CONMED CleanSeal Vessel Sealers are intended to be used in open and mimimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for ubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.

Device Description

CleanSeal Advanced Bipolar Vessel Sealer Maryland is designed to be used, with a compatible MEP-1 electrosurqical generator, in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm arteries and veins. They are sterile, single use bipolar vessel sealing hand pieces featuring double action non-stick coated jaws, three shaft length options, a one-hand controlled handle with latchable lever. The instrument creates a seal by application of radio frequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between the jaws.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "CleanSeal Advanced Bipolar Vessel Sealer Maryland." This document is a regulatory submission to the FDA, demonstrating the device's substantial equivalence to previously cleared predicate devices.

However, the information provided does not contain any details about acceptance criteria, study design for a test set, sample sizes for training or test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML device performance.

The document primarily focuses on:

Device Description and Intended Use: Explains what the device is, how it works, and its surgical applications for sealing and dividing tissue and vessels.
Performance Testing: Mentions that the device has been tested according to FDA guidance for electrosurgical devices.
Biocompatibility Testing: States that biocompatibility testing was conducted and met acceptance criteria.
Chronic Animal Studies: Describes two chronic animal studies (porcine and canine models) comparing the performance of the CleanSeal Maryland with its predicate devices for effective vessel sealing. These are biological/physiological studies, not studies of an AI/ML algorithm's performance.
Shelf Life Study: Indicates a shelf-life study was performed.
Substantial Equivalence Argument: Compares the new device's features (Model numbers, intended use, polarity, dimensional design, rated voltage, shelf-life, sterilization method, and disposability) to its predicate and reference devices to argue for substantial equivalence.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML device. The document refers to a physical electrosurgical device, and the "performance testing" and "chronic animal studies" relate to its mechanical and biological effectiveness, not an AI/ML algorithm's analytical performance on data.

If this device were an AI/ML device, the required information (acceptance criteria for AI metrics, test set details, ground truth, etc.) would be explicitly mentioned in sections describing its software performance and validation. Since those details are absent, it confirms that this is not an AI/ML device submission from which such information could be extracted.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 23, 2023

Comed Corporation Ali Abusaleh Senior Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K231732

Trade/Device Name: CleanSeal Advanced Bipolar Vessel Sealer Maryland Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 18, 2023 Received: September 18, 2023

Dear Ali Abusaleh:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.23
11:57:16-04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

Device Name

CleanSeal Advanced Bipolar Vessel Sealer Maryland

Indications for Use (Describe)

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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Section 6 - 510(k) Summary of Safety and Effectiveness

CONMED CleanSeal Advanced Bipolar Vessel Sealer Maryland

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

A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502

B. Company Contact

Ali AbuSaleh Senior Regulatory Affairs Specialist (708) 407-4324 Aliabusaleh@conmed.com Date prepared: 06/13/2023

C. Device Name

Proprietary Name:	CleanSeal Advanced Bipolar Vessel Sealer Maryland
Catalog Numbers:	CS-M5-23, CS-M5-37, CS-M5-44
Common Name:	Bipolar Vessel Sealing Device
Classification Name:	Electrosurgical cutting & coagulation device and accessories
Regulation Number:	878.4400
Product Code:	GEI
Regulatory Class:	II
Panel:	General and Plastic Surgery

D. Predicate Device

Primary Predicate
Device Name:	LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
Company Name:	Covidien LLC
510(k):	K170869

Secondary Predicate

LigaSure Maryland Jaw Thoracic Sealer/Divider, One-step sealing Nano-coated Device Name: Covidien LLC Company Name: 510(k): K181085

Reference Device

Device Name:	CleanSeal Vessel Sealer 5mm
Company Name:	CONMED
510(k):	K213354

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E. Device Description

F. Intended Use/ Indications for Use

CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surqical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.

