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 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.

AI/ML Overview

This document is a 510(k) Summary for the BiZact Open Sealer/Divider, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study proving the device meets specific acceptance criteria in the way a clinical trial for a novel AI device might. Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this regulatory submission for a medical device.

However, I can extract the available information as it relates to demonstrating the device's performance through testing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with numerical targets that were then met by the device. Instead, it lists various performance testing categories to demonstrate that the device performs as intended and is substantially equivalent to its predicate. The "reported device performance" is summarized as having "demonstrated that the BiZact Open Sealer/Divider performs as intended and is substantially equivalent to its predicate, LF1212A."

Here's a table based on the testing categories provided, with the "reported device performance" being the implicit successful completion of these tests.

Acceptance Criteria Category (as inferred)	Reported Device Performance
IEC 60601-1 Basic Electrical Safety	Met (implicit through successful completion of testing)
IEC 60601-1-2 Electromagnetic Compatibility	Met (implicit through successful completion of testing)
IEC 60601-2-2 Basic Safety for HF Equipment and HF Accessories	Met (implicit through successful completion of testing)
ISO 10993-1 Biocompatibility	Met (implicit through successful completion of testing)
Performance Testing - Device Functionality	Performs as intended (summary statement)
Performance Testing - Bench Tissue burst testing	Successful (implicit through summary statement of substantial equivalence)
Performance Testing - In-vivo acute (hemostasis, thermal spread, lymphatic burst pressure)	Successful (implicit through summary statement of substantial equivalence)
Performance Testing - In-vivo chronic (hemostasis)	Successful (implicit through summary statement of substantial equivalence)
Usability - Design Validation - Summative testing in simulated use environment	Successful (implicit through summary statement of substantial equivalence)

Study Details:

Sample size used for the test set and the data provenance:
- The document mentions "Performance Testing Bench Tissue burst testing" and "Performance Testing In-vivo acute... and chronic". However, specific sample sizes for these tests (e.g., number of tissue samples, number of animal subjects) are not provided in this summary.
- Data provenance: Not explicitly stated, but "In-vivo" testing typically implies animal studies conducted under controlled laboratory conditions, usually retrospective for data analysis.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this device's testing. The ground truth for bench and in-vivo performance testing of a surgical device like this is typically established by direct measurement (e.g., burst pressure, thermal spread measurement, visual assessment of hemostasis by trained researchers/veterinary staff), not an expert panel reviewing data in the way an AI diagnostic device would.
Adjudication method for the test set:
- Not applicable. As the "ground truth" is based on direct measurements and observable outcomes, an adjudication method in the sense of resolving disagreements among experts is not typically used for this type of device testing.
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 device is an electrosurgical instrument, not an AI-powered diagnostic device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware-based surgical device; there is no "algorithm only" performance to evaluate. The device itself is the standalone entity.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Performance Testing Bench Tissue burst testing, In-vivo acute, and In-vivo chronic, the ground truth would be based on direct physiological/biological measurements and observations (e.g., actual burst pressures measured, direct observation and measurement of thermal spread, assessment of hemostasis by trained personnel). In some cases, histology/pathology might be used to confirm tissue effects, but it's not explicitly stated as the primary ground truth source.
The sample size for the training set:
- Not applicable. This summary describes a physical medical device, not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, no training set is involved for this type of device.

Summary

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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 (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 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)

☑ 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: June 10, 2016

510(k) Submitter/Holder

Covidien, llc 5920 Longbow Drive Boulder, CO 80301

Contact

Sharon McDermott Senior Product Specialist, Regulatory Affairs Telephone: 303-581-6789 Fax: 303-516-6313 Email: sharon.1.mcdermott@medtronic.com

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

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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 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.

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.