Product Number (P/N) 20132-250, 20132-251, 20132-253, 20132-254 and 20132-255: The Rigid Argon Plasma Coagulation Applicators are intended for monopolar cutting and coagulation of tissue with and without argon gas or for coagulation and ablation using argon plasma. They are used in open and in laparoscopic surgery.

P/N 20132-256: The Rigid Argon Plasma Coagulation Applicator is intended for monopolar coagulation of tissue using argon plasma. It is used in open surgical procedures.

Device Description

The Erbe APCapplicators are sterile, single-use electrosurgical instruments for monopolar cutting and coagulation with and without argon gas and/or for coagulation and ablation of tissue using argon plasma. They are used in open and/or laparoscopic surgical procedures. The APCapplicators are intended for use with an Erbe Argon Plasma Coagulator Unit Model APC 2 in combination with a compatible Erbe V/O® electrosurgical unit. Note that the APC 2 must be equipped with an APC receptacle with finger switch activation. Activation may either be done via finger switch on the handle of the Erbe APCapplicator or via footswitch.

The applicators are provided in various shaft lengths either with an adjustable spatula/needle electrode or a malleable tip. Adjustable means that by using the rotary wheel the spatula/needle electrode may either be fully withdrawn inside the instrument shaft or extended up to 14mm outside of the shaft. With an extended electrode the user may cut and coagulate tissue with or without argon gas.

AI/ML Overview

The provided text describes a 510(k) premarket notification for electrosurgical accessories (Erbe APCapplicators). This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a device meets specific, quantitative acceptance criteria through rigorous clinical trials or AI performance evaluations.

Therefore, the information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance with effect sizes, adjudication methods) is not applicable to this document.

Here's why and what information IS available:

Why the requested information is not applicable:

Medical Device Type: The Erbe APCapplicators are electrosurgical accessories. Their clearance hinges on demonstrating they perform as intended and are as safe and effective as a known predicate device. This is primarily established through bench testing, performance testing (e.g., tissue testing), material characterization, and adherence to recognized standards for electrical safety, biocompatibility, and sterilization, rather than through complex clinical studies evaluating diagnostic accuracy or human-AI interaction.
510(k) Pathway: The 510(k) pathway is for devices that are substantially equivalent to a legally marketed predicate device. It does not require proof of clinical superiority or a deep dive into AI performance metrics, as would be expected for a novel AI/ML-based diagnostic device.
Nature of "Performance": The "performance" mentioned in this document refers to the device's ability to safely and effectively cut, coagulate, or ablate tissue, and its compatibility with the intended electrosurgical units. It doesn't involve "accuracy" or "detection" rates in the way an AI diagnostic algorithm would be evaluated.

Information Available from the Document (related to device "performance" and "studies"):

Acceptance Criteria/Reported Device Performance:
- Implicit Acceptance Criteria: The device is deemed acceptable if it demonstrates substantial equivalence to the predicate, meaning it performs its intended functions (monopolar cutting, coagulation, ablation using argon plasma) safely and effectively. This is demonstrated through adherence to various standards and performance tests.
- Reported Performance: The document states:
  - "Validation activities in design control that include testing/certification to designated standards and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate device."
  - "The functionality of both groups has been found to be the same." (Referencing reusable predicate vs. single-use proposed device)
- No Quantitative Performance Table: There is no table of quantitative acceptance criteria like sensitivity/specificity or AUC, because this is not an AI diagnostic device.
Sample Sizes and Data Provenance:
- Not Applicable: There are no "test sets" or "training sets" in the context of AI models. The document refers to "Performance Evaluations/Testing" including "Tissue Testing." The sample sizes for these bench and tissue tests are not specified, nor is the origin of the "data" in a geographical or prospective/retrospective sense.
Number of Experts and Qualifications for Ground Truth:
- Not Applicable: There's no "ground truth" to be established by experts in the context of diagnostic agreement, as this is a surgical accessory. "Ground truth" for its performance would implicitly be its ability to physically cut/coagulate tissue in a controlled environment, and its adherence to electrical safety and biocompatibility standards.
Adjudication Method:
- Not Applicable: No adjudication method is described, as there are no expert readings or interpretations to adjudicate.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable: No MRMC study was done, as this is not an AI-assisted diagnostic device where human reader improvement is a relevant metric.
Standalone Performance (Algorithm Only):
- Not Applicable: There is no "algorithm" in the sense of an AI model. The device's "standalone" performance refers to its physical and electrical characteristics conforming to safety and performance standards.
Type of Ground Truth Used:
- Implied through Standards and Bench Testing: The "ground truth" for this device's performance is implicit in its ability to meet engineering specifications, fulfill its intended function (cutting/coagulating tissue) in lab settings, and comply with recognized consensus standards (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility, ISO 11135 for sterilization). It's based on objective physical/electrical measurements and material properties, not clinical outcomes or expert consensus on medical images.
Sample Size for Training Set:
- Not Applicable: No training set in the AI context.
How Ground Truth for Training Set was Established:
- Not Applicable: No training set.

In summary, the provided document is for a traditional medical device (electrosurgical accessory) seeking 510(k) clearance via a substantial equivalence pathway. The framework you've provided for AI/ML diagnostic devices is not applicable to this example.

