Sonicision Cordless Ultrasonic Dissection Device

K153371 · Covidien, LLC · LFL · Mar 28, 2016 · SU

Device Facts

• Record ID: K153371
• Device Name: Sonicision Cordless Ultrasonic Dissection Device
• Applicant: Covidien, LLC
• Product Code: LFL · SU
• Decision Date: Mar 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Sonicision Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter. The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Device Story

Hand-held, battery-powered ultrasonic surgical instrument; consists of 13 cm dissector, generator, and Li-ion battery. Surgeon operates device by applying pressure to tissue between clamping jaw and vibrating probe while activating ultrasonic energy via handpiece button. Device converts electrical energy into ultrasonic energy (approx. 55.5 kHz) to disrupt tissue and coagulate vessels up to 5 mm. Used in open and endoscopic procedures; provides cordless mobility. Surgeon monitors device state via indicator LEDs on handpiece. Benefits include reduced thermal injury and effective hemostasis as an alternative to electrosurgery, lasers, or steel scalpels.

Clinical Evidence

Bench and non-clinical testing only. Ex vivo burst testing demonstrated comparable vessel coagulation strength to predicate. Ex vivo thermal testing showed blade and shaft temperatures comparable to predicate and reference devices. Acute in vivo testing confirmed comparable hemostasis rates. Human factors validation in human cadaver model demonstrated successful completion of representative ENT procedures by practicing surgeons.

Technological Characteristics

Hand-held, cordless ultrasonic dissector. Components: sterile single-use 13 cm dissector, reusable generator, and 14.8 VDC Li-ion battery. Resonant frequency: ~55.5 kHz. Two power modes: minimum (coagulation) and maximum (dissection). Generator sterilized via low-temperature hydrogen peroxide plasma. Features LED status indicators.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury in general, plastic, gynecologic, urologic, orthopedic (spine/joint space), and ENT procedures. Suitable for coagulating isolated vessels up to 5 mm in diameter.

Predicate Devices

• Harmonic FOCUS+ Shears with Adaptive Tissue Technology (K133314)

Reference Devices

• Olympus Thunderbeat 0510IC (K132703)
• Sonicision Generator/Battery (K101797)
• Sonicision 13 cm dissector (K141371)

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

March 28, 2016

Covidien LLC Ms. Nancy Sauer Principal Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K153371

Trade/Device Name: Sonicision Cordless Ultrasonic Dissection Device Regulation Name: Instrument, Ultrasonic Surgical Regulatory Class: Unclassified Product Code: LFL Dated: February 24, 2016 Received: February 26, 2016

Dear Ms. Sauer:

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 device-related 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -A

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) K153371

Device Name

Sonicision™ Cordless Ultrasonic Dissection Device

Indications for Use (Describe)

The Sonicision Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and ioint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

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

| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" stroke-width="2" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary of Safety and Effectiveness

## 510(k) Number: K153371

Date summary prepared: 03/23/16

#### 510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

#### Contact

Nancy Sauer Regulatory Affairs Product Manager Telephone: [phone] Fax: [phone] Email: [e-mail]

#### Regulatory Information

| Trade Name: | Sonicision™ Cordless Ultrasonic Dissection Device<br>• Sonicision Dissector, 13 cm<br>• Sonicision Generator<br>• Sonicision Battery |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Ultrasonic Dissection Device |
| Regulation Number: | NA |
| Regulation Name: | Instrument, Ultrasonic Surgical |
| Regulatory Class: | Unclassified |
| Product Code: | LFL |

#### Predicate Device

The primary predicate device for this submission is the Harmonic FOCUS®+ Shears with Adaptive Tissue Technology (FOCUS+), cleared by 510(k) K133314. The FOCUS+ device is an ultrasonic dissector indicated for use in otorhinolaryngology (ENT) procedures. The Olympus Thunderbeat 0510IC device serves as a reference predicate device (cleared under K132703). The Thunderbeat is a combination ultrasonic/radiofrequency device that has a shaft-based design, similar in size and shape to the Sonicision device assembled with the 13 cm dissector. The Sonicision generator and battery are the same as the designs cleared under 510(k) K101797 and the 13 cm dissector is the same as the design cleared under 510(k) K141371.

#### Device Description

The Sonicision Ultrasonic Dissection Device that is the subject of this 510(k) is a hand-held batterypowered device used to dissect through tissues and to coagulate vessels up to 5 mm in diameter. An assembled Sonicision device includes three components: (1) The Sonicision Dissector, 13 cm; (2) the Sonicision Battery; and (3) the Sonicision Generator. The dissector is a single-use item that is provided to the user in sterile form. The generator and battery are reusable components that are sterilized by the user. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy with a button on the handpiece.

