The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation 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 Maryland Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), 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

Acceptance Criteria and Study for the Voyant Maryland Fusion Device

This document describes the acceptance criteria and the studies that demonstrate the Voyant Maryland Fusion Device meets these criteria. It focuses on the information provided in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests conducted for the Voyant Maryland Fusion device and states that the device "met the predetermined acceptance criteria" for each. However, the specific quantitative acceptance criteria for each test are not explicitly defined in the provided document. The performance is generally reported as meeting pre-determined criteria and being "substantially equivalent" to the predicate device.

Acceptance Criteria (Explicitly stated or Inferred)	Reported Device Performance
EMC, Electrical Safety, and Mechanical Testing: (Inferred: Compliance with IEC 60601 series standards)	Met all acceptance criteria.
Simulated Repeated-Use Testing: (Inferred: Maintained performance over multiple activations)	Met the predetermined acceptance criteria.
System Testing - Burst Pressure: (Inferred: Vessel burst pressure within acceptable limits, comparable to predicate)	Met the predetermined acceptance criteria and is substantially equivalent to the predicate device.
System Testing - Thermal Spread: (Inferred: Thermal spread damage within acceptable limits, comparable to predicate)	Met the predetermined acceptance criteria and is substantially equivalent to the predicate device.
Animal Testing (Chronic Survival Study): (Inferred: Long-term seal quality, device performance, absence of adverse effects on adjacent structures, hemostasis, and signs of hematoma within acceptable limits)	Met the predetermined acceptance criteria.
Software Verification: (Inferred: Correct design, implementation, and performance of the device software script)	(Outcome of unit, integration, and system level software testing, implying successful verification)

2. Sample Size and Data Provenance

Test Set Sample Size: The exact sample sizes for each test are not explicitly mentioned in the provided text.
- Burst pressure testing: "vessels representative of the devices' indications" were used.
- Thermal spread testing: No specific sample size given for tissues.
- Animal testing: "large porcine animal models" were used, but the number is not specified.
Data Provenance: The text does not specify the country of origin for the data. The studies appear to be prospective as they were conducted as part of the device evaluation for 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the number of experts used to establish ground truth or their qualifications for any of the performance tests.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done. The document focuses on the performance of the device itself, not human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study (algorithm/device only without human-in-the-loop performance) was completed for the Voyant Maryland Fusion device. The entire "Discussion of Performance Testing" section details laboratory and animal studies of the device's technical capabilities and clinical performance without human interaction being assessed as part of the primary endpoint.

7. Type of Ground Truth Used

EMC, Electrical Safety, Mechanical Testing, Simulated Repeated-Use Testing, Software Verification: Ground truth for these tests would be based on engineering specifications, regulatory standards (e.g., IEC 60601 series), and predefined functional requirements.
Burst Pressure Testing: Ground truth would be based on quantitative measurement of burst pressure of the sealed vessels, likely compared to a control or predicate device, and potentially established physiological limits for vessel integrity.
Thermal Spread Testing: Ground truth would be based on quantitative measurement of tissue damage (e.g., area of necrosis), likely determined histologically or via thermal imaging, and compared to the predicate device.
Animal Testing: Ground truth would be based on direct observation of physiological outcomes (e.g., hemostasis, presence/absence of hematoma, long-term seal quality, adverse effects on adjacent structures) by veterinary professionals or researchers, potentially supported by pathology (e.g., histological examination of sealed tissues post-mortem).

8. Sample Size for the Training Set

The provided text does not mention any "training set." This type of terminology is typically associated with machine learning or AI algorithm development. The Voyant Maryland Fusion device is described as an electrosurgical device with an "updated software script," but not as an AI-powered diagnostic or assistive tool that would require a distinct training set for algorithm development. The software verification focuses on its design, implementation, and performance, not on learning from data.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable based on the provided document. The software verification was likely based on standard software engineering principles and testing against established functional requirements and specifications.

Summary

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April 8, 2020

Applied Medical Resources Corp. Blake Stacy Regulatory Affairs Analyst 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K200598

Trade/Device Name: Voyant Maryland 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: March 9, 2020 Received: March 9, 2020

Dear Blake Stacy:

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/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 mediation-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

510(k) Number (if known) NA

K200598

Device Name Voyant Maryland Fusion device

Indications for Use (Describe)

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)

|X | 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 Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713 - 8000
Contact Person:	Blake StacyRegulatory Affairs AnalystApplied Medical Resources CorporationTel: (949) 713-8163Fax: (949) 713-8205Email: blake.stacy@appliedmedical.com
Preparation Date:	9 March 2020
Trade Name:	Voyant® Maryland 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
Legally MarketedDevice:	Voyant® Maryland Fusion Device510(k)#: K193292Produce Code: GEI
DeviceDescription:	The Voyant Maryland Fusion device is an advanced bipolar instrumentthat uses RF energy, provided by the Voyant Electrosurgical Generator(K182244), to seal vessels up to and including 7mm in diameter. Thedevice may also be used to seal tissue bundles that can be captured in thedevice jaws. The device features a mechanical, user-actuated blade for thedivision of sealed tissue.
Intended Use:	The Voyant Maryland Fusion device is a bipolar, electrosurgical deviceintended for use with the Voyant Electrosurgical Generator to seal anddivide vessels and tissues bundles.

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The Voyant Maryland Fusion device is a bipolar, electrosurgical device Indications for indicated for use with the Voyant electrosurgical generator in open and Use: 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.

Summary of Technological Characteristics between Subject and Predicate Devices:

The subject and predicate devices are single-use, electrosurgical hand piece devices designed to deliver RF energy to vessels and tissue captured between its jaws for tissue fusion. Both 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.

The subject device design is the same as the predicate, with the exception of the change in software of the device. The fundamental technological features, and intended use of the subject device are the same as the predicate device.

Discussion of Performance Testing:

The FDA guidance documents Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (2016), 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 device's electrical, software, 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 Maryland Fusion device was designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing and met all acceptance criteria.

Simulated repeated-use testing was conducted to verify the continued performance of the subject device over multiple device activations. The result of the study demonstrated that the subject device met the predetermined acceptance criteria.

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System Testing

The following testing was performed using the subject device in comparison to the 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 spread damage produced by the subject and predicate devices.

Analysis of the results of these tests demonstrated that the subject device met the predetermined acceptance criteria and is substantially equivalent to the 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, device 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 the subject device 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 device software script.

Conclusion:

The subject Voyant Maryland Fusion device with the updated software script is substantially equivalent in performance to the predicate Voyant Maryland 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.