Disposable neutral electrodes are self-adhesive, ready-to-use and single-use products and are an accessory for HF surgery in monopolar applications. The electrical circuit between the patient and the HF generator on the passive side.

Device Description

BOWA Neutral Electrodes for adults, children and neonates provide a safe return path for electrosurgical current. The electrode consists of a conductive adhesive area surrounded by a non-conductive border adhesive. The conductive area is split in longitudinal or circumferential direction which enables a quicker detection of disconnection. The electrode backing is fluid resistant. The neutral electrode is single-use only, disposable, and non-sterile. The electrodes are supplied with or without a pre-attached cable. For the non-pre-corded electrodes, a reusable cable is available as accessory.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for BOWA Neutral Electrodes, which are accessories for electrosurgical cutting and coagulation devices. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria for AI-related functions.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using an AI/ML context (e.g., accuracy, sensitivity, specificity) is not present in this document.

This document is for an electrosurgical accessory and its 510(k) submission primarily relies on:

Comparison to predicate devices: Highlighting similarities in intended use, indications for use, principles of operation, and technological characteristics.
Non-clinical performance data: This includes compliance with established electrical safety and biocompatibility standards (e.g., IEC 60601-2-2, ISO 10993-1, ISO 10993-5, ISO 10993-10), shelf-life testing, and reprocessing testing for consumable accessories.

There is no mention of AI/ML components, diagnostic performance metrics (accuracy, sensitivity, specificity), test sets, training sets, ground truth establishment by experts, or MRMC studies.

In summary, this document does not contain the information needed to address the prompt's specific requirements concerning acceptance criteria and study details for an AI-powered device.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

February 15, 2018

BOWA-electronics GmbH & Co. KG % Roxana Cernescu Senior Consultant QA/RA EMERGO Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746

Re: K173877

Trade/Device Name: BOWA Neutral Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 21, 2017 Received: December 21, 2017

Dear Roxana Cernescu:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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

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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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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 -S 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) K173877

Device Name BOWA Neutral Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

DEVICE NAME

K__173877_

1. Submission Sponsor

BOWA-electronic GmbH & Co. KG

Heinrich-Hertz-Strasse 4 - 10

Gomaringen

72810

GERMANY

Contact: Wolf-Ruediger FRITZ

Title: Head of Quality Management / Regulatory Affairs Director

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327.9997

Contact: Roxana CERNESCU

Title: Senior Consultant, Regulatory

3. Date Prepared

2018-01-22

4. Device Identification

Trade Name:	BOWA Neutral Electrodes
Common Name:	Neutral Electrodes
Classification Name:	Electrosurgical cutting and coagulation device and accessories

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Regulation Number:	21 CFR 878.4400
Product Code:	GEI
Device Class:	Class II
Classification Panel:	General & Plastic Surgery

5. Legally Marketed Predicate Device(s)

Manufacturer	Leonhard Lang GmbH	Leonhard Lang GmbH
Trade Name	Skintact® Cool ContactElectrosurgical GroundingPlates with NH 04 Gel	Skintact® Neutral Electrodes forNeonates
510(k) Number	K063161Primary predicate	K140500Secondary predicate

6. Indication for Use Statement

Disposable neutral electrodes are self-adhesive, ready-to-use and single-use products and are an accessory for HF surgery in monopolar applications. The electrodes complete the electrical circuit between the patient and the HF generator on the passive side.

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the BOWA Neutral Electrodes to the predicate devices with respect to intended use, indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate devices.

