Disposable Grounding Pad

K231985 · Shenzhen Mecun Medical Supply Co., Ltd. · GEI · Feb 16, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K231985
• Device Name: Disposable Grounding Pad
• Applicant: Shenzhen Mecun Medical Supply Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The disposable grounding pad is an accessory for high-frequency surgery in monopolar applications. It is self-adhesive, ready-to-use, disposable, and single-patient-use.

Device Story

Disposable grounding pad functions as a return electrode for monopolar electrosurgery; completes electrical circuit between patient and high-frequency (HF) generator. Device consists of conductive adhesive hydrogel layer, aluminum foil/PET conductive laminate, PE-foam backing, and release liner. Applied to patient's muscular or well-vascularized convex skin site near surgical field. Compatible with HF generators equipped with Contact Quality Monitoring (CQM) systems; triggers alarm if safe contact is lost. Used in clinical settings by healthcare professionals. Benefits include safe return of electrical current to generator, preventing patient burns. Single-patient use; disposable.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing per IEC 60601-2-2. Accelerated aging validated a 2-year shelf-life.

Technological Characteristics

Multi-layer construction: PE-foam backing, Al-foil/PET conductive laminate, medical-grade conductive adhesive hydrogel. Dimensions: 124 cm² conductive area. Connectivity: Wired connection to HF generator. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-5, ISO 10993-10. Non-sterile, single-use.

Indications for Use

Indicated for adult patients (>15kg) undergoing high-frequency monopolar electrosurgery. Used as a return electrode to complete the electrical circuit between the patient and the electrosurgical generator.

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)

Submission Summary (Full Text)

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February 16, 2024

Shenzhen Mecun Medical Supply Co., Ltd. Zheng Bo General Manager 2nd Level. 2nd Building, Fuqiang S&T Park, 6 Ailian Industrial Park, Zhugushi, Wulian Community Shenzhen, Guangdong province 518000, China

#### Re: K231985

Trade/Device Name: Disposable Grounding Pad Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 5, 2023 Received: July 5, 2023

#### Dear Zheng Bo:

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 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).

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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 OS 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.

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 mediation-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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.16
13:44:10 -05'00' Mark Trumbore, 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

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# Indications for Use

510(k) Number (if known)

Device Name Disposable Grounding Pad

Indications for Use (Describe)

The disposable grounding pad is an accessory for high-frequency surgery in monopolar applications. It is self-adhesive, ready-to-use, disposable, and single-patient-use.

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

This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.

#### 1. Submitter

| Submitter's Name | Shenzhen Mecun Medical Supply Co., Ltd. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Zheng Bo |
| Address | 2nd Level, 2nd Building, Fuqiang S&T Park, 6 Ailian<br>Industrial Park, Zhugushi, Wulian Community, Longgang<br>Street, Longgang District, Shenzhen City, China |
| Telephone | [phone] |
| Fax number | [phone] |
| E-mail | [e-mail]; [e-mail] |
| Data preparation | February 10, 2024 |

#### 2. Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|----------------------------------------------------------------|
| Trade Name: | Disposable grounding pad |
| Model | MA2000-WAB |
| Classification name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | II |
| Review Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Regulation Number: | 878.4400 |

## 3. Predicate Device Information

| Trade Name | BOWA Neutral Electrodes |
|---------------------|-------------------------------------------------------------------|
| 510(k) Number | K173877 |
| Classification name | Electrosurgical cutting and coagulation device and<br>accessories |
| Classification: | II |
| Review Panel: | General & Plastic Surgery |
| Product code | GEI |
| Regulation No. | 878.4400 |

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#### 4. Device Descriptions

Mecun disposable grounding pad has a cable and a neutral electrode, the electrode consists of a conductive adhesive area surrounded by a non-conductive border.

The neutral electrode is intended to be equipped with a compatible generator which has a CQM, loss of safe contact between the neutral electrode and the patient will result in an alarm.

The disposable grounding pad is a non-sterile, non-active conductor intended to be fastened to a patient and connected to a high frequency surgical equipment, 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 disposable and single-patient use.

#### 5. Indications for Use

The disposable grounding pad is an accessory for high-frequency surgery in monopolar applications. It is self-adhesive, ready-to-use, disposable, and single-patient-use.

