Edge Insulated Blade Electrode

K210338 · Covidien, LLC · GEI · Apr 15, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210338
• Device Name: Edge Insulated Blade Electrode
• Applicant: Covidien, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

Device Story

Edge Insulated Blade Electrode is a sterile, single-use, monopolar accessory for electrosurgical pencils. Device conducts RF current from an electrosurgical generator to target soft tissue for cutting and coagulation. Compatible with standard 3/32" (0.093") shaft insertion diameter electrosurgical pencils. Used by surgeons in various surgical procedures. Device consists of a coated stainless-steel blade with insulation. Output is RF energy delivered to tissue; healthcare provider controls effect via generator settings and manual manipulation of the electrode. Benefits include precise tissue cutting and cauterization during surgery.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity). Electrical safety and EMC testing per IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2. Mechanical/functional bench testing and ex vivo thermal effect testing demonstrated performance equivalent to the predicate.

Technological Characteristics

Monopolar electrosurgical electrode. Materials: stainless steel, silicone, polymer insulation. Dimensions: 2.5" length, 0.093" shaft diameter. Energy: Monopolar RF. Rated voltage: <4500Vpk. Sterilization: Ethylene oxide (EO). Standards: ISO 10993-1 (biocompatibility), IEC 60601-1/2-2 (electrical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients undergoing surgical procedures requiring electrosurgical cutting and cauterization of soft tissue.

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

• Megadyne™ E-Z Clean™ Electrosurgical Electrode (K081791)

Submission Summary (Full Text)

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April 15, 2021

Covidien LLC Miranda Miles Associate Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K210338

Trade/Device Name: Edge Insulated Blade Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 4, 2021 Received: February 5, 2021

Dear Miranda Miles:

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 Mav 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.

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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 and Part 809): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 53 1 -542 of the Act); 21 CFR 1000-1050.

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 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/cdrl-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-ind-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Long H. Chen Long H. Chen-S -s Date: 2021.04.15 16:19:33 -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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210338

Device Name EdgeTM Insulated Blade Electrode

Indications for Use (Describe)

The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

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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### K210338

Image /page/3/Picture/1 description: The image shows the logo for Covidien. The logo consists of a blue square with a grid pattern inside, followed by the word "COVIDIEN" in blue sans-serif font. The grid pattern in the square is made up of smaller squares in varying shades of blue and white.

### 510(k) Summary

Date summary prepared: April 15, 2021

### 510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

### Contact

Miranda Miles Associate Regulatory Affairs Specialist Telephone: [phone] Email: miranda.r.miles(@medtronic.com

### Subject Device

| Trade Name: | Edge™ Insulated Blade Electrode |
|----------------------|----------------------------------------------------------------|
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| | (21 CFR 878.4400, Class II, GEI) |

### Predicate Device

| Trade Name: | Megadyne™ E-Z Clean™ Electrosurgical Electrode |
|----------------------|----------------------------------------------------------------------------------------------------|
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR 878.4400, Class II, GEI) |
| 510(k) Number: | K081791 |
| Recalls: | This device has not been subject to a design-related recall |

No reference devices were used in this submission.

### Device Description

The Edge™ Insulated Blade Electrode (E1455G) is a sterile, single-use, monopolar electrode intended to conduct radiofrequency (RF) current. It is a coated stainless-steel electrode blade with insulation. It is compatible with electrosurgical pencils that have a 0.093" insertion diameter or commonly referred to as a standard 3/32" insertion diameter, this includes the Covidien Valleylab™ Rocker Switch Pencil Family (SEP5000, SEP5015) cleared in K182772.

