Who is the manufacturer of Nissha Medical Technologies Neutral Electrodes?

Nissha Medical Technologies, Ltd. filed the 510(k) submission for Nissha Medical Technologies Neutral Electrodes (K203494).

What is the FDA product code for Nissha Medical Technologies 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 Nissha Medical Technologies Neutral Electrodes?

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

What are the predicate devices for Nissha Medical Technologies Neutral Electrodes?

BOWA Neutral Electrodes (K173877).

Who can help prepare an FDA 510(k) submission like Nissha Medical Technologies 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.

Nissha Medical Technologies Neutral Electrodes

K203494 · Nissha Medical Technologies, Ltd. · GEI · Feb 23, 2021 · General, Plastic Surgery

Device Facts

Record ID	K203494
Device Name	Nissha Medical Technologies Neutral Electrodes
Applicant	Nissha Medical Technologies, Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Feb 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Pediatric

Intended Use

Nissha Medical Technologies Neutral Electrodes - SWAROPLATE: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A2s in a 60 s period occur. Nissha Medical Technologies Neutral Electrodes - Boston Scientific: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4™ and 1A/1B Radiofrequency Generators".

Device Story

Neutral electrodes function as non-sterile, single-use, dispersive return path for electrical current during monopolar HF-surgery; device provides large-area, low-impedance contact with patient skin. Electrodes are self-adhesive and applied to well-vascularized, convex skin sites near the surgical field. Device completes circuit between patient and electrosurgical generator (ESU). Used in clinical settings by healthcare professionals. Benefits include safe return of high-frequency current to prevent thermal injury at the electrode site. Device is passive; no active processing or software.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including thermal performance, contact impedance, adhesion, shelf-life, and electrical safety per IEC 60601-2-2 and IEC 60601-1. Biocompatibility testing performed per ISO 10993-1, 10993-5 (cytotoxicity), and 10993-10 (irritation/sensitization).

Technological Characteristics

Multi-layer construction: PE-foam backing, conductive laminate (Al-foil/PET), and medical-grade conductive adhesive hydrogel. Dimensions vary by patient population (neonates to adults). Connectivity: passive, wired (3m cable) or cable-ready. Sterilization: non-sterile. Complies with IEC 60601-2-2 and ISO 10993.

Indications for Use

Indicated for use as a dispersive return electrode for monopolar high-frequency (HF) electrosurgery in neonates, children, and adults. Contraindicated for use in High Current Mode (applications with heating factors >30 A2s in a 60s period).

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

BOWA Neutral Electrodes (K173877)

Related Devices

K173877 — BOWA Neutral Electrodes · Bowa-Electronics GmbH & Co. KG · Feb 15, 2018
K984276 — DISPOSABLE ELECTROSURGERY GROUNDING PAD · E & M Engineering, Inc. · Feb 10, 1999
K251235 — Electrosurgical Pads · Baisheng Medical Co., Ltd. · Jun 19, 2025
K132136 — SINGLE USE GROUNDING PAD · Lccs Products Limited · Sep 6, 2013
K160366 — Electrosurgical disposable grounding pads · Top-Rank Health Care Co., Ltd. · Aug 19, 2016

