The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments consist of forceps, probes, knives, suction tubes, hooks, elevators and picks used for laparoscopic access and open surgery. These electrosurgical instruments are reusable and available in unibody (one-piece) and dismantlable (modular) designs. They are used as part of an electrosurgical system consisting of a generator and cord attached to the proximal end of the devices to provide power and deliver electrical current from the generator to the distal tips of the devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MicroFrance® Bipolar and Monopolar Electrosurgical Instruments. The submission focuses on demonstrating substantial equivalence to a predicate device (Micro-France Electrosurgical Instruments, K993655) rather than proving the device meets acceptance criteria for a novel technology or AI algorithm. Therefore, the questions related to AI-specific criteria, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this document.

The document primarily details the performance testing conducted to support the claim of substantial equivalence. This testing serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission.

Here's an analysis of the provided information based on the typical requirements for medical device clearance, interpreted through the lens of your questions.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format alongside performance. Instead, it describes general performance testing criteria and reports that the device "passed" or "met user requirements" or "showed no significant difference" compared to the predicate device. The general acceptance criterion for all tests is that the device demonstrates safety and effectiveness comparable to the predicate, and that changes to the device do not raise new questions of safety and effectiveness.

Acceptance Criteria (Inferred from Test Objective)	Reported Device Performance
Lesion Size: Demonstrate effectiveness by evaluating coagulation performance; no significant difference in lesion size compared to predicate (pre-reprocessing); continues to meet user requirements after 150 reprocessing cycles.	Results from side-by-side testing of the predicate and subject devices prior to reprocessing showed no significant difference in lesion size. Test results of the subject device after 150 reprocessing cycles demonstrated that the subject device continues to meet user requirements.
Thermal Effects on Lesion Study: Characterize performance by measuring typical lesion size (length, width, depth) on various tissue densities at different power settings; effective coagulation.	All test samples, at various power settings, on three different tissue types (heart, liver, kidney) showed coagulation was effectively applied by the subject devices.
Physical Characterization: No defects observed during visual inspection.	No defects were observed on the subject devices during visual inspection of physical characteristics.
Dimensional Verification: Measured attributes are within defined tolerances and specifications.	All measured dimensions are within defined tolerances and specifications for the subject devices.
Functional Testing: Key functionality remains similar to predicate; all acceptance criteria passed.	All test samples passed the acceptance criteria for key functionality of the subject devices.
Electrical and Mechanical Testing: No failures during electrical and resistivity testing; applied closing forces similar to predicate; all acceptance criteria passed.	All test samples passed the acceptance criteria for electrical, resistivity, and applied closing force testing of the subject devices.
Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity): Passed acceptance criteria for each test; demonstrating biocompatibility.	All products tested passed the acceptance criteria demonstrating that the devices are biocompatible.
Chemical Characterization of Extractables & Toxicology Risk Assessment: Identified extractables quantified; extractables above Quantification Limit (QL) deemed clinically acceptable after toxicological risk assessment.	Extractables were identified and quantified; any extractables above the QL underwent a toxicological risk assessment and were deemed to be clinically acceptable. Based on evaluations, the risk of induced toxicity during clinical use was deemed clinically acceptable.
Electrical Safety (IEC 60601-1-2, ANSI/AAMI/ES60601-1, AAMI/ANSI/IEC 60601-2-2, IEC 60601-1-6, IECO 60601-2-18): Passed all tests based on relevant standards.	The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments passed all EMC and electrical safety testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify exact sample sizes for each test in terms of number of devices or tissue samples used. It generally refers to "test samples."

