The Voyant Open Fusion Device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open 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 for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and 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 for sterilization procedures, and should not be used for these procedures.

Device Description

The Voyant Open Fusion and Voyant 5mm Fusion devices are advanced bipolar instruments that use RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the devices' jaws. Each device features a mechanical, user-actuated blade for the division of sealed tissue.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Voyant Open Fusion Device and Voyant 5mm Fusion Device.

It's important to note that the provided documents (FDA 510(k) summaries) typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed, comprehensive reports on a device's standalone performance or comparative effectiveness studies with human readers. Therefore, some of the requested information may not be explicitly present or might be inferred from the context of a 510(k) submission.

Acceptance Criteria and Reported Device Performance

The documents state that both devices "met all acceptance criteria" and "met the predetermined acceptance criteria" for various tests. However, the specific quantitative acceptance criteria and the precise performance metrics achieved are not explicitly detailed in the provided text. The submission focuses on stating that the criteria were met, implying satisfactory performance relative to either internal company standards, recognized industry standards, or performance established by the predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Test Category	Acceptance Criteria (Inferred/General)	Reported Device Performance
Electromagnetic Compatibility (EMC)	Compliance with relevant standards of IEC 60601 series.	Met all acceptance criteria.
Electrical Safety	Compliance with relevant standards of IEC 60601 series.	Met all acceptance criteria.
Mechanical Testing (Simulated Repeated-Use)	Continued performance over multiple device activations.	Met predetermined acceptance criteria.
Burst Pressure Testing	Maintain seal integrity under pressure for vessels up to 7mm.	Met predetermined acceptance criteria.
Thermal Spread Testing	Demonstrate acceptable levels of thermal damage.	Met predetermined acceptance criteria.
Animal Testing (Chronic Survival Study)	Evaluate long-term seal quality, device performance, and absence of adverse effects on adjacent structures (hemostasis, no hematoma).	Met predetermined acceptance criteria.
Software Verification	Design, implementation, and performance of software scripts verified.	Demonstrated substantially equivalent performance.

Study Details

1. Sample Sizes and Data Provenance

Test Set (Clinical/Animal):
- Animal Testing: "large porcine animal models" were used. The exact number of animals or vessels tested is not specified.
- Burst Pressure Testing: Used "vessels representative of the devices' indications." The number of vessels is not specified.
- Data Provenance: The studies were conducted by Applied Medical Resources Corp. (presumably within the US, as they are a US-based company submitting to the FDA). The studies appear to be prospective in nature, designed specifically to test the devices.
Training Set (for Software/AI, if applicable): Not applicable. This device is an electrosurgical tool, not an AI/software-based diagnostic or imaging device in the sense that would require a large training dataset for pattern recognition. The software verification mentioned refers to the control software embedded within the device, not a machine learning algorithm trained on data. Therefore, questions 8 and 9 are not directly relevant in this context.

2. Number of Experts and Qualifications for Ground Truth

Animal Testing: The evaluation of "hemostasis and signs of hematoma" would likely involve veterinary professionals or researchers with expertise in animal pathology and surgical outcomes. However, the number and specific qualifications of experts establishing ground truth are not provided in this summary.
Other Testing: For burst pressure, thermal spread, electrical safety, and mechanical testing, the ground truth is established by objective physical measurements and engineering standards, not typically by expert consensus in the same way as a diagnostic medical image.

3. Adjudication Method for the Test Set

Given the nature of the studies (engineering performance, animal model outcomes), formal adjudication methods like "2+1" or "3+1" (common in clinical trial assessments for subjective endpoints or equivocal findings) are not mentioned and generally not applicable to these types of objective performance tests. The results would be based on direct measurements and observations, typically verified by technical experts.

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

No: An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to assess how AI assistance impacts human reader performance in interpreting images or data. The Voyant devices are surgical tools, and their effectiveness is measured by their physical performance (sealing vessels, minimizing thermal spread), not by human interpretation of their output.

5. Standalone Performance Study (Algorithm Only)

Yes (Implied for the device system): The performance testing described (burst pressure, thermal spread, animal studies, EMC, electrical safety, mechanical testing) assesses the device's inherent functionality and capabilities. While the software is a component, the "standalone" performance here refers to the device system itself without direct human "in-the-loop" decision-making augmentation, but rather as an operated tool. The software verification specifically assesses the algorithm/software components in a standalone context.

6. Type of Ground Truth Used

Objective Measurements and Observation/Pathology in Animal Models:
- Burst pressure: Objective physical measurements.
- Thermal spread: Objective physical measurements/histology (implied).
- EMC/Electrical Safety: Compliance with objective engineering standards.
- Mechanical Testing: Objective performance metrics.
- Animal testing: Direct observation of hemostasis and absence of hematoma, potentially supported by pathology or histological evaluation of tissue.

7. Sample Size for the Training Set

Not applicable: As discussed above, this device does not utilize machine learning in a way that requires a "training set" of data for algorithm development. The "software" refers to control logic, not AI models.

8. How Ground Truth for Training Set was Established

Not applicable: (See point 7).