#### 6. Comparisons of technological characteristics with the predicate device

The subject disposable grounding pad and BOWA neutral electrodes (K173877) are similar in intended use, compositions, functions, scientific technology, materials and method of operation, the following table provides a comparison summary:

| Comparison<br>item | Subject Device | Predicate Device (K173877) | |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Manufacturer | Shenzhen Mecun Medical<br>Supply Co., Ltd. | BOWA-electronics GmbH & Co.<br>KG | Remark |
| Product name | Disposable Grounding Pad | BOWA Neutral Electrodes | |
| Product Code | GEI | GEI | Same |
| Regulation<br>Number | 878.4400 | 878.4400 | Same |
| Classification | II | II | Same |
| Intended<br>use&<br>Indication<br>s for Use | The disposable grounding pad<br>is an accessory for high-<br>frequency surgery in<br>monopolar applications. It is<br>self-adhesive, ready-to-use,<br>disposable, and single-patient-<br>use. | Disposable neutral electrodes<br>are self-adhesive, ready-to-use<br>and single-use products and are<br>an accessory for HF surgery in<br>monopolar applications. The<br>electrodes complete the<br>electrical circuit between the<br>patient and the HF generator on<br>the passive side. | Same |
| Prescription or<br>OTC | Prescription | Prescription | Same |
| Mechanism of<br>Action | Neutral electrodes serve to<br>return the current from the<br>patient to the electrosurgical<br>unit (ESU) during HF-surgery<br>in Monopolar application. | Neutral electrodes serve to<br>return the current from the<br>patient to the electrosurgical unit<br>(ESU) during HF-surgery in<br>Monopolar application. | Same |
| Technology<br>overview | Multi-layer device consists of:<br>Backing material;<br>Conductive layer; | Multi-layer device consists of:<br>Backing material;<br>Conductive layer; | Same |
| | Conductive adhesive<br>hydrogel;<br>Cover material | Conductive adhesive hydrogel;<br>Cover material | |
| Intended<br>population | Adult | Neonates, Children, Adults | Similar<br>(included) |
| Anatomical<br>location | Muscular or well vascularized<br>convex skin site, as close as<br>possible to the operating field | Muscular or well vascularized<br>convex skin site, as close as<br>possible to the operating field | Same |
| Weight range<br>according to<br>IEC 60601-2-2 | >15kg (33lbs)<br>Adults | >15kg (33lbs) Adults<br>>5kg (11lbs) Children and Adults<br>Between 5 and 15kg (11 to<br>33lbs) Children<br><5kg (11lbs) Neonates | Similar<br>(included) |
| Conductive<br>area | 124 cm² Adults | 140 cm² Adults<br>110 cm² Children and Adults<br>70 cm² Children<br>40 cm² Neonates | Similar<br>(included) |
| Material | Conductive laminate: Al-<br>foil/PET and medical grade<br>hydrogel<br>Backing: PE-foam<br>Cover: release liner | Conductive laminate: Al-foil/PET<br>and medical grade hydrogel<br>Backing: PE-foam<br>Cover: release liner | Same |
| Maximum<br>power rating | 124 cm²: 400W | 140 cm² not limited<br>110 cm² not limited<br>70 cm² limited to 200W<br>40 cm² limited to 100W | Similar<br>(included) |
| Maximum<br>current density<br>(power setting:<br>400W, load:<br>500Ω) | 6.29 mA/cm²<br>(Electrode pad: 124cm²) | 5.79 mA/cm² (Electrode pad:<br>140cm²)<br>6.45 mA/cm² (Electrode pad:<br>110cm²) | Similar<br>(included) |
| Maximum<br>power density | Adult type: 3.23W/cm² | Adult type: not limited | Similar<br>(included) |
| Maximum<br>permitted<br>voltage for the<br>cable | 500 Vp | 500 Vp | Same |
| Self-adhesive | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Single-<br>use/disposable | Yes | Yes | Same |
| Shelf-life | 2 years | 3 years | Note 1 |
| Biocompatibility | ISO10993-5, ISO10993-10 | ISO10993-5, ISO10993-10 | Same |
| Electrical<br>Performance<br>and Safety | IEC60601-1, IEC60601-1-2,<br>ISO60601-2-2 | IEC60601-1, IEC60601-1-2,<br>ISO60601-2-2 | Same |
| Compatibility<br>with HF<br>generators<br>(ESU) | Yes, if ESU is equipped with a<br>CQM system which fulfils IEC<br>60601-1 | Yes, if ESU is equipped with a<br>CQM system which fulfils IEC<br>60601-1 | Same |
| Accessory | Provide with cable | Provide with or without cable | Similar<br>(included) |

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Note 1:

The shelf-life of subject device has been validated by accelerated aging test, the difference does not raise any new safety and effectiveness issue.

# 7. Performance data

The subject device conforms to the following standards:

- 7.1 Biocompatibility testing
The biocompatibility evaluation for Neutral electrode was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The subject device is contacted with patient's intact skin during the electrosurgery operation for duration of less than 24 hours. The biocompatibility testing includes the following:

- . Cytotoxicity
- Intracutaneous Reactivity .
- Skin Sensitization .

7.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the following standards:

- . IEC 60601-1: 2005 + A1:2012 + A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: 2014 + A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC
- . 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

## 7.3 Performance of appearance and size

The appearance and size of the disposable grounding pad, 3 lots of pads and 5 pieces for each were inspected, the testing results showed the appearance and size of the proposed device met the design requirements.

## 8. Conclusions

Based on device comparison information and performance data, the subject device is as safety and effectiveness as predicate device, and the differences do not raise any new issue of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.