(74 days)
The Voyant Maryland Fusion Device with Single-Step Activation is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and 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.
The Voyant Maryland Fusion device with Single Step is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (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.
The medical device in question is the Voyant® Maryland Fusion Device with Single-Step Activation. It is an electrosurgical device intended for use with the Voyant Electrosurgical Generator to seal and divide vessels and tissue bundles up to 7mm in diameter.
Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a direct table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that the devices "met all acceptance criteria" or that results were "sufficient to represent the subject device is safe and effective."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| EMC, Electrical Safety, and Mechanical Testing | The predicate device met all acceptance criteria in accordance with relevant standards of the IEC 60601 series. Additional electrical safety testing on the subject device also met all acceptance criteria. |
| Simulated Repeated-Use Testing | The subject device met the predetermined acceptance criteria for continued performance over multiple device activations. |
| System Testing (Burst Pressure) | (Performed on predicate device) Representative vessels were sealed, and burst pressure was recorded. The results are considered representative of system performance for the subject device. (No specific threshold or value is provided, but implies satisfactory burst pressure). |
| System Testing (Thermal Spread) | (Performed on predicate device) Thermal spread damage was evaluated. The results are considered representative of system performance for the subject device. (No specific thermal spread limit is provided, but implies acceptable thermal effects). |
| Animal Testing (Long-term Seal Quality, Adverse Effects) | (Performed on predicate device) Evaluated long-term seal quality, device performance, and potential for adverse effects on adjacent structures in large porcine animal models. Vessels were sealed and evaluated for hemostasis and signs of hematoma. The results are sufficient to represent the subject device is safe and effective. |
| Software Verification | Unit, integration, and system level software testing were conducted to evaluate design, implementation, and performance. (Implies all tests passed the defined acceptance criteria for software). |
Note: The document generally indicates that the device "met all acceptance criteria" without specifying the exact numerical thresholds for many of these criteria. This type of summary is common in 510(k) submissions where the focus is on demonstrating substantial equivalence rather than presenting a detailed performance report.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for all test sets. However, it provides some information:
- Burst pressure testing: "vessels representative of the devices' indications" were used. (No specific number mentioned).
- Thermal spread testing: (No specific number mentioned).
- Simulated repeated-use testing: (No specific number mentioned for activations or devices).
- Animal testing: "large porcine animal models" were used. The number of animals or vessels tested is not specified.
Data Provenance:
- Country of Origin: Not explicitly stated, but typically these studies are conducted by the manufacturer or contract research organizations, often in the country where the manufacturer is based (USA, in this case).
- Retrospective or Prospective: The testing described (simulated repeated-use, system testing, animal testing, software verification) are all prospective studies, designed and executed to evaluate the new or modified device. The reference to the predicate device's data suggests that previously collected prospective data from the predicate was leveraged.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the described performance tests. For electrosurgical devices, "ground truth" often refers to objective measurements (e.g., burst pressure, thermal spread measurements, histopathological analysis in animal studies) rather than subjective expert interpretations like in imaging studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given that most of the described tests are objective measurements (e.g., electrical parameters, burst pressure, thermal spread, software testing), an adjudication method as typically understood in studies involving human interpretation (like imaging reads) would not be applicable. For animal studies, evaluation of hemostasis and hematoma would typically follow pre-defined histological or gross pathology criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a direct-use surgical instrument, not an AI-based diagnostic tool requiring human interpretation/reading. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the term "standalone" typically refers to AI algorithms, in the context of this electrosurgical device, the device itself is a "standalone" instrument. The performance tests (electrical, mechanical, system, animal) described are evaluating the performance of the device only (or the device in combination with its specified generator), without a human-in-the-loop actively assisting in output. The software verification tests are also standalone evaluations of the algorithm's performance within the device's control systems.
7. The Type of Ground Truth Used
The ground truth used for various tests includes:
- Objective Measurements: For burst pressure (quantifiable pressure values), thermal spread (measurable tissue damage), and electrical safety/EMC (compliance with quantifiable standards).
