(150 days)
Unify Multifunction Energy Platform and Unify Cart: The CONMED UNIFY is indicated for surgical procedures for the cutting and/or coagulation of tissue when hemostasis is desired. This generator can be used with compatible resectoscopes for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. This generator, when used with compatible vessel sealing devices, is indicated for the ligation and division of tissue bundles, lymphatics, and vessels in open and laparoscopic procedures. Reference instructions for use (IFU) for applicable vessel sealing devices. The vessel sealing function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
CleanSeal Vessel Sealers: CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 7 mm vessels (arteries and veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, and vascular. These procedures include, but are not limited to, hysterectomies, oophorectomies, colectomies, Nissen fundoplication, and adhesiolysis. The CleanSeal Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CleanSeal Vessel Sealer for these procedures.
Unify Bipolar Resection Cables: The ConMed UNIFY Bipolar Resection Cables are used to connect compatible accessories to the ConMed UNIFY ESU. UNIFY Bipolar Resection Cables are used in conjunction with the Bipolar Resection capabilities of the UNIFY ESU for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. The ConMed UNFY Bipolar Resection Cables are intended for use with only compatible resectoscopes (refer to Compatibility for details). Maximum rated voltage 750 V.
Unify Wireless Footswitch: The Wireless Footswitch Kit is intended for use with the ConMed UNIFY™ Advanced Energy Generator for the operation of foot-controlled RF devices.
The Unify Multifunction Energy Platform (Unify MEP) is composed of an electrosurgical generator (Unify ESU) with CleanSeal Technology and CleanSeal Vessel Sealing handpieces. The Unify generator is designed with a touchscreen graphic user interface (GUI) display which allows the user to select monopolar and bipolar modes of operation, choose power settings, adjust user settings options, and create, edit, or delete user programs. The Unify ESU is designed for enhanced control of bleeding and for the electrosurgical destruction of the tissue in multispecialty procedures in the operating room or endoscopy suite. This equipment, in conjunction with connected accessories, is intended to produce high-frequency electrical energy for the controlled destruction of tissue. The CleanSeal Vessel Sealers are designed to seal vessels up to and including 7mm vessels, tissue bundles, and lymphatics. Unify Bipolar Resection Cables are provided to connect between Unify ESU and compatible resectoscopes.
This is not an AI/ML device, so much of the requested information to describe the acceptance criteria and study proving the device meets the criteria is not applicable. The provided text describes a 510(k) premarket notification for an electrosurgical device, which is not an AI/ML product. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing, biocompatibility, and a chronic animal study.
Here's a breakdown of the relevant information from the document as it pertains to the device's validation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the performance testing by stating:
"The Unify MEP has been tested according to the applicable requirements listed in FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' and 'Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery'. Benchtop and ex-vivo comparison testing, in-vivo simulated use testing, and chronic animal studies support that the ConMed Unify MEP is substantially equivalent to the ConMed HelixAR and Valleylab FT10 Electrosurgical Generators in intended use, technology, and system performance."
"Mechanical and electrical verification activities and software validation demonstrate the Unify Multifunction Energy Platform complies with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-1-2, and IEC 62304. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Unify Multifunction Energy Platform are mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the Unify MEP outweigh the residual risks."
The document also provides specific biocompatibility test endpoints and methods, with the reported performance being that the device "met the acceptance criteria":
| Test Endpoint | Test Method | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity | Met acceptance criteria |
| Intracutaneous Irritation | ISO 10993-10: 2010 Standard, Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization. | Met acceptance criteria |
| Sensitization | ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization. | Met acceptance criteria |
| Acute Systemic and Material Mediated Pyrogenicity | ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity. | Met acceptance criteria |
For the chronic animal study, the performance criterion was effective sealing of treated vessels, and the reported performance was:
"After 21 days in the porcine model, the treatment of vascular structures (i.e., arteries, veins, and arterio-venous [A/V] bundles) with the ConMed Unify ESU with the CleanSeal 5mm Maryland vessel sealing hand piece was determined to result in the effective sealing of treated vessels."
2. Sample Size Used for the Test Set and Data Provenance:
- Chronic Animal Study: "porcine model" is specified. The exact number of animals or sealed vessels is not provided, but it is an in-vivo prospective study.
- Benchtop and ex-vivo comparison testing, in-vivo simulated use testing: The document mentions these tests were conducted but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
- Biocompatibility Testing: The number of samples tested for biocompatibility is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as this is not an AI/ML device that requires expert-established ground truth on a test set. The validation relies on technical specifications, ex-vivo, in-vivo, and animal studies.
