(52 days)
The Voyant electrosurgical generator is indicated for use with Voyant devices in open and laparoscopic surgical procedures where the electrosurgical ligation of vessels or tissue bundles is desired.
The Applied Medical Voyant Electrosurgical Generator (ESG) is a tabletop radiofrequency (RF) power supply designed for use in electrosurgery. It operates outside the sterile field and is equipped with a receptacle for Voyant hand piece devices. The ESG enclosure is constructed of various metals and polymers and houses all electrical hardware and software components. The front panel features an LCD and buttons for the navigation, adjustment, and selection of ESG settings.
This document is a 510(k) Premarket Notification from the FDA regarding the Voyant Electrosurgical Generator. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI/ML device that requires extensive acceptance criteria for predictive performance.
Therefore, many of the requested elements for an AI/ML device cannot be found in this document because they are not applicable to the type of device and study presented. The "device" in question is an electrosurgical generator, not an AI model.
Here's a breakdown of the information that can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the format typically seen for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by demonstrating "substantial equivalence" to a predicate device. The performance is assessed through various engineering and system tests comparing the subject device to its predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrically and Software compliant with relevant standards (IEC 60601 series, FDA guidances) | The Voyant ESG was designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing. Software functional testing verified all software requirements were met. Unit, integration, and system level software testing were conducted. |
| Substantially equivalent burst pressure performance with Voyant hand pieces compared to predicate. | "The results of the study demonstrated that the subject generator has substantially equivalent performance to the predicate generator with each Voyant hand piece." |
| Substantially equivalent thermal spread damage performance with Voyant hand pieces compared to predicate. | "Analysis of the measurements demonstrated that the subject generator has substantially equivalent performance to the predicate generator with each Voyant hand piece." |
| No new issues of safety and efficacy compared to the predicate device. | "The subject Voyant Electrosurgical Generator is substantially equivalent in performance to the predicate Voyant Electrosurgical Generator 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." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described (burst pressure, thermal spread, electrical safety, software testing) suggests engineering and bench testing, not a clinical "test set" of patient data as would be used for an AI/ML model. The provenance would be the lab where testing was conducted, but details are absent.
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 is not applicable/provided. Since this is not an AI/ML diagnostic device, there is no "ground truth" established by human experts in the sense of image interpretation or disease diagnosis. The "ground truth" for the engineering tests would be derived from the physical properties and measurements from the predicate device and the subject device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/provided. No adjudication method for expert review of a test set is mentioned, as it's not relevant to this type of device submission.
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
There was no MRMC study done. This is not an AI-assisted diagnostic device. The study focused on the substantial equivalence of the electrosurgical generator itself, not on improving human reader performance. In fact, the document explicitly states: "No chronic survival or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm, but an electrosurgical generator. Its performance is inherent to its electrical and mechanical design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or basis for comparison) in this context is the performance of the legally marketed predicate device. For specific tests:
- Burst pressure and thermal spread: Measured physical properties directly compared to the predicate.
- Electrical safety and EMC: Compliance with international standards (IEC 60601 series).
- Software: Verification against software requirements.
8. The sample size for the training set
This is not applicable/provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable/provided. As above, there is no AI/ML training set.
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October 11, 2018
Applied Medical Resources Corp. Mr. Andrew Nguyen Regulatory Affairs Specialist I 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K182244
Trade/Device Name: Voyant Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 24, 2018 Received: September 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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.htm); 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 mediation-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,
Long H. Chen -S 2018.10.11 15:42:40 -04'00'
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
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Indications for Use
510(k) Number (if known)
K182244
Device Name Voyant Electrosurgical Generator
Indications for Use (Describe)
The Voyant electrosurgical generator is indicated for use with Voyant devices in open and laparoscopic surgical procedures where the electrosurgical ligation of vessels or tissue bundles is desired.
Note: For indications specific to each Voyant device used with the Voyant generator. refer to each device's Instructions for Use (IFU).
| 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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Coagulation
510(k) Summary
| 510(k) Submitter: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713 – 8000 |
|---|---|
| Contact Person: | Andrew NguyenRegulatory Affairs Specialist IApplied Medical Resources CorporationTel: (949) 713-5458Fax: (949) 713-8205Email: andrnguyen@appliedmedical.com |
| Preparation Date: | 17 August 2018 |
| Trade Name: | Voyant® Electrosurgical Generator |
| Common Name: | Electrosurgical Generator |
| Classification: | General and Plastic Surgery Devices - Electrosurgical Cutting andDevice and AccessoriesRegulation: 21 CFR 878.4400Device Class: Class IIProduct Code: GEI |
| Legally MarketedDevice: | Voyant® Electrosurgical Generator510(k)#: K141288Product Code: GEI |
| Device Description: | The Applied Medical Voyant Electrosurgical Generator (ESG) is |
- De is a tabletop radiofrequency (RF) power supply designed for use in electrosurgery. It operates outside the sterile field and is equipped with a receptacle for Voyant hand piece devices. The ESG enclosure is constructed of various metals and polymers and houses all electrical hardware and software components. The front panel features an LCD and buttons for the navigation, adjustment, and selection of ESG settings.
- Intended Use: The Voyant electrosurgical generator is indicated for use with Voyant devices in open and laparoscopic surgical procedures where the electrosurgical ligation of vessels or tissue bundles is desired.
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Summary of Technological Characteristics between Subject and Predicate Devices:
The subject and predicate generators are technologically similar in that both are reusable, electrically isolated, microprocessor controlled power supplies that deliver radiofrequency (RF) energy to connected Applied Medical Voyant hand piece devices for the sealing of vessels and tissue bundles. Both devices operate outside of the sterile field and support compatible devices that operate within the sterile field. They are made of similar materials (i.e. metals and polymers) and have a graphical user interface that displays information to the user regarding device connection, seal cycle status, and alarm conditions. It also contains menu screens and option settings that can be navigated using the soft button keys.
The subject device features a number of upgrades, including a reduction in overall size, a redesigned device connection receptacle, an increased maximum voltage limit, and an enhanced system maintenance verification test.
The overall performance of the subject and predicate generators are substantially equivalent as the sealing algorithms of the Voyant system are not affected by the aforementioned upgrades.
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 and Electrical Safety Testing
The Voyant ESG was designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing.
System Testing
Burst pressure testing was conducted using the subject and predicate Voyant ESGs in conjunction with each legally marketed Voyant hand piece device. The results of the study demonstrated that the subject generator has substantially equivalent performance to the predicate generator with each Voyant hand piece.
Thermal spread testing was performed to evaluate the thermal spread damage produced by the subject and predicate Voyant ESGs when coupled with each legally marketed Voyant hand piece device. Analysis of the measurements demonstrated that the subject generator has substantially equivalent performance to the predicate generator with each Voyant hand piece.
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Clinical
No chronic survival or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance. The performance data detailed in this submission supports the substantial equivalence of the subject device.
Software
Software functional testing was performed on each software subsystem to verify that all software requirements were met.
Unit, integration, and system level software testing were conducted to evaluate the design, implementation, and performance of the device software scripts.
Conclusion:
The subject Voyant Electrosurgical Generator is substantially equivalent in performance to the predicate Voyant Electrosurgical Generator 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.