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## Indications for Use

The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

### Comparison of Technological Characteristics with the Predicate Device

The Edge™ Insulated Blade Electrode (E1455G) device is compared to the predicate device Megadyne™ E-Z Clean™ Electrosurgical Electrode (0012M), as cleared under K081791 in Table 5-1.

| Characteristic | Subject Device<br>Edge™ Insulated Blade<br>Electrode (E1455G) | Predicate Device<br>MegadyneTM E-Z Clean™<br>Electrosurgical Electrode<br>(0012M) [K081791] | Results<br>(compared to<br>predicate) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Regulation | 878.4400 | 878.4400 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| Indications for Use | The Edge™ Insulated Blade<br>Electrode is intended to conduct<br>radio frequency (RF) current for<br>cutting and coagulation from the<br>RF electrosurgical generator to<br>target soft tissue in a broad range<br>of surgical procedures requiring<br>the use of electrosurgery for<br>cutting and cauterization. | E-ZTM Clean electrosurgical<br>electrodes are intended to conduct<br>radio frequency (RF) current for<br>cutting and coagulation from the<br>RF electrosurgical generator to<br>target soft tissue in a broad range<br>of surgical procedures requiring<br>the use of electrosurgery for<br>cutting and cauterization.<br>Some tip configurations have a<br>specific geometry that minimizes<br>blanching and thermal damage in<br>skin incisions when used in<br>conjunction with the generator's<br>Advanced Cutting Effect (ACE)<br>mode. | Equivalent -<br>The subject<br>device is not<br>indicated for<br>use with<br>Advanced<br>Cutting Effect<br>(ACE) mode.<br>Differences do<br>not change the<br>intended use of<br>the device. |
| Contraindications | None | None | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Electrode Material | Stainless steel | Stainless steel | Equivalent |
| Coating | Yes | Yes | Equivalent |
| Insulation | Yes | Yes | Same |
| Length | 2.5" | 2.5" | Same |
| Compatibility | 0.093" shaft insertion diameter | 0.093" shaft insertion diameter | Same |
| Sterilization | Ethylene oxide (EO) | Ethylene oxide (EO) | Same |
| Energy Type | Monopolar radiofrequency | Monopolar radiofrequency | Same |

Table 5-1. Technological and performance characteristics comparison of subject device to predicate device.

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### K210338

| Characteristic | Subject Device<br>EdgeTM Insulated Blade<br>Electrode (E1455G) | Predicate Device<br>MegadyneTM E-Z CleanTM<br>Electrosurgical Electrode<br>(0012M) [K081791] | Results<br>(compared to<br>predicate) |
|----------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Rated Accessory<br>Voltage | <4500Vpk | <10.8kV | Rated<br>accessory<br>voltage does<br>not affect<br>electrical<br>safety or<br>performance. |

### Performance Testing

#### Biocompatibility

The biocompatibility evaluation for the Edge™ Insulated Blade Electrode was conducted in accordance with ISO 10993-1. The testing included the following:

- . Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- Material-Mediated Pyrogenicity .

The direct tissue contacting materials include stainless steel, silicone and polymer insulation. The subject device complies with the relevant clauses of ISO 10993-1.

### Electromagnetic Compatibility (EMC) and Electrical Safety

Electromagnetic compatibility (EMC) and electrical safety were evaluated on the Edge™ Insulated Blade Electrode. The subject device complies with relevant clauses of the IEC 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.

### Mechanical/Functional Bench Testing

Mechanical, electrical, and functional testing were carried out to verify that the subject device performs as expected and conform to requirements defined in related design inputs and product specifications.

### Ex vivo Thermal Effect

Monopolar ex vivo testing evaluated thermal effect resulting from monopolar energy application across a range of power setting and modes on different tissue types. The subject device demonstrated substantial equivalence to the predicate device.

### Conclusion

The comparison of device characteristics and the review of the performance data support the conclusion that the Edge™ Insulated Blade Electrode is substantially equivalent to the predicate

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## K210338

device. The Edge™ Insulated Blade Electrode (E1455G) was found to be as safe and effective as the predicate device Megadyne™ E-Z Clean Electrosurgical Electrode (0012M).