Voyant Open Fusion Device

K153288 · Applied Medical Resources · GEI · Jun 1, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153288
• Device Name: Voyant Open Fusion Device
• Applicant: Applied Medical Resources
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 5mm 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 Story

Bipolar electrosurgical instrument; used with Voyant electrosurgical generator (ESG) in open surgery. Device captures vessels/tissue bundles in jaws; delivers RF energy from generator to seal tissue; user-actuated mechanical blade divides sealed tissue. Operated by surgeons; pistol-grip handle with trigger for jaw closure and activation button. Provides hemostasis; enables vessel/tissue ligation and division. Benefits include efficient tissue sealing and division in open procedures.

Clinical Evidence

No clinical data. Evidence based on non-clinical bench testing (simulated use, safety systems) and preclinical studies (ex vivo porcine tissue seal evaluation/burst pressures; in vivo porcine/ovine models for acute/chronic seal quality and hemostasis).

Technological Characteristics

Bipolar electrosurgical sealer-divider; pistol-grip handle; mechanical blade. RF energy source via Voyant ESG. Updated sealing surface design. Software-controlled energy delivery. Sterilization method not specified.

Indications for Use

Indicated for use in open surgical procedures for ligation and division of vessels up to 5mm 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 Open Fusion Device (K143517)

Reference Devices

• Voyant electrosurgical generator (K141288)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2016

Applied Medical Resources Ms. Jessica Cho Regulatory Affairs Manager 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K153288

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: April 22, 2016 Received: April 25, 2016

Dear Ms. Cho:

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 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 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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K153288

Device Name

Voyant Open Fusion Device

Indications for Use (Describe)

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 5mm 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.

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."

{3}------------------------------------------------

# 510(k) Summary

- 510(k) Submitter: Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 (949) 713 — 8000
- Contact Person: Jessica Cho Manager, Regulatory Affairs Applied Medical Resources Tel: (949) 713 – 7958 Fax: (949) 713 — 8205 Email: [e-mail]
- Preparation Date: November 12, 2015
- Trade Name: Voyant® Open Fusion Device
- Common Name: Bipolar Electrosurgical Sealer-Divider
- Classification: Electrosurgical Cutting and Coagulation Device and Accessories, General and Plastic Surgery Devices, 21 CFR 878.4400, Product Code GEI
- Predicate Device: Voyant® Open Fusion Device (K143517)
- Device Description: The Applied Medical Voyant Open Fusion instrument is designed for use with the Voyant ESG (cleared in K141288). This device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm 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 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 5mm 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:

The subject device design is the same as the predicate, with the exception of an updated sealing surface design and software updates. The subject design has the same fundamental technological features and intended use as the predicate.

{4}------------------------------------------------

The subject and predicate instruments are technologically similar in size, configuration. 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:

A summary of performance testing was included to characterize the subject Open Fusion device. Testing evaluated the subject device's electrical, mechanical and functional capabilities. The subject device was also compared against the predicate to evaluate substantial equivalence with respect to performance in a laboratory setting as well as an animal model. Testing used for subject-predicate comparison focused on the seal quality evaluation and the local tissue effects of the applied RF energy in and surrounding the seal.

Non-clinical: Basic mechanical and functional capabilities were tested for the subject Open Fusion. The following is a summary of testing discussed:

- Simulated repeated use testing
- . Safety systems testing

Preclinical: Preclinical bench (ex vivo porcine vessels/tissue) and animal (in vivo porcine model) studies were summarized to evaluate system safety and to demonstrate that the subject device performance is substantially equivalent to the predicate device; namely:

- Preclinical (ex vivo)
- o Seal evaluation
- o Burst pressures
- Acute animal study (in vivo) .
- o Seal evaluation
- o Thermal damage

In addition, chronic studies (in vivo porcine and ovine models) using the subject device to evaluate seal quality and chronic hemostasis were discussed.

Clinical: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.

## Conclusions Drawn from Testing:

The Applied Medical Voyant Open Fusion is substantially equivalent in performance to the predicate device with respect to intended use (i.e., vessel sealing performance and local tissue effects).