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, i.e. axial opening (straight fire) or lateral opening (side fire).

AI/ML Overview

This document describes the Erbe Elektromedizin GmbH FiAPC plus probes, an electrosurgical device accessory. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new type of device or an AI/software-based system.

Therefore, the information requested in your prompt regarding acceptance criteria and studies that prove a device meets those criteria, particularly for AI/software, is not fully applicable or present in this document. This document describes a medical device accessory and its comparison to an already marketed predicate device, primarily focusing on physical and functional characteristics, and safety and effectiveness relative to that predicate.

However, I can extract the information that is relevant to your prompt based on the provided text, and explicitly state where information is not available or not applicable.

Here's a breakdown of the available information:

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

The document doesn't explicitly list "acceptance criteria" in the way a software/AI device might, with specific metrics to hit. Instead, it focuses on demonstrating comparable performance and meeting design specifications through various tests.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary from text)
Intended Use Equivalence	Same intended use as the predicate device: "The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue."
Technological Characteristics	Largely identical to the predicate device, with minor differences in plug design, distal tip, and materials. These differences were assessed not to raise new safety/effectiveness questions.
Tissue Effects	Comparable tissue effects and comparable ignition distances compared to the predicate device, as demonstrated by side-by-side tissue testing.
Design and Performance Requirements	All design and performance requirements were successfully verified/validated, and all acceptance criteria are met, as shown by bench testing. (Specific criteria are not enumerated, but general successful verification/validation is stated).
Biocompatibility	Compliant with ISO 10993-1; new materials are biocompatible.
Electrical Safety & EMC	Compliant with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2.
Sterilization	Compliant with ISO 11135, achieving an SAL of 10^-6. EO residual testing and limits compliant with ISO 10993-7.
Packaging & Shelf-life	Compliant with ISO 11607-1 and accelerated aged devices (ASTM F 1980).
Safety and Effectiveness	The device does not raise new or different questions of safety and effectiveness compared to the predicate device. The device is as safe and effective as the legally marketed predicate devices.

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

Test Set Description: The "test set" for this device primarily refers to the physical units of the FiAPC plus probes and the predicate device used in bench and tissue testing.
Sample Size:
- For tissue testing: Not explicitly stated beyond "side-by-side tissue testing."
- For other bench tests (EMC, electrical safety, sterilization, packaging): Not explicitly stated for each test, but it is implied that sufficient samples were tested to demonstrate compliance and validate performance.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were conducted internally or by contracted labs as part of the manufacturer's (Erbe Elektromedizin GmbH, Germany) verification and validation activities.

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

This information is not applicable and not provided in the document. The "ground truth" for this type of medical device (argon plasma coagulation probes) is established through biophysical principles, engineering standards, and medical consensus on desired tissue effects, rather than expert annotation of data like in an AI/software context. Tissue effects are measured directly.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from expert opinions in studies involving subjective assessment (e.g., image interpretation for AI). For physical device performance, direct measurements and compliance with objective standards are used.

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:

This information is not applicable and not provided. MRMC studies are specific to evaluating diagnostic accuracy, particularly for imaging devices or AI tools where human interpretation is involved. This device is an electrosurgical accessory, not a diagnostic or AI-assisted system for human readers.

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

This information is not applicable and not provided. This device is a physical electrosurgical probe, not an algorithm or a software-only device.

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

The "ground truth" for this device's performance, as demonstrated in the document, is based on:
- Direct Physical Measurements/Bench Testing: E.g., electrical load capacity, gas flow rate, probe dimensions.
- Compliance with Industry Standards: E.g., ISO 10993-1 for biocompatibility, IEC 60601 series for electrical safety, ISO 11135 for sterilization.
- Observed Tissue Effects: "Comparable tissue effects and comparable ignition distances" to the predicate device. This is a direct physical result rather than an expert consensus or pathology report in the typical sense, though assessment of these effects would involve trained personnel.
- Comparison to Predicate Device: The overarching "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set:

This information is not applicable and not provided. This device is not an AI/machine learning system, so there is no "training set" in the context of AI.

