(61 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of the neutral electrode, with no mention of AI or ML technologies. The device's function is to complete an electrical circuit, which is a standard electrosurgical principle.
No.
The device is an accessory used to complete an electrical circuit during electrosurgery, which is a therapeutic procedure, but the device itself does not provide therapy. It is a return electrode designed to prevent burns during the electrosurgical procedure.
No
Explanation: The device, a disposable neutral electrode, is used to complete an electrical circuit during electrosurgery. Its function is to provide a low-impedance path back to the generator to prevent burns, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like foam backing, aluminum foil, conductive adhesive gel, and a release liner. It also mentions cables and compatibility with electrosurgical generators, indicating a hardware-based 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 used to complete an electrical circuit during electrosurgery. This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description details the physical components and how they function in an electrical circuit for electrosurgery. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on electrical safety, thermal performance, adhesion, and biocompatibility – all relevant to a surgical accessory, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is entirely within the realm of surgical intervention.
N/A
Intended Use / Indications for Use
Disposable neutral electrodes are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).
Product codes
GEI
Device Description
Disposable neutral electrodes are part of a family of patient return electrodes. They are non-sterile, single-use devices used in electrosurgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrodes helps to prevent unintended HF burns. The solid electrosurgical pads are designed to be compatible with generators without Contact Quality Monitoring System (CQMS), and the split electrosurgical pads are designed to be compatible with the Contact Quality Monitoring System (CQMS) of compatible generators. The models share the same design elements (functional design, technology design, packaging, etc.) but have different sizes and shapes. The models are designed for adults, children, and neonates, separate catalog numbers are assigned for the intended patients, and pre-attached cord.
Disposable neutral electrodes consist of foam backing, cable connection area, conductive aluminum foil, conductive adhesive gel layer and release liner. The pads are applied on a release liner. The surface of the conductive aluminum foil is fully covered with a soft, conformable conductive adhesive gel.
The electrode backing is made of foam material. The electrodes are supplied with or without cable. For the non-corded pads, a reusable cable is not available as an accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Select a well convex area (muscle) next to the area to be operated but at least 20 cm far from it, possibly on the forearm, on the thigh or on a whip.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
September 25, 2024
Dongguan Quanding Medical Supplies Co., Ltd. % Jett Li Regulation Manager Guangzhou KEADA Biological Tech Co., Ltd. 6F, No.1 TianTai road Science City, LuoGang District GuangZhou, Guangdong 510000 China
Re: K242204
Trade/Device Name: Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI
Dated: January 23, 2024 Received: July 26, 2024
Dear Jett Li:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-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 Advice (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
2
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,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.09.25 09:02:55 -04'00'
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
Indications for Use (Describe)
Disposable neutral electrodes are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1 510 (k) submitter
1.1 Sponsor
Company Name: Dongguan Quanding Medical Supplies Co., Ltd.
Address: No.3 Yongfa East Road, Dongshan, Qishi Town, Dongguan City, Guangdong, China
Phone: +86- 189 2372 2306
Email: 2851139778@qq.com
Contact Person (including title): Grace Zhao (General Manager)
1.2 Application Correspondent
Guangzhou KEADA Biological Tech Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China Contact Person: Mr. Jett Li Title: Regulation Manager Tel: +86-13512755282 Email: jianda-lee@foxmail.com
2 Date Prepared
2024-01-23
3 Subject Device Information
- Trade Name: Disposable Neutral Electrodes
- Common Name: Disposable Neutral Electrodes
- Classification Name: Electrosurgical cutting and coagulation device and accessories
5
- Review Panel: General & Plastic Surgery
- Product Code: GEI
- Regulation Number: 21 CFR 878.4400
- Regulation Class: 2
4 Predicate device Information
Legally marketed device K203494 Trade Name: Nissha Medical Technologies Neutral Electrodes Classification Name: Electrosurgical cutting and coagulation device and accessories Review Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Regulation Class: 2
5 Device Description
Disposable neutral electrodes are part of a family of patient return electrodes. They are non-sterile, single-use devices used in electrosurgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrodes helps to prevent unintended HF burns. The solid electrosurgical pads are designed to be compatible with generators without Contact Quality Monitoring System (CQMS), and the split electrosurgical pads are designed to be compatible with the Contact Quality Monitoring System (CQMS) of compatible generators. The models share the same design elements (functional design, technology design, packaging, etc.) but have different sizes and shapes. The models are designed for adults, children, and neonates, separate catalog numbers are assigned for the intended patients, and pre-attached cord.
