Disposable biopsy forceps are used to obtain mucosal tissue samples for pathology using monopolar energy, including the avulsion technique, during endoscopic procedures in the gastrointestinal tract, for example the esophagus, stomach, small intestine and colon. Tissue samples will be submitted for pathologic review.

This product is intended only for adult populations.

Device Description

The Avulsion Forceps is used during endoscopic procedures in the gastrointestinal tract. The avulsion technique in Endoscopy involves using both mechanical forces as well as high energy cutting current to tear the tissue away from the gastrointestinal tract.

The Avulsion Forceps consists of a handle on the proximal end that actuates two toothed jaws on the distal end. An Olympus-style active cord connector is included that allows the Avulsion Forceps to be connected to an electrosurgical generator for use with monopolar energy. The device also includes a spring sheath catheter housing the drive cable which transfers the linear motion of the handle slider to open and close the jaws.

AI/ML Overview

The provided text describes the acceptance criteria and the summary of verification activities for the STERIS Avulsion Forceps, a medical device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Reported Device Performance
Structural Integrity Testing	All Avulsion Forceps structural components must, minimally, meet or exceed the structural integrity limits by the predicate hot biopsy forceps.	PASS
Dimensional	All Avulsion Forceps dimensional components must meet the dimensional specification for each forceps.	PASS
Functional Testing	The Avulsion Forceps must function as intended in tortuous conditions.	PASS
Simulation Testing	The Avulsion Forceps retrieve tissue samples.	PASS
Electrical Testing	All Avulsion Forceps electrical requirements must meet current industry standards according to IEC 60601-2-2 (3rd Edition).	PASS
Biocompatibility Testing	The patient contacting components of the device must be biologically safe to use in accordance with ISO-10993-1.	PASS
Shelf-life	The Avulsion Forceps must maintain device performance through a shelf life of 1 year.	PASS

2. Sample size used for the test set and the data provenance:

The document does not specify the individual sample sizes for each test in the test set. It only states that verification activities were performed. The data provenance is not explicitly mentioned as retrospective or prospective, nor are the countries of origin for the data. This information would typically be detailed in the full study reports, not in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts to establish ground truth for the test set. These are engineering and performance tests, not clinical evaluations that would typically involve expert review of cases.

4. Adjudication method for the test set:

Not applicable, as expert adjudication is not mentioned for these types of engineering and performance tests.

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:

No. This document describes a medical device (Avulsion Forceps) for biopsy, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.

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

Not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used:

For the tests described:

Structural Integrity: Ground truth is based on the structural integrity limits of the predicate device.
Dimensional: Ground truth is based on dimensional specifications.
Functional: Ground truth is based on the intended function in tortuous conditions.
Simulation Testing: Ground truth is the successful retrieval of tissue samples.
Electrical: Ground truth is compliance with IEC 60601-2-2 (3rd Edition) industry standards.
Biocompatibility: Ground truth is compliance with ISO-10993-1 for biological safety.
Shelf-life: Ground truth is maintaining device performance for 1 year.

These are primarily engineering and performance standards, not clinical diagnostic ground truth like pathology or outcome data.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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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April 16, 2019

STERIS Corporation Eileen McCafferty Senior Regulatory Specialist 5960 Heisley Rd Mentor, OH 44060

Re:

K183428 Trade/Device Name: Avulsion Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KGE Dated: December 10, 2018 Received: December 11, 2018

Dear Eileen McCafferty:

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

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(21 CFR Part 801); medical device reporting (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,

(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) K183428

Device Name Avulsion Forceps

Indications for Use (Describe)

This product is intended only for adult populations.

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 For Avulsion Forceps

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Eileen McCafferty Contact: Senior Regulatory Affairs Specialist Tel: 440-392-7189 Fax: 440-357-9198 Email: eileen_mccafferty@steris.com

April 3, 2019 Summary Date:

Premarket Notification Number: K183428

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	Avulsion Forceps
Device Classification:	Class II
Common/usual Name:	Electric Biopsy Forceps, Hot Biopsy Forceps
Classification Name:	Endoscopic Electrosurgical unit and accessories
Classification Number:	21 CFR 876.4300
Product Code:	KGE

2. Predicate Device

US Endoscopy Disposable Hot Biopsy Forceps K925361

3. Description of Device

4. Intended Use/Indications for Use

This product is intended only for adult populations.

