PlasmaBlade X 3.0S, PlasmaBlade X 4.0

K181257 · Medtronic Advanced Energy · GEI · Aug 2, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181257
• Device Name: PlasmaBlade X 3.0S, PlasmaBlade X 4.0
• Applicant: Medtronic Advanced Energy
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.

Device Story

PlasmaBlade X 4.0 and X 3.0S are single-use, monopolar RF electrosurgical devices used with qualified generators. X 4.0 features a bendable shaft and rotatable nose piece; X 3.0S features a bendable blade, telescoping shaft, and integrated suction lumen for smoke/fluid evacuation. Operated via integrated hand switch or optional footswitch. Used by surgeons in clinical settings (OR) to cut and coagulate soft tissue. RF energy delivery enables precise tissue interaction. Benefits include controlled thermal effects equivalent to predicate devices, facilitating various surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and comparative in-vivo/ex-vivo animal model performance testing evaluating thermal effects.

Technological Characteristics

Monopolar RF electrosurgical device. System comprises RF generator and disposable electrode handpiece. Features include bendable shafts, rotatable nose pieces (X 4.0), telescoping shafts (X 3.0S), and integrated suction lumen (X 3.0S). Single-use. Operated via hand switch or footswitch.

Indications for Use

Indicated for cutting and coagulation of soft tissue in patients undergoing General, Plastic, Reconstructive, ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, or Neurological procedures.

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

• PlasmaBlade 4.0 (K073057, K082786)
• PlasmaBlade 3.0S (K093695)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

August 2, 2018

Medtronic Advanced Energy Heather Valley Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801

Re: K181257

Trade/Device Name: PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2018 Received: May 11, 2018

Dear Heather Valley:

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. 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/cfdocs/cfpm/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.

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

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 531-542 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 of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer Stevens For Binita S. Ashar, M.D., M.B.A., F.A.C Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K181257

Device Name

PlasmaBlade X 4.0 and PlasmaBlade X 3.0S

Indications for Use (Describe)

The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.

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

| <label> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </label> | <label> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </label> |
|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Medtronic

## 510(k) Summary K181257

| Submitter: | Medtronic Advanced Energy<br>180 International Drive<br>Portsmouth, NH 03801 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Heather Valley, RAC<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | May 09, 2018 |
| Device Trade Name: | PlasmaBlade X 4.0<br>PlasmaBlade X 3.0S |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and<br>accessories (21 CFR 878.4400) |
| Product Code: | GEI |
| Predicate Devices: | PlasmaBlade 4.0 (K073057 Original Submission, K082786<br>Expanded Indications)<br>PlasmaBlade 3.0S (K093695) |
| Device Description: | PlasmaBlade X 4.0<br>The PlasmaBlade™ X 4.0 is a single-use- only device<br>designed for use with qualified Generators as a System<br>(Surgery System). The PlasmaBlade™ X has integrated<br>hand switch control, or alternatively, may be controlled with a<br>qualified Footswitch, supplied as an optional accessory to the<br>Generator. The PlasmaBlade™ X 4.0 consists of a single<br>bendable shaft and rotatable nose piece that can be adjusted<br>by hand. The system components are designed to be used<br>together and operated as a single unit.<br><br>PlasmaBlade X 3.0S<br>The PlasmaBlade™ X 3.0S is a single-use, monopolar RF<br>device. It is designed to be used with the qualified<br>Generators as part of the Surgery System. It can<br>be operated with the integrated hand switch or a qualified<br>Footswitch. The PlasmaBlade™ X 3.0S consists of a single<br>bendable blade and telescoping shaft that can be configured |

{4}------------------------------------------------

in both standard and extended length. The finger grip also
incorporates a suction lumen for the evacuation of smoke and fluids.

| Indications for Use: | Device Name: PlasmaBlade X 4.0 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications: The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures. |
| | Device Name: PlasmaBlade X 3.0S |
| | Indications: The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures. |
| Technological Characteristics: | The predicate PlasmaBlade devices and proposed PlasmaBlade X family of devices are intended for RF based cutting and coagulation. The proposed devices share the same operational characteristics as the predicate platforms, comprised of a radio-frequency generator which supplies RF power to disposable electrode devices for electrosurgical procedures. |
| Summary of Non-Clinical Testing: | Design and material changes were verified through bench testing. |
| | Comparative performance testing was conducted in an in-vivo/ex-vivo animal model to determine thermal effect of the X series against the predicates. The thermal effect of the X series of products was found to be substantially equivalent to that of the predicate devices. |
| Summary of Clinical Tests: Conclusion: | Clinical Testing was not required for these products. The indications for use, technology and performance characteristics of the PlasmaBlade X devices are equivalent to the predicate devices, as such, Medtronic Advanced Energy claims substantial equivalence to the predicates. |