4. Adjudication Method:
Not applicable, as this is not an AI/ML device requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable, as this is not an AI/ML device that assists human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable, as this is not an AI/ML device. The device itself is the "standalone" product being tested. The studies evaluate the performance of the electrosurgical unit and its accessories.
7. Type of Ground Truth Used:
- Functional Ground Truth: For the chronic animal study, the "ground truth" was the observed effective sealing of treated vessels after 21 days in the porcine model, which is an outcomes-based ground truth in an animal model.
- Compliance with Standards: For mechanical, electrical, and software validation, the "ground truth" is adherence to recognized industry standards (AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 62304, ISO 14971) and FDA guidance for electrosurgical devices.
- Biocompatibility: Adherence to ISO standards (ISO 10993-5, -10, -11).
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device that uses a "training set."
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 11, 2022
ConMed Corporation Lisa Anderson Senior Lead Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K213354
Trade/Device Name: Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 4, 2022 Received: February 9, 2022
Dear Lisa Anderson:
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/cdrl/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.
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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) 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.
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) K213354
Device Name
Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Cart
Indications for Use (Describe)
Unify Multifunction Energy Platform and Unify Cart
The CONMED UNIFY is indicated for surgical procedures for the cutting and/or coagulation of tissue when hemostasis is desired.
This generator can be used with compatible resectoscopes for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium.
This generator, when used with compatible vessel sealing devices, is indicated for the ligation of tissue bundles, lymphatics, and vessels in open and laparoscopic procedures. Reference instructions for use (IFU) for applicable vessel sealing devices.
The vessel sealing function has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures.
CleanSeal Vessel Sealers
CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 7 mm vessels (arteries and veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. The CleanSeal Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CleanSeal Vessel Sealer for these procedures.
Unify Bipolar Resection Cables
The CONMED UNIFY Bipolar Resection Cables are used to connect compatible accessories to the CONMED UNIFY ESU. UNIFY Bipolar Resection Cables are used in conjunction with the Bipolar Resection capabilities of the UNIFY ESU for the removal or coagulation of tissue in 0.9% NaCI solution as the irrigation medium. The CONMED UNIFY Bipolar Resection Cables are intended for use with only compatible resectoscopes (refer to Compatibility for details). Maximum rated voltage 750 V.
Unify Wireless FootSwitch
The Wireless Footswitch Kit is intended for use with the CONMED UNIFY™ Advanced Energy Generator for the operation of foot-controlled RF devices.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section 6 - 510(k) Summary of Safety and Effectiveness
ConMed Unify Multifunction Energy Platform with CleanSeal Vessel Sealing Technology
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K213354 as of Jan 12th, 2022.
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
Establishment Registration: 1320894
B. Company Contact
Lisa Anderson Sr. Lead Requlatory Affairs Specialist M: (941) 713-2035
C. Device Name
| Device Name | Unify Multifunction Energy Platform CleanSeal Vessel Sealers, Unify |
|---|---|
| Proprietary Name: | Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories 878.4400 |
| Regulation Number: | GEI |
| Product Code: | II |
| Regulatory Class: | General and Plastic Surgery |
| Panel: |
D. Predicate Device
| Primary Device Name: | HelixAR ABC System |
|---|---|
| Company Name: | ConMed Corporation |
| 510(k): | K172671 |
| Secondary Device Name: | Valleylab FT10 Electrosurgical Platform |
| Company Name: | Covidien LLC |
| 510(k): | K170170 |
| Reference Device Name: | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated |
| Company Name: | Covidien LLC |
| 510(k): | K170869 |
E. Device Description
The Unify Multifunction Energy Platform (Unify MEP) is composed of an electrosurgical generator (Unify ESU) with CleanSeal Technology and CleanSeal Vessel Sealing handpieces. The Unify generator is designed with a touchscreen graphic user interface (GUI) display which allows the user to select monopolar and bipolar modes of operation, choose power settings, adjust user settings options, and create, edit, or delete user programs. The Unify ESU is designed for enhanced control of bleeding
{5}------------------------------------------------
K213354
and for the electrosurgical destruction of the tissue in multispecialty procedures in the operating room or endoscopy suite. This equipment, in conjunction with connected accessories, is intended to produce high-frequency electrical energy for the controlled destruction of tissue.
The CleanSeal Vessel Sealers are designed to seal vessels up to and including 7mm vessels, tissue bundles, and lymphatics. Unify Bipolar Resection Cables are provided to connect between Unify ESU and compatible resectoscopes.
