(88 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of a neutral electrode, with no mention of AI or ML.
No.
The device acts as an accessory for HF-surgery, directing current and creating a circuit, but it doesn't directly deliver therapeutic energy or substances to the patient. It completes the circuit for other devices that perform the therapeutic action.
No
Explanation: The device is described as an accessory for monopolar HF-surgery, acting as a dispersive conductor to return electrical current to a generator after electrosurgery. Its function is therapeutic (to facilitate surgery), not diagnostic (to identify or assess disease).
No
The device description explicitly states it is a "non-sterile non-active dispersive conductor intended to be fastened to a patient," and the performance studies include testing related to physical properties like thermal performance, contact impedance, adhesion, and biocompatibility. These are characteristics of a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that these are "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." This describes a device used during a surgical procedure to manage electrical current, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces this by stating it's 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." This is a functional component of an electrosurgical system, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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".
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Muscular or well vascularized convex skin site, as close as possible to the operating field
Indicated Patient Age Range
Neonates, Children, Adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data
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.
· 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 ) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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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
- 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)
Children and Adults
Between 5 and
15kg (11 to 33lbs)
Children