G. Technological Characteristics

CleanSeal Advanced Bipolar Vessel Sealers Maryland (23cm, 37cm and 44cm) connect to the CleanSeal/Bipolar Resection port on MEP-1 via a three-prong ESU plug with a smart chip containing unique parameters specific to the handpiece model. A hand actuated lever allows the user to open or close the instrument jaws during vessel sealing and cutting. An activation button is incorporated into the body of the handle. When connected to MEP-1 and the jaws are shut, the activation button can be pressed to allow the ESU to deliver energy to the CleanSeal Maryland vessel sealer. The cut trigger allows for the transection of tissue, when the jaws are shut, through the deployment of a stainless-steel knife. A rotator knob on the handle allows for 360° rotation of the shaft to position the jaw accurately on the targeted tissue or vessel. The CleanSeal Maryland comes in three shaft lengths (23 cm, 37 cm, and 44 cm). The device is single use.

H. Performance Testing

CleanSeal Advanced Bipolar Vessel Sealers Maryland have 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 CleanSeal Maryland is substantially equivalent to the Ligasure Maryland Jaw nano-coated (primary predicate), Ligasure Maryland Jaw thoracic nano-coated (secondary predicate) and the CleanSeal Vessel Sealer 5mm (reference device) in intended use, technology, and system performance.

Mechanical and electrical verification activities demonstrate the CleanSeal Advanced Bipolar Vessel Sealers Maryland complies with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2 and 60601-2-18 . Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of CleanSeal Maryland is mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the CleanSeal Maryland outweigh the residual risks.

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Biocompatibility Test -

The CleanSeal Advanced Bipolar Vessel Sealer Marylance 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 Maryland met acceptance criteria for all biocompatibility test endpoints.

J. Chronic Animal Study

A chronic animal study was conducted according to FDA guidance, "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 first test evaluated, in a porcine model, the performance of the CleanSeal Maryland with MEP-1 (Test system) in comparison to the LigaSure Maryland with Nanocoating and Valleylab FT10 ESU. (Primary predicate). After 21 days in the porcine model, the treatment of vascular structures (i.e., arteries, veins, and arterio-venous [AV] bundles) with the test system was determined to result in the effective sealing of treated vessels. The second test evaluated, in a canine model, the performance of the CleanSeal Maryland with MEP-1 (Test system) in comparison to the LigaSure Maryland thoracic with Nanocoating and Valleylab FT10 ESU, (Secondary predicate). After 21 days in the canine model, the treatment of vascular structures in the thoracic cavity (i.e., Pulmonary arteries, veins, and arterio-venous [A/V] bundles) with the test system was determined to result in the effective sealing of treated vessels.

K. Shelf Life

CleanSeal Advanced Bipolar Vessel Sealer Maryland has a one-year shelf-life based on results of an accelerated aging study. The shelf-life study evaluated the device specifications and package integrity/sterile barrier. The device met all acceptance criteria to support a shelf-life of one year.

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 confirms that the CleanSeal Advanced Bipolar Vessel Sealer Maryland is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, LigaSure Maryland Jaw Thoracic Sealer/Divider, One-step sealing Nano-coated and CleanSeal 5mm Vessel Sealer.

