Who is the manufacturer of BOWA Neutral Electrodes?

Bowa-Electronics GmbH & Co. KG filed the 510(k) submission for BOWA Neutral Electrodes (K173877).

What is the FDA product code for BOWA Neutral Electrodes?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for BOWA Neutral Electrodes?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BOWA Neutral Electrodes?

Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 Gel (K063161); Skintact® Neutral Electrodes for Neonates (K140500).

Who can help prepare an FDA 510(k) submission like BOWA Neutral Electrodes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BOWA Neutral Electrodes

K173877 · Bowa-Electronics GmbH & Co. KG · GEI · Feb 15, 2018 · General, Plastic Surgery

Device Facts

Record ID	K173877
Device Name	BOWA Neutral Electrodes
Applicant	Bowa-Electronics GmbH & Co. KG
Product Code	GEI · General, Plastic Surgery
Decision Date	Feb 15, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Pediatric

Indications for Use

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 Story

BOWA Neutral Electrodes are single-use, self-adhesive, non-sterile accessories for monopolar HF surgery. They provide a return path for electrosurgical current between the patient and the HF generator. The device consists of a conductive adhesive area (split to enable disconnection detection) surrounded by a non-conductive border adhesive. The backing is fluid-resistant. Electrodes are applied to a well-vascularized, convex skin site near the operating field. The device is used in clinical settings by healthcare professionals. It functions as a passive component in the electrosurgical circuit; it does not process data or provide clinical outputs. By ensuring a safe return path for current, it prevents patient burns and electrical hazards during electrosurgical procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-2-2, IEC 60601-1), biocompatibility (ISO 10993-5, ISO 10993-10), shelf-life validation, and reprocessing testing for reusable cables.

Technological Characteristics

Multi-layer construction: Al-foil/PET conductive laminate, medical-grade hydrogel, PE-foam backing, and release liner. Split conductive area design for disconnection monitoring. Dimensions vary by patient population (40-140 cm²). Complies with IEC 60601-2-2 and ISO 10993-1. Non-sterile, single-use. Compatible with ESU systems featuring Contact Quality Monitoring (CQM).

Indications for Use

Indicated for use as a return electrode for electrosurgical current in monopolar HF surgery for neonates, children, and adults.

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

Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 Gel (K063161)
Skintact® Neutral Electrodes for Neonates (K140500)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173877 Device Name BOWA Neutral Electrodes Indications for Use (Describe) 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. 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) # 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." {3}------------------------------------------------ # 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 | {4}------------------------------------------------ | 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 Contact Electrosurgical Grounding Plates with NH 04 Gel | Skintact® Neutral Electrodes for Neonates | | 510(k) Number | K063161 Primary predicate | K140500 Secondary 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 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. # 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. {5}------------------------------------------------ | Manufacturer | BOWA-electronics GmbH & Co. KG | Leonhard Lang GmbH | Leonhard Lang GmbH | Device Comparison | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Trade Name | BOWA Neutral Electrodes | Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 Gel | Skintact® Neutral Electrodes for Neonates | | | 510(k) Number | K173877 | K063161 | K140500 | N/A | | Product Code | GEI | GEI | GEI | Same | | Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | | Regulation Name | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Same | | Indications for Use | 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. | Skintact Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue. | Skintact Neutral Electrodes for Neonates are designed for use with electrosurgical generators for cutting and coagulation of human tissue of newborn or prematurely born patients of between approximately 1 and 11 lbs (0.45 kg and 4.99 kg) | Wording is different, but the Intended Use is the same, reference Section 12, 12.2.1. | | Prescription or ОТС | Prescription | Prescription | Prescription | Same | | Manufacturer | BOWA-electronics GmbH & Co. KG | Leonhard Lang GmbH | Leonhard Lang GmbH | Device Comparison | | Trade Name | BOWA Neutral Electrodes | Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 Gel | Skintact® Neutral Electrodes for Neonates | | | Mechanism of Action | Neutral electrodes serve to return the current from the patient to the electrosurgical unit (ESU) during HF- surgery in monopolar application. | Neutral electrodes serve to return the current from the patient to the electrosurgical unit (ESU) during HF- surgery in monopolar application. | Neutral electrodes serve to return the current from the patient to the electrosurgical unit (ESU) during HF- surgery in monopolar application. | Same | | Technology Overview | Multi-layer device consisting of: Backing material Conductive layer Conductive adhesive hydrogel Cover material | Multi-layer device, details of the layers are not known | Multi-layer device, details of the layers are not known | Similar | | Population | Neonates, Children, Adults | Children and Adults | Neonates | The combination of Children, Adults and Neonates leads to the Same population | | Anatomical Location | Muscular or well vascularized convex skin site, as close as possible to the operating field | Muscular or well vascularized convex skin site, as close as possible to the operating field | Muscular or well vascularized convex skin site, as close as possible to the operating field | Same | | Weight range according to IEC 60601-2-2 | >15kg (33lbs) Adults >5kg (11lbs) Children and Adults Between 5 and 15kg (11 to 33lbs) Children | >15kg (33lbs) >5kg (11lbs) Between 5 and 15kg (11 to 33lbs) | | Same Same Same | | Manufacturer | BOWA-electronics GmbH & Co. KG | Leonhard Lang GmbH | Leonhard Lang GmbH | Device Comparison | | Trade Name | BOWA Neutral Electrodes | Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 Gel | Skintact® Neutral Electrodes for Neonates | | | | <5kg (11lbs) Neonates | | Between 0.45 and 4.99kg (1lbs to 11lbs) | Same | | Conductive area | 140 cm² Adults 110 cm² Children and Adults 70 cm² Children 40 cm² Neonates | 118 cm² 107 cm² 66 cm² | 34 cm² | Similar | | Power | 140 cm² not limited 110 cm² not limited 70 cm² limited to 200W 40 cm² limited to 100W | 118 cm² not limited 107 cm² not limited 66 cm² limited to 120W | 34 cm² maximum Watt must be determined for mode of operation | Similar | | Material | Conductive laminate: Al-foil / PET and medical grade hydrogel Backing: PE-foam Cover: release liner | Conductive laminate: Al-foil / PET and medical grade hydrogel Backing: PE-foam Cover: 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 with ISO 10993-1: | Yes | Yes | Yes | Same | | Manufacturer | BOWA-electronics GmbH & Co. KG | Leonhard Lang GmbH | Leonhard Lang GmbH | Device Comparison | | Trade Name | BOWA Neutral Electrodes | Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 Gel | Skintact® Neutral Electrodes for Neonates | | | 10993-5 and 10993-10 | | | | | | Complies with relevant clauses of IEC 60601-2-2 | Yes | Yes | Yes | Same | | Electrical Safety Testing Passed | Yes | Yes | Yes | Same | | Compatibility with HF Generators (ESU) | Yes, if ESU is equipped with a CQM System which fulfils IEC 60601-1 | Yes, if ESU is equipped with a CQM System which fulfils IEC 60601-1 | Yes, if ESU is equipped with a CQM System which fulfils IEC 60601-1 | Same | | Packaging | Sealed pouch | Sealed pouch | Sealed pouch | Same | | Accessory | For electrodes provided without cable, reusable cable available | For electrodes provided without cable, reusable cable available | For electrodes provided without cable, reusable cable available | Same | # Table 5A – Comparison of Characteristics {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # 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: {9}------------------------------------------------ - . 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.

BOWA Neutral Electrodes

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Indications for Use

Device Story

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Indications for Use

Regulatory Classification

Identification

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Submission Summary (Full Text)

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