Voyant Open Sealer-Divider Device

K143517 · Applied Medical Resources · GEI · Mar 27, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143517
• Device Name: Voyant Open Sealer-Divider Device
• Applicant: Applied Medical Resources
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation 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; performs vessel/tissue bundle ligation 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 sealing. Performance validated via bench testing and animal models.

Clinical Evidence

No clinical data. Evidence includes bench testing (mechanical strength, durability, electrical safety per IEC 60601-1/2-2, EMC per IEC 60601-1-2), ex vivo porcine vessel/tissue studies (seal evaluation, thermal damage, burst pressures), and in vivo canine studies (acute and chronic seal quality and hemostasis).

Technological Characteristics

Bipolar electrosurgical sealer/divider. Pistol-grip form factor. RF energy source (via Voyant generator). Mechanical user-actuated blade. Standards: IEC 60601-1 (mechanical/electrical safety), IEC 60601-2-2 (electrosurgical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for use in open surgical procedures for ligation and division of vessels up to 5mm in diameter and tissue bundles. Contraindicated for tubal coagulation or sterilization procedures.

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)

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

March 27, 2015

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

Re: K143517

Trade/Device Name: Voyant Open Sealer/Divider 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 10, 2015 Received: March 11, 2015

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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" (21CFR 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 -S

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)

K143517

Device Name

Voyant Open Sealer/Divider Device

#### Indications for Use (Describe)

The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation 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.

| 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 Corp. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 (949) 713 – 8000

Jessica Cho Contact Person: Manager, Regulatory Affairs Applied Medical Resources Tel: (949) 713 – 7958 Fax: (949) 713 - 8205 Email: [e-mail]

Preparation Date: December 11, 2014

Trade Name: Voyant® Open Sealer/Divider 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 Devices: Trade Name: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider 510(k) #: K123444 Product Code: GEI
- Device Description: The Applied Medical Voyant Open Sealer/Divider 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 Sealer/Divider 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.

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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 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:

Testing was performed on the subject Voyant® device to demonstrate electrical, mechanical and functional capabilities in accordance with IEC 60601-1-2 and IEC 60601-2-2. The subject device was also 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.

Non-clinical: Basic mechanical and functional capabilities were tested for the subject Sealer/Divider. The following is a summary of components and testing performed:

- Sealer-Divider Device
- Mechanical strength testing per IEC 60601-1 о
- Durability testing o
- O Destructive testing per IEC 60601-2-2
- Integrated System
- Electrical safety testing per IEC 60601-1, IEC 60601-2-2 o
- Electromagnetic compatibility testing per IEC 60601-1-2 o
- Safety systems testing o

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

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

In addition, a chronic study (in vivo canine 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.

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## Conclusions Drawn from Testing:

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