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 4, 2019

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

Re: K183445

Trade/Device Name: Erbe APCapplicators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 2, 2019 Received: January 7, 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/ofdocs/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 531-542 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -ટે૩

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183445

Device Name

Rigid Argon Plasma Coagulation Applicator (APCapplicator)

Indications for Use (Describe)

P/N 20132-256: The Rigid Argon Plasma Coagulation Applicator is intended for monopolar coagulation of tissue using argon plasma. It is used in open surgical procedures.

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:	Ms. Julia WellerSpecialist Regulatory Affairs
Date Prepared:	December 7th, 2018
Trade/Proprietary Name:	Erbe APCapplicators
Common Name:	Rigid Argon Plasma Coagulation Applicators
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 APC Handle and Applicators – K003462

Device Description:

Indications for Use:

Part Number (P/N) 20132-250, 20132-251, 20132-253, 20132-253, 20132-254 and 20132-255: The Rigid Argon Plasma Coagulation Applicators are intended for monopolar cutting and coagulation of tissue with and without argon gas or for coagulation and ablation using argon plasma. They are used in open and laparoscopic surgery.

P/N 20132-256: The Rigid Argon Plasma Coagulation Applicator is intended for monopolar coagulation and ablation of tissue using argon plasma. It is used in open surgical procedures.

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

Characteristics	Predicate:Erbe APC Handle and Applicators	Proposed:Erbe APCapplicators
Manufacturer	Erbe Elektromedizin GmbH(Germany)	Erbe Elektromedizin GmbH(Germany)
Submitter	Erbe USA Inc. (USA)	Erbe Elektromedizin GmbH
510(k) Number	K003462	N/A
Trade/Proprietary Name	Erbe APC Handle and Applicators	Erbe APCapplicators
Indications for UseStatement	APC coagulation	Part Number (P/N): 20132-250,20132-251, 20132-252, 20132-253,20132-254 and 20132-255: TheRigid Argon Plasma CoagulationApplicators are intended formonopolar cutting and coagulationof tissue with and without argon gasor for coagulation and ablation usingargon plasma. They are used inopen and in laparoscopic surgery.P/N 20132-256: The Rigid ArgonPlasma Coagulation Applicator isintended for monopolar coagulationand ablation of tissue using argonplasma. It is used in open surgicalprocedures.
Prescription orОТС	Prescription	Prescription
Materials	Stainless steel, ceramic, plastics,adhesive.Additionally 20132-044 and -054include tungsten.Additionally 20132-040 includestungsten and silicone.APC handle consists of stainlesssteel, plastics and silicone.	Stainless steel, ceramic, plastics,printing color.Additionally 20132-251, -253,-255 and -256 include tungsten.
Dimensions	- shaft diameter: 2.3mm, 5mm and6mm- shaft length: 25mm, 35mm, 50mm,100mm and 320mm	- shaft diameter: 5mm- shaft length: 35mm, 100mm and350mm
Configurations	- shaft: straight or angled- tip: adjustable needle or spatulaelectrode, malleable tip, rigid tip	- shaft: straight- tip: adjustable needle or spatulaelectrode, malleable tip
Compatibility	ICC/APC 300, VIO/APC 2	VIO/APC 2
SterilizationMethod Used	Steam sterilization	Ethylene Oxide
Shelf Life	N/A	three (3) years
Condition provided	non-sterile, reusable	sterile, single-use

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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 (IEC 60601-1:2005, MOD)* *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 surgical accessories *
*Other versions of this standard were also tested to and certified.
· IEC 60601-2-18: Edition 3.0 2009-08 Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, . labelling and information to be supplied - Part 1: General requirements
. ISO 11135:2014 Sterilization of health-care products - Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices
. ISO 11737-1 Second edition 2006-04-01 Sterilization of medical devices -Microbiological methods - Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]
· ISO 11607-1 First edition 2006-04-15 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]
· ISO 11607-2 First edition 2006-04-15 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]
· ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

Performance Evaluations/Testing

· Tissue Testing
Performance Testing

U.S Requlations

21 CFR 820.30, Design Controls .
. 21 CFR 801, Labeling

Guidance Documents

Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s .
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General . Surgery Guidance for Industry and Food and Drug Administration Staff
. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff
. Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices . - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff

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Conclusion:

The proposed intended use was modified for clarification identifying all functions (e.g. cut and coagulation) that may be performed with the instruments as compared to the predicate devices which specify only argon plasma coagulation in their indications for use statement and rely on the intended uses of the compatible Units for the other available functions. Hence, the intended use of the proposed and predicate APC applicators is equivalent.

The notable difference when comparing the predicate and proposed devices, involves the predicate devices being reusable and the proposed devices being single use. Nevertheless, the functionality of both groups has been found to be the same.

The principles of operation and technological characteristics as well as the performance characteristics of the proposed and predicate device are equivalent. The materials used for the construction of the applicators are similar. Validation activities in design control that include testing/certification to designated standards and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate device. In conclusion, the proposed APCapplicators are as safe and efficacious as the predicate APC applicators.

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.