The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening.

AI/ML Overview

This FDA 510(k) summary describes a device (FiAPC plus probes) that is an electrosurgical accessory, not an AI/ML powered device. As such, it does not involve acceptance criteria related to algorithmic performance, ground truth, expert opinions, sample sizes for training/test sets, or MRMC studies that are typically associated with AI/ML devices.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. The evaluation is centered on the physical and functional characteristics of the probes, particularly a new variant with a modified tip design.

Here's an analysis of the provided information within the context of hardware/electrosurgical accessory evaluation:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to its physical and functional performance, safety, and equivalence to predicate devices. These criteria are established through adherence to various international and FDA-specific guidance documents and standards.

Acceptance Criteria Category	Reported Device Performance and Compliance
Functional Equivalence (Tissue Effects & Ignition Distance)	- Equivalent tissue effects (coagulation depth and area): Demonstrated through side-by-side tissue testing. The subject device showed comparable coagulation depth and area to the predicate device. - Equivalent ignition distances: Confirmed through side-by-side tissue testing. Compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020.
Design Controls	- Verification of design change: Performed in compliance with 21 CFR 820.30 to ensure safety and effectiveness of the device.
Sterilization	- Sterilization validation: Complied with ISO 11135. - Sterility Assurance Level (SAL): Documented at 10^-6, aligning with FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". - EO residual testing: Complied with ISO 10993-7.
Packaging and Shelf-life	- Packaging and shelf-life validation: Complied with ISO 11607-1. - Accelerated aging: Performed using ASTM F 1980, demonstrating safety and effectiveness for the defined shelf-life.
Biocompatibility	- Biocompatibility testing: Complied with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". - No toxicologically relevant released substances: Chemical characterization showed no such substances. - No cytotoxic, sensitizing, irritating, or acute systemic toxic properties: Demonstrated by testing. - Absence of pyrogens: Fulfilled criteria. - Biocompatible over entire life cycle: Conclusion based on tests.
Electromagnetic Compatibility (EMC) & Electrical Safety	- Successful testing: Complied with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2, as applicable.
Software Impact (of parent device)	- Software documentation: Complied with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions". - Probe recognition and mode limitation: Software updates in the parent device allow for this. - No impact on safety/performance: User interface updates do not affect safety or performance. - No changes to mode parameters, gas flow, or performance-relevant specifications: Confirmed.

Given that this is a hardware device (electrosurgical probes) and not an AI/ML software device, the following points are not applicable or interpreted differently:

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. For physical testing (e.g., tissue testing, sterilization), sample sizes would be determined by relevant engineering standards for statistical significance and regulatory compliance, but are not specified in this summary. The data provenance would be from internal lab studies and external testing facilities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Tissue effects are assessed by objective measurements (e.g., coagulation depth, area) rather than expert consensus on a 'truth' dataset.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image review), which is not the case here.
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, as this is not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this device does not involve an algorithm. The probes are medical instruments used by human operators.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical performance aspects like tissue effects, the "ground truth" would be the objective measurements obtained from laboratory testing (e.g., histological analysis of tissue for coagulation depth) and instrumental measurements for ignition distance.
The sample size for the training set: Not applicable, as there is no training set for an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION" also in blue.

March 21, 2025

Erbe Elektromedizin GmbH Matthias Kollek Regulatory Affairs Specialist Waldhoernlestrasse 17 Tuebingen, 72072 Germany

Re: K243451

Trade/Device Name: FiAPC plus probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 18, 2025 Received: February 18, 2025

Dear Matthias Kollek:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

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For

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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243451

Device Name

FiAPC plus probes

Indications for Use (Describe)

The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

Applicant	Erbe Elektromedizin GmbH
	Waldhoernlestrasse 17
	72072 Tuebingen
	Germany
	Tel: 0049-7071-755-0
	Fax: 0049-7071-755-179
Contact Person	Dr. Matthias Kollek
	Regulatory Affairs Specialist
	E-Mail: Matthias.Kollek@erbe-med.com
Date Prepared	March 18, 2025
Device Information
Trade/Proprietary Name:	FiAPC® plus probes
Common Name:	Argon-enhanced endoscopic electrosurgical electrode
Classification Name	Electrosurgical cutting and coagulation device and accessories
Regulation Number:	21 CFR 878.4400
Class:	II
Product Code:	GEI
Legally Marketed Predicate Devices	Primary
	FIAPC plus probes - K242044
	Secondary
	ERBE APC Integrated Filter Probes and Adapter - K060183

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Device Description

Description of Changes

Compared to the initial clearance (K242044), a new probe variant with modified tip design (i.e. modified ceramic) is added. The new variant has a circumferential opening compared to an axial opening (straight fire) and lateral opening (side fire) in the initial clearance.

Indications for Use

The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.

