The Codman Electrosurgical Generator is a compact source of high radiofrequency RF energy to be used with monopolar and bipolar instruments to cut and coagulate tissue during surgical procedures. This is achieved by the selection of electrosurgical accessories (e. g. monopolar or bipolar instruments), different operating modes and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Indicator lights give the operator feedback on the status.

The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through an instrument's finger switch and/or a foot pedal.

The maximum power output of the device in CUT mode is 80 watts (at 600 Ohms load), and 80 watts in COAG mode (at 400 Ohms load). Operating frequency of the device is maintained at 4.0 MHz.

The device offers both monopolar and bipolar output wave forms. Both monopolar mode and bipolar mode offers one CUT and one COAG wave form, translating into a total of 4 operating modes for the user.

The Codman Electrosurgical Generator is packaged together with power cord and instruction manual. Typical accessories are a foot pedal with cable (part of this 510(k) submission) and appropriate monopolar and bipolar cables, electrodes and instruments, which are cleared and available separately.

The Codman Electrosurgical Generator is a prescription device.

AI/ML Overview

This document describes the non-clinical performance testing for the Codman Electrosurgical Generator, a Class II medical device (Product Code: GEI, Regulation Number: 21 CFR 878.4400). The device is indicated for cutting and coagulation of soft tissue in neurosurgical procedures. The study was conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to the predicate device, Sutter CURIS® RF Generator (K171869).

1. Table of Acceptance Criteria and Reported Device Performance

Test Area	Acceptance Criteria	Reported Device Performance
Electrical Safety	Compliance to IEC 60601-1:2005 + A1:2012; ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012	Passed
	Compliance to IEC 60601-2-2:2017 (Generator)	Passed
	Compliance to IEC 60601-2-2:2009 (Foot Pedal)	Passed
Electromagnetic Compatibility	Compliance to IEC 60601-1-2:2014	Passed
Risk Management	Compliance to ISO 14971:2007	Passed
Software Performance	Compliance to IEC 62304:2006	Passed
System Performance Testing	Met all design specifications and performance requirements, equivalent to predicate device	Passed
Thermal Effects on Tissue	Met all design specifications and performance requirements, equivalent to predicate device	Passed
Usability	Met all design specifications and performance requirements, equivalent to predicate device	Passed
Transport Simulation	Met all design specifications and performance requirements, equivalent to predicate device	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for individual tests. However, it indicates that "a number of non-clinical performance tests" were completed. The testing was conducted in accordance with internal R&D processes and FDA guidance for 510(k) submissions for electrosurgical devices. The data provenance is internal to Integra LifeSciences Corporation, as indicated by "internal verification and validation testing." The testing is described as "non-clinical bench testing," implying it was conducted in a laboratory setting, not with human subjects, and therefore is prospective in nature for the device's development and regulatory submission. The country of origin of the data is not specifically mentioned, but the sponsor and correspondent companies are US and Germany-based respectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The study is a non-clinical performance evaluation of an electrosurgical generator, focusing on engineering and regulatory standards compliance. It does not involve human subjects or the establishment of ground truth by clinical experts in the way that diagnostic or AI-assisted studies would.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation where adjudication would be necessary. The tests are objective measurements against defined standards.

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 a non-clinical performance study of an electrosurgical generator, not a diagnostic or AI-assisted study involving human readers.

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

Not applicable. This is a medical device, an electrosurgical generator, which is designed to be used by trained personnel (human-in-the-loop). The "performance" here refers to the device's adherence to engineering standards and functional specifications, not an algorithm's standalone diagnostic ability.

7. The Type of Ground Truth Used

The "ground truth" for this study is defined by established international and national standards for medical device safety, electromagnetic compatibility, risk management, and software performance (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 14971, IEC 62304) and the device's internal design specifications and performance requirements.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that requires a training set. The study involves hardware and software performance testing against predefined standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/ML product, there is no training set and thus no ground truth to be established for it.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

April 11, 2019

KLS Martin GmbH + Co. KG Hanna Huttmeyer Regulatory Affairs Manager Am Flughafen 18 Freiburg im Breisgau, 79108 DE

Re: K183526

Trade/Device Name: Codman Electrosurgical Generator, Foot Pedal Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 8, 2019 Received: March 12, 2019

Dear Hanna Huttmeyer:

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.