The location for the conduct of these tests is implied by the submitter's address (Integra LifeSciences Corporation, Princeton, NJ, USA, and Integra MicroFrance, France). The data provenance is prospective bench, electrical, and biocompatibility testing conducted specifically for this 510(k) submission. No patient data (retrospective or prospective) was used for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI algorithm or diagnostic tool where human experts would establish ground truth for a test set. The validation relies on objective physical, electrical, and biological testing against established standards and comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is not an AI algorithm for diagnostic interpretation, there is no expert adjudication process for image or data interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The device itself is a standalone electrosurgical instrument (without software).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is implicitly established by:

Engineering specifications and tolerances: For physical and dimensional verification.
Industry and international standards: For electrical safety (e.g., IEC 60601 series) and biocompatibility (e.g., ISO 10993 series).
Comparison to the legally marketed predicate device: For performance aspects like lesion size and functional similarity, demonstrating that the new device performs "similarly" or "no significant difference" from a device already deemed safe and effective.
Scientific principles in biology and toxicology: For biocompatibility and chemical characterization assessments.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

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.

May 14, 2021

Integra MicroFrance c/o Ms. Malena Zammetti Regulatory Affairs Specialist II Integra LifeSciences Corporation 1100 Campus Rd. Princeton, NJ 08540

Re: K210942

Trade/Device Name: MicroFrance Monopolar and Bipolar Electrosurgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, Dated: March 29, 2021 Received: March 30, 2021

Dear Ms. Zammetti:

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/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 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/cdrl-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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Indications for Use

510(k) Number (if known) K210942

Device Name

MicroFrance® Bipolar and Monopolar Electrosurgical Instruments

Indications for Use (Describe)

The electrosurgical instruments are intended to remove tissue and/or control bleeding.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter Information
Submitter	Integra LifeSciences Corporation1100 Campus Rd.Princeton, NJ, USA 08540On behalf of:Integra MicroFranceLe Pavillon, Saint Aubin Le Monial Allier, 03160FranceContact: Olivier Doizon, Manager, Quality+33 (0) 470 67 98 0olivier.doizon @ integralife.com
U.S. Contacts:	Primary Contact:Ms. Malena ZammettiRegulatory Affairs Specialist II717-818-8774malena.zammetti @ integralife.comSecondary Contact:Ms. Jocelyn RaposoDirector, Regulatory Affairs508-813-7015Jocelyn.Raposo @ integralife.com
Establishment RegistrationNumber:	9680837
Date 510(k) Summary Prepared:	May 14, 2021
II. Device
Trade or Propriety Name:	MicroFrance® Bipolar and Monopolar ElectrosurgicalInstruments
Common or Usual Name:	Electrosurgical cutting and coagulation accessories
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification Panel:	General and Plastic Surgery
Regulation:	Class II, 21 CFR 878.4400
Product Code:	GEI

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III. Predicate Device

The predicate devices for this submission are the MicroFrance Electrosurgical Instruments, K993655, which were cleared on 12/21/1999.

IV. Device Description

V. Indications for Use

The electrosurgical instruments are intended to remove tissue and/or control bleeding.

VI. Comparison of Characteristics with the Predicate Devices

The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments are substantially eqivalent to the predicate devices, the Micro-France Electrosurgical Instruments. The subject devices have the same indications for use, operating principles, clinical utility and similar design specifications and materials as the predicate devices. To comply with the latest electrical safety and EMC standards, material changes and minor componenet changes were made. The componenet changes include minor dimensional changes to subassemblies to ensure proper final assembly of the subject devices and to maintain the same finished dimensional specifications as the predicate devices. The table below provides a comparison between the subject devices and the predicate devices.

Comparison of the Predicate and Subject Device
	Predicate Device:Micro-FranceElectrosurgicalInstruments, Various(K993655)	Subject Device:MicroFrance® Bipolar andMonopolar ElectrosurgicalInstruments(This Submission)	Difference and Justification
FDA Product Code	GEI	Same as predicate	No difference
Classification	Class II - 21 CFR 878.4400	Same as predicate	No difference
Classification Name	Electrosurgical cutting andcoagulation device andaccessories	Same as predicate	No difference
Indications for Use	The electrosurgicalinstruments are used toremove tissue and/or controlbleeding.	Same as predicate	No difference
Type	Various dismantlable(modular) and unibodybipolar and monopolarinstruments	Same as predicate	No difference
Device Sterility	Non-Sterile	Same as predicate	No difference
Reusable	Yes	Same as predicate	No difference
ReprocessingMethods (cleaningand sterilization)	Manual and Automatedcleaning andSteam sterilization	Same as predicate	No difference
Design	Multiple bipolar andmonopolar instrument	Changes to the insulationcoating materials and thickness;	The performance, electricalsafety and EMC test results

