The Voyant Fine Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures, including head and neck procedures, where 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.

Device Description

The Applied Medical Voyant Fine 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 and in head and neck procedures. 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Voyant Fine Fusion electrosurgical device. It details the device’s indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in a quantitative format for clinical effectiveness. Instead, it describes various tests and states whether the device "passed" or demonstrated "substantial equivalence" to a predicate device.

However, based on the Discussion of Performance Testing section, we can infer some criteria and outcomes:

Test Category	Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Intracutaneous Reactivity, Sensitization), ASTM F2148 (Sensitization)	"The device passed all biocompatibility testing according to the acceptance criteria contained in the respective standards."
Sterilization	Compliance with ISO 11137-2 and AAMI TIR 33	"Validation of the sterilization process for this device was performed according the recognized consensus standards ISO 11137-2 and AAMI TIR 33." The packaging, sterilization method, and shelf life are "identical to that of the previously cleared Voyant Fine Fusion device (K143536)."
EMC	Compliance with applicable sections of IEC 60601-1-2 and IEC 60601-2-2	"There have been no changes to the subject device that impact its electromagnetic compatibility (EMC) as presented in K143536. The device was designed and previously tested according to the applicable sections of IEC 60601-1-2 and IEC 60601-2-2."
Electrical Safety	Compliance with applicable sections of IEC 60601-1 and IEC 60601-2-2	"An electrical safety evaluation... was been conducted according to the applicable sections of IEC 60601-1 and IEC 60601-2-2 and presented in K143536." "Relevant tests from these standards were repeated to confirm the safety of the updated button design." (Implies compliance was confirmed).
Preclinical Bench	Performance substantially equivalent to the LigaSure predicate for vessels up to 7mm and head and neck procedures, including seal evaluation and burst pressures.	"Preclinical bench (ex vivo porcine vessels/tissue) and animal (in vivo ovine model) studies were performed to evaluate system safety and to demonstrate that the subject device performance is substantially equivalent to the predicate device for the expanded indications including vessels up to 7mm in diameter and head and neck procedures." Specific results included "Seal evaluation" and "Burst pressures of arteries and veins."
Preclinical Animal	Performance substantially equivalent to the LigaSure predicate for vessels up to 7mm and head and neck procedures, including seal evaluation, thermal damage, and thermal spread metrics; chronic hemostasis and no hematomas.	"Preclinical bench (ex vivo porcine vessels/tissue) and animal (in vivo ovine model) studies were performed to evaluate system safety and to demonstrate that the subject device performance is substantially equivalent to the predicate device for the expanded indications including vessels up to 7mm in diameter and head and neck procedures." "Acute animal studies (in vivo) [evaluated] Seal evaluation and Thermal damage and thermal spread (Minimum, maximum, median, mode)." "In addition, chronic studies (in vivo ovine and canine model) were conducted using the subject device to evaluate long term seal quality and resulted in chronic hemostasis and no signs of hematomas."

Key takeaway: The primary "acceptance criteria" for this 510(k) submission is showing substantial equivalence to existing, legally marketed predicate devices, particularly the LigaSure Curved, Small Jaw, Open Sealer/Divider (K113572) and the previous Voyant Fine Fusion (K143536). Performance is demonstrated by comparing the subject device against these predicates in a laboratory and animal setting.

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

Sample Size for Test Set:
- Bench (ex vivo): "porcine vessels/tissue" were used, but a specific number is not provided.
- Acute Animal (in vivo): "ovine model" was used, but a specific number of animals or vessels is not provided.
- Chronic Animal (in vivo): "ovine and canine model" were used, but a specific number of animals is not provided.
Data Provenance: The studies were preclinical (ex vivo and in vivo animal models). They are performed in a laboratory setting, not from human patients. The specific country of origin for the data is not provided in this summary.

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

This type of information is typically not applicable to preclinical bench or animal studies where objective measurements (e.g., burst pressure, thermal spread measurements, histological examination by veterinary pathologists) establish "truth" rather than expert consensus on imaging or clinical findings. The document does not mention the use of human experts to establish ground truth for the test set in the context of diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable. This is not a human clinical trial involving subjective assessments that would require adjudication. Preclinical studies rely on objective measurements and established scientific methodologies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an electrosurgical instrument, not an AI or imaging algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device's performance is intrinsically linked to its operation by a human surgeon.

7. The Type of Ground Truth Used

For Biocompatibility, Sterilization, EMC, Electrical Safety: Ground truth is established by adherence to recognized consensus standards (e.g., ISO 10993 series, ISO 11137-2, AAMI TIR 33, IEC 60601 series).
For Preclinical Bench (ex vivo): Ground truth is established through objective measurements such as seal evaluation methods and quantitative burst pressure measurements of vessels.
For Preclinical Animal (in vivo): Ground truth is established through objective measurements and observations including seal evaluation, thermal damage and spread metrics (minimum, maximum, median, mode), and histological assessment for chronic hemostasis and lack of hematomas. Comparison against the predicate device's performance also serves as a benchmark.

