(23 days)
The Voyant [5mm/Maryland] Fusion device 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 sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Voyant 5mm and Maryland Fusion devices are advanced bipolar instruments that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288 & K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue.
This FDA 510(k) summary for the Voyant 5mm Fusion Device and Voyant Maryland Fusion Device (K193292) does not contain information about a study with acceptance criteria and observed device performance in the way a clinical trial or algorithm performance study would.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K141288, K172624, K182653). The core argument for safety and efficacy relies on the fact that the subject devices are identical in material and technological characteristics to the predicates, and thus, the existing performance, sterility, shelf life, and electrical testing of the predicate devices are leveraged.
Therefore, the requested tables and details regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific submission as it's not a de novo study for a novel device or AI algorithm.
However, I can extract the acceptance criteria and "results" as presented in the document based on the performance testing of the predicate devices, which are deemed sufficient for the subject devices due to identical design.
Here's a breakdown of the information that is available (or not available) based on your request, framed within the context of substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission based on identical design, the "acceptance criteria" are implied by the standards and successful results achieved by the predicate devices. The document states that the predicate devices "met all acceptance criteria" for the listed tests.
| Test Method (as performed on Predicate Devices) | Implied Acceptance Criteria (Met "Pass") | Reported Device Performance (for Predicate Devices) |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (per ISO 10993-5) | Met ISO 10993-5 criteria | Pass |
| Intracutaneous Reactivity (per ISO 10993-10) | Met ISO 10993-10 criteria | Pass |
| Sensitization (per ISO 10993-10, ASTM F2148) | Met ISO 10993-10 / ASTM F2148 criteria | Pass |
| Electrical: | ||
| IEC 60601-1 (General requirements for basic safety and essential performance) | Met IEC 60601-1 standards | Pass |
| IEC 60601-1-2 (Electromagnetic compatibility) | Met IEC 60601-1-2 standards | Pass |
| IEC 60601-2-2 (Particular requirements for the safety of high frequency surgical equipment) | Met IEC 60601-2-2 standards | Pass |
| Mechanical Testing: | ||
| Simulated repeated use testing (jaw force, electrical continuity) | Maintained jaw force and electrical continuity | Pass |
| Destructive jaw force testing (mechanical functionality and integrity of the jaw) | Maintained mechanical functionality and integrity | Pass |
| Bench Testing: | ||
| Burst pressure testing on representative vessels | Achieved satisfactory burst pressure | Pass |
| Thermal spread testing (evaluate thermal spread damage) | Satisfactory thermal spread damage profile | Pass |
| Animal Testing: | ||
| Chronic survival study (chronic hemostasis and signs of hematoma) | Demonstrated chronic hemostasis; no signs of hematoma | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document for any of the tests. The document refers to "representative vessels" and "surgical sites" for the bench and animal testing, respectively, but does not provide numbers.
- Data Provenance: The data comes from prior testing associated with the predicate devices (K141288, K172624, K182653). The document does not specify the country of origin or if the studies were retrospective or prospective, though animal and bench testing are typically prospective experiments.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This submission is not evaluating an AI algorithm or diagnostic device requiring expert interpretation of results to establish ground truth. The tests are laboratory-based (biocompatibility, electrical, mechanical, bench) and animal studies, which have objective endpoints.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, no expert consensus or adjudication process is described for these types of engineering and biological tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document does not describe any MRMC study. The device is an electrosurgical tool, not a diagnostic imaging device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study:
- No. The device is a surgical instrument. This concept is not applicable.
7. Type of Ground Truth Used:
- For biocompatibility tests: Standardized laboratory assays based on cell viability, immune response, etc.
- For electrical tests: Measurement against established IEC standards.
- For mechanical tests: Objective measurements of force, integrity, and electrical continuity.
- For bench testing: Measurements of burst pressure and thermal spread, which are objective physical parameters.
- For animal testing: Histological examination, observation of hemostasis, and absence of hematoma, likely evaluated by veterinary pathologists or study investigators based on established criteria.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI or machine learning device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable.
