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 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.

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing but does not explicitly state "acceptance criteria" in a tabular format with specific numerical targets. Instead, it frames the performance evaluation as comparing the subject device against a predicate device to demonstrate "substantial equivalence." The reported device performance is described qualitatively in relation to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Seal Quality Evaluation	Subject device performance found to be substantially equivalent to the predicate device.
Burst Pressures (Ex Vivo)	Subject device performance found to be substantially equivalent to the predicate device.
Thermal Damage (In Vivo)	Subject device performance found to be substantially equivalent to the predicate device.
Chronic Hemostasis (In Vivo)	Subject device performance was evaluated and found acceptable for the subject device.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Preclinical):
- Sample Size: Not explicitly stated with specific numbers of vessels or tissue bundles. The document mentions "ex vivo porcine vessels/tissue" and "in vivo porcine model."
- Data Provenance: Porcine (animal model). The nature of the study (ex vivo and in vivo) indicates prospective data collection for the purpose of this evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The document describes laboratory and animal studies, not human expert evaluations for ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given the preclinical nature of the tests (ex vivo and in vivo animal models), an adjudication method in the sense of human expert review is unlikely to have been directly used. The evaluation would likely have involved standardized measurement protocols and analysis by researchers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." The comparison was between the subject device and a predicate device in preclinical settings.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is an electrosurgical device, not an AI algorithm. The performance described is for the physical device itself.

7. The Type of Ground Truth Used:

Preclinical Bench Setup: Measured physical properties (e.g., burst pressures) of sealed vessels/tissue.
In Vivo Animal Model: Direct observation of seal integrity, thermal damage, and chronic hemostasis in living porcine tissue.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument (electrosurgical device), not a machine learning algorithm that requires a "training set" in the computational sense. The "training" for such devices involves design, engineering, and manufacturing processes, which are not detailed in terms of a data-driven training set.

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

Not applicable for the reasons stated above (not an AI algorithm).

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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
(949) 713-8000

Contact Person: Jessica Cho Manager, Regulatory Affairs Applied Medical Resources Tel: (949) 713-7958 Fax: (949) 713-8205 Email: jcho@appliedmedical.com
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).

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.