Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard electrosurgical instruments and their performance testing, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as "electrosurgical instruments" intended "to remove tissue and/or control bleeding," which are therapeutic actions.

Diagnostic

No

Explanation: The device is an electrosurgical instrument used to remove tissue and control bleeding, which are interventional or therapeutic purposes, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical instruments (forceps, probes, knives, etc.) and is used as part of an electrosurgical system with a generator and cord, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "remove tissue and/or control bleeding." This is a surgical procedure performed directly on the patient's body.
Device Description: The description details instruments like forceps, probes, knives, etc., used for laparoscopic and open surgery. These are tools for physical manipulation of tissue.
Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.

The information provided clearly describes a surgical instrument used for therapeutic purposes (tissue removal and bleeding control) during a surgical procedure, not a diagnostic test performed on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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 demonstrate substantial equivalence between the subject and predicate devices.

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.

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.

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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K993655

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

1

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 Corporation
1100 Campus Rd.
Princeton, NJ, USA 08540

On behalf of:
Integra MicroFrance
Le Pavillon, Saint Aubin Le Monial Allier, 03160
France
Contact: Olivier Doizon, Manager, Quality
+33 (0) 470 67 98 0
olivier.doizon @ integralife.com |
| U.S. Contacts: | Primary Contact:
Ms. Malena Zammetti
Regulatory Affairs Specialist II
717-818-8774
malena.zammetti @ integralife.com

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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

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.

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-France
Electrosurgical
Instruments, Various
(K993655)	Subject Device:
MicroFrance® Bipolar and
Monopolar Electrosurgical
Instruments
(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 and
coagulation device and
accessories	Same as predicate	No difference
Indications for Use	The electrosurgical
instruments are used to
remove tissue and/or control
bleeding.	Same as predicate	No difference
Type	Various dismantlable
(modular) and unibody
bipolar and monopolar
instruments	Same as predicate	No difference
Device Sterility	Non-Sterile	Same as predicate	No difference
Reusable	Yes	Same as predicate	No difference
Reprocessing
Methods (cleaning
and sterilization)	Manual and Automated
cleaning and
Steam sterilization	Same as predicate	No difference
Design	Multiple bipolar and
monopolar instrument	Changes to the insulation
coating materials and thickness;	The performance, electrical
safety and EMC test results

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| | designs as cleared per
K993655 | changes to the monopolar pin
connector and bipolar screw set
alignment; and Minor
dimensional changes to
subassembly components to
accommodate increase in
thickness of Rislan insulation
coating. | demonstrate that the subject
devices do not raise any new
questions of safety and are
substantially equivalent to the
predicate devices. |
|-----------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Materials as cleared per
K993655 | Materials remain the same as the
predicate device except for the
insulation coating and the
bipolar connector material

Insulation coating: From Rislan®
ES BLUE 7413 M
(Blue Polyamide) to Rislan®
ESY BLUE 7414
(Blue Polyamide)

Bipolar connector: From PEEK
(Polyether ether ketone) to
Propylux® (Polypropylene)

Monopolar Connector:
Connector pin is partially coated
with Rislan® ESY BLUE 7414 | The performance, electrical
safety, EMC, and
biocompatibility test results
demonstrate that the subject
devices do not raise any new
questions of safety and
effectiveness and are
substantially equivalent to the
predicate devices. |
| Packaging | Packaging types as cleared
per 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 effective
for their intended use by evaluating
coagulation performance.	Results from side-by-side testing of the predicate
and subject devices prior to reprocessing showed
no significant difference in the lesion size.
supporting substantial equivalence between the
subject and predicate devices. Test results of the
subject device after 150 reprocessing cycles
demonstrates that the subject device continues to
meet user requirements.
Thermal Effects on Lesion
Study	To characterize the performance of the
subject devices by measuring the
typical lesion size (length, width and
depth) they generate on a range of
tissue densities ( heart, liver and
kidney) at three power settings:
minimal, default and maximal.	All test samples, at various power settings, on
three different tissue types showed coagulation
was effectively applied by the subject devices,
supporting substantial equivalence between the
subject and predicate devices.
Physical Characterization	Perform a visual inspection of the
physical characteristics for defects.	No defects were observed on the subject devices
during the visual inspection of the physical
characteristics, supporting substantial
equivalence between the subject and predicate
devices.
Dimensional Verification	Measure the device attributes and
confirm they are within defined	All measured dimensions are within defined
tolerances and specifications for the subject
	tolerances and specifications.	devices, supporting substantial equivalence
between the subject and predicate devices.
Functional Testing	Verify key functionality of the subject
devices remains similar to the
predicate devices.	All test samples passed the acceptance criteria
for key functionality of the subject devices,
supporting substantial equivalence between the
subject and predicate devices.
Electrical and Mechanical
Testing	Verify no failures occur during
electrical and resistivity testing of the
subject devices.
Measure the applied closing forces are
similar for the subject and predicate
devices.	All test samples passed the acceptance criteria
for electrical, resistivity and applied closing
force testing of the subject devices, supporting
substantial equivalence between the subject and
predicate devices.
Biocompatibility Testing
Test	Test Method Summary	Results
Cytotoxicity Study using the
ISO Elution Method
(1X MEM)
ISO 10993-5	To evaluate the potential cytotoxic
effect of a test article extract using an
in vitro mammalian cell culture.	All products tested passed the acceptance criteria
demonstrating that the devices are biocompatible
and therefore are substantially equivalent to the
predicate devices.
ISO Guinea Pig Maximization
Sensitization Test
ISO 10993-10	To evaluate the potential of the test
article extracts to cause delayed
dermal contact sensitization in the
guinea pig.	All products tested passed the acceptance criteria
demonstrating that the devices are biocompatible
and therefore are substantially equivalent to the
predicate devices.
ISO Intracutaneous Study in
Rabbits
ISO 10993-10	To evaluate the potential of test article
extracts to induce local dermal
irritation following intracutaneous
injection in rabbits.	All products tested passed the acceptance criteria
demonstrating that the devices are biocompatible
and therefore are substantially equivalent to the
predicate devices.
Acute Systemic Toxicity
ISO 10993-11	To evaluate the acute systemic toxicity
of the test article extracts following
intravenous or intraperitoneal injection
in mice.	All products tested passed the acceptance criteria
demonstrating that the devices are biocompatible
and therefore are substantially equivalent to the
predicate devices.
Chemical Characterization of
Extractables
ISO 10993-18	To perform a chemical
characterization to identify and
quantitate the extractables and/or
leachables that may be released from
the test articles.	Extractables were identified and quantified, any
extractables above the Quantification Limit (QL)
underwent a toxicological risk assessment and
were deemed to be clinically acceptable.
Toxicology Risk Assessment
ISO 10993-17	To assess extractables identifed during
chemical characterization testing.	Based on the chemical results evaluated in the
toxicological risk assessments, the risk of
induced toxicity during clinical use of the subject
devices had been deemed to be clinically
acceptable.

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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

7

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.