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 3mm 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 coagulation for sterilization procedures. Do not use for these procedures.

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 (ForceTriad), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing 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 Sealer/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ device via the 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. The combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.

AI/ML Overview

Based on the provided text, the device in question is the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.

The core of this submission is not about a new AI/ML device with acceptance criteria for algorithm performance. Instead, it's about a medical device (an electrosurgical instrument) that is seeking to expand its Indications for Use to include an adolescent population (12-21 years of age), building upon its previous clearance for adults (22+ years of age).

Therefore, many of the questions about AI/ML specific studies (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of device and submission.

Here's an attempt to address the relevant points based on the provided text, and to explicitly state when information is not available or not applicable for this device type:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not describe acceptance criteria in the typical sense for an AI/ML device's algorithmic performance. Instead, it demonstrates continued acceptable performance and substantial equivalence to a predicate device. The "acceptance criteria" here are implicitly tied to the safety and performance standards relevant to electrosurgical devices.

Acceptance Criteria (Implied / Relevant Performance Factors for Electrosurgical Device)	Reported Device Performance (from "Performance Summary")
Electrical Safety (e.g., meeting IEC 60601-1)	Meets IEC 60601-1 Basic Electrical Safety
Electromagnetic Compatibility (e.g., meeting IEC 60601-1-2)	Meets IEC 60601-1-2 Electromagnetic Compatibility
Basic Safety for HF Equipment and Accessories (e.g., meeting IEC 60601-2-2)	Meets IEC 60601-2-2 Basic Safety for HF Equipment and HF Accessories
Biocompatibility (e.g., meeting ISO 10993-1)	Meets ISO 10993-1 Biocompatibility
Device Functionality (e.g., proper operation)	Performance Testing Device Functionality conducted
Tissue Sealing Performance (e.g., burst strength)	Bench Tissue - burst testing (renal artery and lymph) conducted
In-vivo Performance (e.g., hemostasis, thermal spread)	In-vivo - acute (hemostasis, thermal spread) and chronic (hemostasis) testing conducted
Safety and Efficacy in Expanded Age Group (relative to predicate)	Clinical Literature Summary supports that treatments in tonsillectomy for adults and adolescents are very similar without creating additional risk concerns. No design or specification changes were made.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for specific tests. The "Performance Testing" section mentions "bench tissue - burst testing (renal artery and lymph)" and "in-vivo - acute (hemostasis, thermal spread) and chronic (hemostasis)". The sample sizes for these tests are not provided in this summary.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory/bench and animal (in-vivo) testing rather than human clinical trials for this 510(k) submission. The "Clinical Literature Summary" refers to existing literature, but its provenance is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is not a study requiring expert ground truth for classification or interpretation, as it's a physical medical device. The "Clinical Literature Summary" likely relies on the expertise of the medical community as a whole.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is not a diagnostic device with interpretative tasks requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As it's not an AI/ML device, the concept of "ground truth" as it applies to diagnostic algorithms is not relevant. For the physical device, performance is evaluated against engineering specifications, physiological measurements (e.g., burst pressure, thermal spread), and clinical outcomes (e.g., hemostasis). The "Clinical Literature Summary" relies on existing medical literature regarding tonsillectomy procedures in different age groups.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device with a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/ML device with a training set.

Summary

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November 6, 2018

Covidien, LLC Rebecca Clark Senior Regulatory Affairs Specialist 5920 Longbow Drive Boulder, CO 80301

Re: K182451

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: September 6, 2018 Received: September 7, 2018

Dear Rebecca Clark:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K182451

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Covidien. The logo consists of a blue square with a lighter blue vertical line and a white rectangle in the center. To the right of the square is the word "COVIDIEN" in a dark blue sans-serif font.

510(k) Summary Date summary prepared: October 30, 2018

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Rebecca Clark Senior Regulatory Affairs Specialist Telephone: 303-581-6427 Fax: 303-516-8316 Email: rebecca.a.clark@medtronic.com

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 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: K171066 (cleared June 8, 2017) Manufacturer: Covidien

Device Description

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How provided

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

Image /page/4/Picture/3 description: The image shows a medical device inside of a clear plastic package. The device is white and gray and has a long, thin needle extending from the front. A blue tube is connected to the device. The device is held in place by a white cardboard cutout.

Provided as viewed in the image below.

