Voyant Open Fusion Device

K162676 · Applied Medical Resources · GEI · Dec 1, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K162676
• Device Name: Voyant Open Fusion Device
• Applicant: Applied Medical Resources
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 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 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 Story

Bipolar electrosurgical instrument; used with Voyant electrosurgical generator; performs vessel/tissue bundle sealing and division in open surgery. Device features pistol-grip handle, trigger for jaw closure, and activation button. RF energy delivered to tissue captured in jaws; mechanical user-actuated blade divides sealed tissue. Used by surgeons in clinical settings. Benefits include effective hemostasis and tissue management during open procedures.

Clinical Evidence

No clinical data. Evidence based on bench testing (ex vivo porcine vessels/tissue) and animal studies (in vivo porcine model). Bench testing evaluated seal quality and burst pressures. Animal studies evaluated seal quality, thermal damage, and chronic hemostasis.

Technological Characteristics

Bipolar electrosurgical instrument; pistol-grip handle; RF energy source (via Voyant generator); mechanical blade for tissue division. Designed for vessels up to 7mm. No specific material standards or software algorithm class provided.

Indications for Use

Indicated for use in open surgical procedures for ligation and division 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

• LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider (K123444)

Reference Devices

• Voyant Open Fusion (K153288)

Submission Summary (Full Text)

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

December 1, 2016

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

Re: K162676

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: September 23, 2016 Received: September 26, 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.

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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, 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

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# Indications for Use

510(k) Number (if known) K162676

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 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.

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 Corp. |
|----------------------------------|---------------------------------|
| 22872 Avenida Empresa | |
| Rancho Santa Margarita, CA 92688 | |
| [phone] | |

- Contact Person: Jessica Cho Manager, Regulatory Affairs Applied Medical Resources Tel: [phone] Fax: [phone] Email: [e-mail]
Preparation Date: September 23, 2016

- Voyant® Open Fusion Device Trade Name:
- 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 Devices: Trade Name: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider Product Code: GEI 510(k) #: K123444
- Reference Device: Trade Name: Voyant Open Fusion 510(k) #: K153288 Product Code: GEI
- 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 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, useractuated 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 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:

The subject and predicate instruments are technologically similar in size, configuration. They are designed to deliver RF energy to vessels up to 7mm 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 Submitted:

The subject device was tested side-by-side against the predicate to evaluate substantial equivalence with respect to performance in a laboratory setting as well as an animal model. Side-by-side testing focused on the seal quality evaluation and the local tissue effects of the applied RF energy in and surrounding the seal.

Preclinical: Preclinical bench (ex vivo porcine vessels/tissue) and animal (in vivo porcine model) studies were performed 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
- Burst pressures o
- Acute animal study (in vivo)
- o Seal evaluation
- o Thermal damage

In addition, a chronic study (in vivo porcine model) was conducted using the subject device to evaluate seal quality and chronic hemostasis.

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).