(28 days)
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.
The Voyant® Open Fusion device is a bipolar electrosurgical instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288), in open procedures where the ligation and division of vessels up to and including 7 mm in diameter and tissue bundles are desired.
Based on the provided text, the device in question is the Voyant Open Fusion Device, an Bipolar Electrosurgical Sealer-Divider. The document describes its premarket notification (510(k)) to the FDA, asserting its substantial equivalence to a predicate device (Voyant® Open Fusion Device, K162676).
It's important to note that this document pertains to an electrosurgical device used for sealing and dividing vessels and tissue bundles, not an AI/algorithm-based diagnostic or prognostic device. Therefore, many of the typical acceptance criteria and study aspects listed in the prompt (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
The "study" described focuses on the device's physical and functional performance, rather than the performance of an AI algorithm.
Here's a breakdown of the requested information based on the provided text, highlighting what is applicable and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | The Voyant Open Fusion Device complies with IEC 60601-1;ed.3.1;2012 and IEC 60601-2-2;ed.6;2017. |
| Electromagnetic Compatibility (EMC) | The Voyant Open Fusion Device complies with IEC 60601-1-2;ed.3;2007. |
| Mechanical Performance (Durability) | Durability testing was performed to verify the continued performance of the subject device over multiple device activations. The result of the study demonstrated that the subject device met the predetermined acceptance criteria. |
| Burst Pressure (Vessel Sealing Strength) | Burst pressure testing was conducted on the subject and predicate Voyant Open Fusion 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 device met the predetermined acceptance criteria. |
| Thermal Spread | Thermal spread testing was performed to evaluate the thermal spread damage produced by the subject and predicate Voyant Open Fusion Devices. Vessels representative of the devices' indications were sealed and measurements of the fused areas were taken. Analysis of the measurements demonstrated that the subject device met the predetermined acceptance criteria. |
| Long-term Seal Quality (Preclinical Chronic Survival) | A chronic survival study was performed to evaluate long-term seal quality, device performance, and potential for adverse effects 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 Verification | Unit, integration, and system level verification were conducted to evaluate the implementation and performance of the device software script. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text refers to "vessels representative of the devices' indications" for "Burst pressure testing," "Thermal spread testing," and the "chronic survival study." However, it does not specify the exact sample sizes (e.g., number of vessels, number of animals/subjects) used for these tests. It also does not directly state the data provenance in terms of country of origin or whether the studies were purely retrospective or prospective, though the description of preclinical studies implies a prospective design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as this is a physical electrosurgical device, not an AI or diagnostic imaging device that requires expert-established ground truth from medical images. The "ground truth" for this device's performance would be direct measurements (burst pressure, thermal spread, observed hemostasis/hematoma) in laboratory and preclinical settings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3. Performance was measured objectively.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as this is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as this is not an algorithm, but a physical electrosurgical tool operated by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established through direct physical measurements and observations in benchtop and preclinical animal studies. This includes:
- Quantitative measurements: Burst pressure (for seal strength), measurements of fused areas (for thermal spread).
- Qualitative observations: Evaluation for hemostasis and signs of hematoma in the chronic survival study.
- Compliance with standards: Electrical safety and EMC testing against IEC standards.
8. The sample size for the training set
This question is not applicable as this is not an AI/machine learning device requiring a "training set." The verification of the device's software focused on "unit, integration, and system level verification" rather than algorithm training.
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" for this type of device.
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April 13, 2018
Applied Medical Resources Corporation Patricia Villarreal, Regulatory Affairs Analyst 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K180699
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: March 15, 2018 Received: March 16, 2018
Dear Patricia Villarreal:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
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,
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) K180699
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.
| 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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510(k) Summary
| 510(k) Submitter: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713 - 8000 |
|---|---|
| Contact Person: | Patricia VillarrealRegulatory Affairs AnalystApplied Medical Resources CorporationTel: (949) 713-6235Fax: (949) 713-8200Email: patricia.villarreal@appliedmedical.com |
| Preparation Date: | March 15, 2018 |
| Trade Name: | Voyant® Open Fusion Device |
| Common Name: | Bipolar Electrosurgical Sealer-Divider |
| Classification: | General and Plastic Surgery - Electrosurgical Cutting and Coagulation Deviceand AccessoriesRegulation: 21 CFR 878.4400Device Class: Class IIProduct Code: GEI |
| Predicate Device: | Voyant® Open Fusion Device510(k)#: K162676Product Code: GEI |
| DeviceDescription: | The Voyant® Open Fusion device is a bipolar electrosurgical instrument thatuses RF energy, provided by the Voyant Electrosurgical Generator (K141288),in open procedures where the ligation and division of vessels up to and including7 mm in diameter and tissue bundles are desired. |
| Intended Use: | The Voyant Open Fusion Device is a bipolar, electrosurgical device indicated foruse with the Voyant electrosurgical generator in open procedures where theligation and division of vessels and tissue bundles is desired. |
| The device can seal and divide vessels up to and including 7mm in diameter andtissue bundles that can be captured in the jaws of the device. | |
| The device has not been shown to be effective for tubal sterilization or tubalcoagulation for sterilization procedures, and should not be used for theseprocedures. |
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Summary of Technological Characteristics between Subject and Predicate Devices:
The subject device design is the same as the predicate, with the exception of the change in software of the device. The subject device has a similar design as the predicate. The fundamental technological features, and intended use of the subject device are the same as the predicate.
The subject and predicate instruments 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 a 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:
The 2016 FDA Guidance, Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery, was considered in evaluating the subject device's electrical, mechanical 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 Open Fusion Device complies with IEC 60601-1;ed.3.1;2012 and IEC 60601-2-2;ed.6;2017 for electrical safety testing and IEC 60601-1-2;ed.3;2007 for electromagnetic compatibility testing.
Bench
Burst pressure testing was conducted on the subject and predicate Voyant Open Fusion 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 device met the predetermined acceptance criteria.
Durability testing was performed to verify the continued performance of the subject device over multiple device activations. The result of the study demonstrated that the subject device met the predetermined acceptance criteria.
Preclinical
Thermal spread testing was performed to evaluate the thermal spread damage produced by the subject and predicate Voyant Open Fusion Devices. Vessels representative of the devices' indications were sealed and measurements of the fused areas were taken. Analysis of the measurements demonstrated that the subject device met the predetermined acceptance criteria.
A chronic survival study was performed to evaluate long-term seal quality but also to evaluate 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 Verification
Unit, integration, and system level verification were conducted to evaluate the implementation and performance of the device software script.
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Conclusion:
The subject Voyant Open Fusion Device is substantially equivalent in performance to the predicate Voyant Open 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.
§ 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.