The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.

Device Description

The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory. The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.

AI/ML Overview

The provided text describes the acceptance criteria and performance testing for a medical device called the "Reusable Monopolar Active Cord." However, it does not describe a study that uses a test set, ground truth established by experts, or any of the elements typically found in studies for AI/Machine Learning devices (like MRMC studies, standalone performance, training set details, etc.).

This document is a 510(k) Premarket Notification for a traditional medical device, specifically an accessory (an active cord) for electrosurgical units. The "studies" described are standard engineering verification and validation tests to ensure the device meets its design specifications and functions as intended, not clinical trials or AI performance evaluations.

Therefore, for most of the requested points, the information is not present in the provided text.

Here's an attempt to answer based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Reported Device Performance
Structural Integrity Testing	All Reusable Monopolar Active Cord structural components must, minimally, meet or exceed the structural integrity limits by the predicate active cord	PASS
Dimensional	All Reusable Monopolar Active Cord dimensional components must meet the dimensional specification for each active cord	PASS
Functional Testing	The Reusable Monopolar Active Cord must function as intended.	PASS
Simulation Testing	The Reusable Monopolar Active Cord must provide monopolar energy to hot devices.	PASS
Electrical Testing	All Reusable Monopolar Active Cord electrical requirements must meet current industry standards according to IEC 60601-2-2:2017 and IEC 60601-1:2005	PASS

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

Sample Size: Not specified. The document refers to "verification activity" and "performance testing" but does not detail sample sizes for each test type. These are physical product tests, not data-based studies.
Data Provenance: Not applicable in the context of data for an AI/ML model. The tests are performed on physical units of the device.

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

Not applicable. This is a traditional device; "ground truth" in the context of AI/ML is not relevant here. The "truth" is whether the device meets engineering specifications and functions correctly.

4. Adjudication method for the test set:

Not applicable. There is no expert adjudication process described, as it's not an AI/ML model being assessed.

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. An MRMC study is not mentioned as this is not an AI/ML device.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not applicable in the AI/ML sense. The "ground truth" for the device's performance is its adherence to predefined engineering specifications, industry standards (IEC 60601-x), and functional intent.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device and does not have a "training set."

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device and does not have a "training set."

Summary

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October 25, 2019

United States Endoscopy Group Inc. Mr. Gregory Land Sr. Regulatory Affairs Specialist 5976 Heisley Road Mentor, Ohio 44060

Re: K192518

Trade/Device Name: Reusable Monopolar Active Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2019 Received: September 13, 2019

Dear Mr. Land:

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.

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542 of the Act); 21 CFR 1000-1050.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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-

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192518

Device Name Reusable Monopolar Active Cord

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in a light blue color, resembling water waves.

510(k) Summary For Reusable Monopolar Active Cord K192518

United States Endoscopy Group Inc A Division of STERIS Corporation 5976 Heisley Road Mentor, OH 44060

Contact: Mr Gregory Land Senior Regulatory Affairs Specialist Tel: 440-392-7424 Fax: 440-357-9198 Email: greg_land@steris.com

Summary Date: September 12, 2019

US Endoscopy ■ 5976 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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STERIS Traditional 510(k) PREMARKET NOTIFICATION Reusable Monopolar Active Cord - K192518

1. Device Name

Trade Name:	Reusable Monopolar Active Cord
Device Classification:	Class II
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Classification Number:	21 CFR 878.4400
Product Code:	GEI

2. Predicate Device

K982748 New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets

3. Description of Device

The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory.

The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.

4. Indications for Use

Description of Technological Similarities and Differences ട്.

