PlasmaBlade TnA Tonsil and Adenoid Dissection Device

K152703 · Medtronic Advanced Energy · GEI · Jul 8, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152703
• Device Name: PlasmaBlade TnA Tonsil and Adenoid Dissection Device
• Applicant: Medtronic Advanced Energy
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PEAK PlasmaBlade TnA device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

Device Story

Single-use, disposable electrosurgical instrument for ENT surgery; includes Tonsil and Adenoid tips. Adenoid tip features wire electrode and bendable suction lumen for evacuation of tissue, fluids, and smoke. Device connects to PlasmaBlade ENT handpiece and is powered by compatible electrosurgical generators (PULSAR I, PULSAR II, AEX). Operated by surgeon via handpiece buttons or optional footswitch. Delivers radio-frequency (RF) energy to cut and coagulate soft tissue. Provides clinical benefit by enabling precise tissue dissection with integrated suction for site clearance. Used in clinical settings by otolaryngologists.

Clinical Evidence

No clinical data. Bench testing and in-vivo animal model testing performed to verify design and performance. Thermal effect in animal model demonstrated substantial equivalence to predicate.

Technological Characteristics

Single-use, sterile, monopolar electrosurgical instrument. Features wire electrode and bendable suction lumen. RF energy source. Compatible with PULSAR I, PULSAR II, and AEX generators. Manual operation via handpiece or footswitch.

Indications for Use

Indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery, specifically adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

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

• PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device (K083415)
• Arthrocare ENT Plasma Wands (K014290)

Reference Devices

• PULSAR I (K073057)
• PULSAR II (K102029)
• AEX (K143175)

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

July 8. 2016

Medtronic Advanced Energy Lydia Sakakeeny, Ph.D. Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, NH 03801

Re: K152703

Trade/Device Name: PlasmaBlade TnA Tonsil and Adenoid Dissection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 7, 2016 Received: June 8, 2016

Dear Dr. Sakakeeny:

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.

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Page 2 - Lydia Sakakeeny, Ph.D.

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 the quality systems (QS) 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.

## Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PEAK PlasmaBlade TnA (Adenoid Tip)

#### Indications for Use

510(k) Number (if known): K152703

Device Name: PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device

#### Indications for Use:

The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Medtronic

### 510(k) Summary

| Submitter: | Medtronic Advanced Energy<br>180 International Drive<br>Portsmouth, NH 03801 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lydia Sakakeeny, PhD<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail:[e-mail] |
| Date Summary Prepared: | September 10, 2015 |
| Device Trade Name: | PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR 878.4400) |
| Product Code: | GEI |
| Predicate Device: | K083415 PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection<br>Device<br>K014290 (Original) Arthrocare ENT Plasma Wands |
| Device Description: | The PEAK PlasmaBlade® TnA is a single-use, disposable,<br>electrosurgical instrument consisting of two PlasmaBlade tips (Tonsil tip<br>and Adenoid tip) designed to be attached to the PlasmaBlade ENT<br>handpiece (cleared as the PEAK PlasmaBlade TnA handpiece via<br>K083415). The device also includes a wire cleaning brush designed to<br>remove eschar build up and maintain a clear channel for suction. |
| | The Adenoid Tip consists of a wire electrode housed in a plastic tip with<br>a bendable suction lumen that allows for the evacuation of tissue, fluids,<br>and smoke. It connects to the suction shaft of the handpiece. |
| | These device is used with PULSAR I (K073057), PULSAR II (K102029)<br>and AEX (K143175) Electrosurgical Generators. It provides radio-<br>frequency energy for cutting and coagulation of soft tissue. The PEAK<br>PlasmaBlade ENT handpiece has integrated buttons for Cut and Coag,<br>which may be used to operate the device, or it may be activated with an<br>optional footswitch supplied with the Generators. |
| Intended Use: | The PEAK PlasmaBlade TnA device is only indicated for cutting and<br>coagulation of soft tissue during otolaryngology (ENT) surgery including<br>adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine). |
| Technological Characteristics: | The PEAK PlasmaBlade TnA, Adenoid Tip is similar to the predicate<br>devices in that they are single use, sterile, electrosurgical instruments<br>used to cut and coagulate soft tissue utilizing RF powered distal ends. A<br>enable the suction of fluid and smoke from the surgical site. |
| Summary of Non-Clinical Testing: | The design and performance of the modified Adenoid Tip were verified<br>and validated through bench testing. |
| | Comparative performance testing was conducted in an in-vivo animal<br>model. Thermal effect of the PEAK PlasmaBlade Adenoid Tip in the in-<br>vivo model was substantially equivalent to that of the predicate device. |
| | All bench and pre-clinical testing that testing confirmed that the different<br>technological characteristics of the subject device and the respective<br>predicates do not raise any new issues of safety or effectiveness. |
| Summary of Clinical Tests: | Clinical testing was not required for this product. |
| Conclusion: | The indications for use, technology and performance characteristics of<br>the modified PEAK PlasmaBlade TnA (specifically the Adenoid Tip) are<br>equivalent to the predicate devices' and therefore Medtronic Advanced<br>Energy claims substantial equivalence to the predicate devices. |

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Technological differences between the modified adenoid tip and its predicates exist however they do not adversely impact the safety or efficacy of the devices.

For example, the modified adenoid tip and the original PEAK PlasmaBlade Adenoid tip are monopolar electrosurgical instruments with same operating principle, the modified tip utilizes a wire electrode while the predicate utilizes a blade electrode.

Similarly, while ENT Plasma Wands provide bipolar RF energy coupled with saline to the operatvie site and the PEAK PlasmaBlade adenoid tip delivers monopolar RF energy to the operative site, in vivo pre-clinical testing has confirmed that the thermal damage imparted by the two technologies are equivalent and does not raise concerns over safety or efficacy.