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Manufacturer	BOWA-electronicsGmbH & Co. KG	Leonhard LangGmbH	Leonhard LangGmbH	Device Comparison
Trade Name	BOWA NeutralElectrodes	Skintact® CoolContactElectrosurgicalGrounding Plateswith NH 04 Gel	Skintact® NeutralElectrodes forNeonates
510(k)Number	K173877	K063161	K140500	N/A
Product Code	GEI	GEI	GEI	Same
RegulationNumber	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400	Same
RegulationName	Electrosurgicalcutting andcoagulation deviceand accessories	Electrosurgicalcutting andcoagulation deviceand accessories	Electrosurgicalcutting andcoagulation deviceand accessories	Same
Indications forUse	Disposable neutralelectrodes are self-adhesive, ready-to-use and single-useproducts and arean accessory for HFsurgery inmonopolarapplications. Theelectrodescomplete theelectrical circuitbetween thepatient and the HFgenerator on thepassive side.	Skintact Cool ContactElectrosurgicalGrounding Plates aredesigned for usewith electrosurgicalgenerators forcutting andcoagulation ofhuman tissue.	Skintact NeutralElectrodes forNeonates aredesigned for usewith electrosurgicalgenerators forcutting andcoagulation ofhuman tissue ofnewborn orprematurely bornpatients of betweenapproximately 1 and11 lbs (0.45 kg and4.99 kg)	Wording isdifferent, but theIntended Use is thesame, referenceSection 12, 12.2.1.
Prescription orОТС	Prescription	Prescription	Prescription	Same
Manufacturer	BOWA-electronicsGmbH & Co. KG	Leonhard LangGmbH	Leonhard LangGmbH	Device Comparison
Trade Name	BOWA NeutralElectrodes	Skintact® CoolContactElectrosurgicalGrounding Plateswith NH 04 Gel	Skintact® NeutralElectrodes forNeonates
Mechanism ofAction	Neutral electrodesserve to return thecurrent from thepatient to theelectrosurgical unit(ESU) during HF-surgery inmonopolarapplication.	Neutral electrodesserve to return thecurrent from thepatient to theelectrosurgical unit(ESU) during HF-surgery inmonopolarapplication.	Neutral electrodesserve to return thecurrent from thepatient to theelectrosurgical unit(ESU) during HF-surgery inmonopolarapplication.	Same
TechnologyOverview	Multi-layer deviceconsisting of:Backing materialConductive layerConductiveadhesive hydrogelCover material	Multi-layer device,details of the layersare not known	Multi-layer device,details of the layersare not known	Similar
Population	Neonates, Children,Adults	Children and Adults	Neonates	The combination ofChildren, Adultsand Neonates leadsto the Samepopulation
AnatomicalLocation	Muscular or wellvascularizedconvex skin site, asclose as possible tothe operating field	Muscular or wellvascularized convexskin site, as close aspossible to theoperating field	Muscular or wellvascularized convexskin site, as close aspossible to theoperating field	Same
Weight rangeaccording toIEC 60601-2-2	>15kg (33lbs)Adults>5kg (11lbs)Children and AdultsBetween 5 and15kg (11 to 33lbs)Children	>15kg (33lbs)>5kg (11lbs)Between 5 and 15kg(11 to 33lbs)		SameSameSame
Manufacturer	BOWA-electronicsGmbH & Co. KG	Leonhard LangGmbH	Leonhard LangGmbH	Device Comparison
Trade Name	BOWA NeutralElectrodes	Skintact® CoolContactElectrosurgicalGrounding Plateswith NH 04 Gel	Skintact® NeutralElectrodes forNeonates
	<5kg (11lbs)Neonates		Between 0.45 and4.99kg (1lbs to 11lbs)	Same
Conductivearea	140 cm² Adults110 cm² Childrenand Adults70 cm² Children40 cm² Neonates	118 cm²107 cm²66 cm²	34 cm²	Similar
Power	140 cm² not limited110 cm² not limited70 cm² limited to200W40 cm² limited to100W	118 cm² not limited107 cm² not limited66 cm² limited to120W	34 cm² maximumWatt must bedetermined formode of operation	Similar
Material	Conductivelaminate:Al-foil / PET andmedical gradehydrogelBacking: PE-foamCover: release liner	Conductive laminate:Al-foil / PET andmedical gradehydrogelBacking: PE-foamCover: release liner	Not exactly known	Same
Self-adhesive	Yes	Yes	Yes	Same
Sterile	Non-sterile	Non-sterile	Non-sterile	Same
Single-Use /disposable	Yes	Yes	Yes	Same
Shelf Life	36 months	24 months	24 months	Similar
Complies withISO 10993-1:	Yes	Yes	Yes	Same
Manufacturer	BOWA-electronicsGmbH & Co. KG	Leonhard LangGmbH	Leonhard LangGmbH	Device Comparison
Trade Name	BOWA NeutralElectrodes	Skintact® CoolContactElectrosurgicalGrounding Plateswith NH 04 Gel	Skintact® NeutralElectrodes forNeonates
10993-5 and10993-10
Complies withrelevantclauses of IEC60601-2-2	Yes	Yes	Yes	Same
ElectricalSafety TestingPassed	Yes	Yes	Yes	Same
Compatibilitywith HFGenerators(ESU)	Yes, if ESU isequipped with aCQM System whichfulfils IEC 60601-1	Yes, if ESU isequipped with aCQM System whichfulfils IEC 60601-1	Yes, if ESU isequipped with aCQM System whichfulfils IEC 60601-1	Same
Packaging	Sealed pouch	Sealed pouch	Sealed pouch	Same
Accessory	For electrodesprovided withoutcable,reusable cableavailable	For electrodesprovided withoutcable,reusable cableavailable	For electrodesprovided withoutcable,reusable cableavailable	Same

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of BOWA Neutral Electrodes and in showing substantial equivalence to the predicate devices, BOWA completed a number of non-clinical performance tests. The BOWA Neutral Electrodes meet all the requirements for overall design, biocompatibility, electrical safety, and reprocessing, as applicable, with results confirming that the design output meets the design inputs and specifications for the devices.

The BOWA Neutral Electrodes passed all the testing in accordance with internal requirements, and international standards shown below to support substantial equivalence of the predicate devices:

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. The device passed performance testing conducted according to standard IEC 60601-2-2:2009 "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" and IEC 60601-1, relevant requirements. The testing conducted included: Contact impedance for new and aged devices, Resistance, Shelf-life, Isolation of active accessory, Patient lead.
. Biocompatibility testing per ISO 10993-1 confirmed that the finished devices are biocompatible, and do not induce new risks. The following testing per ISO 10993-5 Cytotoxicity, and ISO 10993-10 (Skin Irritation and Sensitization) shown no adverse results.
. Shelf Life Testing – According to real time aging of the BOWA Neutral Electrodes and subsequent electrical safety testing it could be proven that the BOWA Neutral Electrodes can be labeled with a shelf-life of 36 (thirty-six) months.
. Reprocessing Testing – The BOWA Neutral Electrodes Cable reusable was subject to extensive reprocessing procedures simulating recommended procedures, as manual cleaning and disinfection, automated cleaning and disinfection as well as steam sterilization. Subsequently the main components of the cable were subject to electrical safety testing which proved that all requirements could be fulfilled.

10. Clinical Performance Data

No human clinical testing is required to support the medical device as the intended use is equivalent to the predicate devices. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The BOWA Neutral Electrodes, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate devices.

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.