(226 days)
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.
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.
The provided text describes the 510(k) premarket notification for a "Disposable Grounding Pad" (K231985). This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of the device's clinical performance against detailed acceptance criteria in the way one might see for a diagnostic AI device.
Therefore, the requested information elements related to "acceptance criteria," "reported device performance," "sample size," "ground truth," "expert qualifications," "adjudication method," "MRMC study," and "standalone performance" are not applicable in the context of this regulatory submission for a medical accessory like a disposable grounding pad.
Instead, the submission demonstrates adherence to recognized standards and verifies physical and electrical properties.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
Since this is not a performance study in the diagnostic sense, there isn't a direct "acceptance criteria" table for diagnostic accuracy. Instead, the device is evaluated against recognized standards and design requirements. The "performance data" section details compliance with these standards.
| Acceptance Criteria (Standards & Requirements) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility (ISO 10993-1, -5, -10) | - Cytotoxicity testing conducted.- Intracutaneous Reactivity testing conducted.- Skin Sensitization testing conducted.Result: Passed, in accordance with ISO 10993-1, -5, -10. |
| Electrical Safety (IEC 60601-1: 2005 + A1:2012 + A2:2020) | Result: Complies with the standard. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2: 2014 + A1:2020) | Result: Complies with the standard. |
| Particular Requirements for HF Surgical Equipment Accessories (IEC 60601-2-2:2017) | Result: Complies with the standard. |
| Appearance and Size (Design Requirements) | Inspections performed on 3 lots (5 pieces each).Result: Met design requirements. |
| Shelf-life | Validated by accelerated aging test. The difference (2 years for subject device vs. 3 years for predicate) does not raise new safety/effectiveness issues. |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Appearance and Size Inspection: 3 lots, 5 pieces per lot (total 15 units).
- Biocompatibility, Electrical Safety, EMC: The text does not specify the sample size for these tests, which typically involve a representative number of units to demonstrate compliance with the respective standards. The tests are for the device itself, not on patient data.
- Data Provenance: The tests are performed on the manufactured device itself, not on patient data. Thus, "country of origin of the data" and "retrospective or prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The "ground truth" for this type of device (a passive accessory) is based on engineering specifications and compliance with recognized safety and performance standards. No experts were used to establish a "ground truth" in the clinical diagnostic sense. Compliance with standards is typically verified by testing laboratories or internal quality control.
4. Adjudication method for the test set:
This is not applicable. There was no need for adjudication as the device is not making a diagnostic claim or involving subjective interpretation. Performance is measured against objective engineering and biological safety standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a "Disposable Grounding Pad," an accessory for electrosurgery. It is not an AI diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a passive medical accessory, not an algorithm or software-driven device.
7. The type of ground truth used:
The "ground truth" is established by the recognized international and national standards (e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC) and the device's design specifications for physical properties.
8. The sample size for the training set:
This is not applicable. There is no training set as this is not an AI/machine learning product.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 AilianIndustrial Park, Zhugushi, Wulian Community, LonggangStreet, Longgang District, Shenzhen City, China |
| Telephone | +86-755-86062204 |
| Fax number | +86-755-86062204 |
| james@szcsqy.com; manager@mecun.com | |
| 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 andaccessories |
| 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:
| Comparisonitem | Subject Device | Predicate Device (K173877) | |
|---|---|---|---|
| Manufacturer | Shenzhen Mecun MedicalSupply Co., Ltd. | BOWA-electronics GmbH & Co.KG | Remark |
| Product name | Disposable Grounding Pad | BOWA Neutral Electrodes | |
| Product Code | GEI | GEI | Same |
| RegulationNumber | 878.4400 | 878.4400 | Same |
| Classification | II | II | Same |
| Intendeduse&Indications for Use | The disposable grounding padis an accessory for high-frequency surgery inmonopolar applications. It isself-adhesive, ready-to-use,disposable, and single-patient-use. | Disposable neutral electrodesare self-adhesive, ready-to-useand single-use products and arean accessory for HF surgery inmonopolar applications. Theelectrodes complete theelectrical circuit between thepatient and the HF generator onthe passive side. | Same |
| Prescription orOTC | Prescription | Prescription | Same |
| Mechanism ofAction | Neutral electrodes serve toreturn the current from thepatient to the electrosurgicalunit (ESU) during HF-surgeryin Monopolar application. | Neutral electrodes serve toreturn the current from thepatient to the electrosurgical unit(ESU) during HF-surgery inMonopolar application. | Same |
| Technologyoverview | Multi-layer device consists of:Backing material;Conductive layer; | Multi-layer device consists of:Backing material;Conductive layer; | Same |
| Conductive adhesivehydrogel;Cover material | Conductive adhesive hydrogel;Cover material | ||
| Intendedpopulation | Adult | Neonates, Children, Adults | Similar(included) |
| Anatomicallocation | Muscular or well vascularizedconvex skin site, as close aspossible to the operating field | Muscular or well vascularizedconvex skin site, as close aspossible to the operating field | Same |
| Weight rangeaccording toIEC 60601-2-2 | >15kg (33lbs)Adults | >15kg (33lbs) Adults>5kg (11lbs) Children and AdultsBetween 5 and 15kg (11 to33lbs) Children<5kg (11lbs) Neonates | Similar(included) |
| Conductivearea | 124 cm² Adults | 140 cm² Adults110 cm² Children and Adults70 cm² Children40 cm² Neonates | Similar(included) |
| Material | Conductive laminate: Al-foil/PET and medical gradehydrogelBacking: PE-foamCover: release liner | Conductive laminate: Al-foil/PETand medical grade hydrogelBacking: PE-foamCover: release liner | Same |
| Maximumpower rating | 124 cm²: 400W | 140 cm² not limited110 cm² not limited70 cm² limited to 200W40 cm² limited to 100W | Similar(included) |
| Maximumcurrent density(power setting:400W, load:500Ω) | 6.29 mA/cm²(Electrode pad: 124cm²) | 5.79 mA/cm² (Electrode pad:140cm²)6.45 mA/cm² (Electrode pad:110cm²) | Similar(included) |
| Maximumpower density | Adult type: 3.23W/cm² | Adult type: not limited | Similar(included) |
| Maximumpermittedvoltage for thecable | 500 Vp | 500 Vp | Same |
| Self-adhesive | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Single-use/disposable | Yes | Yes | Same |
| Shelf-life | 2 years | 3 years | Note 1 |
| Biocompatibility | ISO10993-5, ISO10993-10 | ISO10993-5, ISO10993-10 | Same |
| ElectricalPerformanceand Safety | IEC60601-1, IEC60601-1-2,ISO60601-2-2 | IEC60601-1, IEC60601-1-2,ISO60601-2-2 | Same |
| Compatibilitywith HFgenerators(ESU) | Yes, if ESU is equipped with aCQM system which fulfils IEC60601-1 | Yes, if ESU is equipped with aCQM system which fulfils IEC60601-1 | Same |
| Accessory | Provide with cable | Provide with or without cable | Similar(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.
§ 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.