BiZact Open Sealer/Divider

K160539 · Covidien · GEI · Jun 15, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160539
• Device Name: BiZact Open Sealer/Divider
• Applicant: Covidien
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 15, 2016
• 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

BiZact is a sterile, single-use, hand-held bipolar electrosurgical instrument; used in open general surgery and adult ENT procedures (e.g., tonsillectomy). Device connects to Valleylab LS10 Vessel Sealing Generator via 10-foot cord; generator identifies device via embedded RFID tag. During operation, device delivers RF energy to tissue; tissue-sensing circuitry measures electrical resistance; generator output adjusts instantaneously to maintain controlled tissue response for permanent fusion. Physician operates device to ligate/divide vessels, tissue bundles, and lymphatics. Benefits include precise, controlled tissue fusion; reduced thermal spread to sensitive structures. Device output is physical tissue ligation/division; healthcare provider uses visual confirmation of tissue effect to guide surgical progress.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical safety per IEC 60601-1, EMC per IEC 60601-1-2, HF equipment safety per IEC 60601-2-2, biocompatibility per ISO 10993-1), performance testing (device functionality, tissue burst pressure), in-vivo studies (acute hemostasis, thermal spread, lymphatic burst pressure; chronic hemostasis), and summative usability validation in simulated environments.

Technological Characteristics

Bipolar electrosurgical instrument; RF tissue fusion technology. Materials biocompatible per ISO 10993-1. Connectivity via proprietary connector with RFID tag for generator identification. Single-use, hand-held form factor. Energy source: Valleylab LS10 Vessel Sealing Generator. Software-controlled power output based on real-time tissue impedance sensing.

Indications for Use

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

• LigaSure™ Small Jaw, Open Sealer/Divider (K152286)

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 15, 2016

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

Re: K160539

Trade/Device Name: Bizact Open 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: May 24, 2016 Received: May 25, 2016

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. Isting 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 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.

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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 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,

# 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) K160539

Device Name BiZact Open Sealer/Divider

#### 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)

| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) Summary

Date summary prepared: June 10, 2016

#### 510(k) Submitter/Holder

Covidien, llc 5920 Longbow Drive Boulder, CO 80301

### Contact

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

### Name of Device

Trade Name: BiZact™ Open Sealer/Divider Common Name: Bipolar electrosurgical instrument Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II. GEI).

#### Predicate Devices

The BiZact, Open Sealer/Divider was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:

| Device Common Name: | Bipolar electrosurgical instrument |
|---------------------|------------------------------------------|
| Trade Name: | LigaSure™ Small Jaw, Open Sealer/Divider |
| Catalog Number: | LF1212A |
| 510(k) Number: | K152286 |
| Manufacturer: | Covidien, llc |

### Device Description

The BiZact Open Sealer/Divider is sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the Valleylab™ LS10 Vessel Sealing Generator for ligation of vessels, tissue bundles, and lymphatics during open general surgical procedures.

The BiZact attaches to the Valleylab LS10 Vessel Sealing Generator with a 10 foot cord containing a connector. The generator is able to identify the BiZact device via the RFID tag embedded in the connector. The generator delivers precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion by incorporating tissue sensing circuitry to constantly measure the electrical resistance of the tissue and instantaneously adjust the generator output to maintain the desired power.

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### 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 open general 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.

#### Testing Summary:

Verification and validation results demonstrate that the BiZact Open Sealer/Divider performs as intended and is substantially equivalent to its predicate, LF1212A. The following summarizes testing conducted to establish safety and substantial equivalence:

- IEC 60601-1 Basic Electrical Safety ●
- IEC 60601-1-2 Electromagnetic Compatibility ●
- IEC 60601-2-2 Basic Safety for HF Equipment and HF Accessories ●
- ISO 10993-1 Biocompatibility ●
- Performance Testing - Device Functionality
- Performance Testing Bench Tissue burst testing ●
- Performance Testing In-vivo acute (hemostasis, thermal spread, lymphatic burst pressure,) ● and chronic (hemostasis)
- Usability - Design Validation - Summative testing in simulated use environment

### Conclusion on Substantial Equivalence

The proposed BiZact Open Sealer/Divider is substantially equivalent to the predicate LigaSure Small Jaw Open Sealer/Divider. Both devices have the same intended use and fundamental technology. The proposed device has some intentional design and indications differences that enable it to be well suited for its indicated uses. Testing demonstrated that these differences do not raise any new questions of safety or effectiveness.