BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

K171066 · Covidien, LLC · GEI · Jun 8, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171066
• Device Name: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
• Applicant: Covidien, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The tissue fusion function of the device can be used on veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures. It is also indicated for adult ENT procedures, including tonsillectomy, for the ligation of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures. The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.

Device Story

Sterile, single-use, hand-held electrosurgical device; utilizes RF tissue fusion technology. Connects to compatible electrosurgical generators (ForceTriad, Valleylab LS10, Valleylab FT10) via 10-foot cord with proprietary connector. Generator identifies device via RFID tag or barcode. Device features pistol-grip design with integrated cutting blade. Used in open general surgery and adult ENT procedures (tonsillectomy) by surgeons. Operation involves applying mechanical pressure via jaw mechanism while generator delivers bipolar RF energy; algorithm adjusts output based on tissue electrical resistance to achieve permanent fusion. Output allows for simultaneous ligation and division of vessels/tissue bundles. Benefits include efficient hemostasis and tissue sealing in open procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical safety, EMC, biocompatibility per ISO 10993-1, sterilization validation per ISO 11135:2014), ex-vivo porcine renal artery burst pressure studies, and pre-clinical porcine studies (lymphatic sealing, acute hemostasis, lateral thermal spread, and chronic hemostasis) comparing the subject device to the predicate across three compatible generator platforms.

Technological Characteristics

Materials: stainless steel, PPA, ceramic, ETFE, silicone, PTFE lubricants. Energy: Bipolar RF. Form factor: Pistol-grip, single-use, sterile. Connectivity: Proprietary connector with RFID/barcode for generator identification. Sterilization: Ethylene Oxide (EO). Standards: IEC 60601-1, IEC 60601-2-2, ISO 10993-1, ISO 11135:2014.

Indications for Use

Indicated for adult patients undergoing open general surgical procedures, including tonsillectomy, requiring ligation and division of vessels, tissue bundles, and lymphatics up to 3 mm in diameter. Contraindicated for tubal sterilization or tubal coagulation 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

• BiZact™ Open Sealer/Divider (K160539)

Reference Devices

• ForceTriad Energy Platform (K051644, K070162, K102913, K110268)
• Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654)
• Valleylab FT10 Energy Platform (K151649, K170170)

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

June 8, 2017

Covidien Ms. Sharon McDermott Senior Specialist Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301

Re: K171066

Trade/Device Name: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 7, 2017 Received: April 10, 2017

Dear Ms. McDermott:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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. Jennifer R. Stevenson -S3

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) K171066

Device Name

BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divide

Indications for Use (Describe)

The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired.

The tissue fusion function of the device can be used on veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.

It is also indicated for adult ENT procedures, including tonsillectomy, for the ligation of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.

The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.

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

| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 2 L14 14 L2 14 Z M3 3 L13 3 L13 13 L3 13 Z M4 4 L12 4 L12 12 L4 12 Z M5 5 L11 5 L11 11 L5 11 Z M6 6 L10 6 L10 10 L6 10 Z M7 7 L9 7 L9 9 L7 9 Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 2 L14 14 L2 14 Z M3 3 L13 3 L13 13 L3 13 Z" fill="white"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.

# 510(k) Summary

Date summary prepared: May 17, 2017

## 510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

# Contact

Sharon McDermott Senior Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone] Email: [e-mail]

# Name of Device

| Trade Name: | BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
|----------------------|----------------------------------------------------------------------------------------------------|
| Catalog Number: | BZ4212A |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR<br>878.4400, Class II, GEI) |

# Predicate Device

| Trade Name: | BiZact™ Open Sealer/Divider |
|------------------|-------------------------------|
| Catalog Numbers: | BZ4112 |
| Common Name: | Bipolar Vessel Sealing Device |
| 510(k) Number: | K160539 (cleared 6/15/16) |
| Manufacturer: | Covidien |

# Device Description

The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the ForceTriad Energy Platform (K051644, K070162, K102913, and K110268), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654), or the Valleylab FT10 Energy Platform (K151649, K170170) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.

The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider attaches to a compatible electrosurgical generator with a 10 foot cord containing a proprietary connector. The generator is able to identify the BiZact™ device via the RFID tag embedded in the connector (Valleylab LS10 LS Series single Channel Vessel Sealing Generator and Valleylab FT10 Electrosurgical Platform) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.

