The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.

Device Description

The Erbe Argon Plasma Coagulation Unit Model APC 3 is an APC unit for use in conjunction with an Erbe Electrosurgical Unit (ESU) compatible Model (currently Model VIO® 3). The APC 3 (as well as VIO 3) can be mounted/secured to a cart or on a ceiling mount using fastening sets, i.e. connecting cables and hardware. The APC 3 is connected to an argon gas source via a pressure reducer and connected to the VIO 3 which powers and controls the APC unit. The ESU further provides a touch-screen monitor (i.e., interactive display) with an onscreen tutorial, settings and operational information as well as safety features (i.e., audio and visual error system). When using the APC 3 together with the VIO 3, the user is offered various APC Modes as well as argon-supported Modes which can be adjusted by the physician via effect levels in order to achieve the desired tissue effect. The ESU VIO 3 provides the high-frequency (HF) current required for thermal coagulation. For argon plasma coagulation and ablation, the HF current is applied non-contact to the tissue to be coagulated through ionized and hence electrically conductive argon gas (argon plasma). The argon gas is ionized in the high-frequency electrical field between the electrode of the applicator and the tissue. For argon-assisted cutting, the ESU provides the regular cutting/coagulation Mode while the argon gas provided by the APC 3 circulates the active electrode. This application is with contact to tissue.

Applicators or probes connected to the APC 3 for coagulating tissue via argon plasma and/or for cutting tissue supported by argon gas may be activated via footswitches connected to the ESU or by use of applicators that have an activation finger switch.

The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.

AI/ML Overview

This document describes the Erbe Argon Plasma Coagulation Unit APC 3 with Accessories, and its substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics and safety standards rather than clinical performance or AI-driven improvements in human reading. Therefore, much of the requested information regarding AI acceptance criteria, clinical study specifics (sample size, expert involvement, MRMC studies, ground truth), and training set details for AI cannot be extracted from this document because it is about an electrosurgical device, not an AI/ML-driven diagnostic device.

Here's a breakdown of what can be extracted, and where limitations exist based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide specific quantitative acceptance criteria or detailed performance metrics in a table format for clinical efficacy. Instead, it focuses on general safety, performance, and substantial equivalence to a predicate device based on technical specifications and adherence to recognized standards.

Acceptance Criteria (Implied from the document):

Safety: Adherence to electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
Performance: Ability to deliver argon gas for argon plasma coagulation, ablation, and argon-assisted cutting as intended. This is assessed through "Output/Mode Comparison," "Tissue Testing," and "Capacitive Coupling" as listed in the "Performance Evaluations/Testing" section.
Usability: Conformance to usability engineering standards (e.g., IEC 62366, IEC 60601-1-6).
Compatibility: Operation with compatible Erbe VIO Electrosurgical Generators (ESU) and specific applicators/probes.
Substantial Equivalence: Demonstrating that the new device has "essentially the same principles of operation, technological characteristics, as well as performance characteristics as the predicate APC unit."

Reported Device Performance:
The document states that "Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate." However, specific numerical performance data (e.g., coagulation efficacy rates, ablation depth measurements, cutting speeds) are not provided. The "Output/Mode Comparison" and "Tissue Testing" are mentioned as performance evaluations, but their results are summarized qualitatively as proving substantial equivalence.

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

This document describes a medical device (an electrosurgical unit), not an AI/ML diagnostic algorithm tested on a dataset of patient data. Therefore, the concepts of "test set sample size" and "data provenance" in the context of clinical/imaging data are not applicable here. The testing involves engineering and performance validation of the device itself, rather than testing on a retrospective or prospective clinical dataset.

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

Not applicable. This is not an AI/ML diagnostic device requiring expert annotation of medical images or data to establish ground truth for a test set. The validation is technical and engineering-focused.

4. Adjudication method for the test set

Not applicable. As this is not a diagnostic device involving human interpretation of data, there is no need for adjudication of readings.

