The Voyant Fine Fusion 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 3mm 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 3mm 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

Based on the provided text, the acceptance criteria and study details for the Voyant Fine Fusion device can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-2.	Demonstrated compliance.
Mechanical Strength	Compliance with IEC 60601-1.	Tested and demonstrated.
Durability	Not explicitly defined, but implied through durability testing.	Tested and demonstrated.
Destructive Testing	Compliance with IEC 60601-2-2.	Tested and demonstrated.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	Tested and demonstrated.
Safety Systems	Not explicitly defined, but implied through safety systems testing.	Tested and demonstrated.
Seal Evaluation (Bench/Ex Vivo)	To show substantial equivalence to the predicate device for vessels up to 3mm. Specific metrics (e.g., burst pressure threshold) are not detailed but are implied.	Performed a side-by-side comparison against the predicate device to evaluate seal quality. Conclusion: Substantially equivalent seal performance to the predicate device for vessels up to and including 3mm.
Thermal Damage (Bench/Ex Vivo)	To show substantial equivalence to the predicate device. Specific metrics (e.g., thermal spread limits) are not detailed but are implied.	Performed a side-by-side comparison against the predicate device to evaluate thermal damage. Conclusion: Substantially equivalent local tissue effects to the predicate device.
Burst Pressures (Bench/Ex Vivo)	To show substantial equivalence to the predicate device. Specific thresholds are not detailed.	Tested comparing the subject device to the predicate device. Conclusion: Substantially equivalent vessel sealing performance (implied by burst pressure testing) to the predicate device.
Seal Evaluation (Acute Animal Study)	To show substantial equivalence to the predicate device.	Performed a side-by-side comparison against the predicate device in an in vivo canine model to evaluate seal quality. Conclusion: Substantially equivalent seal performance to the predicate device.
Thermal Damage (Acute Animal Study)	To show substantial equivalence to the predicate device.	Performed a side-by-side comparison against the predicate device in an in vivo canine model to evaluate thermal damage. Conclusion: Substantially equivalent local tissue effects to the predicate device.
Seal Quality & Chronic Hemostasis (Chronic Animal Study)	To demonstrate efficacy and absence of hematomas over time.	Conducted a chronic study in an in vivo canine model to evaluate seal quality and chronic hemostasis, with no signs of hematomas.
Biocompatibility	Compliance with ISO 10993, FDA Blue Book Memorandum #G95-1, and 2013 FDA Draft Guidance.	Device passed all biocompatibility testing according to acceptance criteria in respective standards.
Sterilization	Validated to an SAL (Sterility Assurance Level) of 10⁻⁶ in accordance with ISO 11137-2 and AAMI TIR 33.	The Fine Fusion Device is validated to an SAL of 10⁻⁶.
Shelf Life	Maintenance of sterility and protection from damage throughout shelf life (via ship testing, environmental conditioning).	Testing conducted on aged and conditioned units met all acceptance criteria, ensuring sterility and protection from damage.

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

Test Set Sample Sizes:
- Bench (Ex Vivo): "ex vivo porcine vessels/tissue" - specific number of vessels/tissue samples not provided.
- Acute Animal Study (In Vivo): "in vivo canine model" - specific number of animals not provided.
- Chronic Animal Study (In Vivo): "in vivo canine model" - specific number of animals not provided.
Data Provenance:
- The bench testing used "porcine vessels/tissue," indicating animal tissue.
- The animal studies (acute and chronic) used an "in vivo canine model," indicating animal data.
- The studies appear to be prospective as they were specifically performed to evaluate the new device and compare it against the predicate.

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

The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the performance testing. The "ground truth" for these tests seems to be defined by the direct measurements and observations from the experimental procedures (e.g., burst pressure, thermal spread, visual assessment of seals and hematomas).

4. Adjudication Method for the Test Set

The document does not describe any expert adjudication methods (e.g., 2+1, 3+1). The evaluation criteria suggest direct measurement and comparison rather than subjective human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so such a study would not be applicable.

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

This question is not applicable. The Voyant Fine Fusion is a physical electrosurgical device, not an algorithm. Its performance is evaluated by its physical characteristics and its effect on tissue, not by an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing was primarily based on:

Direct physical measurements: Such as mechanical strength, electrical safety parameters, burst pressures.
Histological/Pathological observations: For thermal damage, seal quality, and absence of hematomas in animal tissue.
Biological responses: Observed in chronic animal studies for hemostasis.

8. The Sample Size for the Training Set

There is no mention of a training set. This device is not an AI/ML-based device; therefore, the concept of a "training set" for an algorithm does not apply.

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

As there is no training set for an algorithm, this question is not applicable.

Summary

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

April 16, 2015

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

Re: K143536

Trade/Device Name: Voyant Fine 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: March 13, 2015 Received: March 17, 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 (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" (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 (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 -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) K143536

Device Name

Voyant Fine Fusion

Indications for Use (Describe)

The device can seal and divide vessels up to and including 3mm 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)
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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

April 15, 2014 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 Device: Trade Name: LigaSure Curved, Small Jaw, Open Sealer/Divider 510(k) #: K102470, 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 3mm 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.

The Voyant Fine Fusion is a bipolar, electrosurgical device indicated for use with Intended Use: 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 3mm 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 3mm and tissue captured between the jaws of the device for tissue fusion. Both instruments feature scissor-grip style 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 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 Fine Fusion. The following is a summary of components and testing performed:

Sealer-Divider Device
- о Mechanical strength testing per IEC 60601-1
- 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:

. Bench (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 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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Biocompatibility: The patient contact materials of the Fusion device were verified for biocompatibility in accordance with ISO 10993, FDA Blue Book Memorandum #G95-1, and the 2013 FDA Draft Guidance document Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The device passed all biocompatibility testing according to the acceptance criteria contained in the respective standards.

Sterilization: Validation of the sterilization process for the Fine Fusion was performed in accordance with ISO 11137-2 and AAMI TIR 33. The Fine Fusion Device is validated to an SAL of 10°.

Shelf Life: Testing was conducted on aged and conditioned units to ensure that the sterier is maintained throughout the device's shelf life. Ship testing, including simulated transit and storage conditions such as drop, vibration, and compression, was performed to ensure the Fine Fusion device packaging will protect the units from damage during transit and handling. Environmental conditioning was performed per ISTA P2A and included exposure to temperature extremes and humidity. Shelf life testing met all the acceptance criteria.

Conclusions Drawn from Testing:

The Applied Medical Voyant Fine Fusion is substantially equivalent in performance to the predicate device for vessels up to and including 3 mm (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.