Compatible Electrosurgical Generators

BZ4212A, BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider compatible with:

Code: FORCETRIAD	Code: VLLS10GEN	Code: VLFT10GEN
Force Triad Energy Platform	Valleylab™ LS10 VesselSealing Generator	Valleylab™ FT10 EnergyPlatform

Patient Contacting Materials in BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

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

Comparison of Technological Characteristics with the Predicate Device

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) and is unchanged from the predicate device, as cleared under K171066, in terms of intended use, design, performance, and technological characteristics. The only difference is that the Indications for Use has been changed to include an adolescent population (12-21 years of age).

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K182451
CHARACTERISTIC	PROPOSED DEVICE	PREDICATE DEVICE	Comment
	BiZact (BZ4212A)	BiZact (BZ4212A)
	K182451	K171066
Class Regulation	878.44	878.44	Same
Class	II	II	Same
Product Code	GEI	GEI	Same
Indications for Use	The BiZact device is abipolar instrumentintended for use inopen surgicalprocedures whereligation and division ofvessels, tissue bundles,and lymphatics isdesired.The tissue fusionfunction of the devicecan be used onvessels(arteries andveins) and lymphaticsup to and including 3mm diameter. TheBiZact device isindicated for use inopen general surgicalprocedures.It is also indicated foradult and adolescentENT procedures (12years of age andabove), includingtonsillectomy, for theligation and division ofvessels, tissue bundlesand lymphatics 2-3 mmaway from unintendedthermally sensitivestructures.The BiZact device hasnot been shown to beeffective for tubalsterilization or tubalcoagulation forsterilization procedures.Do not use for theseprocedures.	The BiZact device is abipolar instrumentintended for use inopen surgicalprocedures whereligation and division ofvessels, tissue bundles,and lymphatics isdesired.The tissue fusionfunction of the devicecan be used onvessels(arteries andveins) and lymphaticsup to and including 3mm diameter. TheBiZact device isindicated for use inopen general surgicalprocedures.It is also indicated foradult ENT procedures,includingtonsillectomy, for theligation and division ofvessels, tissue bundlesand lymphatics 2-3 mmaway from unintendedthermally sensitivestructures.The BiZact device hasnot been shown to beeffective for tubalsterilization or tubalcoagulation forsterilization procedures.Do not use for theseprocedures.	Expansion to includeadolescent in theindication.
Contraindications	None	None	Same
Instrument Design	Pistol Grip	Pistol Grip	Same
K182451
Energy Type	Electrical (RF)bipolar energy	Electrical (RF) bipolar energy	Same
CHARACTERISTIC	PROPOSED DEVICE	PREDICATE DEVICE	Comment
	BiZact (BZ4212A)	BiZact (BZ4212A)
Compatible EnergyPlatform(s) and 510(k)s	Valleylab ForceTriad™	Valleylab ForceTriad™	Same
	(K102913)	(K102913)
	Valleylab FT10 EnergyPlatform, ValleylabFX8 FX Series EnergyPlatform(K181389)	Valleylab FT10 EnergyPlatform, ValleylabFX8 FX Series EnergyPlatform(K181389)	Same
	ValleylabTM LS, LSSeries Single ChannelVessel SealingGenerator (K143654)	ValleylabTM LS, LSSeries Single ChannelVessel SealingGenerator (K143654)	Same
Energy Activation(Generator)	Handswitch (Allcompatible generators)	Handswitch (Allcompatible generators)	Same
	Footswitch(ForceTriad) (ValleylabVLFT10)	Footswitch(ForceTriad) (ValleylabVLFT10)	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	EO	EO	Same
Vessel Size Range	Up to and including 3mm	Up to and including 3mm	Same

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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 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.

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Performance Summary

Verification and validation results demonstrate that the BiZact Adolescent Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider performs as intended. 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 (renal artery and lymph)
. Performance Testing - In-vivo - acute (hemostasis, thermal spread) and chronic (hemostasis)

No design or specification changes are associated with expanded indication, therefore the previous performance testing listed above remains applicable.

Clinical Literature Summary

A study of clinical literature for tonsillectomy procedures in adults and adolescents show that treatments in tonsillectomy considering risk factors such as bleeding, and anatomical measurements of the treatment area in adults and adolescents are very similar without creating additional risk concerns for using the BiZact device to perform ENT procedures in both populations.

Conclusion on Substantial Equivalence

The proposed BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) for use in adolescents defined as (12-21 years of age in this submission) is substantially equivalent to the predicate BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) for use in adults defined as (22+ years of age). Supporting clinical literature attached to this submission shows that inclusion of adolescents in the indications for this device do not raise new questions of safety or efficacy.

All performance and design specifications remain the same as for the previously cleared design. The subject device is substantially equivalent to the 510(k) cleared 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.