Voyant 5mm Fusion Device, Voyant Maryland Fusion Device

K193292 · Applied Medical Resources Corp. · GEI · Dec 20, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K193292
• Device Name: Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
• Applicant: Applied Medical Resources Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Voyant 5mm and Maryland Fusion devices are bipolar, electrosurgical devices intended for use with the Voyant Electrosurgical Generator to seal and divide vessels and tissue bundles.

Device Story

Bipolar electrosurgical handpiece; delivers RF energy from Voyant Electrosurgical Generator to seal vessels/tissue bundles; features pistol-grip handle, trigger for jaw closure, button for energy activation, and mechanical user-actuated blade for tissue division. Used in open and laparoscopic procedures by surgeons. Device seals vessels up to 7mm diameter; provides hemostasis; reduces surgical time/blood loss. No design changes from predicates; leverages existing performance data.

Clinical Evidence

No clinical data. Evidence consists of bench testing (burst pressure, thermal spread, jaw force, electrical continuity) and animal testing (chronic survival study evaluating hemostasis and hematoma). Biocompatibility testing per ISO 10993-1 (cytotoxicity, intracutaneous reactivity, sensitization) and electrical safety per IEC 60601 series.

Technological Characteristics

Single-use bipolar electrosurgical handpiece; pistol-grip form factor; RF energy source (via Voyant Generator); mechanical blade for tissue division. Biocompatibility per ISO 10993-1; electrical safety per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Indications for Use

Indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures for ligation and division of vessels up to 7mm in diameter and tissue bundles. Contraindicated for tubal sterilization or tubal coagulation for 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

• Voyant 5mm Fusion Device (K141288, K172624)
• Voyant Maryland Fusion Device (K182653)

Submission Summary (Full Text)

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December 20, 2019

Applied Medical Resources Corp. Blake Stacy Regulatory Affairs Analyst 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K193292

Trade/Device Name: Voyant 5mm Fusion Device, Voyant Maryland 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: November 27, 2019 Received: November 27, 2019

Dear Blake Stacy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For: Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K193292

Device Name

Voy ant [5mm/M ary land] Fusion device

#### Indications for Use (Describe)

The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generatorin open and laparoscopic procedures where the 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 sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Type of Use (Select one or both, as applicable)

> 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 Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA 92688<br>(949) 713 - 8000 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Blake Stacy<br>Regulatory Affairs Analyst<br>Applied Medical Resources Corp.<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | 27 November 2019 |
| Trade Name: | Voyant® 5mm Fusion Device<br>Voyant® Maryland Fusion Device |
| Common Name: | Bipolar Electrosurgical Sealer-Divider |
| Classification: | General and Plastic Surgery Devices - Electrosurgical Cutting and<br>Coagulation Device and Accessories<br>Regulation: 21 CFR 878.4400<br>Device Class: Class II<br>Product Code: GEI |
| Legally Marketed<br>Device: | Voyant® 5mm Fusion Device<br>510(k)#: K141288, K172624<br>Produce Code: GEI |
| | Voyant® Maryland Fusion Device<br>510(k)#: K182653<br>Produce Code: GEI |
| Device<br>Description: | The Voyant 5mm and Maryland Fusion devices are advanced bipolar<br>instruments that uses RF energy, provided by the Voyant Electrosurgical<br>Generator (K141288 & K182244), to seal vessels up to and including 7mm<br>in diameter. The devices may also be used to seal tissue bundles that can<br>be captured in the device jaws. The devices feature a mechanical, user-<br>actuated blade for the division of sealed tissue. |
| Intended Use: | The Voyant 5mm and Maryland Fusion devices are bipolar, electrosurgical<br>devices intended for use with the Voyant Electrosurgical Generator to seal<br>and divide vessels and tissue bundles. |

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# K193292

#### Page 2 of 4

Indications for The Voyant [5mm/Maryland] Fusion device is a bipolar. electrosurgical device indicated for use with the Voyant electrosurgical generator in open Use: and laparoscopic 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.

