(50 days)
No
The summary describes a standard electrosurgical device using RF energy for sealing and cutting tissue, with no mention of AI or ML capabilities in its function, description, or performance studies.
Yes
The device is used to perform a medical procedure (ligation of vessels and tissue bundles) to treat a condition, which falls under the definition of a therapeutic device.
No
The device description clearly states its purpose as an electrosurgical device for sealing and dividing vessels and tissue using RF energy, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is an "advanced bipolar instrument" that uses RF energy and features a "mechanical, user-actuated blade," indicating it is a physical hardware device. While it mentions software testing, this is likely for controlling the hardware components.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Voyant Maryland Fusion device is an electrosurgical device used during surgical procedures (laparoscopic procedures) to seal and divide vessels and tissue bundles using RF energy. It directly interacts with the patient's internal tissues.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the body. Its function is to perform a therapeutic action (sealing and dividing tissue) within the body.
Therefore, the Voyant Maryland Fusion device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant Electrosurgical Generator in 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 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 Voyant Maryland Fusion device (Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217) is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288, K182244), 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, 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 device's electrical, software, and functional capabilities. The tests addressed below were utilized to demonstrate safety and efficacy of the subject device and substantial equivalence to the predicate device.
EMC, Electrical Safety, and Mechanical Testing
The Voyant Maryland Fusion device (Model Numbers: EB015, EB017, EB215, EB216, EB217) was designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing.
Simulated repeated-use and destructive jaw force testing were conducted to verify the mechanical integrity of the subject device's jaws.
System Testing
Burst pressure testing was conducted using the subject and predicate devices. Vessels representative of the devices' indications were sealed and the burst pressure for each vessel was recorded. The results of the study demonstrated that the subject has substantially equivalent performance to the predicate.
Thermal spread testing was performed to evaluate the thermal spread damage produced by the subject and predicate devices. Analysis of the measurements demonstrated that the subject has substantially equivalent performance to the predicate.
Clinical
A chronic survival study was performed to evaluate long-term seal quality, device performance, and the potential for an adverse effect on adjacent structures. Vessels representative of the devices' indications were sealed and evaluated for hemostasis and signs of hematoma. The result of the study demonstrated that the subject device met the predetermined acceptance criteria. Software
Unit, integration, and system level software testing were conducted to evaluate the design, implementation, and performance of the device software script.
Conclusion:
The subject Voyant Maryland Fusion device (Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217) is substantially equivalent in performance to the predicate Voyant 5mm Fusion device with respect to intended use (i.e. vessel sealing performance and local tissue effects) and does not raise any new issues of safety and efficacy.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2018
Applied Medical Resources Corp. Mr. Andrew Nguyen Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K182653
Trade/Device Name: Voyant Maryland Fusion Device (Model Numbers: EB015, EB017, EB215, EB216, EB217). Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 24, 2018 Received: October 25, 2018
Dear Mr. Nguyen:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Long Long H. Chen Digitally sig Date: 2018.11.14 15:50:03 -5 -05'00' 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
2
Indications for Use
510(k) Number (if known) K182653
Device Name
Voyant Maryland Fusion Device (Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217)
Indications for Use (Describe)
The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant Electrosurgical Generator in 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 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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3
510(k) Summary
| 510(k) Submitter: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688
(949) 713 – 8000 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrew Nguyen
Regulatory Affairs Specialist I
Applied Medical Resources Corporation
Tel: (949) 713-5458
Fax: (949) 713-8205
Email: andrnguyen@appliedmedical.com |
| Preparation Date: | 24 September 2018 |
| Trade Name: | Voyant® Maryland Fusion Device
(Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217) |
| Common Name: | Bipolar Electrosurgical Sealer-Divider |
| Classification: | General and Plastic Surgery Devices – Electrosurgical Cutting and Coagulation
Device and Accessories
Regulation: 21 CFR 878.4400
Device Class: Class II
Product Code: GEI |
| Legally Marketed
Device: | Voyant® 5mm Fusion Device
510(k)#: K172624
Produce Code: GEI |
| Device
Description: | The Voyant Maryland Fusion device (Model Numbers: EB015, EB016, EB017,
EB215, EB216, EB217) is an advanced bipolar instrument that uses RF energy,
provided by the Voyant Electrosurgical Generator (K141288, K182244), 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, user-actuated blade for the division of sealed tissue. |
| Intended Use: | The Voyant Maryland Fusion device is a bipolar, electrosurgical device
indicated for use with the Voyant Electrosurgical Generator in 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. |
4
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.
Summary of Technological Characteristics between Subject and Predicate Devices:
The subject and predicate devices are technologically similar in that both are single-use, electrosurgical hand piece devices designed to deliver RF energy to vessels and tissue captured between its jaws for tissue fusion. Both devices feature 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.
The subject device features an updated jaw design, software script, and an additional shaft length configuration.
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 device's electrical, software, and functional capabilities. The tests addressed below were utilized to demonstrate safety and efficacy of the subject device and substantial equivalence to the predicate device.
EMC, Electrical Safety, and Mechanical Testing
The Voyant Maryland Fusion device (Model Numbers: EB015, EB017, EB215, EB216, EB217) was designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing.
Simulated repeated-use and destructive jaw force testing were conducted to verify the mechanical integrity of the subject device's jaws.
System Testing
Burst pressure testing was conducted using the subject and predicate devices. Vessels representative of the devices' indications were sealed and the burst pressure for each vessel was recorded. The results of the study demonstrated that the subject has substantially equivalent performance to the predicate.
Thermal spread testing was performed to evaluate the thermal spread damage produced by the subject and predicate devices. Analysis of the measurements demonstrated that the subject has substantially equivalent performance to the predicate.
Clinical
A chronic survival study was performed to evaluate long-term seal quality, device performance, and the potential for an adverse effect on adjacent structures. Vessels representative of the devices' indications
5
were sealed and evaluated for hemostasis and signs of hematoma. The result of the study demonstrated that the subject device met the predetermined acceptance criteria. Software
Unit, integration, and system level software testing were conducted to evaluate the design, implementation, and performance of the device software script.
Conclusion:
The subject Voyant Maryland Fusion device (Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217) is substantially equivalent in performance to the predicate Voyant 5mm Fusion device with respect to intended use (i.e. vessel sealing performance and local tissue effects) and does not raise any new issues of safety and efficacy.