(50 days)
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.
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.
This document is a 510(k) Premarket Notification from the FDA for a medical device, the Voyant Maryland Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's efficacy against a defined set of acceptance criteria in a clinical or diagnostic setting. Therefore, a direct answer to the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device validation cannot be fully provided from this document alone.
However, based on the provided text, we can infer and construct some approximations related to performance testing in the context of device safety and efficacy demonstration for a 510(k) submission.
Re-interpretation of Acceptance Criteria and Performance Study for a 510(k) Device:
For a 510(k) device, "acceptance criteria" largely revolve around demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The "study that proves the device meets the acceptance criteria" refers to the non-clinical and, if applicable, clinical performance testing conducted to support this claim of substantial equivalence.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a non-diagnostic device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this electrosurgical device, the acceptance criteria are implicitly related to demonstrating performance that is substantially equivalent to the predicate device, particularly in terms of vessel sealing and minimizing thermal spread. Specific quantitative acceptance criteria or thresholds are not explicitly listed in this summary, but the outcome of the tests indicates equivalence.
| Performance Metric (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Burst Pressure (Vessel Sealing Quality) | "The results of the study demonstrated that the subject has substantially equivalent performance to the predicate." |
| Thermal Spread (Tissue Damage) | "Analysis of the measurements demonstrated that the subject has substantially equivalent performance to the predicate." |
| Long-term Seal Quality / Hemostasis | "The result of the study demonstrated that the subject device met the predetermined acceptance criteria." |
| Adverse Effect on Adjacent Structures | "The result of the study demonstrated that the subject device met the predetermined acceptance criteria." |
| Mechanical Integrity (Jaw Force) | Tested to "verify the mechanical integrity of the subject device's jaws." (Implicitly, it met the requirements.) |
| EMC and Electrical Safety | "Designed and evaluated in accordance with relevant standards of the IEC 60601 series..." (Implicitly, it met standards.) |
| Software Functionality and Performance | "Unit, integration, and system level software testing were conducted to evaluate the design, implementation, and performance of the device software script." (Implicitly, it performed as designed.) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Sizes: Not explicitly stated for any of the tests (burst pressure, thermal spread, chronic survival study). The document mentions "vessels representative of the devices' indications" were used.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (in vitro, ex vivo, or animal studies as implied by "chronic survival study") and retrospective as they are conducted for a regulatory submission. They are not human clinical trials in the traditional sense discussed for diagnostic AI.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this device and its 510(k) submission. The "ground truth" here is objective physical measurements (like burst pressure, thermal spread, mechanical force) or direct observation of biological outcomes (hemostasis, hematoma) in pre-clinical models, not expert interpretations of medical images or patient data.
4. Adjudication Method for the Test Set
This is not applicable. As there are no human readings or interpretations involved in establishing the "ground truth" (instead, it's objective physical or biological measurements), no adjudication method (e.g., 2+1, 3+1) is described or needed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This is an electrosurgical device, not a diagnostic AI algorithm that assists human readers. Therefore, an MRMC study and effects on human reader performance are irrelevant.
6. Standalone (i.e., Algorithm Only Without Human-in-the Loop Performance) Study
This is not applicable in the sense of an "algorithm." The device itself has functionality (e.g., vessel sealing, tissue division). The performance studies conducted (burst pressure, thermal spread, chronic survival) are essentially "standalone" evaluations of the device's physical and functional capabilities, not an algorithmic output.
7. Type of Ground Truth Used
The ground truth used for performance evaluation appears to be:
- Objective Biophysical Measurements: Burst pressure, thermal spread, mechanical jaw force.
- Biological Outcome Data: Observation of hemostasis and absence of hematoma, and lack of adverse effects on adjacent structures from the "chronic survival study."
- Compliance with Standards: Electrical safety and EMC standards (IEC 60601 series).
8. Sample Size for the Training Set
This is not applicable. This document describes an electrosurgical device, not an AI/machine learning model that requires a "training set." The "software script" mentioned is likely embedded control software, not adaptive AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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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
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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
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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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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: | 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 CoagulationDevice and AccessoriesRegulation: 21 CFR 878.4400Device Class: Class IIProduct Code: GEI |
| Legally MarketedDevice: | Voyant® 5mm Fusion Device510(k)#: K172624Produce Code: GEI |
| DeviceDescription: | 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 sealvessels up to and including 7mm in diameter. The device may also be used toseal tissue bundles that can be captured in the device jaws. The device featuresa mechanical, user-actuated blade for the division of sealed tissue. |
| Intended Use: | The Voyant Maryland Fusion device is a bipolar, electrosurgical deviceindicated for use with the Voyant Electrosurgical Generator in laparoscopicprocedures where the ligation and division of vessels and tissue bundles isdesired.The device can seal and divide vessels up to and including 7mm in diameterand tissue bundles that can be captured in the jaws of the device. |
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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
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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.
§ 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.