(56 days)
No
The summary describes a passive electrosurgical accessory with no mention of AI/ML terms, image processing, or data training/testing.
No
The device is described as an "accessory for HF surgery in monopolar applications" and specifically as a "neutral electrode" that provides a "safe return path for electrosurgical current." This indicates it's a component used within a surgical procedure rather than a device designed to directly treat a disease or condition.
No
The device is described as an accessory for HF surgery (electrosurgery), providing a return path for electrical current. Its function is to complete an electrical circuit, not to diagnose a condition or disease.
No
The device description clearly states it is a physical electrode with conductive and non-conductive adhesive areas, designed to be a physical accessory for HF surgery. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory for HF surgery in monopolar applications, providing a return path for electrosurgical current. This is a therapeutic/surgical function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details the physical components and function related to conducting electrical current during surgery. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
Therefore, this device falls under the category of a surgical accessory or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
GEI
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.
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
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.
Non-clinical performance tests completed to demonstrate safety and effectiveness and substantial equivalence to predicate devices include:
- 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. Testing included: Contact impedance for new and aged devices, Resistance, Shelf-life, Isolation of active accessory, Patient lead.
- Biocompatibility testing per ISO 10993-1, ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Skin Irritation and Sensitization).
- Shelf Life Testing: Real-time aging and subsequent electrical safety testing confirmed a 36-month shelf-life.
- Reprocessing Testing: For the reusable cable, simulating recommended procedures such as manual cleaning and disinfection, automated cleaning and disinfection, and steam sterilization, followed by electrical safety testing of main components.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
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
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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)
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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 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.
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| 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 | |
| |