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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (BiZact Tonsillectomy Device) and does not contain information about an AI/ML-based device or its performance criteria related to AI/ML tasks.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device's performance. The document focuses on the substantial equivalence of a physical electrosurgical device to a predicate device, based on mechanical, electrical, functional, biocompatibility, sterilization, and animal (ex-vivo/in-vivo) studies.

The request asks for:

Table of acceptance criteria and reported device performance (for AI/ML): Not applicable, as this is not an AI/ML device. The document summarizes various engineering and biological tests, but not specific AI performance metrics like sensitivity, specificity, or AUC.
Sample size for test set and data provenance: The document mentions "fresh porcine renal arteries" for burst pressure, "porcine model" for lymphatic and acute hemostasis studies, and a "chronic hemostasis porcine study." It does not specify sample sizes in terms of number of cases for these animal studies beyond indicating they were sufficient for verification. Data provenance is "porcine model" (animal data), which is prospective in the context of these experiments. There is no human patient data test set for AI.
Number of experts and qualifications for ground truth: Not applicable for an AI/ML device. Ground truth in this context would be physical measurements, biological response, or pathological findings from the animal studies, not expert consensus on AI outputs.
Adjudication method: Not applicable for an AI/ML device.
MRMC comparative effectiveness study: Not applicable, as there's no AI component or human reader interaction with AI.
Standalone AI performance: Not applicable.
Type of ground truth: For the physical device, it's based on physiological and pathological outcomes in animal models (e.g., vessel burst pressure, acute hemostasis, lymphatic sealing, lateral thermal spread over time).
Sample size for training set: Not applicable, as there is no AI training set.
How ground truth for training set was established: Not applicable.

In summary, the provided document describes a medical device clearance for an electrosurgical tool, not an AI/ML device. Therefore, none of the requested information pertaining to AI/ML acceptance criteria and performance studies can be found or inferred from the text.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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: May 17, 2017

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Sharon McDermott Senior Specialist, Regulatory Affairs Telephone: 303-581-6789 Fax: 303-530-6313 Email: sharon.l.mcdermott@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 CFR878.4400, 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

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.

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 DEVICEBiZact (BZ4212A)	PREDICATE DEVICEBiZact (BZ4112)	Comment
Class Regulation	878.44	878.44	Same
Class	II	II	Same
Product Code	GEI	GEI	Same
CHARACTERISTIC	PROPOSED DEVICEBiZact (BZ4212A)	PREDICATE DEVICEBiZact (BZ4112)	Comment
Indications for Use	The BiZact device is a bipolarinstrument intended for use in opensurgical procedures where ligationand division of vessels, tissuebundles, and lymphatics is desired.The tissue fusion function of thedevice can be used on vessels(arteries and veins) and lymphaticsup to and including 3 mm diameter.The BiZact device is indicated foruse in open general surgicalprocedures.It is also indicated for adult ENTprocedures, includingtonsillectomy, for the ligation anddivision of vessels, tissue bundlesand lymphatics 2-3 mm away fromunintended thermally sensitivestructures.The BiZact device has not beenshown to be effective for tubalsterilization or tubal coagulation forsterilization procedures. Do not usefor these procedures.	The BiZact device is a bipolarinstrument intended for use in opensurgical procedures where ligationand division of vessels, tissuebundles, and lymphatics is desired.The tissue fusion function of thedevice can be used on vessels(arteries and veins) and lymphaticsup to and including 3 mm diameter.The BiZact device is indicated foruse in open general surgicalprocedures.It is also indicated for adult ENTprocedures, including tonsillectomy,for the ligation and division ofvessels, tissue bundles andlymphatics 2-3 mm away fromunintended thermally sensitivestructures.The BiZact device has not beenshown to be effective for tubalsterilization or tubal coagulation forsterilization procedures. Do not usefor 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 EnergyPlatform(s) and 510(k)s	Valleylab LS10 Vessel SealingGenerator (K143654)	Valleylab LS10 Vessel SealingGenerator (K143654)	Same
	Valleylab Force TriadElectrosurgical Generator(K051644, K070162, K102913)	No	Single-generatorcompatibility consideredsufficient for initial releaseof BZ4112.
	Valleylab FT10 ElectrosurgicalPlatform (K151649, K170170)	No	Compatibility with a singlegenerator was consideredsufficient for initial releaseof the predicate BZ4112.
Energy Activation(Generator)	Handswitch	Handswitch	Predicate BZ4112 is onlycompatible with the LS10generator. Neither thepredicate BZ4112 norsubject BZ4212A can befootswitch- activated on the
	Footswitch(ForceTriad)(Valleylab VLFT10)	No	Valleylab LS10.Activation by hand or footdoes not lead to anydifference in energy output,therefore does not affectperformance.
Hand-activated buttondesign	Single stage	Single stage	Same
CHARACTERISTIC	PROPOSED DEVICEBiZact (BZ4212A)	PREDICATE DEVICEBiZact (BZ4112)	Comment
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 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.

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.