Who is the manufacturer of BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

Covidien, LLC filed the 510(k) submission for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356).

What is the FDA product code for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

K193356 · Covidien, LLC · GEI · Mar 2, 2020 · General, Plastic Surgery

Device Facts

Record ID	K193356
Device Name	BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Applicant	Covidien, LLC
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 2, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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 of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures. It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 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 ENT procedures (tonsillectomy). Device connects to compatible electrosurgical generators (ForceTriad, Valleylab LS10, Valleylab FT10) via 10-foot cord with proprietary connector. Generator identifies device via RFID or barcode. During surgery, physician activates device via handswitch or footswitch; generator delivers RF energy to tissue. Device incorporates integrated cutting blade for tissue division. Generator algorithm dynamically adjusts energy output based on real-time electrical resistance of tissue to achieve fusion. Output allows ligation of vessels/lymphatics up to 3 mm. Benefits include effective vessel sealing and division 2-3 mm from thermally sensitive structures, reducing intra-operative blood loss.

Clinical Evidence

Prospective, multi-center, single-arm clinical study of 60 pediatric subjects (ages 3-12) undergoing tonsillectomy. Primary endpoint: intra-operative blood loss, which was significantly lower than the benchmark derived from meta-analysis. No adverse events (AEs) were related to the device. 13 AEs were related to the tonsillectomy procedure (e.g., dehydration, throat pain, fever); none were serious. No hospital admissions or readmissions occurred.

Technological Characteristics

Bipolar RF electrosurgical instrument. Materials: stainless steel, polyphthalamide, ceramic, ethylene-tetrafluoroethylene, silicone, PETE lubricants. Pistol grip design with integrated cutting blade. Energy source: compatible electrosurgical generators (ForceTriad, VLLS10GEN, VLFT10GEN). Connectivity: proprietary connector with RFID/barcode for generator identification. Sterilization: Ethylene Oxide. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-1.

Indications for Use

Indicated for adult, children, and adolescent patients (3 years and older) undergoing open general surgical procedures and ENT procedures, including tonsillectomy, for ligation and division of vessels, tissue bundles, and lymphatics up to 3 mm in diameter. Contraindicated for tubal coagulation/sterilization.

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™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K182451)

Related Devices

K160539 — BiZact Open Sealer/Divider · Covidien · Jun 15, 2016
K182451 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider · Covidien, LLC · Nov 6, 2018
K171066 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider · Covidien, LLC · Jun 8, 2017
K153017 — Voyant Fine Fusion · Applied Medical Resources · Jul 6, 2016
K143536 — Voyant Fine Fusion Device · Applied Medical Resources · Apr 16, 2015