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Integra LifeSciences Corporation Traditional 510(k) Premarket Submission Codman® Electrosurgical Generator

Image /page/2/Picture/2 description: The image shows the Integra logo. The word "INTEGRA" is written in gray, with the tagline "LIMIT UNCERTAINTY" written in a smaller font size below it. To the right of the text is a graphic of several green squares of varying sizes.

Section 6 - 510(k) Summary

510(k) Summary Codman Electrosurgical Generator K183526

1. Submission Sponsor (Owner)

Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield, MA 02048

Phone: +1 781-971-5692 Contact: Jennifer Siu Title: Sr. Regulatory Affairs Specialist Email: Jennifer.siu@integralife.com

2. Submission Correspondent

KLS Martin GmbH + Co. KG Am Flughafen 18 79108 Freiburg, Germany

Phone: +49 761 557 997-0 Fax: +49 761 557 997-137

Contact: Hanna Hüttmeyer Title: Regulatory Affairs Email: hanna.huettmeyer@klsmartin.com

3. Date Prepared

December 17th, 2018

4. Device Identification

Trade/Proprietary Name:	Codman Electrosurgical Generator
Common/Usual Name:	Electrosurgical Generator
Classification Name:	Electrosurgical, cutting & coagulation & accessories
Regulation Number:	21 CFR 878.4400
Product Code:	GEI
Device Class:	Class II
Classification Panel:	General and Plastic Surgery

5. Legally Marketed Predicate Device

Sutter CURIS® RF Generator by Sutter Medizintechnik GmbH; K171869

{3}------------------------------------------------

Integra LifeSciences Corporation Traditional 510(k) Premarket Submission Codman® Electrosurgical Generator

Image /page/3/Picture/2 description: The image shows the word "INTEGRA" in gray font. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in a smaller, green font. To the right of the word "INTEGRA" are four green squares of varying sizes. The squares are arranged in a diagonal line, with the largest square at the top and the smallest square at the bottom.

6. Indication for Use Statement

The Generator is indicated for use for cutting and coagulation of soft tissue in neurosurgical procedures.

7. Device Description

The maximum power output of the device in CUT mode is 80 watts (at 600 Ohms load), and 80 watts in COAG mode (at 400 Ohms load). Operating frequency of the device is maintained at 4.0 MHz.

The device offers both monopolar and bipolar output wave forms. Both monopolar mode and bipolar mode offers one CUT and one COAG wave form, translating into a total of 4 operating modes for the user.

The Codman Electrosurgical Generator is a prescription device.

8. Substantial Equivalence Discussion

The following table compares the Codman Electrosurgical Generator to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	Integra LifeSciences Corporation	Sutter Medizintechnik GmbH
Trade Name	Codman® ElectrosurgicalGenerator(Subject Device)	CURIS® RF Generator(Predicate Device)
Manufacturer	Integra LifeSciences Corporation	Sutter Medizintechnik GmbH
Trade Name	Codman® ElectrosurgicalGenerator(Subject Device)	CURIS® RF Generator(Predicate Device)
510(k) Number	TBD	K171869
Product Code	GEI	GEI
Regulation Number	21 CFR 878.4400	21 CFR 878.4400
Regulation Name	Electrosurgical, cutting & coagulation& accessories	Electrosurgical, cutting & coagulation &accessories
Indications for Use	The Generator is indicated for use forcutting and coagulation of soft tissuein neurosurgical procedures.	Orthopedic, arthroscopic, spinal andneurosurgical:For resection and coagulation of softtissues and hemostasis of blood vessels inorthopedic, arthroscopic, spinal andneurosurgical proceduresFor soft tissue resection and coagulationduring arthroscopic surgical procedures ofknee, shoulder, ankle, elbow, hip and wrist.Cutting:Snoring, submucosal palatal shrinkage,traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhagecontrol, epistaxis treatment and turbinateshrinkage, skin incisions, biopsy, cysts,abscesses, tumors, cosmetic repairs,development of skin flaps, skin tags,blepharoplastyBlended Cutting and Coagulation:Snoring, submucosal palatal shrinkage,traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhagecontrol, epistaxis treatment and turbinateshrinkage, skin tags, papilloma keloids,keratosis, verrucae, basal cell carcinoma,nevi, fistulas, epithelioma, cosmetic repairs,cysts, abscesses, development of skinflapsHemostasis and nonablative Coagulation:Control of bleeding, epilation,teleangiectasiaBipolar:Pinpoint, precise coagulation, pinpointhemostasis in any field (wet or dry),snoring, submucosal palatal shrinkage,traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhagecontrol, epistaxis treatment and turbinateshrinkage
Premarket Submissionsurgical Generator
	Integra LifeSciences Corporation	Sutter Medizintechnik GmbH
	Codman® ElectrosurgicalGenerator(Subject Device)	CURIS® RF Generator(Predicate Device)
	Metal & plastics	Metal & plastics
	No	no
	Yes	yes
	IEC 60601-1 all applicablerequirements met	IEC 60601-1 all applicable requirementsmet