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

Not applicable. This device is not an AI-assisted diagnostic tool, so an MRMC study and
assessment of human reader improvement with AI assistance is irrelevant.

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

Not applicable. This is not an algorithm. It is a hardware medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation is based on engineering standards, physical measurements, and comparison to the predicate device's established performance characteristics. It relies on:

Compliance with recognized consensus standards: e.g., electrical safety, electromagnetic compatibility, usability (IEC, ISO standards listed).
Physical (in-vitro/bench) testing: "Output/Mode Comparison," "Tissue Testing," "Capacitive Coupling." These tests would compare the device's output and tissue effects to specifications and the predicate.
Functional verification: Ensuring the device operates as intended when connected to compatible components.

It does not involve "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI/ML system that requires a "training set" of data.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2019

Erbe Elektromedizin GmbH Julia Weller Specialist Regulatory Affairs Waldhoernlestrasse 17 Tuebingen, 72072 De

Re: K191234

Trade/Device Name: Erbe Argon Plasma Coagulation Unit APC 3 with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: May 3, 2019 Received: May 8, 2019

Dear Julia Weller:

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

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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 (OS) 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 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) K191234

Device Name

Erbe Argon Plasma Coagulation Unit APC 3 with Accessories

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 [AS REQUIRED BY 21 CFR 807.92(C)]

Submitted By:	Erbe Elektromedizin GmbHWaldhoernlestrasse 1772072 TuebingenGermanyTel: 0049-7071-755-0Fax: 0049-7071-755-179
Contact Person:	Mr. Henry KutzSpecialist Regulatory Affairs
Date Prepared:	May 3, 2019
Trade/Proprietary Name:	Erbe APC Unit Model APC 3 with Accessories
Common Name:	Argon Plasma Coagulation Unit
Classification Name and Code:	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR Part 878.4400)
Regulatory Class:	II
Product Code:	GEI
Legally MarketedPredicate Device:	Erbe VIO APC Model APC 2 with Accessories,510(k) Number K024047

Device Description:

The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC

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user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.

Indications for Use Statement:

Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):