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#### Indications for Use

The Sonicision Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

#### Technological Characteristics

#### Sonicision 13 cm dissector

This is a sterile single-use device that includes the following features:

- . Active blade that vibrates at ultrasonic frequency and delivers the energy that provides the tissue effect.
- Clamping jaw that the surgeon uses to provide pressure to vessels, tissues, or vascular bundles as needed to deliver the desired tissue effect.
- Controls for activating the delivery of ultrasonic energy and for opening and closing the clamping ● iaw.
- Features that interface with the Sonicision generator and the Sonicision battery ●

#### Sonicision Generator

This is a reusable component that is sterilized by the user facility using a low-temperature hydrogen peroxide plasma process. It has the following features

- Transducer that converts electrical energy into ultrasonic energy (resonant frequency of approximately 55.5 kHz)
- . Indicator LEDs that notify the user of the state of the assembled device
- Control software

#### Sonicision Battery

This is a reusable component that is sterilized by the user facility using a low-temperature hydrogen peroxide plasma process. It has the following features

- Li-ion chemistry
- 14.8 VDC, rechargeable

#### Comparison to the Predicate Device

#### Similarities

- . Same intended use and indicated for the same types of surgeries
- Same contraindications ●
- Same operating principle a metal waveguide vibrates at ultrasonic frequencies to create thermal . and mechanical effects that disrupt cells and tissues. The user can also apply pressure with the passive jaw to achieve specific tissue effects (e.g., coagulating a vessel).
- Same resonant frequency, approx. 55.5 kHz
- Both have two modes of operation: a minimum power mode that is used for vessel coagulation ● and a maximum power mode that is used for dissection.

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### Differences

The table below outlines the major differences between the two devices.

| Characteristic | Sonicision | FOCUS+ |
|-----------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Power source | 14.8 VDC Lithium-ion battery | Electrical current delivered through<br>Ethicon Gen11 generator |
| Instrument form factor | Shaft-based design | Shears-style design |
| Jaw shape | Straight | Curved |
| Footswitching option | No | Yes |
| Audio and Visual Indicators | Visual and audio indicators produced<br>by the hand-held device | Audio and visual indicators produced by<br>the generator. |

The impact of these differences was evaluated through:

(1) Comparative studies described below showing equivalent performance of the Sonicision and FOCUS+ devices

(2) Comparison to a reference predicate, the Thunderbeat 0510IC device, a shaft-based device also indicated for use in ENT surgery, which has a similar size and shape to the Sonicision device.

(3) Human factors evaluation of the 13 cm Sonicision Cordless Ultrasonic Dissection Device for use in ENT surgeries, also described below

#### Performance

Because the Sonicision Cordless Ultrasonic Dissection Device has been previously cleared for use in other types of surgery, the performance testing in this 510(k) focused only on the testing needed to demonstrate suitability of the Sonicision system for otorhinolaryngology (ENT) surgical procedures and substantial equivalence to the predicate device for characteristics deemed relevant for ENT surgical procedures.

- . Ex vivo burst testing showed that blood vessels coagulated by the Sonicision device had comparable burst strength to the same type of blood vessels coagulated by the FOCUS+ device.
- . Ex vivo tissue testing showed that the maximum temperature of the Sonicision active blade was comparable to the maximum temperature of the FOCUS+ active blade after multiple activations on mesentery.
- . Ex vivo tissue testing showed that the maximum temperature of the Sonicision distal shaft was comparable to the maximum temperature of the Thunderbeat distal shaft after multiple activations on mesentery in the ultrasonic mode.
- Acute in vivo testing showed that the Sonicision device and the FOCUS+ device achieved comparable rates of hemostasis.
- . Usability/ human factors validation in a human cadaver model demonstrated that practicing surgeons could successfully complete representative ENT procedures using the 13 cm Sonicision device. The surgeons, who were predominantly users of the FOCUS+ device for ENT surgeries, found that the 13 cm Sonicision device is clinically acceptable for use in ENT surgical procedures.

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#### Conclusion

The comparison of device characteristics and the review of the performance data support the conclusion that the 13 cm Sonicision Cordless Ultrasonic Dissection Device is substantially equivalent to the Harmonic FOCUS+ Shears with Advanced Tissue Technology device with regard to a general indication for use in otorhinolaryngology (ENT) surgery.