Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

K222284 · Applied Medical Resources Corporation · GEI · Oct 14, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222284
• Device Name: Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
• Applicant: Applied Medical Resources Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 14, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Voyant Maryland Fusion device with Single Step is a bipolar, electrosurgical device intended for use with the Voyant Electrosurgical Generator to seal and divide vessels and tissues bundles

Device Story

Bipolar electrosurgical instrument; used with Voyant Electrosurgical Generator. Delivers RF energy to seal vessels up to 7mm and tissue bundles captured in jaws; features mechanical user-actuated blade for tissue division. Used in open and laparoscopic procedures by surgeons. Device provides hemostasis via RF-induced tissue fusion; benefits include reduced bleeding and efficient tissue management. Operates via pistol-grip handle with trigger for jaw closure and button for energy activation.

Clinical Evidence

Bench testing only. Includes electrical safety/EMC testing per IEC 60601, simulated repeated-use testing, burst pressure testing, and thermal spread evaluation. Chronic survival study in porcine models evaluated seal quality, hemostasis, and adjacent tissue effects, leveraging data from the predicate device.

Technological Characteristics

Single-use bipolar electrosurgical handpiece. Pistol-grip design with mechanical blade. RF energy source (Voyant Generator). Materials and design evaluated per IEC 60601 series for electrical safety and EMC. Sterilization method not specified.

Indications for Use

Indicated for use with Voyant electrosurgical generator in open and laparoscopic procedures for ligation of vessels up to 7mm and tissue bundles. Contraindicated for tubal coagulation for sterilization.

Regulatory Classification

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.

Predicate Devices

• Voyant Maryland Fusion device (K200598)

Reference Devices

• LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing (K181085)

Submission Summary (Full Text)

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October 14, 2022

Applied Medical Resources Corporation Blake Stacy Senior Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688

## Re: K222284

Trade/Device Name: Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 15, 2022 Received: September 16, 2022

## 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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K222284

Device Name

Voyant Maryland Fusion Device with Single-Step Activation

Indications for Use (Describe)

The Voyant Maryland Fusion Device with Single-Step Activation 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.

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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# K22284

# 510(k) Summary

| 510(k) Submitter: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA 92688<br>(949) 713 - 8000 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Blake Stacy<br>Senior Regulatory Affairs Specialist<br>Applied Medical Resources Corporation<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | 1 August 2022 |
| Trade Name: | Voyant® Maryland Fusion Device with Single-Step Activation |
| Common Name: | Bipolar Electrosurgical Sealer-Divider |
| Classification: | General and Plastic Surgery Devices – Electrosurgical Cutting and<br>Coagulation Device and Accessories<br>Regulation: 21 CFR 878.4400<br>Device Class: Class II<br>Product Code: GEI |
| Legally Marketed<br>Device: | Voyant® Maryland Fusion Device<br>510(k)#: K200598<br>Produce Code: GEI |
| Reference Device: | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing<br>510(k)#: K181085<br>Produce Code: GEI |
| Device<br>Description: | The Voyant Maryland Fusion device with Single Step is an advanced<br>bipolar instrument that uses RF energy, provided by the Voyant<br>Electrosurgical Generator (K182244), to seal vessels up to and including<br>7mm in diameter. The device may also be used to seal tissue bundles that<br>can be captured in the device jaws. The device features a mechanical, user-<br>actuated blade for the division of sealed tissue. |
| Intended Use: | The Voyant Maryland Fusion device with Single Step is a bipolar,<br>electrosurgical device intended for use with the Voyant Electrosurgical<br>Generator to seal and divide vessels and tissues bundles |

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#### Summary of Technological Characteristics between Subject and Predicate Devices:

The subject, predicate, and reference 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 handle design. The fundamental technological features, and intended use of the subject device are the same as the predicate device. The handle design of the subject device is similar to the reference 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 device's electrical, software, and functional capabilities. Where noted, testing done on the predicate device is sufficient to demonstrate safety and performance of the subject device.

#### EMC, Electrical Safety, and Mechanical Testing

The predicate 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. Additional electrical safety testing was done on the subject device 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.

#### System Testing

The following testing of the predicate device is representative of system performance of the subject device:

- -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.

#### 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 on the predicate device are sufficient to represent the subject device is safe and effective.

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# K22284

#### Software Verification

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

#### Conclusion:

The subject Voyant Maryland Fusion device with Single Step Activation 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.