(66 days)
No
The summary describes a standard electrosurgical device for vessel sealing and division using RF energy. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation. The performance studies focus on seal evaluation and thermal damage, typical for this type of device, and do not suggest any AI/ML components.
No
The device is an electrosurgical device for sealing and dividing vessels and tissue bundles, which describes a surgical tool, not a therapeutic device.
No
The device is an electrosurgical device used for sealing and dividing vessels and tissue, not for diagnosis.
No
The device description clearly states it is a physical instrument with jaws and a mechanical blade, designed for use with an electrosurgical generator to apply RF energy. This indicates a hardware device, not software only.
Based on the provided information, the Voyant Open Fusion Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Voyant Open Fusion Device is a surgical tool used directly on vessels and tissue bundles within the body during open procedures.
- The intended use and device description clearly state its function is for the ligation and division of vessels and tissue bundles using electrosurgical energy. This is a therapeutic and surgical function, not a diagnostic one.
- There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the Voyant Open Fusion Device is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 coagulation for sterilization procedures, and should not be used for these procedures.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing, abstract design representing movement or progress.
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.
1
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 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.
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
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Predicate Devices: Trade Name: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider Product Code: GEI 510(k) #: K123444
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Reference Device: Trade Name: Voyant Open Fusion 510(k) #: K153288 Product Code: GEI
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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.
4
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).