(105 days)
The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation 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.
The Applied Medical Voyant Open Sealer/Divider 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.
This document is a 510(k) premarket notification for the Voyant Open Sealer/Divider Device. It does not contain information about acceptance criteria and device performance in the format requested. The document describes the device, its intended use, and summaries of performance testing conducted to demonstrate substantial equivalence to a predicate device.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information on a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data) in a quantifiable manner for specific performance metrics.
- Sample size for a training set or how ground truth for a training set was established.
Instead, the document focuses on:
- Device Description and Intended Use: The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device for use with the Voyant electrosurgical generator in open procedures for the ligation and division of vessels and tissue bundles up to 5mm in diameter.
- Predicate Device: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider (K123444).
- Performance Testing Summary (Non-clinical & Preclinical):
- Non-clinical (Bench Testing): Mechanical strength, durability, destructive testing (per IEC 60601-1, IEC 60601-2-2), electrical safety, electromagnetic compatibility, and safety systems testing.
- Preclinical (ex vivo porcine vessels/tissue and in vivo canine model): Evaluated system safety and efficacy. Side-by-side testing against the predicate focused on:
- Seal evaluation
- Thermal damage
- Burst pressures (ex vivo)
- Acute animal study (in vivo): Seal evaluation and thermal damage.
- Chronic Study: An in vivo canine model was used to evaluate seal quality and chronic hemostasis for the subject device.
- Conclusion: The device is substantially equivalent in performance to the predicate device with respect to intended use (vessel sealing performance and local tissue effects).
- Clinical Data: The premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text, as this document outlines a traditional medical device 510(k) submission, not an AI/ML-based device submission that would typically have such detailed information about acceptance criteria, test sets, ground truth, and reader studies.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2015
Applied Medical Resources Corporation Ms. Jessica Cho Manager, Regulatory Affairs 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K143517
Trade/Device Name: Voyant Open Sealer/Divider 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 10, 2015 Received: March 11, 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
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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 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)
Device Name
Voyant Open Sealer/Divider Device
Indications for Use (Describe)
The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation 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.
| 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
Preparation Date: December 11, 2014
Trade Name: Voyant® Open Sealer/Divider 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 Devices: Trade Name: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider 510(k) #: K123444 Product Code: GEI
- Device Description: The Applied Medical Voyant Open Sealer/Divider 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 Sealer/Divider 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.
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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 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:
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 Sealer/Divider. The following is a summary of components and testing performed:
- Sealer-Divider Device
- Mechanical strength testing per IEC 60601-1 о
- 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:
- . Preclinical (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.
Clinical: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
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Conclusions Drawn from Testing:
The Applied Medical Voyant Open Sealer/Divider is substantially equivalent in performance to the predicate device with respect to intended use (i.e., vessel sealing performance and local tissue effects).
§ 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.