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ട്. Description of Technological Similarities and Differences

The US Endoscopy (USE) Avulsion Forceps are very similar to the USE Disposable Hot Biopsy Forceps in intended use and mode of operation. The major differences between the USE Avulsion Forceps and the USE Hot Biopsy Forceps include the indication for use in avulsion technique that the predicate did not have. However, this does not affect the intended use of the device as the intended use of each device is to resect tissue for removal and/or further diagnosis. The proposed and predicate devices have the same technological characteristics in that both devices use electrical energy and manual traction (pull force) to resect tissue. Avulsion is a resection technique that uses a different setting on the electrical surgical generator (Cut as opposed to Coagulation) and a different application of that energy (continuous flow as opposed to modulated flow). This change in technique does not affect the fact that the Avulsion forceps and its predicate both use manual traction and electrical energy to resect tissue for the purpose of removal and/or further diagnosis.

Also, the Avulsion Forceps use a single drive cable to control the jaws, whereas the predicate hot biopsy forceps use a dual drive cable system, and the Avulsion Forceps has a toothed cup while the predicate had a plain cup type. The difference in cup design has no effect on the intended use of the devices as both cup types can be used to grasp tissue and deliver current. These proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.

6. Description of Safety and Substantial Equivalence

Table 5-1 summarizes the difference between the proposed device and the predicate.

Feature	ProposedAvulsion Forceps	Predicate K925361/AUSE Disposable HotBiopsy Forceps	Comparison
Intended use /Indications for Use	Disposable biopsy forcepsare used to obtain mucosaltissue samples forpathology usingmonopolar energy,including the avulsiontechnique, duringendoscopic procedures inthe gastrointestinal tract,for example theesophagus, stomach, smallintestine and colon. Tissuesamples will be submittedfor pathologic review. The	The US EndoscopyDisposable hot biopsyforceps are used to obtainmucosal tissue samplesusing monopolar energyduring endoscopicprocedures.	Proposed deviceincludesindications for usein avulsiontechniques.Avulsion is aresectiontechnique that usesa different settingon the electricalsurgical generator(Cut as opposed toCoagulation) and adifferent
Feature	ProposedAvulsion Forceps	Predicate K925361/AUSE Disposable HotBiopsy Forceps	Comparison
	product is intended onlyfor adult populations.		application of thatenergy(continuous flowas opposed tomodulated flow).This change intechnique does notaffect the fact thatthe AvulsionForceps and itspredicate both usemanual tractionand electricalenergy to resecttissue for thepurpose ofremoval and/orfurther diagnosis.
Mode of Operation	Hand Control	Hand Control	Identical
Jaws Shape	SerratedImage: Serrated Jaws	OvalImage: Oval Jaws	The proposedavulsion forcepsjaw design utilizestoothed cups,while the predicatehot biopsy forcepsutilizes plain cups.This differencehas no effect onthe intended use orsafety of thedevices as bothjaws are used tograsp tissue anddeliver current.
Outer TubeDiameter	$Φ$ 2.6 mm	$Φ$ 2.6 mm	Identical
Minimum WorkingChannel	$Φ$ 2.8 mm	$Φ$ 2.8 mm	Identical
Working Length	230 cm	230 cm	Identical
Energy	Yes	Yes	Identical
Monopolar/Bipolar	Monopolar	Monopolar	Identical
Biocompatibility	Yes	Yes	Identical
Feature	ProposedAvulsion Forceps	Predicate K925361/AUSE Disposable HotBiopsy Forceps	Comparison
Packaging	Sterile Tyvek pouch	Sterile Tyvek pouch	Identical
Disposable	Yes	Yes	Identical
Supplied Sterile	Yes	Yes	Identical
Accessories	None	None	Identical
Shelf-life	1 year	1 year	Identical

Table 5-1. Predicate Device Comparison Table

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STERIS Traditional 510(k) PREMARKET NOTIFICATION AVULSION FORCEPS

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STERIS Traditional 510(k) PREMARKET NOTIFICATION AVULSION FORCEPS

Table 5-2 summarizes the verification activities that were performed with respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the Avulsion Forceps device.

Table 5-2. Summary of Verification Activities.
Testing	Acceptance Criteria	Proposed AvulsionForceps
StructuralIntegrity Testing	All Avulsion Forceps structural componentsmust, minimally, meet or exceed the structuralintegrity limits by the predicate hot biopsyforceps	PASS
Dimensional	All Avulsion Forceps dimensional componentsmust meet the dimensional specification foreach forceps	PASS
FunctionalTesting	The Avulsion Forceps must function asintended in tortuous conditions	PASS
SimulationTesting	The Avulsion Forceps retrieve tissue samples	PASS
ElectricalTesting	All Avulsion Forceps electrical requirementsmust meet current industry standards accordingto IEC 60601-2-2 (3rd Edition)	PASS
BiocompatibilityTesting	The patient contacting components of thedevice must be biologically safe to use inaccordance with ISO-10993-1	PASS

7. Conclusion

Shelf Life for 12

months

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K925361), Class II (21 CFR 876.4300), product code KGE.

The Avulsion Forceps must maintain device

performance through a shelf life of 1 year

PASS

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).