	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)
Characteristics	FIAPC plus probes	FIAPC plus probesK242044	Argon Plasma Coagulation(APC) Integrated FilterProbes and AdapterK060183
Manufacturer	Erbe ElektromedizinGmbH (Germany)	Erbe ElektromedizinGmbH (Germany)	Erbe ElektromedizinGmbH (Germany)
Regulationnumber	878.4400	878.4400	878.4400
Regulatoryclass	II	II	II
Productcode	GEI	GEI	GEI
Indicationsfor use	The flexible FIAPC probesare intended for argonplasma coagulation andablation of tissue.	The flexible FiAPC probesare intended for argonplasma coagulation andablation of tissue.	The APC Integrated FilterProbes are intended foruse in Argon PlasmaCoagulation (APC).The devices are used totreat many conditions inendoscopy for varioussurgical procedures.
Prescription or OTC	Prescription	Prescription	Prescription

Comparison of Technological Characteristics

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Characteristics	Subject Device	Predicate Device (Primary)	Predicate Device (Secondary)
Compatibility	Erbe APC 2 with VIO D or S seriesErbe APC 3 with VIO 3	Erbe APC 2 with VIO D or S seriesErbe APC 3 with VIO 3	Erbe APC 300 with ICC seriesErbe APC 2 with VIO seriesErbe APC 3 with VIO 3
Materials	Stainless steel, plastics, ceramics, silver	Stainless steel, plastics, ceramics, silver	Stainless steel, plastics, tungsten, ceramics
Beam Type	Axial, lateral (sidefire) and circumferential	Axial and lateral (sidefire)	Axial, lateral (sidefire) and circumferential
Probe Dimensions	Beam form Diameter [mm] Length [m] Axial 2.3 2.2 Axial 2.3 3.0 Sidefire 2.3 2.2 Circumf. 2.3 2.2			Beam form Diameter [mm] Length [m] Axial 2.3 2.2 Axial 2.3 3.0 Sidefire 2.3 2.2	Beam form Diameter [mm] Length [m] Axial 1.5 1.5 Axial 1.5 3.0 Axial 2.3 2.2 Axial 2.3 3.0 Axial 3.2 2.2 Sidefire 2.3 2.2 Circumf. 2.3 2.2
Plug	Filter integrated plug with instrument recognition	Filter integrated plug with instrument recognition	Filter integrated plug with instrument recognition
Max. electrical load capacity	5000 Vp	5000 Vp	5000 Vp
Max. gas flow rate	2.4 l/min	2.4 l/min	2.4 l/min
Energy delivery	Argon plasma (Monopolar high frequency current)	Argon plasma (Monopolar high frequency current)	Argon plasma (Monopolar high frequency current)
Condition Provided/ Use Condition	Sterile, single-use	Sterile, single-use	Sterile, single-use
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

Compared to the previously cleared device (primary predicate) an additional probe variant with modified tip design (ceramic) was added, i.e. circumferential probe. The same beam outlet type was already cleared for the secondary predicate device (K060183). Except for the ceramic tip, the added probe is virtually identical to the cleared variants. Due to the different tip design, the way how the argon plasma beam is applied, differs compared to the already cleared probes. To exclude a negative impact on safety and effectiveness and to show substantial equivalence, side-by-side tissue testing was conducted in compliance with FDA Guidance

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"Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020, analogous to the tissue testing of the initial 510(k) K242044. Compared to the predicate device, the subject device showed equivalent tissue effects (coagulation depth and area) and equivalent ignition distances.

In addition, design controls in compliance with 21 CFR 820.30 were performed to verify the design change and to ensure safety and effectiveness of the device.

Summary of non-clinical bench performance testing

Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device.

Functional testing and design controls to verify both safety and performance of the subject device was performed in compliance with 21 CFR 820.30 to ensure that the subject device performs as intended and meets design specifications.

Tissue testing was performed in compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020, to validate the thermal effect on tissue and ignition distance compared to the predicate device.

Sterilization validation was performed in compliance with ISO 11135 and documentation was provided according to FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" showing an SAL of 10-6. EO residual testing and limits are in compliance with ISO 10993-7.

Packaging and shelf-life validation was performed in compliance with ISO 11607-1 and accelerated aged devices (ASTM F 1980) showing safety and effectiveness for the defined shelf-life.

Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to demonstrate biocompatibility of the used materials. No released substances were identified in toxicologically relevant concentrations as part of the chemical characterization. The test material showed no cytotoxic, sensitizing, irritating or acute systemic toxic properties. It also fulfilled the criteria for the absence of pyrogens. Based on the tests carried out, the product can be classified as biocompatible over its entire life cycle.

Electromagnetic compatibility and Electrical safety of the subject device was successfully tested in compliance with of IEC 60601-1; IEC 60601-2-2; IEC 60601-2-18 and IEC 60601-1-2, as applicable.

Software documentation in compliance with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions" was provided for the Software updates of the parent device related to the subject device. The software updates allow probe Page 4 of 5

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recognition and limit the use of the FiAPC plus probes to certain modes. In addition, there are updates to the user interface that do not impact the safety and performance of the subject device. No changes were made to the available mode parameters, gas flow or other performance relevant specifications.

Conclusion

The subject device has the same intended use, the same fundamental design, substantially equivalent performance characteristics, and the same energy source as the predicate device. The subject device was tested as described above to demonstrate reasonable assurance of safety and effectiveness of the probe with modified tip design. The subject device does not raise new or different questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate device(s).

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.