FiAPC plus probes

K243451 · Erbe Elektromedizin GmbH · GEI · Mar 21, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K243451
• Device Name: FiAPC plus probes
• Applicant: Erbe Elektromedizin GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 21, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

FiAPC plus probes are sterile, single-use flexible electrosurgical instruments for argon plasma coagulation (APC) and tissue ablation. Probes connect to compatible Erbe electrosurgical units (ESU) via a plug containing an integrated filter and instrument recognition system. The device consists of a long tube for insertion into an endoscope working channel, terminating in a distal tip (axial, lateral, or circumferential) that releases argon plasma. Operated by physicians in clinical/endoscopic settings, the device uses high-frequency monopolar current to ionize argon gas, creating a plasma beam for tissue coagulation. The integrated recognition system ensures compatibility with specific parent devices, preventing operation with non-compatible units. The device benefits patients by providing controlled, non-contact tissue coagulation and ablation during endoscopic procedures.

Clinical Evidence

Bench testing only. Evaluated tissue effects (coagulation depth/area) and ignition distances compared to predicate. Biocompatibility (ISO 10993-1), sterilization (ISO 11135, SAL 10^-6), packaging/shelf-life (ISO 11607-1, ASTM F 1980), and electrical safety/EMC (IEC 60601 series) testing performed. No clinical data.

Technological Characteristics

Materials: stainless steel, plastics, ceramics, silver. Energy: Monopolar high-frequency current with argon gas. Max electrical load: 5000 Vp. Max gas flow: 2.4 l/min. Connectivity: Plug-based instrument recognition for Erbe APC/VIO units. Sterilization: Ethylene Oxide. Form factor: Flexible tube for endoscopic use with axial, lateral, or circumferential distal tips.

Indications for Use

Indicated for argon plasma coagulation and ablation of tissue in patients undergoing endoscopic surgical procedures.

Regulatory Classification

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.

Predicate Devices

• FIAPC plus probes (K242044)
• ERBE APC Integrated Filter Probes and Adapter (K060183)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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# 510(k) SUMMARY

| Applicant | Erbe Elektromedizin GmbH |
|------------------------------------|----------------------------------------------------------------|
| | Waldhoernlestrasse 17 |
| | 72072 Tuebingen |
| | Germany |
| | Tel: [phone] |
| | Fax: [phone] |
| Contact Person | Dr. Matthias Kollek |
| | Regulatory Affairs Specialist |
| | E-Mail: [e-mail] |
| 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

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.

#### 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<br>(Primary) | Predicate Device<br>(Secondary) |
|-------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteri<br>stics | FIAPC plus probes | FIAPC plus probes<br>K242044 | Argon Plasma Coagulation<br>(APC) Integrated Filter<br>Probes and Adapter<br>K060183 |
| Manufactur<br>er | Erbe Elektromedizin<br>GmbH (Germany) | Erbe Elektromedizin<br>GmbH (Germany) | Erbe Elektromedizin<br>GmbH (Germany) |
| Regulation<br>number | 878.4400 | 878.4400 | 878.4400 |
| Regulatory<br>class | II | II | II |
| Product<br>code | GEI | GEI | GEI |
| Indications<br>for use | The flexible FIAPC probes<br>are intended for argon<br>plasma coagulation and<br>ablation of tissue. | The flexible FiAPC probes<br>are intended for argon<br>plasma coagulation and<br>ablation of tissue. | The APC Integrated Filter<br>Probes are intended for<br>use in Argon Plasma<br>Coagulation (APC).<br>The devices are used to<br>treat many conditions in<br>endoscopy for various<br>surgical procedures. |
| Prescriptio<br>n 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 series<br>Erbe APC 3 with VIO 3 | Erbe APC 2 with VIO D or S series<br>Erbe APC 3 with VIO 3 | Erbe APC 300 with ICC series<br>Erbe APC 2 with VIO series<br>Erbe 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).