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Features	Subject Device: CleanSealAdvanced Bipolar Vessel SealerMaryland	Reference Device: CleanSealVessel Sealer 5mm	Predicate Device:LigaSureMaryland Jaw Opensealer/Divider, One-step sealingNano-coatedLF1923, LF1937 and LF1944	Secondary Predicate:LigaSureMaryland Jaw ThoracicSealer/Divider, One-step sealingNano-coatedLF1930T	Comparison/Discussion
ModelNumbers510(k)IntendedUse/Indicationsfor Use	CS-M5-23, CS-M5-37 and CS-M5-44K231732CONMED CleanSeal VesselSealers are intended to be usedin open and minimally invasiveprocedures for the ligation anddivision of tissue bundles,lymphatics, and vessels up to andincluding 6 mm vessels (arteries,veins, pulmonary arteries,pulmonary veins). The handpieceis indicated for use ingynecological and generalsurgical procedures, includingurologic, thoracic, and vascular.These procedures include, butare not limited to, hysterectomies,oophorectomies, colectomies,Nissen fundoplication, andadhesiolysis. CleanSeal vesselsealer has not been shown to beeffective for tubal sterilization ortubal coagulation for sterilizationprocedures. Do not useCleanSeal vessel sealer for theseprocedures.	CS-M5-23, CS-M5-37 and CS-M5-44K213354CONMED CleanSeal VesselSealers are intended to be used inopen and minimally invasiveprocedures for the ligation anddivision of tissue bundles,lymphatics, and vessels up to andincluding 7 mm vessels (arteriesand veins). The handpiece isindicated for use in gynecologicaland general surgical procedures,including urologic, thoracic, andvascular. These proceduresinclude, but are not limited to,hysterectomies, oophorectomies,colectomies, Nissenfundoplication, and adhesiolysis.CleanSeal VS has not beenshown to be effective for tubalsterilization or tubal coagulationfor sterilization procedures. Do notuse CleanSeal VS for theseprocedures.	K170869The LigaSure Sealer/Divider is abipolar electrosurgical instrumentintended for use in minimallyinvasive or open surgicalprocedures where ligation anddivision of vessels, tissuebundles, and lymphatics isdesired. The LigaSure Sealer/Divider can be used on vessels(arteries and veins) up to andincluding 7 mm. It is indicated foruse in general surgery and suchsurgical specialties as urologic,vascular, thoracic, andgynecologic. Procedures mayinclude, but are not limited to,Nissen fundoplication,colectomy, cholecystectomy,adhesiolysis, hysterectomy,oophorectomy, etc.The LigaSure system has notbeen shown to be effective fortubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use theLigaSure system for theseprocedures.	K181085The LigaSure Sealer/Divider is abipolar electrosurgical instrumentintended for use in minimally invasiveor open surgical procedures whereligation and division of vessels, tissuebundles, and lymphatics is desired.The LigaSure Sealer/ Divider can beused on vessels (arteries, veins,pulmonary arteries, pulmonary 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, Nissenfundoplication, 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.	Similar
	Polarity	Bipolar	Bipolar	Bipolar	Bipolar
	Features	Subject Device: CleanSealAdvanced Bipolar Vessel SealerMaryland	Reference Device: CleanSealVessel Sealer 5mm	Predicate Device:LigaSureMaryland Jaw Opensealer/Divider, One-step sealingNano-coated	Secondary Predicate:LigaSureMaryland Jaw ThoracicSealer/Divider, One-step sealingNano-coated	Comparison/Discussion
	ModelNumbers	CS-M5-23, CS-M5-37 and CS-M5-44	CS-M5-23, CS-M5-37 and CS-M5-44	LF1923, LF1937 and LF1944	LF1930T
510(k)	K231732	K213354	K170869	K181085
DimensionalDesign	Jaw size: 5mmLength of shaft: 23cm, 37cm and44cmTip Shape: Curve similar toMaryland curve;	Jaw size: 5mmLength of shaft: 23cm, 37cm and44cmTip Shape: Curve similar toMaryland curve;	Jaw size: 5mmLength of shaft: 23cm, 37cm and44cmTip Shape: Curve similar toMaryland curve;	Jaw size: 5mmLength of shaft: 37 cmTip Shape: Curve similar to Marylandcurve;	Similar
	RatedVoltage	350Vpk	350Vpk	288Vpk	288Vpk	Similar
Shelf-life	1 years	1 year	3 years	3 years	Similar
SterilizationMethod	Ethylene oxide, SAL of 10-6	Ethylene oxide, SAL of 10-6	Ethylene oxide, SAL of 10-6	Ethylene oxide, SAL of 10-6	Identical
Disposabledevice	Single patient use device	Single patient use device	Single patient use device	Single patient use device	Identical

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Regulation Number and Section

§ 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.