# How Provided

The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is provided sterile and is intended for single use.

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### Compatible Electrosurgical Generators:

- ForceTriad Energy Platform (K051644, K070162, K102913, and K110268) ●
- . Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654)
- . Valleylab FT10 Energy Platform (K151649, K170170)

# Patient Contacting Materials

Patient contacting materials in the manufacture of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) include stainless steel, Polyphthalamide (PPA), ceramic, Ethylene-tetrafluoroethylene, silicone and PFTE lubricants.

## Indications for Use

The BiZact™ device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

The tissue fusion function of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in general open surgical procedures.

It is also indicated for adult ENT procedures, including tonsillectomy for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.

The BiZact™ device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.

## Comparison of Technological Characteristics with the Predicate Device

BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) and its predicate BiZact™ Open Sealer/Divider, BZ4112, share the same fundamental technology and indications for use. The BZ4212A uses the same vessel fusion technology as the predicate BZ4112 device to achieve its intended use. Both devices apply this technology to surgications using an instrument connected to an electrically (AC) powered generator to manipulate and control bipolar RF energy. In addition, both instruments rely on the combination of a generator-controlled power output, mechanical force/pressure applied to tissue through the use of the jaw mechanism, and proper gap between electrode surfaces to achieve effective sealing of tissue.

| CHARACTERISTIC | PROPOSED DEVICE<br>BiZact (BZ4212A) | PREDICATE DEVICE<br>BiZact (BZ4112) | Comment |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class Regulation | 878.44 | 878.44 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| CHARACTERISTIC | PROPOSED DEVICE<br>BiZact (BZ4212A) | PREDICATE DEVICE<br>BiZact (BZ4112) | Comment |
| Indications for Use | The BiZact device is a bipolar<br>instrument intended for use in open<br>surgical procedures where ligation<br>and division of vessels, tissue<br>bundles, and lymphatics is desired.<br><br>The tissue fusion function of the<br>device can be used on vessels<br>(arteries and veins) and lymphatics<br>up to and including 3 mm diameter.<br>The BiZact device is indicated for<br>use in open general surgical<br>procedures.<br><br>It is also indicated for adult ENT<br>procedures, including<br>tonsillectomy, for the ligation and<br>division of vessels, tissue bundles<br>and lymphatics 2-3 mm away from<br>unintended thermally sensitive<br>structures.<br><br>The BiZact device has not been<br>shown to be effective for tubal<br>sterilization or tubal coagulation for<br>sterilization procedures. Do not use<br>for these procedures. | The BiZact device is a bipolar<br>instrument intended for use in open<br>surgical procedures where ligation<br>and division of vessels, tissue<br>bundles, and lymphatics is desired.<br><br>The tissue fusion function of the<br>device can be used on vessels<br>(arteries and veins) and lymphatics<br>up to and including 3 mm diameter.<br>The BiZact device is indicated for<br>use in open general surgical<br>procedures.<br><br>It is also indicated for adult ENT<br>procedures, including tonsillectomy,<br>for the ligation and division of<br>vessels, tissue bundles and<br>lymphatics 2-3 mm away from<br>unintended thermally sensitive<br>structures.<br><br>The BiZact device has not been<br>shown to be effective for tubal<br>sterilization or tubal coagulation for<br>sterilization procedures. Do not use<br>for these procedures. | Same |
| Contraindications | None | None | Same |
| Instrument Design | Pistol Grip | Pistol Grip | Same |
| Energy Type | Electrical (RF) bipolar energy | Electrical (RF) bipolar energy | Same |
| Compatible Energy<br>Platform(s) and 510(k)s | Valleylab LS10 Vessel Sealing<br>Generator (K143654) | Valleylab LS10 Vessel Sealing<br>Generator (K143654) | Same |
| | Valleylab Force Triad<br>Electrosurgical Generator<br>(K051644, K070162, K102913) | No | Single-generator<br>compatibility considered<br>sufficient for initial release<br>of BZ4112. |
| | Valleylab FT10 Electrosurgical<br>Platform (K151649, K170170) | No | Compatibility with a single<br>generator was considered<br>sufficient for initial release<br>of the predicate BZ4112. |
| Energy Activation<br>(Generator) | Handswitch | Handswitch | Predicate BZ4112 is only<br>compatible with the LS10<br>generator. Neither the<br>predicate BZ4112 nor<br>subject BZ4212A can be<br>footswitch- activated on the |
| | Footswitch<br>(ForceTriad)<br>(Valleylab VLFT10) | No | Valleylab LS10.<br>Activation by hand or foot<br>does not lead to any<br>difference in energy output,<br>therefore does not affect<br>performance. |
| Hand-activated button<br>design | Single stage | Single stage | Same |
| CHARACTERISTIC | PROPOSED DEVICE<br>BiZact (BZ4212A) | PREDICATE DEVICE<br>BiZact (BZ4112) | Comment |
| Proprietary Connector | Yes | Yes | Same |
| In-Line Activation | Yes | Yes | Same |
| Cutting Mechanism<br>Design | Integrated cutting blade | Integrated cutting blade | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization Method | EO | EO | Same |
| Vessel Size Range | Up to and including 3 mm | Up to and including 3 mm | Same |

