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 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.

AI/ML Overview

This document describes the FDA's decision to clear the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356) for an expanded indication to include children aged 3 to less than 12 years. The key basis for this clearance is the demonstration of substantial equivalence to a previously cleared device (K182451).

The provided text details a clinical study to support the expanded indication but does not provide specific acceptance criteria in a quantitative table format that directly correlates to a device's performance in terms of metrics like sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. This is because the BiZact device is a surgical instrument, not an AI or diagnostic device. Its performance is assessed through safety and effectiveness in a surgical context, primarily focusing on clinical outcomes.

Therefore, I will interpret "acceptance criteria" here as the clinical safety and effectiveness benchmarks that the device needed to meet for the expanded indication, and "device performance" as the clinical outcomes observed in the study.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356)

Given that this is a surgical device, not an AI or diagnostic tool, the "acceptance criteria" are based on clinical safety and effectiveness endpoints for the surgical procedure it facilitates. The study primarily aimed to demonstrate that expanding the indication to include children (3 to <12 years) does not introduce new safety or effectiveness concerns compared to its existing use in adults and adolescents.

1. Table of Acceptance Criteria (Clinical Endpoints for Expanded Indication) and Reported Device Performance

Acceptance Criterion (Clinical Endpoint)	Reported Device Performance in Clinical Study
Primary Objective: Intra-operative blood loss (quantitatively assess effectiveness).	Significantly less than the benchmark derived from a large meta-analysis. (This met the primary objective).
Safety: Occurrence of device-related adverse events (AEs).	0 out of 60 subjects had adverse events related to the use of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider.
Safety: Occurrence of serious adverse events (SAEs).	0 out of 60 subjects qualified as serious AEs.
Safety: Device-related readmissions/hospitalizations to manage adverse events.	None of the subjects were admitted or readmitted to the hospital during this study for adverse events. (Note: Four subjects had 5 dehydration events requiring outpatient IV fluids, but no hospital admission.)
Overall Effectiveness and Safety for Expanded Population.	The clinical study demonstrated that the addition of children patients (3 to <12 years) does not raise new questions of safety or effectiveness, supporting the conclusion that the device is substantially equivalent to the predicate for this expanded indication. The device performed as expected, with favorable clinical outcomes and a low incidence of device-related or serious adverse events. Tonsillectomy-related AEs (e.g., fever, vomiting, throat pain) were observed, but these were related to the procedure itself, not the device, and were largely manageable.

2. Sample Size and Data Provenance for the Test Set (Clinical Study)

Sample Size: Sixty (60) pediatric subjects.
Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "multi-center" study, suggesting multiple sites potentially within one or more countries. It was a prospective clinical study.

3. Number of Experts and Qualifications for Ground Truth Establishment (Clinical Study)

Number of Experts: Investigators (referring to the operating surgeons/clinicians at each site) and an Independent External Medical Monitor. The exact number of investigators is not specified (since it was multi-center). Only one Independent External Medical Monitor is mentioned.
Qualifications: "Investigators" are physicians performing the tonsillectomy and assessing patients. The "Independent External Medical Monitor" typically holds medical qualifications (e.g., MD) and experience in clinical trial oversight, often specializing in the relevant medical field (ENT/pediatrics in this case), to ensure patient safety and data integrity. Specific years of experience are not provided.

4. Adjudication Method for the Test Set (Clinical Study)

Adjudication of adverse events was performed by the "Investigators and an Independent External Medical Monitor." This suggests a process where initial assessment is made by the site investigator, and then reviewed/confirmed by an independent monitor. The specific "2+1" or "3+1" type of formal consensus is not explicitly detailed, but there was an independent review process for AE assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a surgical instrument, not an AI or diagnostic imaging system. Therefore, an MRMC study designed to assess human reader performance with or without AI assistance is not relevant to its evaluation. The study focused on clinical outcomes of using the device during surgery.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This is a surgical device, always used with human-in-the-loop (i.e., by a surgeon). There is no "algorithm only" performance to evaluate. Its function is directly tied to the surgeon's use during a procedure.

7. Type of Ground Truth Used (Clinical Study)

Clinical Outcomes and Expert Assessment: The ground truth for safety and effectiveness was established through direct clinical observation of intra-operative blood loss, patient follow-up for adverse events, and assessment by clinical investigators and an independent medical monitor. This combines objective clinical measurements (blood loss) with subjective clinical evaluations of patient well-being and adverse event causality.

8. Sample Size for the Training Set

Not applicable. This is a hardware surgical device, not a machine learning model. There is no concept of a "training set" for the device itself.
However, if we consider "training" in a broader sense as prior experience or data that informed the device's design and previous clearances, then the predicate device (K182451) and its associated studies (likely including animal studies, bench testing, and potentially clinical data on adults/adolescents) could be seen as foundational.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for the device. The device's design and performance claims are based on engineering principles, bench testing (e.g., burst pressure), biocompatibility testing, a previously cleared predicate device, and prior animal/clinical studies described in previous 510(k) submissions. These prior studies would have established their ground truth through standard preclinical and clinical methods relevant to surgical devices.

Summary

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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.

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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

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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 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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 (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.

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Characteristic	Proposed DeviceBiZact Device	Predicate DeviceBiZact 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 bipolarinstrument intended for use in opensurgical procedures where ligation anddivision of vessels, tissue bundles, andlymphatics is desired.The tissue fusion function of the devicecan be used on vessels (arteries andveins) and lymphatics up to andincluding 3 mm diameter. The BiZactdevice is indicated for use in opengeneral surgical procedures.It is also indicated for adult, childrenand adolescent ENT procedures (3years of age and above), includingtonsillectomy, for the ligation anddivision of vessels, tissue bundles andlymphatics 2-3 mm away fromunintended thermally sensitivestructures.The BiZact device has not been shownto be effective for tubal sterilization ortubal coagulation for sterilizationprocedures. Do not use for theseprocedures.	The BiZact device is a bipolarinstrument intended for use in opensurgical procedures where ligation anddivision of vessels, tissue bundles, andlymphatics is desired.The tissue fusion function of the devicecan be used on vessels (arteries andveins) and lymphatics up to andincluding 3 mm diameter. The BiZactdevice is indicated for use in opengeneral surgical procedures.It is also indicated for adult andadolescent ENT procedures (12 yearsof age and above), includingtonsillectomy, for the ligation anddivision of vessels, tissue bundles andlymphatics 2-3 mm away fromunintended thermally sensitivestructures.The BiZact device has not been shownto be effective for tubal sterilization ortubal coagulation for sterilizationprocedures. Do not use for theseprocedures.	Expansionto includechildrenpopulation.
	Contraindications	None		None	Same
	Instrument Design	Pistol Grip		Pistol Grip	Same
	Energy Type	Electrical (RF) bipolar energy		Electrical (RF) bipolar energy	Same
	Compatible EnergyPlatforms	ForceTriad™ Energy PlatformValleylab™ LS10 GeneratorValleylab™ FT10 Energy Platform		ForceTriad™ Energy PlatformValleylab™ LS10 GeneratorValleylab™ 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 ButtonDesign	Single Stage	Single Stage	Same
Proprietary Connector	Yes	Yes	Same
In-Line Activation	Yes	Yes	Same
Cutting MechanismDesign	Integrated cutting blade	Integrated cutting blade	Same
Single Use	Yes	Yes	Same
Sterile	Yes	Yes	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same

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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.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.