#### Discussion of Technological Characteristics between Subject and Predicate Devices:

The subject and predicate devices are identical in both material and technological characteristics. All the devices in question are single-use, electrosurgical hand piece designed to deliver RF energy to vessels and tissue captured between its jaws for tissue fusion. Each device features a pistol-grip style handle with a trigger for jaw closure and a button energy activation. The devices are equipped with a mechanical, user-actuated blade for the division of sealed tissue.

#### Discussion of Indications for Use:

The differences in indications between the subject and predicate devices do not impact how the devices seal and divide vessels and tissue bundles. When the devices are used as labelled, the safety and effectiveness is not affected. Choosing to perform a surgery open or laparoscopically is up to the discretion of the end-user, but the decision is not related to the performance of the device. The difference in indications does not affect the patient population or the types of procedures being performed.

#### Discussion of Performance Testing:

The FDA guidance documents Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (2016), Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery (2016), and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) were considered in evaluating the subject devices' electrical, software, and functional capabilities. As the proposed labeling change resulted in no design changes, the tests and data utilized to demonstrate safety and efficacy of the predicate devices are suitable for use in the assessment of the subject devices. As there have been no changes to the design of the subject devices from the predicate devices, this submission leverages performance, sterility, shelf life, and electrical testing provided in previous submissions.

#### Biocompatibility

In accordance with ISO 10993-1 and the 2016 FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", the subject devices met all acceptance criteria for the following biocompatibility evaluations:

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

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K193292

# Electrical

The predicate Voyant 5mm and Maryland Fusion devices were designed and evaluated in accordance with the IEC 60601 series for electromagnetic compatibility and electrical testing. The devices met all acceptance criteria for the following relevant standards:

- IEC 60601-1 ●
- IEC 60601-1-2
- IEC 60601-2-2

# Mechanical Testing

| Test Method | Device | Result |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------|
| Simulated repeated use testing was<br>conducted to evaluate jaw force and<br>electrical continuity | Voyant 5mm Fusion<br>(K141288 and K172624) | Pass |
| Destructive jaw force testing was conducted<br>to evaluate the mechanical functionality and<br>integrity of the jaw. | Voyant Maryland Fusion<br>(K182653) | Pass |
| | Voyant 5mm Fusion<br>(K141288) | Pass |
| | Voyant Maryland Fusion<br>(K182653) | Pass |

## Bench Testing

| Test Method | Device | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------|
| Burst pressure testing was conducted on<br>representative vessels. The vessels were<br>sealed and the burst pressure for each vessel<br>was recorded. | Voyant 5mm Fusion<br>(K141288 and K172624) | Pass |
| Thermal spread testing was performed to<br>evaluate thermal spread damage.<br>Representative vessels were sealed and<br>measurements of the fused areas were<br>analyzed. | Voyant Maryland Fusion<br>(K182653) | Pass |
| | Voyant 5mm Fusion<br>(K141288 and K172624) | Pass |
| | Voyant Maryland Fusion<br>(K182653) | Pass |

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# K193292

## Animal Testing

| Test Method | Device | Result |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------|
| A chronic survival study was performed on<br>vessels representative of the devices'<br>indications. The surgical sites were evaluated<br>for chronic hemostasis and signs of<br>hematoma. | Voyant 5mm Fusion<br>(K141288 and K172624) | Pass |
| | Voyant Maryland Fusion<br>(K182653) | Pass |

# Conclusion:

The subject Voyant 5mm Fusion and Voyant Maryland Fusion devices are substantially equivalent in performance to the predicate Voyant 5mm Fusion and Maryland Fusion devices with respect to intended use (i.e. vessel sealing performance and local tissue effects) and do not raise any new issues of safety and efficacy. The existing performance testing of the predicate devices was evaluated and found to be suitable to demonstrate the safety and efficacy of the subject devices. A summary of the testing can be seen in the discussion of performance testing.