The Reusable Monopolar Active Cord is very similar to Model SB 223 BiPolar Cord Set in Indications for Use and mode of operation. The differences between the Reusable Monopolar Active Cord and the Predicate are the type of energy provided to the device, connection to the Active Endoscopic accessories, and the use life. The predicate device and the proposed device differ in the application of energy. The predicate device is used for Bipolar applications whereas the proposed device is used for Monopolar applications. Monopolar and Bipolar

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applications differ in the path the energy takes. In Bipolar applications the active device transmits the energy to an electrosurgical device and completes the electric circuit. In Monopolar applications the active device transmits the energy to an electrosurgical device and a separate return device completes the electric circuit. The differences between Monopolar and Bipolar applications are inconsequential to an Active Cord device because both devices transmit energy from an electrosurgical generator to an electrosurgical device. The connections to Active Endoscopic accessory are different geometries between the proposed and predicate device. Both connections have a conductive insert with an internal diameter capable of connecting to Active Endoscopic accessories, but the proposed device has a step feature to provide an audible click and tactile feedback when connected to an Active Endoscopic accessory. Another difference between the proposed and predicate devices is the use life of the devices. The predicate device is single use and the proposed device is reusable. Although the predicate is single use, the devices are not patient contacting and cleaning instructions are provided to the user in the Instructions for Use. 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	ProposedReusable MonopolarActive Cord	Predicate K982748New Deantronics, Inc.Model SB 223 and SB224 BiPolar Cord Sets	Comparison
Indications foruse	The active cord isintended to delivermonopolar electricalcurrent from theelectrosurgical unit toaccessories requiringmonopolar electricalcurrent during endoscopicprocedures	Electrosurgical accessory.The BiPolar Cord Set foruse with foot switchingelectrosurgical accessoriesto conduct high-frequencyelectrical current intendedto remove tissue andcontrol bleeding.	Both devices providea conduit forelectrical energy froman electrosurgical unit(ESU) to an accessoryrequiring electricalcurrent to function.However, theproposed indicationsare specific for theproposed device anddo not mentionindications of thedevices it may beconnected to.
Length	10 feet	10 feet	Identical
Feature	ProposedReusable MonopolarActive Cord	Predicate K982748New Deantronics, Inc.Model SB 223 and SB224 BiPolar Cord Sets	Comparison
Monopolar/Bipolar	Monopolar	Bipolar	Predicate device isBipolar whereas theproposed device ismonopolar
ESU connection	8mm Bovie Style Pin	8mm Bovie Style Pin	Identical
ActiveEndoscopicaccessoryconnection	Hollow connector with0.115inch ID and a0.110inch ID step feature	Hollow connector with a0.113inch ID	The proposed devicehas a feature in theActive Endoscopicaccessory end toprovide the user withaudible/tactilefeedback when thecord is connected
ProvidesAudible/Tactilefeedback whenconnected toActiveEndoscopicAccessory	Yes	No	The proposed devicehas a feature in theActive Endoscopicaccessory end toprovide the user withaudible/tactilefeedback when thecord is connected
Reusable	Yes	No	The proposed deviceis reusable and thepredicate device isnot.
Sterility	Non-sterile	Sterile and non-sterileconfigurations	The proposed deviceis supplied non-sterileand the predicatedevice is supplied inboth sterile and non-sterile configurations.

Table 5-1. Predicate Device Comparison Table

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STERIS Traditional 510(k) PREMARKET NOTIFICATION Reusable Monopolar Active Cord - K192518

7. Performance Testing

Table 5-2 summarizes the verification activity that was performed with its respective acceptance criteria to verify the safety or effectiveness of the Reusable Monopolar Active Cord.

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Testing	Acceptance Criteria	Proposed ReusableMonopolar ActiveCord
StructuralIntegrity Testing	All Reusable Monopolar Active Cordstructural components must, minimally, meetor exceed the structural integrity limits by thepredicate active cord	PASS
Dimensional	All Reusable Monopolar Active Corddimensional components must meet thedimensional specification for each active cord	PASS
FunctionalTesting	The Reusable Monopolar Active Cord mustfunction as intended.	PASS
SimulationTesting	The Reusable Monopolar Active Cord mustprovide monopolar energy to hot devices.	PASS
ElectricalTesting	All Reusable Monopolar Active Cord electricalrequirements must meet current industrystandards according to IEC 60601-2-2:2017and IEC 60601-1:2005	PASS

Table 5-2. Summary of Verification Activities.

8. Conclusion

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 (K982748), Class II (21 CFR 878.4400), product code GEI.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.