F. Intended Use / Indications for Use
Unify Multifunction Energy Platform and Unify Cart
The CONMED UNIFY is indicated for surgical procedures for the cutting and/or coagulation of tissue when hemostasis is desired. This generator can be used with compatible resectoscopes for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. This generator, when used with compatible vessel sealing devices, is indicated for the ligation and division of tissue bundles, lymphatics, and vessels in open and laparoscopic procedures. Reference instructions for use (IFU) for applicable vessel sealing devices.
The vessel sealing function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
CleanSeal Vessel Sealers
CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 7 mm vessels (arteries and veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, and vascular. These procedures include, but are not limited to, hysterectomies, oophorectomies, colectomies, Nissen fundoplication, and adhesiolysis.
The CleanSeal Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CleanSeal Vessel Sealer for these procedures.
Unify Bipolar Resection Cables
The ConMed UNIFY Bipolar Resection Cables are used to connect compatible accessories to the ConMed UNIFY ESU. UNIFY Bipolar Resection Cables are used in conjunction with the Bipolar Resection capabilities of the UNIFY ESU for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. The ConMed UNFY Bipolar Resection Cables are intended for use with only compatible resectoscopes (refer to Compatibility for details). Maximum rated voltage 750 V.
Unify Wireless Footswitch
The Wireless Footswitch Kit is intended for use with the ConMed UNIFY™ Advanced Energy Generator for the operation of foot-controlled RF devices.
G. Technological Characteristics
The Unify MEP is similar to the predicate devices in that the system includes an electrosurgical generator with vessel sealing capabilities used in conjunction with monopolar and bipolar handpieces, footswitches, and an accessory cart. The Unify MEP design includes the non-ABC monopolar and bipolar modes present in the HelixAR Electrosurgical Generator. The design also includes Vessel
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K213354
Sealing, Soft Coag, and Bipolar Resection modes similar to those in the Valleylab FT10. The output panel of Unify Multifunction Energy Platform provides receptacles for monopolar and bipolar hand- and foot-controlled devices and footswitches. The accessory cart also accommodates the use of additional Unify MEP devices, smoke evacuation units, and accessory storage. The Unify MEP provides Automatic Return Monitoring (ARM) for dual dispersive electrodes as well as visual and audible alerts similar to those used in the predicate designs. The Unify MEP is safe and effective and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.
| Features | Unify Multifunction EnergyPlatform | HelixAR ABC System | ValleyLab FT10/ LigaSureMaryland Jaw Sealer/Divider |
|---|---|---|---|
| Indications forUse | The Unify ESU is indicated forsurgical procedures for the cuttingand/or coagulation of tissue whenhemostasis is desired. The UnifyESU can be used with compatibleresectoscopes for the removal orcoagulation of tissue in 0.9% NaCIsolution as the irrigation medium.The Unify ESU can be used inconjunction with ConMedcompatible vessel sealing handpieces, which are intended to beused in open and laparoscopicprocedures for the ligation anddivision of tissue bundles,lymphatics, and vessels.ConMed CleanSeal Vessel Sealersare intended to be used in open andminimally invasive procedures forthe liqation and division of tissuebundles, lymphatics, and vessels upto and including 7 mm vessels(arteries and veins). The handpieceis indicated for use in gynecologicaland general surgical procedures,including urologic, thoracic, andvascular. These procedures include,but are not limited to,hysterectomies, oophorectomies,colectomies, Nissen fundoplication,and adhesiolysis. | The HelixAR ESU is intended todeliver argon gas, as well as a high-frequency electrical current for thecutting and/or coagulation of tissue. | The FT10 is a high frequencyelectrosurgical generator intendedfor use with monopolar and bipolaraccessories for cutting andcoagulating tissue. When used withcompatible sealing devices, it isindicated for sealing vessels up toand including 7 mm, tissue bundles,and lymphatics. The generator canalso be used with compatibleresectoscopes for endoscopicallycontrolled removal or coagulation oftissue using 0.9% NaCI solution asthe irrigation medium. The tissuefusion function has not been shownto be effective for tubal sterilizationor tubal coagulation for sterilizationprocedures. Do not use this functionfor these procedures.The LigaSure Sealer/Divider is abipolar electrosurgical instrumentintended for use in minimallyinvasive or open surgicalprocedures where ligation anddivision of vessels, tissue bundles,and lymphatics is desired. TheLigaSure Sealer/ Divider can beused on vessels (arteries and veins)up to and including 7 mm. It isindicated for use in general surgeryand such surgical specialties asurologic, vascular, thoracic, andgynecologic. Procedures mayinclude, but are not limited to,Nissen fundoplication, colectomy,cholecystectomy, adhesiolysis,hysterectomy, oophorectomy, etc.The LigaSure system has not beenshown to be effective for tubalsterilization or tubal coagulation forsterilization procedures. Do not usethe LigaSure system for theseprocedures. |