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## Performance Data:

Verification and validation results demonstrate that the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider performs as intended and is substantially equivalent to its predicate, BZ4112. The following summarizes testing conducted to establish safety and substantial equivalence:

## Sterilization/Shelf life

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) underwent sterilization using a validated ethylene oxide cvcle in accordance with ISO 11135: 2014 "Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.

Both packaging and product stability testing (time-based/ambient storage conditions and at higher temperatures for accelerated testing) were conducted to determine the shelf life for the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A)

# Basic Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety testing and EMC were conducted on the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A). The system complies with the relevant portions of IEC 60601-1 (Basic Safety), IEC 60601-2-2 (HF Equipment & Accessories) and IEC 60601-2-2 (EMC)

#### ISO 10993-1 Biocompatibility

The biocompatibility evaluation of the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) was conducted in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process." The BZ4212A is categorized as an External Communicating device; blood path, indirect with limited exposure (< 24 hrs). Testing included the following:

- Cytotoxicity
- Sensitization ●
- Irritation ●
- System Toxicity
- Hemolysis ●
- Pyrogen Testing

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## Mechanical/ Functional

Mechanical, electrical, and functional testing was carried out to verify that the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) performs as expected and conforms to requirements defined in design inputs and subsequent product specifications. Characteristics such as jaw gap, jaw force and device resistance were evaluated.

#### Ex-vivo Renal Burst Pressure

A bench study utilizing fresh porcine renal arteries up to and including 4 mm in diameter was conducted to evaluate burst pressure of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A). Three generators were used in this study: ForceTriad Energy Platform, the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator, and the Valleylab FT10 Energy Platform.

## Ex-Vivo/Lymphatic

A pre-clinical study using a porcine model was conducted to evaluate the lymphatic duct sealing performance of the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) device in comparison to the predicate BZ4112 device. Testing was conducted using three generators: ForceTriad Energy Platform, the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator, and the Valleylab FT10 Energy Platform.

## In-Vivo Acute

A pre-clinical study using a porcine model was conducted to verify acute hemostasis and lateral thermal spread with the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) and the predicate BZ4112 device. Testing was conducted using the three generators: ForceTriad Energy Platform, the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator, and the Valleylab FT10 Energy Platform.

#### Chronic Animal Study

A chronic hemostasis porcine study was conducted to verify the performance of the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) using three generators ForceTriad Energy Platform, the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator, and the Valleylab FT10 Energy Platform.

#### Clinical Studies

This premarket notification submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

#### Compliance to Standards

Testing was conducted to all relevant clauses of standards referenced in testing summaries above.

#### Conclusion on Substantial Equivalence

The proposed BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) is substantially equivalent to the predicate BiZact Open Sealer/Divider (BZ4112). Both devices have the same indication for use and fundamental technology. The proposed device has some minor design differences to accommodate large scale manufacturing, improved look and feel, and has been shown to be compatible with the ForceTriad Energy Platform, the Valleylab™ LS10 Vessel Sealing Generator, and the Valleylab FT10 Energy Platform. These differences do not raise any new questions of safety or effectiveness. Testing demonstrates that the changes to not adversely affect performance.