Table 6A - Comparison of Characteristics

{4}------------------------------------------------

Integra LifeSciences Corporation

Traditional 510(k) Premarket Submission Codman® Electrosurgical Generator

Image /page/4/Picture/3 description: The image shows the Integra logo. The word "INTEGRA" is in large, gray, sans-serif font. Below it, in smaller green font, is the phrase "LIMIT UNCERTAINTY". To the right of the text are three green squares of varying sizes, arranged in a column.

{5}------------------------------------------------

Manufacturer Trade Name

Battery Operated AC Powered Electrical Safety

Electromagnetic

Compatibility

HF Electrical Safety

Material

met

IEC 60601-1-2 all applicable requirements

IEC 60601-2-2 all applicable requirements

9. Non-Clinical Performance Data

IEC 60601-1-2 all applicable

IEC 60601-2-2 all applicable

requirements met

As part of demonstrating safety and effectiveness of Codman Electrosurgical Generator and in showing substantial equivalence to the predicate device that is subject to this 510(k) submission, Integra LifeSciences Corporation completed a number of non-clinical performance tests against applicable standards.

Test	Pass / fail criteria	Results
1	Electrical safety	Compliance to IEC 60601-1:2005 + A1:2012;ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012	Passed
2	Electrical safety	Compliance to IEC 60601-2-2:2017 (Generator)Compliance to IEC 60601-2-2:2009 (Foot Pedal)	Passed
3	Electromagnetic compatibility	Compliance to IEC 60601-1-2:2014	Passed
4	Risk Management	Compliance to ISO 14971:2007	Passed
5	Software Performance	Compliance to IEC 62304:2006	Passed

Table 6B - Performance Standards Testing Summary

To demonstrate that the Codman Electrosurgical Generator meets all design specifications and performance requirements, nonclinical bench testing has been performed in accordance with the internal R&D process in compliance with the proposals and recommendations of FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016.

In particular, tests have been carried out with respect to the following subject areas:

Electromagnetic Compatibility and Electrical Safety
System Performance Testing ●
Thermal effects on tissue ●
Usability
Transport simulation ●

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the text "K183526 - Page 5 of 5" in blue font. Below the text is the word "INTEGRA" in gray font, with the words "LIMIT UNCERTAINTY" in smaller font below it. To the right of the word "INTEGRA" are four green squares of varying sizes.

Internal verification and validation testing confirms that product specifications are met which are equivalent to the predicate device in technological characteristics. The testing results support that the requirements for performance and electrical safety testing were met for the acceptance of the device. The Codman Electrosurgical Generator passed all testing and supports the claims of substantial equivalence to the predicate device.

10. Statement of Substantial Equivalence

Based upon the intended use, design, operating principles, patient/user interface, comparison to the predicate device, and testing conducted, it is concluded that the subject device, Codman Electrosurgical Generator, is substantially equivalent to the predicate device, Sutter CURIS® RF Generator (K171869), and therefore does not raise different questions of safety and effectiveness.

{7}------------------------------------------------

Indications for Use

510(k) Number (if known) K183526

Device Name Codman Electrosurgical Generator

Indications for Use (Describe)

The Generator is indicated for use for cutting and coagulation of soft tissue in neurosurgical procedures.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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.