| TargetPopulation | All patient populations | All patient populations | All patient populations |
| Duty Cycle | 15s ON / 30s OFF | 15s ON / 30s OFF | 10s ON / 30s OFFfor any mode for 4 hours |
| Features | Unify Multifunction EnergyPlatform | HelixAR ABC System | ValleyLab FT10/ LigaSureMaryland Jaw Sealer/Divider |
| Energy Type | High Frequency (RF) | High Frequency (RF) withintegrated Argon Beam Coagulation | High Frequency (RF) ~434kHzOptional Argon Module |
| Degree ofProtection | Type CF | Type CF | Type CF |
| Design | - Patient Contact MonitoringSystem- Continuous microprocessorsafety monitoring- LCD with touchscreen- Smart Accessory Connection- Monopolar Remote PowerControl | - Patient Contact MonitoringSystem- Continuous microprocessorsafety monitoring- LCD- Monopolar Remote PowerControl | - Patient Contact MonitoringSystem- Continuous microprocessorsafety monitoring- LCD with touchscreen- Smart Accessory Connection |
| Connections | - Monopolar- Bipolar- Bipolar Vessel Sealing- Bipolar Resection- Dispersive Electrode | - Monopolar- Bipolar- ABC- Dispersive Electrode | - Monopolar- Bipolar- Bipolar Vessel Sealing- Bipolar Resection- Dispersive Electrode |
| Accessories | CartCorded and Wireless FootswitchBipolar Resection Cable | CartCorded and Wireless Footswitch | CartCorded FootswitchBipolar Resection Cable |
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H. Performance Testing
The Unify MEP has been tested according to the applicable requirements listed in FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" and "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery". Benchtop and ex-vivo comparison testing, in-vivo simulated use testing, and chronic animal studies support that the ConMed Unify MEP is substantially equivalent to the ConMed HelixAR and Valleylab FT10 Electrosurgical Generators in intended use, technology, and system performance.
Mechanical and electrical verification activities and software validation demonstrate the Unify Multifunction Energy Platform complies with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-1-2, and IEC 62304. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Unify Multifunction Energy Platform are mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the Unify MEP outweigh the residual risks.
l. Biocompatibility Test
The CleanSeal 5mm Vessel Sealer (CleanSeal 5mm VS) used with Unify ESU is in compliance with 2020 FDA Guidance of Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The biological test results support that the CleanSeal 5mm VS met the acceptance criteria for the following biocompatibility test endpoints.
| Test Endpoint | Test Method |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for InVitro Cytotoxicity |
| Intracutaneous Irritation | ISO 10993-10: 2010 Standard, Biological Evaluation of Medical Devices, Part10: Tests for Irritation and Skin Sensitization. |
| Sensitization | ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10: Tests for |
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| Test Endpoint | Test Method |
|---|---|
| Irritation and Skin Sensitization. | |
| Acute Systemic andMaterial MediatedPyrogenicity | ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Tests forSystemic Toxicity. |
J. Chronic Animal Study
A chronic animal study was conducted according to FDA quidance, "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016; and "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020. The study evaluated the performance of the ConMed Unify ESU with the CleanSeal 5mm Maryland vessel sealing handpiece (Test system) in comparison to the Valleylab FT10 ESU with the LigaSure Maryland with Nanocoating, 37 cm (Predicate system). After 21 days in the porcine model, the treatment of vascular structures (i.e., arteries, veins, and arterio-venous [A/V] bundles) with the ConMed Unify ESU with the CleanSeal 5mm Maryland vessel sealing hand piece was determined to result in the effective sealing of treated vessels.
K. Reprocess
The Unify Reusable Bipolar Resection Cable (BPR Cable) was tested to be compatible with ConMed Unify ESU and Karl Storz or Richard Wolf resectoscopes. The BPR Cable may be cleaned and sterilized up to 50 use cycles. The BPR Cable is designed and manufactured as a reusable device in accordance with FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and FDA recognized consensus standard ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
L. Substantial Equivalence
The differences between the predicate devices and the proposed device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission, including but not limited to the bench tests, tissue validation, chronical animal study and the benefit-risk analysis, confirms that the Unify MEP is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the ConMed HelixAR and Valleylab FT10 Electrosurgical Generators. The CleanSeal Vessel Sealer, in conjunction with Unify MEP, is also substantially equivalent to the reference device LigaSure Maryland Jaw Sealer/Divider (K170869) used with the predicate ValleyLab FT10.
§ 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.