8. The Sample Size for the Training Set

Not applicable. The Voyant Fine Fusion is a physical electrosurgical device, not a machine learning model. Therefore, there is no "training set" in the AI/ML sense. "Training" would refer to the engineering design and iteration process, not data-driven model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for an AI/ML model for this device. Ground truth in the context of product development for this type of device would relate to engineering specifications, material properties, and functional requirements, all established through standard engineering and scientific principles.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the hair and neck of each figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

July 6, 2016

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

Re: K153017

Trade/Device Name: Voyant Fine Fusion Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 31, 2016 Received: June 1, 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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 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

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Indications for Use

510(k) Number (if known) K153017

Device Name

Voyant Fine Fusion

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

Jessica Cho Contact Person: Manager, Regulatory Affairs Applied Medical Resources Tel: (949) 713 – 7958 Fax: (949) 713 - 8205 Email: jcho@appliedmedical.com
October 13, 2015 Preparation Date:
Voyant® Fine Fusion Trade Name:
Common Name: Bipolar Electrosurgical Sealer-Divider
Electrosurgical Cutting and Coagulation Device and Accessories, General and Classification: Plastic Surgery Devices, 21 CFR 878.4400, Product Code GEI
Predicate Devices: Trade Name: LigaSure Curved, Small Jaw, Open Sealer/Divider 510(k) #: K113572, Product Code: GEI

Trade Name: Voyant Fine Fusion 510(k) #: K143536, Product Code: GEI

Device Description: The Applied Medical Voyant Fine 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 and in head and neck procedures. 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 Fine Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures, including head and neck procedures, where 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.

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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.

Substantial equivalence discussion between Subject and Predicate:

The subject device is similar in construction to the previously cleared Fine Fusion device (K143536). The difference between the two devices is the indications for use and minor design changes that do not impact the overall functionality of the device. The minor design changes include:

. Material changes
- o Cosmetic color changes that are not related to function
- o Addition of a mechanical lubricant
. The previously cleared Fine Fusion had two tactile clicks during activation. Squeezing the ring handles to the second click resulted in energy output. The device was updated to have only a single click to activate RF output.

The main difference between the subject device and previously cleared Fine Fusion is the indications for use.

The subject and LigaSure predicate instruments are technologically similar in size, configuration, and operation. They are designed to deliver RF energy to vessels up to 7mm and tissue bundles captured between the jaws of the device for tissue fusion. Both instruments are used in head and neck procedures and feature scissor-grip style handles with ring handles for opening and closing the jaws and a button between the handles for energy activation. The instruments are equipped with a mechanical, user-actuated blade for the division of sealed tissue.

Discussion of Performance Testing:

Biocompatibility

The subject device is an external communicating device in contact with tissue/bone/dentin for a limited duration (<24 hours). The following tests were conducted on the Fine Fusion:

I Cytotoxicity (per ISO 10993-5)
. Intracutaneous Reactivity (per ISO 10993-10)
Sensitization (per ISO 10993-10, ASTM F2148) .

The device passed all biocompatibility testing according to the acceptance criteria contained in the respective standards.

Sterilization

Validation of the sterilization process for this device was performed according the recognized consensus standards ISO 11137-2 and AAMI TIR 33.

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The subject device is a single use sterilized device. The packaging, sterilization method, and shelf life of the subject device are identical to that of the previously cleared Voyant Fine Fusion device (K143536).

EMC (Electromagnetic Compatibility)

There have been no changes to the subject device that impact its electromagnetic compatibility (EMC) as presented in K143536. The device was designed and previously tested according to the applicable sections of IEC 60601-1-2 and IEC 60601-2-2.

Electrical Safety

The Voyant Fine Fusion Device is an electrosurgical instrument intended to contact the patient and has been designed in consideration of electrical safety. An electrical safety evaluation of the Fine Fusion was been conducted according to the applicable sections of IEC 60601-1 and IEC 60601-2-2 and presented in K143536.

Relevant tests from these standards were repeated to confirm the safety of the updated button design.

Substantial equivalence testing

The subject device was tested side-by-side against the LigaSure predicate to evaluate substantial equivalence with respect to performance in a laboratory setting as well as an animal model. Side-byside testing focused on thermal performance, the seal quality evaluation and the local tissue effects of the applied RF energy in and surrounding the seal for the expanded indications including vessels up to 7mm in diameter and head and neck procedures.

Preclinical: Preclinical bench (ex vivo porcine vessels/tissue) and animal (in vivo ovine model) studies were performed to evaluate system safety and to demonstrate that the subject device performance is substantially equivalent to the predicate device for the expanded indications including vessels up to 7mm in diameter and head and neck procedures; namely:

. Bench (ex vivo)
- o Seal evaluation
- o Burst pressures of arteries and veins
. Acute animal studies (in vivo)
- o Seal evaluation
- Thermal damage and thermal spread
  - . Minimum, maximum, median, mode

In addition, chronic studies (in vivo ovine and canine model) were conducted using the subject device to evaluate long term seal quality and resulted in chronic hemostasis and no signs of hematomas.

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

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Substantial Equivalence:

A comparison of intended use, technological characteristics, physical configuration, and performance of the subject Applied Medical Voyant Fine Fusion device to both predicate devices has shown that the subject device is substantially equivalent. This supports the expanded indications from the previously cleared Voyant Fine Fusion device (K143536) to include head and neck procedures and vessels up to 7mm in diameter.

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.