In summary: This 510(k) submission explicitly states that the subject devices are identical to predicate devices and therefore leverages the prior testing data of those predicates. It does not present new studies with a detailed breakdown of acceptance criteria and performance for a novel device or AI algorithm, but rather relies on the successful historical performance of prior substantially equivalent devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
December 20, 2019
Applied Medical Resources Corp. Blake Stacy Regulatory Affairs Analyst 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K193292
Trade/Device Name: Voyant 5mm Fusion Device, Voyant Maryland 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: November 27, 2019 Received: November 27, 2019
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
{1}------------------------------------------------
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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K193292
Device Name
Voy ant [5mm/M ary land] Fusion device
Indications for Use (Describe)
The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generatorin 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 sterilization or 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperw ork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwoork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| 510(k) Submitter: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713 - 8000 |
|---|---|
| Contact Person: | Blake StacyRegulatory Affairs AnalystApplied Medical Resources Corp.Tel: (949) 713-8163Fax: (949) 713-8205Email: blake.stacy@appliedmedical.com |
| Preparation Date: | 27 November 2019 |
| Trade Name: | Voyant® 5mm Fusion DeviceVoyant® Maryland Fusion Device |
| 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® 5mm Fusion Device510(k)#: K141288, K172624Produce Code: GEI |
| Voyant® Maryland Fusion Device510(k)#: K182653Produce Code: GEI | |
| DeviceDescription: | The Voyant 5mm and Maryland Fusion devices are advanced bipolarinstruments that uses RF energy, provided by the Voyant ElectrosurgicalGenerator (K141288 & K182244), to seal vessels up to and including 7mmin diameter. The devices may also be used to seal tissue bundles that canbe captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue. |
| Intended Use: | The Voyant 5mm and Maryland Fusion devices are bipolar, electrosurgicaldevices intended for use with the Voyant Electrosurgical Generator to sealand divide vessels and tissue bundles. |
{4}------------------------------------------------
K193292
Page 2 of 4
Indications for The Voyant [5mm/Maryland] Fusion device is a bipolar. electrosurgical device indicated for use with the Voyant electrosurgical generator in open Use: and 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. 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.
Discussion of Technological Characteristics between Subject and Predicate Devices:
The subject and predicate devices are identical in both material and technological characteristics. All the devices in question are single-use, electrosurgical hand piece designed to deliver RF energy to vessels and tissue captured between its jaws for tissue fusion. Each device features 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.
Discussion of Indications for Use:
The differences in indications between the subject and predicate devices do not impact how the devices seal and divide vessels and tissue bundles. When the devices are used as labelled, the safety and effectiveness is not affected. Choosing to perform a surgery open or laparoscopically is up to the discretion of the end-user, but the decision is not related to the performance of the device. The difference in indications does not affect the patient population or the types of procedures being performed.
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 devices' electrical, software, and functional capabilities. As the proposed labeling change resulted in no design changes, the tests and data utilized to demonstrate safety and efficacy of the predicate devices are suitable for use in the assessment of the subject devices. As there have been no changes to the design of the subject devices from the predicate devices, this submission leverages performance, sterility, shelf life, and electrical testing provided in previous submissions.
Biocompatibility
In accordance with ISO 10993-1 and the 2016 FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", the subject devices met all acceptance criteria for the following biocompatibility evaluations:
- . Cytotoxicity (per ISO 10993-5)
- Intracutaneous Reactivity (per ISO 10993-10) ●
- Sensitization (per ISO 10993-10, ASTM F2148) ●
{5}------------------------------------------------
Electrical
The predicate Voyant 5mm and Maryland Fusion devices were designed and evaluated in accordance with the IEC 60601 series for electromagnetic compatibility and electrical testing. The devices met all acceptance criteria for the following relevant standards:
- IEC 60601-1 ●
- IEC 60601-1-2
- IEC 60601-2-2
Mechanical Testing
| Test Method | Device | Result |
|---|---|---|
| Simulated repeated use testing wasconducted to evaluate jaw force andelectrical continuity | Voyant 5mm Fusion(K141288 and K172624) | Pass |
| Destructive jaw force testing was conductedto evaluate the mechanical functionality andintegrity of the jaw. | Voyant Maryland Fusion(K182653) | Pass |
| Voyant 5mm Fusion(K141288) | Pass | |
| Voyant Maryland Fusion(K182653) | Pass |
Bench Testing
| Test Method | Device | Result |
|---|---|---|
| Burst pressure testing was conducted onrepresentative vessels. The vessels weresealed and the burst pressure for each vesselwas recorded. | Voyant 5mm Fusion(K141288 and K172624) | Pass |
| Thermal spread testing was performed toevaluate thermal spread damage.Representative vessels were sealed andmeasurements of the fused areas wereanalyzed. | Voyant Maryland Fusion(K182653) | Pass |
| Voyant 5mm Fusion(K141288 and K172624) | Pass | |
| Voyant Maryland Fusion(K182653) | Pass |
{6}------------------------------------------------
K193292
Animal Testing
| Test Method | Device | Result |
|---|---|---|
| A chronic survival study was performed onvessels representative of the devices'indications. The surgical sites were evaluatedfor chronic hemostasis and signs ofhematoma. | Voyant 5mm Fusion(K141288 and K172624) | Pass |
| Voyant Maryland Fusion(K182653) | Pass |
Conclusion:
The subject Voyant 5mm Fusion and Voyant Maryland Fusion devices are substantially equivalent in performance to the predicate Voyant 5mm Fusion and Maryland Fusion devices with respect to intended use (i.e. vessel sealing performance and local tissue effects) and do not raise any new issues of safety and efficacy. The existing performance testing of the predicate devices was evaluated and found to be suitable to demonstrate the safety and efficacy of the subject devices. A summary of the testing can be seen in the discussion of performance testing.
§ 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.