The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired.

The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

Device Description

The Voyant 5mm Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

AI/ML Overview

The medical device discussed is the Voyant 5mm Fusion Device, an electrosurgical device for laparoscopic procedures to ligate and divide vessels and tissue bundles.

Here's an analysis of its acceptance criteria and the study that proves it meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table with numerical acceptance criteria values alongside numerical reported device performance in the traditional sense of a diagnostic AI product. Instead, it describes compliance with standards and the outcome of specific bench tests.

Acceptance Criteria Category	Reported Device Performance	Study Type
Mechanical Safety	Complies with IEC 60601-1:2005	Mechanical Testing
Electrical Safety	Complies with IEC 60601-1:2005 and IEC 60601-2-2:2009	Electrical Safety Testing
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2007	EMC Testing
Burst Pressure (Vessel Sealing Strength)	Demonstrated that the subject device met the predetermined acceptance criteria (comparison to predicate on vessels up to 7mm).	Bench (Burst Pressure Testing)
Thermal Spread (Local Tissue Damage)	Analysis of measurements demonstrated that the subject device met the predetermined acceptance criteria (comparison to predicate).	Bench (Thermal Spread Testing)
Software Functionality	Unit, integration, and system level verification were conducted to evaluate the implementation and performance of the device software script.	Software Verification
Substantial Equivalence	The subject device is substantially equivalent in performance to the predicate Voyant 5mm Fusion Device with respect to intended use (i.e. vessel sealing performance and local tissue effects) and does not raise any new issues of safety and efficacy.	Overall conclusion based on all tests.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Bench Tests (Burst Pressure & Thermal Spread): The document states "Vessels representative of the devices' indications were sealed" but does not specify the number of vessels or samples used for the burst pressure and thermal spread tests.
Data Provenance: Not specified. These are bench tests, so the "data" would be the results from the physical testing of the device on isolated vessels/tissue. Country of origin for such tests is typically the manufacturing or testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the device is a surgical instrument, not a diagnostic AI system requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for the performance tests (e.g., burst pressure, thermal spread) are objective measurements taken from the physical properties and effects of the device.

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

Not applicable. This device is not an AI diagnostic tool and does not involve human adjudication of results in the way clinical studies often do. The tests performed are objective, measurable physical tests.

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. The device is a surgical instrument, not an AI diagnostic tool that assists human readers. No MRMC study was mentioned or required.

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

Not applicable. The device is a surgical instrument, not an AI algorithm. Its performance is inherent in its electrosurgical capabilities.

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

The "ground truth" for this device's performance is based on objective physical measurements and compliance with established engineering and medical device standards.

For burst pressure: The actual pressure at which a sealed vessel ruptures.
For thermal spread: Direct measurements of the extent of thermal damage to tissue.
For electrical safety and EMC: Compliance with specified international standards (IEC 60601 series).

8. The sample size for the training set

Not applicable. This device is a physical electrosurgical instrument, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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February 13, 2018

Applied Medical Resources Corporation Andrew Nguyen Regulatory Affairs Analyst 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K172624

Trade/Device Name: Voyant 5mm Fusion Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 28, 2017 Received: September 29, 2017

Dear Andrew Nguyen:

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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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. 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) K172624

Device Name Voyant 5mm Fusion Device

Indications for Use (Describe)

The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

510(k) Submitter:	Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 (949) 713 – 8000
Contact Person:	Andrew Nguyen Regulatory Affairs Analyst Applied Medical Resources Corporation Tel: (949) 713-5458 Fax: (949) 713-8205 Email: andrnguyen@appliedmedical.com
Preparation Date:	August 31, 2017
Trade Name:	Voyant® 5mm Fusion Device
Common Name:	Bipolar Electrosurgical Sealer-Divider
Classification:	General and Plastic Surgery Devices - Electrosurgical Cutting and Coagulation Device and Accessories Regulation: 21 CFR 878.4400 Device Class: Class II Product Code: GEI
Predicate Device:	Voyant® 5mm Laparoscopic Tissue Sealer-Divider Device 510(k)#: K141288 Product Code: GEI
Device Description:	The Voyant 5mm Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.
Intended Use:	The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired.
	The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.
	The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

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Summary of Technological Characteristics between Subject and Predicate Devices:

The subject device design is the same as the predicate, with the exception of the shaft length. The subject design has the same fundamental technological features and intended use as the predicate.

The subject and predicate instruments are technologically identical in configuration and operation. They are designed to deliver RF energy to vessels and tissue captured between the jaws of the device for tissue fusion. Both instruments feature pistol-grip style handles with a trigger for jaw closure and button on the back of the handle for energy activation. The instruments are equipped with a mechanical, user-actuated blade for the division of sealed tissue.

Discussion of Performance Testing:

The 2016 FDA Guidance, Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery, was considered in evaluating the subject device's electrical, mechanical and functional capabilities. The tests addressed below were utilized to demonstrate safety and efficacy of the subject device and substantial equivalence to the predicate device.

EMC, Electrical Safety, and Mechanical Testing

The Voyant 5mm Fusion Device complies with IEC 60601-1:2005 for mechanical testing, IEC 60601-1:2005 and IEC 60601-2-2:2009 for electrical safety testing, and IEC 60601-1-2:2007 for electromagnetic compatibility testing.

Bench

Burst pressure testing was conducted on the subject and predicate Voyant 5mm Fusion Devices. Vessels representative of the devices' indications were sealed and the burst pressure for each vessel was recorded. The results of the study demonstrated that the subject device met the predetermined acceptance criteria.

Thermal spread testing was performed to evaluate the thermal spread damage produced by the subject and predicate Voyant 5mm Fusion Devices. Vessels representative of the devices' indications were sealed and measurements of the fused areas were taken. Analysis of the measurements demonstrated that the subject device met the predetermined acceptance criteria.

Clinical

No animal or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance. The performance data detailed in this submission supports the substantial equivalence of the subject device.

Software Verification

Unit, integration, and system level verification were conducted to evaluate the implementation and performance of the device software script.

Conclusion:

The subject Voyant 5mm Fusion Device is substantially equivalent in performance to the predicate Voyant 5mm Fusion Device with respect to intended use (i.e. vessel sealing performance and local tissue effects) and does not raise any new issues of safety and efficacy.

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.