- Biological/Pathological Outcomes: For animal studies, this would involve macroscopic and potentially microscopic examination of sealed vessels and surrounding tissues to assess hemostasis, presence of hematoma, and tissue damage, serving as the "ground truth" for seal quality and safety.
- Software Design Specifications: For software verification, the "ground truth" is adherence to predefined design requirements and functional specifications.
8. The Sample Size for the Training Set
The document describes performance testing for an electrosurgical device, not an AI/ML product. Therefore, the concept of a "training set" (used for training machine learning models) is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" is not applicable, the question of how its ground truth was established is also not applicable.
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October 14, 2022
Applied Medical Resources Corporation Blake Stacy Senior Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K222284
Trade/Device Name: Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 15, 2022 Received: September 16, 2022
Dear Blake Stacy:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Voyant Maryland Fusion Device with Single-Step Activation
Indications for Use (Describe)
The Voyant Maryland Fusion Device with Single-Step Activation is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K22284
510(k) Summary
| 510(k) Submitter: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713 - 8000 |
|---|---|
| Contact Person: | Blake StacySenior Regulatory Affairs SpecialistApplied Medical Resources CorporationTel: (949) 713-8163Fax: (949) 713-8205Email: blake.stacy@appliedmedical.com |
| Preparation Date: | 1 August 2022 |
| Trade Name: | Voyant® Maryland Fusion Device with Single-Step Activation |
| Common Name: | Bipolar Electrosurgical Sealer-Divider |
| Classification: | General and Plastic Surgery Devices – Electrosurgical Cutting andCoagulation Device and AccessoriesRegulation: 21 CFR 878.4400Device Class: Class IIProduct Code: GEI |
| Legally MarketedDevice: | Voyant® Maryland Fusion Device510(k)#: K200598Produce Code: GEI |
| Reference Device: | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing510(k)#: K181085Produce Code: GEI |
| DeviceDescription: | The Voyant Maryland Fusion device with Single Step is an advancedbipolar instrument that uses RF energy, provided by the VoyantElectrosurgical Generator (K182244), to seal vessels up to and including7mm in diameter. The device may also be used to seal tissue bundles thatcan 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 with Single Step is a bipolar,electrosurgical device intended for use with the Voyant ElectrosurgicalGenerator to seal and divide vessels and tissues bundles |
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Summary of Technological Characteristics between Subject and Predicate Devices:
The subject, predicate, and reference devices 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 for energy activation. The devices are equipped with a mechanical, user-actuated blade for the division of sealed tissue.
The subject device design is the same as the predicate, with the exception of the change in handle design. The fundamental technological features, and intended use of the subject device are the same as the predicate device. The handle design of the subject device is similar to the reference device.
Discussion of Performance Testing:
The FDA guidance documents Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (2020), 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. Where noted, testing done on the predicate device is sufficient to demonstrate safety and performance of the subject device.
EMC, Electrical Safety, and Mechanical Testing
The predicate Voyant Maryland Fusion device was designed and evaluated in accordance with relevant standards of the IEC 60601 series for electromagnetic compatibility and electrical testing and met all acceptance criteria. Additional electrical safety testing was done on the subject device and met all acceptance criteria.
Simulated repeated-use testing was conducted 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.
System Testing
The following testing of the predicate device is representative of system performance of the subject device:
- -Burst pressure testing using vessels representative of the devices' indications. These vessels were sealed, and the burst pressure of each vessel was recorded.
- -Thermal spread testing to evaluate the thermal spread damage produced by the subject and predicate devices.
Animal Testing
A chronic survival study was performed using large porcine animal models 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 results of the study on the predicate device are sufficient to represent the subject device is safe and effective.
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K22284
Software Verification
Unit, integration, and system level software testing were conducted to evaluate the design, implementation, and performance of the device software.
Conclusion:
The subject Voyant Maryland Fusion device with Single Step Activation is substantially equivalent in performance to the predicate Voyant Maryland 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.