Characteristics	Predicate:Erbe VIO APC Model APC 2 withAccessories	Proposed:Erbe APC Unit Model APC 3 withAccessories
Manufacturer	Erbe Elektromedizin GmbH(Germany)	Same
510(k)	K024047	N/A
Trade/ProprietaryName	Erbe VIO APC Model APC 2 withAccessories	Erbe APC Unit Model APC 3 withAccessories
Indications for Use	The Erbe VIO APC with Accessoriesis intended to deliver argon gas forargon plasma coagulation of tissuewhen used in conjunction with acompatible Erbe VIO ElectrosurgicalGenerator (ESU) and applicators orprobes.	The Erbe APC 3 with accessories isintended to deliver argon gas forargon plasma coagulation andablation of tissue as well as argon-assisted cutting of tissue when usedin conjunction with a compatibleErbe VIO Electrosurgical Generator(ESU) and applicators or probes.
Prescription orОТС	Prescription (Rx)	Same
Materials
Unit	Metal sheet, plastics, wiring, metalfittings	Same
Applicators	Stainless steel, ceramic, plastics,tungsten, printing color	Same
Probes	Stainless steel, ceramic, plastics,tungsten, glue, silicone	Same
Pressure Reducer	Metal, plastic, tubing, metal fittings,pressure gauge	Same
Fastening Sets	N/A	metal, wiring, plastics
Technical / Performance Data
Unit gas flow rate(adjustable)	0.1-8 l/min limited by therespective instrument connected,adjustable in 0.1 I steps	Same
Gas Type Used	Argon 4.8 (99.998% purity) or higher	Same
Input/Line	No direct line input / poweredthrough compatible VIO ESU	Same
Protective Circuits	Detection of specific type ofaccessory/instruments (e.g.applicator or probe) through the VIOESU	Same
Characteristics	Predicate:Erbe VIO APC Model APC 2 withAccessories	Proposed:Erbe APC Unit Model APC 3 withAccessories
ReceptacleConfiguration	Up to two sockets.(one APC/FiAPC socket or twoAPC/FiAPC sockets or oneAPC/FiAPC socket and onemonopolar/bipolar/multifunctional socket)	Up to two sockets.(one FiAPC socket or one FiAPCsocket and one monopolar/ bipolar/multifunctional socket)
Units compatiblewith the APC Unit	Erbe ESU Model VIO D and VIO Sseries [K060484,K083452 andK080715]	Erbe ESU Model VIO 3 [K190823 -pending]
Applicators andProbes compatiblewith the APC Unit	APC raspatory handle and tip[K992764]	N/A
	APC applicator [K992769]	N/A
	APC handle and applicators[K003462]	N/A
	APCprobe [K013348]	N/A
	FiAPC probes [K060183]HybridAPC probe [K143306]	SameSame
	APCapplicators [K183445]	Same
Other compatibleequipment	VIO Cart [K023886]	Same
Labeling	APC 2 Unit- packaging label- user manual- service manual	APC 3 Unit- packaging label- user manual- service manual
	Applicators and probes- packaging label- notes on use	Applicators and probes- packaging label- notes on useNote: Compatibility to APC 3 added.
	Pressure reducer- packaging label- notes on use	Pressure reducer- packaging label- notes on useNote: Compatibility to APC 3 added.
	N/A	Fastening sets- packaging label
	VIO Cart- packaging label- user manual	VIO Cart- packaging label- user manualNote: Compatibility to APC 3 added.
	APC Unit: N/A - no patient contact	Same
Biocompatibility	Applicators and probes: direct patientcontact	Same
	Pressure reducer and VIO Cart:N/A - no patient contact	Pressure reducer, VIO Cart andfastening sets:N/A - no patient contact
Provided condition	APC Unit : non-sterile, reusable	Same
	Applicators and probes: sterile,disposable (single-use)	Same
	Pressure reducer and VIO Cart: non-sterile, reusable	Pressure reducer, VIO Cart andfastening sets: non-sterile, reusable
Shelf Life	Not Applicable for reusable Unit andAccessories (i.e. pressure reducerand VIO Cart)	Not Applicable for reusable Unit andAccessories (i.e. pressure reducer,VIO Cart and fastening set)
Characteristics	Predicate:Erbe VIO APC Model APC 2 withAccessories	Proposed:Erbe APC Unit Model APC 3 withAccessories
	Three (3) years for single useHybridAPC probe andAPCapplicators and five (5) years forFiAPC probes.	Same

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Verification/Validation Activities (Including Applied/Certified Standards and Guidance Documents):

FDA Recognized Consensus Standards

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance* *Other versions of this standard were also tested to and certified.
IEC 60601-1-2 Edition 4.0:2014-02 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests* *Other versions of this standard were also tested to and certified.
· IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surqical accessories* *Other versions of this standard were also tested to and certified
. IEC 62304:2006 + A1:2015 Medical device software - Software life cycle processes
· IEC 62366:2007 + A1:2014 Medical Devices Application Of Usability Engineering To Medical Devices
IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment Part 1 -. 6: General requirements for basic safety and essential performance - Collateral standard: Usability
· ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
EN 1041:2008 + A1:2013 Information supplied by the manufacturer of medical . devices
ISTA 2A:2011 Partial Simulation Performance Test Packaged-Products 150 Ib (68 . kg) or Less

Performance Evaluations/Testing

· Output/Mode Comparison
· Tissue Testing
· Capacitive Coupling (per Standard Number 60601-2-2)
· Accessory Testing

Conclusion:

The intended use of the proposed Erbe APC 3 was clarified identifying all functions that may be performed with the Unit when used in combination with a compatible Erbe VIO ESU and applicators or probes. The proposed Unit has essentially the same principles of operation, technological characteristics, as well as performance characteristics as the predicate APC unit. Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate.

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.