Summary of Gaps in Information (from the perspective of the original prompt):

The provided 510(k) summary is designed to demonstrate substantial equivalence, not to provide a full scientific publication with detailed methodologies and results for each test. Key quantitative details like exact sample sizes for animal/vessel testing, specific numerical acceptance thresholds (e.g., minimum burst pressure in mmHg, maximum thermal spread in mm), and the precise qualifications of evaluators are not included in this high-level summary. This is typical for a 510(k) submission, where the focus is on the conclusion that acceptance criteria were met and substantial equivalence was achieved.

Summary

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June 5, 2020

Applied Medical Resources Corp. Sherif Nakhla Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K201212

Trade/Device Name: Voyant Open 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: May 5, 2020 Received: May 5, 2020

Dear Sherif Nakhla:

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.

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

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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 (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 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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K201212

Device Name Voyant Open 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 for sterilization procedures, and should not be used for these procedures.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K201212

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 for sterilization procedures, and should not be used for these procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

510(k) Submitter:	Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713 – 8000
Contact Person:	Sherif NakhlaRegulatory Affairs SpecialistApplied Medical Resources CorporationTel: (949) 713-8346Fax: (949) 713-8205Email: sherif.nakhla@appliedmedical.com
Preparation Date:	05/05/2020
Trade Name:	Voyant® Open Fusion Device & Voyant® 5mm Fusion Device
Common Name:	Bipolar Electrosurgical Sealer-Divider
Classification:	General and Plastic Surgery Devices – Electrosurgical Cutting andCoagulation Device and AccessoriesRegulation: 21 CFR 878.4400Device Class: Class IIProduct Code: GEI
PrimaryPredicate Device:	Voyant® Open Fusion Device510(k)#: K180699Product Code: GEIVoyant® 5mm Fusion Device510(k)#: K193292Produce Code: GEI
DeviceDescriptions:	The Voyant Open Fusion and Voyant 5mm Fusion devices are advancedbipolar instruments that use RF energy, provided by the VoyantElectrosurgical Generator (K182244), to seal vessels up to and including7mm in diameter. The devices may also be used to seal tissue bundles thatcan be captured in the devices' jaws. Each device features a mechanical,user-actuated blade for the division of sealed tissue.
Intended Use:	The Voyant Open Fusion and Voyant 5mm Fusion devices are bipolar,electrosurgical devices intended for use with the Voyant ElectrosurgicalGenerator to seal and divide vessels and tissues bundles.

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Indications For Voyant Open Fusion Device:

Use:

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.

Voyant 5mm Fusion Device:

Summary of Technological Differences between Subject and Predicate Devices:

The subject and predicate devices are single-use, electrosurgical devices designed to achieve tissue fusion (via RF energy) on vessels and tissue captured between the device jaws. The devices feature a pistol-grip style handle with a trigger for jaw closure and a button for energy activation. The devices are equipped with a mechanical, user-actuated blade for the division of sealed tissue.

Each subject device design is the same as its respective predicate, with the exceptions of the change in software for both devices, the design of the Voyant Open Fusion device plug was updated, and the extension of the Voyant 5mm Fusion device's shelf life from 18 months to 36 months. The fundamental technological features and intended use of each subject device are the same as its predicate device.

Discussion of Performance Testing:

The FDA guidance documents Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (2020), Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery (2016), and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) were considered in evaluating the subject devices' electrical, software, and functional capabilities. The tests addressed below were utilized to demonstrate safety and efficacy of the subject devices and substantial equivalence to the respective predicate devices.

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EMC, Electrical Safety, and Mechanical Testing

Both the Voyant Open Fusion and Voyant 5mm Fusion devices were designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing and met all acceptance criteria. The EMC and Electrical Safety testing was conducted in K162676 for Voyant Open Fusion device, and in K141288 and K172624 for Voyant 5mm Fusion device.

Simulated repeated-use testing was conducted to verify the continued performance of each subject device over multiple device activations. The results of the studies demonstrated that both subject devices met the predetermined acceptance criteria.

System Testing

The following testing was performed using each of the subject devices in comparison to its respective predicate:

-Burst pressure testing using vessels representative of the devices' indications. These vessels were sealed, and the burst pressure of each vessel was recorded.
Thermal spread testing to evaluate the thermal damage produced by the subject and predicate devices.

The results of these tests demonstrated that both subject devices met the predetermined acceptance criteria and each subject device is substantially equivalent to its respective predicate device with respect to these test endpoints.

Animal Testing

A chronic survival study was performed using large porcine animal models to evaluate long-term seal quality, devices' performance, and the potential for an adverse effect on adjacent structures. Vessels representative of the devices' indications were sealed and evaluated for hemostasis and signs of hematoma. The results of the study demonstrated that both subject devices met the predetermined acceptance criteria.

Software Verification

Unit, integration, and system level software testing were conducted to evaluate the design, implementation, and performance of the devices' software scripts.

Conclusion:

Results of performance testing demonstrated that both the subject Voyant Open Fusion and subject Voyant 5mm Fusion devices, with the updated software scripts, are substantially equivalent to the predicate Voyant Open Fusion device and predicate 5mm Open Fusion device, respectively, for requested intended use.

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.