(265 days)
No
The document describes a standard electrosurgical device using RF energy for sealing and dividing tissue, with no mention of AI or ML capabilities in its operation or intended use.
Yes.
The device seals and divides vessels and tissue, which is a therapeutic action.
No
This device is an electrosurgical tool designed for sealing and dividing vessels and tissue, not for diagnosis. It is used in open procedures for therapeutic purposes.
No
The device description clearly states it is a bipolar, electrosurgical instrument with a mechanical blade, indicating it is a hardware device that uses RF energy from a generator.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Voyant Fine Fusion device is a bipolar, electrosurgical device used in open procedures to seal and divide vessels and tissue bundles using RF energy. This is a surgical tool used directly on the patient's body during a procedure, not a test performed on a sample outside the body.
The text focuses on the device's function in surgical procedures and its performance in sealing and dividing tissue, which are characteristics of a surgical device, not an IVD.
N/A
Intended Use / Indications for 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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head and neck
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
- Seal evaluation
- Burst pressures of arteries and veins
- Acute animal studies (in vivo)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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 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.
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
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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
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Electrosurgical Cutting and Coagulation Device and Accessories, General and Classification: Plastic Surgery Devices, 21 CFR 878.4400, Product Code GEI
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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 (