(122 days)
No
The summary describes a standard electrosurgical device using RF energy for tissue sealing and division, with no mention of AI or ML capabilities in its function, description, or testing.
Yes
The device is designed for the ligation and division of vessels and tissue bundles, which is a therapeutic intervention in surgical procedures.
No
Explanation: The device is an electrosurgical device used for vessel and tissue ligation and division, which is a therapeutic function, not a diagnostic one. It uses RF energy to seal vessels and tissue, which is an interventional procedure.
No
The device description clearly states it is a bipolar, electrosurgical device with a mechanical, user-actuated blade, indicating it is a hardware device that uses RF energy. The performance studies also focus on mechanical, electrical, and functional capabilities of the hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "ligation and division of vessels and tissue bundles" during "open procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "bipolar instrument that uses RF energy... to seal vessels" and a "mechanical, user-actuated blade for the division of sealed tissue." This is a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or manipulate tissue within the body during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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.
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
open procedures
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)
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.
- Sealer-Divider Device
- Mechanical strength testing per IEC 60601-1
- Durability testing
- Destructive testing per IEC 60601-2-2
- Integrated System
- Electrical safety testing per IEC 60601-1, IEC 60601-2-2
- Electromagnetic compatibility testing per IEC 60601-1-2
- Safety systems testing
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)
- Seal evaluation
- Thermal damage
- Burst pressures
- Acute animal study (in vivo)
- Seal evaluation
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 stylized image of three human profiles facing right, with flowing lines representing hair or movement. The profiles are arranged in a staggered formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
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
1
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 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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.
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 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.
5
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).