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	designs as cleared perK993655	changes to the monopolar pinconnector and bipolar screw setalignment; and Minordimensional changes tosubassembly components toaccommodate increase inthickness of Rislan insulationcoating.	demonstrate that the subjectdevices do not raise any newquestions of safety and aresubstantially equivalent to thepredicate devices.
Materials	Materials as cleared perK993655	Materials remain the same as thepredicate device except for theinsulation coating and thebipolar connector materialInsulation coating: From Rislan®ES BLUE 7413 M(Blue Polyamide) to Rislan®ESY BLUE 7414(Blue Polyamide)Bipolar connector: From PEEK(Polyether ether ketone) toPropylux® (Polypropylene)Monopolar Connector:Connector pin is partially coatedwith Rislan® ESY BLUE 7414	The performance, electricalsafety, EMC, andbiocompatibility test resultsdemonstrate that the subjectdevices do not raise any newquestions of safety andeffectiveness and aresubstantially equivalent to thepredicate devices.
Packaging	Packaging types as clearedper K993655	Same as predicate	No difference

VII. Performance Data

The following bench, electrical safety, electromagnetic compatibility (EMC), and biocompatibility testing has been performed in support of the substantial equivalence determination.

Performance Bench Testing
Test	Test Method Summary	Results
Lesion Size	To demonstrate the subject devices,monopolar and bipolar, are effectivefor their intended use by evaluatingcoagulation performance.	Results from side-by-side testing of the predicateand subject devices prior to reprocessing showedno significant difference in the lesion size.supporting substantial equivalence between thesubject and predicate devices. Test results of thesubject device after 150 reprocessing cyclesdemonstrates that the subject device continues tomeet user requirements.
Thermal Effects on LesionStudy	To characterize the performance of thesubject devices by measuring thetypical lesion size (length, width anddepth) they generate on a range oftissue densities ( heart, liver andkidney) at three power settings:minimal, default and maximal.	All test samples, at various power settings, onthree different tissue types showed coagulationwas effectively applied by the subject devices,supporting substantial equivalence between thesubject and predicate devices.
Physical Characterization	Perform a visual inspection of thephysical characteristics for defects.	No defects were observed on the subject devicesduring the visual inspection of the physicalcharacteristics, supporting substantialequivalence between the subject and predicatedevices.
Dimensional Verification	Measure the device attributes andconfirm they are within defined	All measured dimensions are within definedtolerances and specifications for the subject
	tolerances and specifications.	devices, supporting substantial equivalencebetween the subject and predicate devices.
Functional Testing	Verify key functionality of the subjectdevices remains similar to thepredicate devices.	All test samples passed the acceptance criteriafor key functionality of the subject devices,supporting substantial equivalence between thesubject and predicate devices.
Electrical and MechanicalTesting	Verify no failures occur duringelectrical and resistivity testing of thesubject devices.Measure the applied closing forces aresimilar for the subject and predicatedevices.	All test samples passed the acceptance criteriafor electrical, resistivity and applied closingforce testing of the subject devices, supportingsubstantial equivalence between the subject andpredicate devices.
Biocompatibility Testing
Test	Test Method Summary	Results
Cytotoxicity Study using theISO Elution Method(1X MEM)ISO 10993-5	To evaluate the potential cytotoxiceffect of a test article extract using anin vitro mammalian cell culture.	All products tested passed the acceptance criteriademonstrating that the devices are biocompatibleand therefore are substantially equivalent to thepredicate devices.
ISO Guinea Pig MaximizationSensitization TestISO 10993-10	To evaluate the potential of the testarticle extracts to cause delayeddermal contact sensitization in theguinea pig.	All products tested passed the acceptance criteriademonstrating that the devices are biocompatibleand therefore are substantially equivalent to thepredicate devices.
ISO Intracutaneous Study inRabbitsISO 10993-10	To evaluate the potential of test articleextracts to induce local dermalirritation following intracutaneousinjection in rabbits.	All products tested passed the acceptance criteriademonstrating that the devices are biocompatibleand therefore are substantially equivalent to thepredicate devices.
Acute Systemic ToxicityISO 10993-11	To evaluate the acute systemic toxicityof the test article extracts followingintravenous or intraperitoneal injectionin mice.	All products tested passed the acceptance criteriademonstrating that the devices are biocompatibleand therefore are substantially equivalent to thepredicate devices.
Chemical Characterization ofExtractablesISO 10993-18	To perform a chemicalcharacterization to identify andquantitate the extractables and/orleachables that may be released fromthe test articles.	Extractables were identified and quantified, anyextractables above the Quantification Limit (QL)underwent a toxicological risk assessment andwere deemed to be clinically acceptable.
Toxicology Risk AssessmentISO 10993-17	To assess extractables identifed duringchemical characterization testing.	Based on the chemical results evaluated in thetoxicological risk assessments, the risk ofinduced toxicity during clinical use of the subjectdevices had been deemed to be clinicallyacceptable.

