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 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 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 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Voyant Open Fusion Device). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for an AI/ML device. Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number and qualifications of experts, and details about MRMC studies are not applicable to this document.

However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of what can be inferred and what cannot, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present explicit acceptance criteria with numerical targets in the same way an AI/ML device approval might. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on performance testing. The performance indicators are related to the device's functional capabilities and safety.

Performance Characteristic	Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary)
Vessel Sealing Performance	Must be equivalent to the predicate device in sealing vessels up to and including 5mm in diameter.	Demonstrated equivalence to the predicate device in seal quality and chronic hemostasis for vessels up to 5mm.
Tissue Bundle Sealing Performance	Must be equivalent to the predicate device in sealing tissue bundles that can be captured in the jaws.	Demonstrated equivalence to the predicate device in seal quality and chronic hemostasis for tissue bundles.
Local Tissue Effects (Thermal Damage)	Must be equivalent to the predicate device in terms of thermal damage to surrounding tissue.	Showed equivalent thermal damage compared to the predicate device.
Mechanical Capabilities	Must meet basic mechanical requirements for the device.	Satisfied through simulated repeated use testing.
Functional Capabilities	Must meet basic functional requirements for the device.	Satisfied through simulated repeated use testing.
Safety Systems	Must operate safely.	Passed safety systems testing.
Burst Pressures (Ex Vivo)	Must achieve burst pressures equivalent to or better than the predicate device.	Testing summarized to evaluate system safety and substantial equivalence. (Specific values not provided)

2. Sample size used for the test set and the data provenance:

Test Set Size: Not explicitly stated as a number of "samples" in the context of an AI/ML test set. The testing involved:
- Ex vivo porcine vessels/tissue: The quantity of vessels/tissue used is not specified.
- In vivo porcine model: Not specified how many animals or how many sealing procedures were performed.
- In vivo ovine model: Not specified how many animals or how many sealing procedures were performed.
Data Provenance: The studies were conducted in a preclinical setting (laboratory and animal models). The country of origin is not specified, but the submission is to the U.S. FDA. The testing was prospective in nature, designed to evaluate the subject device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This document describes a traditional medical device (electrosurgical) evaluation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth labeling for a test set. The "ground truth" here is the physical performance of the device (seal quality, thermal damage, burst pressure) as observed and measured in the preclinical studies, often by engineers, researchers, and potentially veterinarians/surgeons involved in the animal studies.

4. Adjudication method for the test set:

Not Applicable. As there are no "experts" establishing a "ground truth" through consensus or independent review in the AI/ML sense, there's no adjudication method described. Performance was assessed through direct measurement and observation in laboratory and animal settings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. An MRMC study is typically performed for imaging diagnostics to assess how human readers' performance improves with AI assistance. This is an electrosurgical device, not an imaging diagnostic, and no human readers or AI assistance are involved in its primary function or evaluation as described.

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

Not Applicable. This is not an algorithm. The performance evaluation is the "standalone" device performance, as it's a physical tool evaluated in isolation and comparison to a predicate device in a laboratory and animal setting.

7. The type of ground truth used:

The "ground truth" for this device's performance evaluation was empirical observation and measurement in controlled preclinical studies:
- Seal quality evaluation: Visual inspection, potentially histological analysis.
- Burst pressures: Physical measurement of pressure resistance.
- Thermal damage: Histological analysis of tissue surrounding the seal.
- Chronic hemostasis: Observation in chronic animal studies.
- Mechanical and functional capabilities: Direct testing on the device.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that uses a "training set" in the computational sense.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary

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

June 1, 2016

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

Re: K153288

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: April 22, 2016 Received: April 25, 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 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) K153288

Device Name

Voyant Open Fusion Device

Indications for Use (Describe)

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.

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: November 12, 2015
Trade Name: Voyant® Open Fusion 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 Device: Voyant® Open Fusion Device (K143517)
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 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 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 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.

Summary of Technological Characteristics between Subject and Predicate:

The subject device design is the same as the predicate, with the exception of an updated sealing surface design and software updates. The subject design has the same fundamental technological features and intended use as the predicate.

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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:

A summary of performance testing was included to characterize the subject Open Fusion device. Testing evaluated the subject device's electrical, mechanical and functional capabilities. The subject device was also compared against the predicate to evaluate substantial equivalence with respect to performance in a laboratory setting as well as an animal model. Testing used for subject-predicate comparison 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 Open Fusion. The following is a summary of testing discussed:

Simulated repeated use testing
. Safety systems testing

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

In addition, chronic studies (in vivo porcine and ovine models) using the subject device to evaluate seal quality and chronic hemostasis were discussed.

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.