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: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products. February 23, 2021 Nissha Medical Technologies LTD Marcel Salchner Director of European Quality, Regulatory & Innovation Torbay Business Park, Woodview Road Paignton, Devon TQ4 7HP United Kingdom Re: K203494 Trade/Device Name: Nissha Medical Technologies 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 29, 2020 Received: December 30, 2020 Dear Marcel Salchner: 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/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-devices/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 (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-regulatoryassistance/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 Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K203494 Device Name Nissha Medical Technologies Neutral Electrodes Indications for Use (Describe) Nissha Medical Technologies Neutral Electrodes - SWAROPLATE: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A2s in a 60 s period occur. Nissha Medical Technologies Neutral Electrodes - Boston Scientific: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4™ and 1A/1B Radiofrequency Generators". | Type of Use ( Select one or both, as applicable ) | | |--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | **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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" written in smaller, light gray letters. The logo is simple and modern. # 510(k) Summary Nissha Medical Technologies Neutral Electrodes # 1) Submission Sponsor/Correspondent Nissha Medical Technologies Ltd. Torbay Business Park, Woodview Road Paignton, Devon TQ4 7HP United Kingdom Establishment Registration Number: 3008933393 Contact: Marcel Salchner Title: Director of European Quality, Regulatory & Innovation Phone: +43 512 219313 Email: msalchner@nisshamedical.com 2) Date Prepared 2020-12-29 #### 3) Device Identification Trade Name: Nissha Medical Technologies Neutral Electrodes Common Name: Neutral Electrodes Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Device Class: Class II Review Panel: General & Plastic Surgery # 4) Legally Marketed Predicate Device(s) | Manufacturer | BOWA-electronics GmbH & Co. KG | |---------------|-----------------------------------| | Trade Name | BOWA Neutral Electrodes | | 510(k) Number | K173877 Primary predicate | #### 5) Indication for Use Statement Nissha Medical Technologies Neutral Electrodes - SWAROPLATE: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HFgenerator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A2s in a 60 s period occur. 002_510(k)_Summary {4}------------------------------------------------ #### Nissha Medical Technologies Neutral Electrodes - 510(k) Submission Nissha Medical Technologies Neutral Electrodes - Boston Scientific: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HFgenerator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4TM and 1A/1B Radiofrequency Generators''. #### 6) Device Description A neutral electrode is a non-sterile non-active dispersive conductor intended to be fastened to a patient and connected to an electrosurgical diathermy generator, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. It is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This medical device is intended for single-use. #### 7) Substantial Equivalence Discussion The following table compares the Nissha Medical Technologies 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. | Manufacturer | BOWA-electronics GmbH & Co. KG | Nissha Medical Technologies Ltd. | Device Comparison | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | Trade Name | BOWA Neutral Electrodes | Nissha Medical Technologies Neutral Electrodes | N/A | | 510(k) Number | K173877 | K203494 | N/A | | Product Code | GEI | GEI | Same | | Regulation Number | 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 | 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 | Nissha Medical Technologies Neutral Electrodes - SWAROPLATE: Neutral electrodes are an accessory for monopolar HF- surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF- | Wording is different, but the Intended Use is identical | | Manufacturer | BOWA-electronics GmbH & Co. KG | Nissha Medical Technologies Ltd. | Device Comparison | | | complete the electrical circuit between the patient and the HF generator on the passive side. | generator. Neutral electrodes are self-adhesive, ready-to- use disposable products. The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A²s in a 60 s period occur. Nissha Medical Technologies Neutral Electrodes – Boston Scientific: Neutral electrodes are an accessory for monopolar HF- surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF- generator. Neutral electrodes are self-adhesive, ready-to- use disposable products. The Boston Scientific Neutral Electrodes REF DGP-PMC2- 5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP- PM2-25 are intended to be used in combination with the devices "Boston Scientific G4TM and 1A/1B Radiofrequency Generators". | | | Prescription or OTC | Prescription | Prescription | Same | | | 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. | | | Mechanism of Action | | | Same | | Technology Overview | Multi-layer device | Multi-layer