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 2, 2020 Covidien, LLC Juma Hoshino Regulatory Affairs Manager 5920 Longbow Drive Boulder, Colorado 80301 # Re: K193356 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: December 3, 2019 Received: December 4, 2019 Dear Juma Hoshino: 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/cfpmn/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. {1}------------------------------------------------ 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193356 #### Device Name BiZact™ Tonsillectomy Device Advanced Bipolar Tissue 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 of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures. It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 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> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle and a light blue vertical line inside it. To the right of the square is the word "COVIDIEN" in a dark blue sans-serif font. ## 510(k) Summary Date summary prepared: March 2, 2020 ### 510(k) Submitter/Holder Covidien Ilc 5920 Longbow Drive Boulder, CO 80301 ## Contact: Juma Hoshino Regulatory Affairs Manager Telephone: 303-530-6541 Email: juma.hoshino@medtronic.com ### Name of Device | Trade Name: | BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divide | |----------------------|-----------------------------------------------------------------------------------------------------| | Catalog Number: | BZ4212A | | Common Name: | Bipolar Vessel Sealing Device | | Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR §878.4400, Class II, GEI) | ## Predicate Device | Trade Name: | BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | |-----------------|---------------------------------------------------------------------| | Catalog Number: | BZ4212A | | Common Name: | Bipolar Vessel Sealing Device | | 510(k) Number: | K182451 (cleared November 6, 2018) | | Manufacturer: | Covidien llc | #### Device Description The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider is a sterile, single use, hand-held electrosurgical device that incorporates radio frequency (RF) tissue fusion technology for a desired tissue effect when used with the ForceTriad™ Energy Platform (Force Triad), the Valleylab™ LS10 Generator (VLLS10GEN), or the Valleylab™ FT10 Energy Platform (VLFT10GEN) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures. The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider via the radiofrequency identification (RFID) tag embedded in the connector (VLLS10GEN and VLFT10GEN) 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 tissue. #### How Provided The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is provided sterile and is intended for single use. {4}------------------------------------------------ ## Compatible Electrosurgical Generators: - ForceTriad™ Energy Platform (ForceTriad) . - . Valleylab™ LS10 Generator (VLLS10GEN) - Valleylab™ FT10 Energy Platform (VLFT10GEN) . ## 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 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, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation of vessels, tissue bundles and lymphatics 2-3 mm away from unintended sensitive structures. The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures. ### Patient Contacting Materials Patient contacting materials in the manufacture of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider include stainless steel. Polyphthalamide, ceramic, ethylene-tetrafluoroethylene, silicone, and PETE lubricants. ### Comparison of Technological Characteristics with the Predicate Device BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is unchanged from the predicate device, as cleared under K182451, in terms of intended use, design, performance, and technological characteristics. The only difference is that the indications for use have been updated to include children population (3 years to less than 12 years). Tonsillectomy is a very well characterized surgical risks and adverse events are similar for all age ranges. While there is a change in the indicated patient population, the clinical study has demonstrated that the addition of children patients does not raise new questions of safety or effectiveness. Therefore, the subject device is substantially equivalent to the predicate device. {5}------------------------------------------------ | Characteristic | Proposed Device BiZact Device | Predicate Device BiZact Device (K182451) | Comment | | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------|------| | Class Regulation | 21 CFR §878.4400 | 21 CFR §878.4400 | Same | | | | Class | II | II | Same | | | | Product Code | GEI | GEI | Same | | | | 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, children and adolescent ENT procedures (3 years of age and above), 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. | 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 and adolescent ENT procedures (12 years of age and above), 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. | Expansion to include children population. | | | | | Contraindications | None | | None | Same | | | Instrument Design | Pistol Grip | | Pistol Grip | Same | | | Energy Type | Electrical (RF) bipolar energy | | Electrical (RF) bipolar energy | Same | | | Compatible Energy Platforms | ForceTriad™ Energy Platform Valleylab™ LS10 Generator Valleylab™ FT10 Energy Platform | | ForceTriad™ Energy Platform Valleylab™ LS10 Generator Valleylab™ FT10 Energy Platform | Same | | Energy Activation | Handswitch • ForceTriad™ Energy Platform • Valleylab™ LS10 Generator • Valleylab™ FT10 Energy Platform | Handswitch • ForceTriad™ Energy Platform • Valleylab™ LS10 Generator • Valleylab™ FT10 Energy Platform | Same | | | | | Footswitch • ForceTriad™ Energy Platform • Valleylab™ FT10 Energy Platform | Footswitch • ForceTriad™ Energy Platform • Valleylab™ FT10 Energy Platform | Same | | | | Hand-activated Button Design | Single Stage | Single Stage | Same | | | | Proprietary Connector | Yes | Yes | Same | | | | In-Line Activation | Yes | Yes | Same | | | | Cutting Mechanism Design | Integrated cutting blade | Integrated cutting blade | Same | | | | Single Use | Yes | Yes | Same | | | | Sterile | Yes | Yes | Same | | | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same | | | {6}------------------------------------------------ ## Performance Characteristics No design or specification changes are associated with the expanded indication of the BiZact™ Tonsillectorny Device Advanced Bipolar Tissue Sealer/Divider. Evidence of safety and effectiveness was presented in the previously submitted 510(k)s and includes the following: - . Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 - Biocompatibility (ISO 10993-1) . - Device functionality - Bench burst pressure . - In vivo acute and chronic animal studies ● ## Clinical Studies A prospective, multi-center, single arm clinical study was conducted to demonstrate the safety and effectiveness of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider for the use with the pediation. Sixty (60) pediatric subjects ranging in age from three (3) to twelve (12) were enrolled in the study and all underwent tonsillectomy with the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider. The primary outcome of intra-operative blood loss of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider was significantly less than the benchmark derived from a large meta-analysis, meeting the primary objective. During the course of the clinical study, adverse events (AEs) were identified and assessed by the Investigators and an Independent External Medical Monitor in terms of severity and relatedness to the device and procedure. The assessment findings were that: a) none (0) of the events were related to use of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider: b) none (0) of the events qualified as serious AEs, and; c) thirteen (13) AEs were related to the tonsillectomy procedure itself. These include fever, vomiting, swollen tongue, throat pain, ear pain, and dehydration. The majority of these tonsillectomy-related AEs were treated at home by caregivers with pain medication. Four (4) subjects with five (5) events of dehydration, received outpatient intervention in the form of IV fluids administered in emergency rooms or a surgery center. None of the subjects were admitted or readmitted to the hospital during this study. #### Conclusions The proposed BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider with indications for use in Children (3 years to less than 12 years) is substantially equivalent to the predicate BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider with indications for use in adults and adolescents (12 years of age and above). The clinical study conducted with the proposed device has demonstrated that the subject device is substantially equivalent to the predicate device.