Disposable neutral electrodes consist of foam backing, cable connection area, conductive aluminum foil, conductive adhesive gel layer and release liner. The pads are applied on a release liner. The surface of the conductive aluminum foil is fully covered with a soft, conformable conductive adhesive gel.
6
The electrode backing is made of foam material. The electrodes are supplied with or without cable. For the non-corded pads, a reusable cable is not available as an accessory.
6 Indications for Use
Disposable neutral electrodes are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).
| IEC60601-1 | Medical electrical equipment -Part 1: General requirements
for basic safety and essential performance |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance -
Collateral Standard: Electromagnetic disturbances -
Requirements and tests |
| 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. |
| ISO 10993-5:2009 | biological evaluation of medical devices -- part 5: tests for in
vitro cytotoxicity. |
| ISO 10993-10:2010 | biological evaluation of medical devices - part 10: tests for
skin sensitization. |
| ISO 10993-23: 2021 | biological evaluation of medical devices - part 10: tests for
irritation |
7 Complied Standards
7
8 Performance Testing
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 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.
9 Biocompatibility
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.
10 Clinical Performance
No human clinical testing is required to support the medical device as the intended use is equivalent
8
to the predicate devices. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11 Comparison with Predicate Device
| Description | Subject Device | Predicate Device | Device Comparison | ||
|---|---|---|---|---|---|
| Manufacturer | Dongguan Quanding | ||||
| Medical Supplies Co., Ltd. | Nissha Medical | ||||
| Technologies Ltd. | - | ||||
| 510(k) Number | - | K203494 | - | ||
| 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 indicated for use to | |||||
| adhere to the patient over the | |||||
| entire pad surface to | |||||
| complete an electrical circuit | |||||
| during electrosurgery | |||||
| between the electrosurgical | |||||
| generator, the active | |||||
| electrode and the patient. | |||||
| Solid Electrosurgical pads | |||||
| are for use with generators | |||||
| that do not have a Contact | |||||
| Quality Monitoring System | |||||
| (CQMS). Split | |||||
| Electrosurgical pads are for | |||||
| use with generators that have | |||||
| a CQMS (i.e. | |||||
| REM,ARM,NESSY etc.). | 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. | Words is | ||||
| different, but the | |||||
| Indications for | |||||
| Use is identical | |||||
| Description | Subject Device | Predicate Device | Device | ||
| Comparison | |||||
| 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". | |||||
| Prescription or | |||||
| OTC | Prescription | Prescription | Same | ||
| Mechanism of | |||||
| Action | Disposable neutral electrodes | ||||
| are indicated for use to | |||||
| adhere to the patient over the | |||||
| entire pad surface to | |||||
| complete an electrical circuit | |||||
| during electrosurgery | |||||
| between the electrosurgical | |||||
| generator, the active | |||||
| electrode and the patient. | Neutral electrodes serve to | ||||
| return the current from the | |||||
| patient to the electrosurgical | |||||
| unit (ESU) during HF | |||||
| surgery in monopolar | |||||
| application. | Words is | ||||
| different, but the | |||||
| Mechanism of | |||||
| Action is identical | |||||
| Technology | |||||
| Overview | Multi-layer device consisting | ||||
| of: | Multi-layer device | ||||
| consisting of: | Similar | ||||
| Description | Subject Device | Predicate Device | Device | ||
| Comparison | |||||
| Conductive aluminum foil | |||||
| Backing material | |||||
| Conductive adhesive gel | |||||
| layer | |||||
| Release liner | Backing material | ||||
| Conductive layer | |||||
| Conductive adhesive | |||||
| hydrogel | |||||
| Cover material | |||||
| Population | Neonates, Children, Adults | Neonates, Children, Adults | Same | ||
| Anatomical | |||||
| Location | Select a well convex area | ||||
| (muscle) next to the area to | |||||
| be operated but at least 20 | |||||
| cm far from it, possibly on | |||||
| the forearm, on the thigh or | |||||
| on a whip. | Muscular or well | ||||
| vascularized convex skin | |||||
| site, as close as possible to | |||||
| the operating field | Similar | ||||
| Weight range | |||||
| according to | |||||
| IEC 60601-2-2 | >15kg: Adults | ||||
| Between 5 and 15kg: | |||||
| Children | |||||
| 15kg (33lbs) Adults |
5kg (11lbs) Children and
Adults
Between 5 and 15kg (11 to
33lbs) Children
15kg Adults: 130-173 cm²
Between 5 and 15kg
Children: 65-94cm²