(226 days)
Not Found
No
The description focuses on the physical and electrical properties of a disposable grounding pad, with no mention of AI or ML capabilities.
No
The device is described as an accessory for high-frequency surgery, specifically a disposable grounding pad, which acts as a conductor for the return of electrical current to a generator after electrosurgery. Its purpose is to complete an electrical circuit rather than to directly deliver therapeutic energy or substances to treat a condition.
No
The device is a disposable grounding pad used in high-frequency electrosurgery to complete an electrical circuit for therapeutic purposes (surgery), not to diagnose a condition.
No
The device description clearly outlines physical components like a cable, neutral electrode, conductive adhesive area, and non-conductive border, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems.
- Device Function: The description clearly states the device is a "disposable grounding pad" used as an "accessory for high-frequency surgery in monopolar applications." Its function is to create a circuit for the return of electrical current during electrosurgery.
- No Specimen Examination: The device does not interact with or analyze any specimens derived from the human body (like blood, urine, tissue, etc.) for diagnostic purposes.
- Direct Patient Contact: The device is applied directly to the patient's skin to facilitate the surgical procedure, not to analyze a sample from the patient.
Therefore, the intended use and function of this device fall outside the scope of In Vitro Diagnostics. It is a surgical accessory used in conjunction with electrosurgical equipment.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
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.
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
Adult
Intended User / Care Setting
Prescription Use
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)
- Biocompatibility testing: conducted in accordance with the International Standard ISO 10993-1. Testing includes Cytotoxicity, Intracutaneous Reactivity, and Skin Sensitization.
- Electrical safety and electromagnetic compatibility (EMC) testing: results show compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Performance of appearance and size: 3 lots of pads and 5 pieces for each were inspected, testing results showed the appearance and size met design requirements.
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 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).
1
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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3
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 |
| Industrial Park, Zhugushi, Wulian Community, Longgang | |
| Street, 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 and |
| accessories | |
| Classification: | II |
| Review Panel: | General & Plastic Surgery |
| Product code | GEI |
| Regulation No. | 878.4400 |
4
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
| item | Subject Device | Predicate Device (K173877) | |
|---|---|---|---|
| Manufacturer | Shenzhen Mecun Medical | ||
| Supply Co., Ltd. | BOWA-electronics GmbH & Co. | ||
| KG | Remark | ||
| Product name | Disposable Grounding Pad | BOWA Neutral Electrodes | |
| Product Code | GEI | GEI | Same |
| Regulation | |||
| Number | 878.4400 | 878.4400 | Same |
| Classification | II | II | Same |
| Intended | |||
| use& | |||
| Indication | |||
| s 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. | 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. | Same | ||
| Prescription or | |||
| OTC | Prescription | Prescription | Same |
| 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. | Same | ||
| Technology | |||
| overview | Multi-layer device consists of: | ||
| Backing material; | |||
| Conductive layer; | Multi-layer device consists of: | ||
| Backing material; | |||
| Conductive layer; | Same | ||
| Conductive adhesive | |||
| hydrogel; | |||
| Cover material | Conductive adhesive hydrogel; | ||
| Cover material | |||
| Intended | |||
| population | Adult | Neonates, Children, Adults | Similar |
| (included) | |||
| 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 | ||
| Weight range | |||
| according to | |||
| IEC 60601-2-2 | >15kg (33lbs) | ||
| Adults | >15kg (33lbs) Adults |
5kg (11lbs) Children and Adults
Between 5 and 15kg (11 to
33lbs) Children