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Bench Testing

Performance bench testing was conducted in alignment with the FDA's guidance document, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued March 9, 2020, and included the following testing: lesion size, thermal effects on lesion study, physical characterization, dimensional, verification, functional, electrical and mechanical testing. Lesion size testing of the predicate and subject devices prior to reprocessing showed no significant difference in the lesion size between the subject and predicate devices. Test results of

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the subject device after 150 reprocessing cycles demonstrates that the subject device continues to meet user requirements. Thermal effects testing was performed using three tissue types (heart, liver and kidney). All test samples, at various power settings, on the three different tissue types showed coagulation was effectively applied by the subject devices. No defects were observed on the subject devices during the visual inspection of the physical characteristics. The dimensional verification confirmed that all measured dimensions are within defined tolerances and specifications for the subject devices. All functional testing samples passed the acceptance criteria for key functionality of the subject devices. The electrical and mechanical test samples passed the acceptance criteria for electrical, resistivity and applied closing force. These bench test results demomstrate substantial equivalence between the subject and predicate devices.

Electrical safety and electromagnetic compatibility (EMC)

EMC and electrical safety testing were conducted in accordance with IEC 60601-1-2:2014, Edition 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, ANSI/AAMI/ES60601-1:2005/ (R)2012 and A1:2012, C1:2009/ (R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), AAMI/ANSI/IEC 60601-2-2:2017, Edition 6.0, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, IEC 60601-1-6:2013, Edition 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, and IECO 60601-2-18:2009, Edition 3.0, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment. The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments passed all EMC and electrical safety testing.

Software Verification and Validation Testing

The MicroFrance® Bipolar and Monopolar Electrosurgical Instruments do not contain software.

Biocompatibility Testing

Biocompatibility testing was conducted in accordance with ISO 10993-1:2018. Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process and FDA's guidance documents, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" issued September 4, 2020 and Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued March 9, 2020.

Animal Studies

No animal studies were performed, as appropriate verification of the changes was achieved based on the comparison to the predicate devices and from the results of the bench testing. biocompatibility evaluation, electromechanical compatibility (EMC), and electrical safety testing.

Clinical Studies

No clinical studies were performed, as appropriate verification and validation of the changes was

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achieved based on the comparison to the predicate devices and from the results of the performance testing, biocompatibility evaluation, electromechanical compatibility (EMC), and electrical safety testing.

VII. Conclusions

The proposed MicroFrance® Bipolar and Monopolar Electrosurgical Instruments are identical in intended use, indications, operating principles, technology, and clinical utility compared to the predicate devices. The changes to the subassembly dimensional specifications and material specifications have been verified and validated. The test results demonstrate that the subject devices do not raise new questions of safety and effectiveness and are substantially equivalent to the predicate devices.

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.