device | Similar | | Manufacturer | BOWA-electronics GmbH & Co. KG | Nissha Medical Technologies Ltd. | Device Comparison | | | Backing material Conductive layer Conductive adhesive hydrogel Cover material | Backing material Conductive layer Conductive adhesive hydrogel Cover material | | | Population | Neonates, Children, Adults | Neonates, Children, Adults | Same | | 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 | Same | | | >15kg (33lbs) Adults | >15kg (33lbs) Adults | | | Weight range according to IEC 60601-2-2 | >5kg (11lbs) Children and Adults Between 5 and 15kg (11 to 33lbs) Children <5kg (11lbs) Neonates | >5kg (11lbs) Children and Adults Between 5 and 15kg (11 to 33lbs) Children <5kg (11lbs) Neonates | Same | | Conductive area | 140 cm² Adults 110 cm² Children and Adults 70 cm² Children 40 cm² Neonates | 128-170 cm² Adults 105 - 110 cm² Children and Adults 71 - 72 cm² Children 32-37 cm² Neonates | Similar | | | 140 cm² not limited | Adults not limited | | | Power | 110 cm² not limited 70 cm² limited to 200W 40 cm² limited to 100W | Children and Adults not limited Children limited to 250W Neonates limited to 150W | 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 | Same | | Cable length for pre- wired electrodes | 3 meters | 3 meters | Same | #### Table 1 - Comparison of Characteristics 002 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" in smaller, gray letters. # Nissha Medical Technologies Neutral Electrodes – 510(k) Submission 002_510(k)_Summary 3 {6}------------------------------------------------ Image /page/6/Picture/6 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is in large, blue, sans-serif font. Below the word "NISSHA" are the words "MEDICAL TECHNOLOGIES" in a smaller, gray, sans-serif font. Nissha Medical Technologies Neutral Electrodes – 510(k) Submission 002_510(k)_Summary 4 {7}------------------------------------------------ | Image: NISSHA logo | | | |--------------------|--------------|--| | MEDICAL | TECHNOLOGIES | | # Nissha Medical Technologies Neutral Electrodes - 510(k) Submission | Manufacturer | BOWA-electronics GmbH & Co. KG | Nissha Medical Technologies Ltd. | Device Comparison | |----------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Sterile | Non-sterile | Non-sterile | Same | | Single-Use / disposable | Yes | Yes | Same | | Shelf Life | 36 months | 24 months | Similar | | Complies with ISO 10993-1; 10993- 5 and 10993-10 | Yes | Yes | Same | | Complies with relevant clauses of IEC 60601-2-2 | Yes | Yes | Same | | Electrical Safety Testing Passed | Yes | Yes | Same | | Compatibility with HF Generators (ESU) | Yes, if ESU is equipped with a CQM System which fulfils IEC 60601-1 | Yes, several ESUs have been evaluated for compatibility and a "Declaration of Compatibility" is available for end-users. | Similar | | Packaging | Sealed pouch | Sealed pouch | Same | | Accessory | For electrodes provided without cable, reusable cable available | For electrodes provided without cable, reusable cable available | Same | # 8) Non-Clinical Performance Data As part of demonstrating safety and effectiveness of Nissha Medical Technologies Neutral Electrodes and in showing substantial equivalence to the predicate devices, Nissha Medical Technologies completed several non-clinical performance tests. The Nissha Medical Technologies Neutral Electrodes meet all the requirements for overall design, biocompatibility and electrical safety with results confirming that the design output meets the design inputs and specifications for the devices. The Nissha Medical Technologies Neutral Electrodes passed all the testing in accordance with internal requirements, and international standards shown below to support substantial equivalence of the predicate devices: · The device passed performance testing conducted according to standard IEC 60601-2-2:2017 "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: Thermal performance, Contact impedance, Adhesion, Shelf-life, Cord attachment, Cord connector and Cord insulation. · Biocompatibility testing per ISO 10993-1 confirmed that the finished devices are biocompatible, and do not induce new risks. Testing per ISO 10993-5 Cytotoxicity was showing a slight reactivity, and ISO 10993-10 (Skin Irritation and Sensitization) was showing no adverse results. 002_510(k)_Summary {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for Nissha Medical Technologies. The word "NISSHA" is in large, blue, sans-serif font. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is simple and modern. · Shelf Life Testing – According to accelerated aging of the Nissha Medical Technologies Neutral Electrodes and subsequent electrical safety testing, as it is required in subclause 201.15.101.8 of the standard IEC 60601-2-2, it has been demonstrated that the Nissha Medical Technologies Neutral Electrodes can be labeled with a shelf-life of 24 months. #### 9) 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. #### 10) 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. All the comparisons described in this document clearly show that the neutral electrodes from Nissha Medical Technologies are substantially equivalent to the competitor products from BOWA. Despite small differences in detail, all products comply with the state of the art and are suitable for the intended use.