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

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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August 26, 2024

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

Re: K242044

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: July 12, 2024 Received: July 12, 2024

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 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.

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"

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(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 OS regulation reguires device manufacturers to review and approve changes to device design and production (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 (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.

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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website 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.

Long H. Chen -SDDate: 2024.08.26 10:37:08 -04'00'

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) K242044

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)

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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	July 12, 2024
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	ERBE APC INTEGRATED FILTER PROBES;
	ERBE APC INTEGRATED FILTER PROBE
	ADAPTER - K060183

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Device Description

Indications for Use

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

The intended use of the subject device and legally marketed predicate device is the same. Compared to the predicate device, the indications for use statement of the subject device additionally includes the term ablation of tissue for clarification in accordance with the parent device APC 3 (K191234) which was cleared for "argon plasma coagulation and ablation of tissue" ... "when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes"

	Subject Device	Predicate Device	Comments
Characteristics	FiAPC® plus probes	Argon Plasma Coagulation (APC)Integrated Filter Probesand AdapterK060183
Manufacturer	Erbe Elektromedizin GmbH(Germany)	Erbe Elektromedizin GmbH(Germany)	Same
Regulationnumber	878.4400	878.4400	Same
Regulatoryclass	II	II	Same
Product code	GEI	GEI	Same
Indications foruse	The flexible FiAPC probes areintended for argon plasmacoagulation and ablation oftissue.	The APC Integrated Filter Probesare intended for use in ArgonPlasma Coagulation(APC). The devices are used totreat many conditions inendoscopy for various surgicalprocedures.	SameIntendedUse
Prescription orOTC	Prescription	Prescription	Same
Compatibility	Erbe APC 2 with VIO D or Sseries	Erbe APC 300 with ICC seriesErbe APC 2 with VIO series	Similar

Comparison of Technological Characteristics

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Erbe Elektromedizin GmbH Traditional 510(k) for FiAPC® plus probes

	Erbe APC 3 with VIO 3	Erbe APC 3 with VIO 3
Materials	Stainless steel, plastics, ceramics, silver	Stainless steel, plastics, tungsten, ceramics	Similar
Beam Type	Axial and lateral (sidefire)	Axial, lateral (sidefire) and circumferential	Similar
Probe Dimensions	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	Similar; optimized design of the distal end (rounded tip)
Plug	Filter integrated plug with instrument recognition	Filter integrated plug with instrument recognition	Similar; optimized plug design
Max. electrical load capacity	5000 Vp	5000 Vp	Same
Max. gas flow rate	2.4 l/min	2.4 l/min	Same
Energy delivery	Argon plasma (Monopolar high frequency current)	Argon plasma (Monopolar high frequency current)	Same
Condition Provided/ Use Condition	Sterile, single-use	Sterile, single-use	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same

The specifications of the subject device are largely identical compared to the predicate device. Both devices are sterile, single-use devices which apply the same kind of energy, offer the same beam types, have the same probe dimensions, a filter integrated plug and the same max, electrical load capacity,

Minor differences are related to the pluq design of the distal tip and the used materials.

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 "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020. Compared to the predicate device, the subject device showed comparable tissue effects and comparable ignition distances.

As shown by bench testing, all design and performance requirements were successfully verified/validated, and all acceptance criteria are met. Biocompatibility testing in compliance with FDA recognized consensus standard ISO 10993-1 shows that the new materials are biocompatible. The provided testing demonstrates that the subject device is as safe and effective as the legally marketed predicate devices and does not raise new or different questions of safety and effectiveness.

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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 compared to the predicate device.

EMC and Electrical safety of the subject device was tested in compliance with FDA recognized versions of IEC 60601-1; IEC 60601-2-2; IEC 60601-2-18: and IEC 60601-1-2, as applicable. 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.

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).

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 and the minor differences in technological characteristics were assessed with regards to safety and effectiveness. Taken together, 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.

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.