	Oval	Round
Toggle material	420 Stainless Steel	302 Stainless Steel
Mechanism to deploy bag	Automatic with compression of pusher rod	Same

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Characteristic	Anchor™ Tissue Retrieval System™ by CONMED	Predicate Device K172940
Mechanism to redeploy bag	Automatic with compression of pusher rod	Same
Mechanism to separate bag from introducer	Push button	Same
Bag volume	6000mL	125-1800mL

The differences between the predicate device and the proposed device do not raise any different risks of safety or effectiveness.

H. Summary of Performance Testing

Design verification activities demonstrate the device meets design specifications. These activities include verification of bag volume, drawstring length, puncture resistance, multiple deployments, insertion/removal force, and bag burst pressure. Design validation activities consisted of simulated use in a cadaver model. Users performance including insertion, multiple assessed device deplovments. device/specimen removal, clarity of instructions for use and overall reliability and quality of the device. The results of design validation testing were acceptable.

Conclusion l.

Supporting information per this premarket submission confirms that the Anchor™ Tissue Retrieval System™ by CONMED is as safe and effective for its intended use as the predicate Anchor Tissue Retrieval System™.

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.