Disposable General Electrode

K152059 · Modern Medical Equipment Manufacturing Limited · GEI · Apr 21, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152059
• Device Name: Disposable General Electrode
• Applicant: Modern Medical Equipment Manufacturing Limited
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.

Device Story

Disposable General Electrode consists of conductive tip (blade, needle, or ball), insulated shaft, and conductive post. Device connects to monopolar electrosurgical pencil to receive high-frequency current from electrosurgical generator. Operator (physician) uses device to deliver current to target tissue for cutting or coagulation. Insulation prevents accidental conduction. Used in clinical settings during electrosurgical procedures. Output is thermal effect on tissue; benefits include precise tissue management during surgery.

Clinical Evidence

Bench testing only. Comparative simulation study on porcine kidney, liver, and muscle tissue across various power settings (50W-300W) for Cut and Coagulation modes showed no significant difference in performance or eschar buildup compared to the predicate. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity) and sterilization residual testing (ISO 10993-7) confirmed safety.

Technological Characteristics

Stainless steel shaft (2.36mm diameter) with Polyolefin/Teflon shrink wrap or ABS/HIPS overmold insulation. Tip configurations: Blade, Needle, Ball. Monopolar energy delivery. Complies with IEC 60601-1 and IEC 60601-2-2. Sterilization via Ethylene Oxide (ETO).

Indications for Use

Indicated for patients undergoing electrosurgical procedures requiring soft tissue cutting and/or coagulation.

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

• Disposable Electrode Series (K091672)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 21, 2016

Modern Medical Equipment Manufacturing Limited Thomas Chan Tsz Fung Regulatory Supervisor 35-41 Tai Lin Pai Rd., Unit F, 4th Fl., Gold King Ind. Bldg, Kwai Chung, N.T. Hong Kong, China

Re: K152059

Trade/Device Name: Disposable General Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 24, 2015 Received: July 24, 2015

Dear Thomas Chan Tsz Fung:

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 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -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) K152059

Device Name Disposable General Electrode

Indications for Use (Describe)

The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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| 1. 510(k) Owner | |
|----------------------------|------------------------------------------------------|
| Name: | Modern Medical Equipment Manufacturing Limited |
| Address: | Modern Medical Equipment Mfg., Ltd. |
| | 35-41 Tai Lin Pai Rd., Unit F, |
| | 4th Fl., Gold King Ind. Bldg |
| | Kwai Chung, N.T. Hong Kong, China |
| Telephone: | (852) 2420 9068 |
| Fax: | (852) 2481 1234 |
| Contact person: | Thomas, Chan Tsz Fung |
| Date of preparation: | 20 Jul, 2015 |
| 2. Device | |
| Name of Device: | Disposable General Electrode |
| Trade or proprietary name: | Disposable General Electrode |
| Common or usual name: | Disposable General Electrode |
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Class: | II |

### 3. Device description

Disposable General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1

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and IEC60601-2-2.

#### 4. Indication for Use

The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.

#### 5. Predicate device

Disposable Electrode Series with 510(k) number K091672.

#### 6. Technological characteristic

The proposed Disposable General Electrode is a stainless steel shaft insulted by wrapping different electrical insulation materials included of Polyolefin Shrink Wrap, Teflon Shrink Wrap or ABS/HIPS overmold or their combinations. The shaft diameter is about 2.36mm. One end of shaft acts as the electrode tip which is shaped as Blade, Needle or Ball and the other end as conductive post which insert into the nozzle of electrosurgical pencil from which it receives the electrical current..

The conductive electrode tip delivers high frequency current onto a target tissue for cutting and/or coagulation during an electro-surgery. The insulation material prevents accidental conduction of the electrosurgical current from this point to the patient.

The construction of proposed electrode and the predicted device is identical. There are no new questions raised regarding to effectiveness and safety.

#### 7. Substantial Equivalence

The technological characteristic in both proposed device and predicate device is identical. Moreover, performance testing data showed that operation result by using proposed device and predicate device shall be the same.

#### 8. Performance Testing Data

Validation and Verification testing was performed on the device and packaging.

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Simulation Tests include comparative testing was performed on porcine kidney, liver, and muscle for both Cut mode at 50W, 100W, 200W and 300W output power and Coagulation mode at 50W and 100W. It demonstrates that the performance result of device operation and amount of eschar buildup on the tip of electrode are no significant difference between proposed device and predicate device.

9. Safety and Biocompatibility testing data Safety Testing was performed to comply with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)

EO and ECH residue test was performed in accordance to ISO10993-7 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals after aeration in ETO sterilization process. The residue level on the patient contact portion of device shall be met below standard

EO residue ≤ 4 mg per device ECH residue ≤ 10 mg per device

The biological evaluation was performed in accordance with ISO10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. Below tests verified that the material use of the proposed electrode is biocompatibility with intended use.

- Intracutaneous Reactivity Test
- In vitro Cytotoxicity Test
- Skin sensitization tests

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## 10. Conclusion

Based on comparing technological characteristic and performance testing data, we believe the proposed device, Disposable General Electrode is substantial equivalence to predicate device (K091672).