Elliquence Electrodes

• K Number: K142410
• Device Name: Elliquence Electrodes
• Manufacturer: ELLIQUENCE LLC
• Date Cleared: 2015-10-30 ( 428 days)
• Product Code: GEI
• Regulation Number: 878.4400

Intended Use

The Elliquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

Device Description

The elliguence family of electrodes is a collection of monopolar electrodes which are used in association with an electrosurgical generator, elliquence Surgi-Max (K100390). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active tip of the electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coaqulation. The elliquence electrodes are composed of SUS 303 stainless steel, ABS plastic, TEFLON heat shrink tubing, tungsten, brass alloys, and PFA. The basic design of the electrodes consists of an insulated shaft with an uninsulated active tip. All elliquence electrodes share the same materials, design principle, and operating principle, but are available in various shaft and tip configurations in order to satisfy different user preferences. There are eight shaft form "families" which vary in length (1.9 cm to 60 cm), shape (straight, angled, bayonet, and curved), diameter (1/16" and 3/32"), and malleability: (1) FlexTrode Malleable Electrodes, (2) Depth Gauge FlexTrodes, (3) Clear-Vu Bayonet Electrodes, (4) Empire microlncision Needle Electrodes, (5) MicroFibre Electrode, (6) Standard Electrode, (7) Medical Electrode, and (8) Surg-e Tip Electrode. The electrode tips are available in three fundamental configurations: (1) loop (round loop, diamond loop, and triangle loop), (2) ball, and (3) blade (fine wire, needle, and spatula).

Predicate Devices

K082786, K962044, K964602

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties, materials, and electrical performance of electrosurgical electrodes, with no mention of AI or ML capabilities.

Therapeutic

Yes.
The device is used to perform surgical procedures such as resection, incision, and hemostasis in soft tissue, which directly treats a condition or disease.

Diagnostic

No
The device is described as electrodes used for resection, incision, and hemostasis in soft tissue surgical procedures, which are therapeutic functions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of various materials (stainless steel, ABS plastic, etc.) and describes their function in transferring electrical power to tissue. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the electrodes are for use by a physician in soft tissue surgical procedures for resection, incision, and hemostasis. This is a therapeutic and surgical application, not a diagnostic one performed on in vitro samples.
• Device Description: The description details a collection of monopolar electrodes used with an electrosurgical generator to transfer electrical power to tissue at the surgical site for cutting or coagulation. This is a surgical tool, not a device designed to examine specimens outside the body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to directly interact with tissue during surgery.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Elliquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

Product codes

GEI

Device Description

The elliguence family of electrodes is a collection of monopolar electrodes which are used in association with an electrosurgical generator, elliquence Surgi-Max (K100390). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active tip of the electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coaqulation.

The elliquence electrodes are composed of SUS 303 stainless steel, ABS plastic, TEFLON heat shrink tubing, tungsten, brass alloys, and PFA. The basic design of the electrodes consists of an insulated shaft with an uninsulated active tip.

All elliquence electrodes share the same materials, design principle, and operating principle, but are available in various shaft and tip configurations in order to satisfy different user preferences. There are eight shaft form "families" which vary in length (1.9 cm to 60 cm), shape (straight, angled, bayonet, and curved), diameter (1/16" and 3/32"), and malleability: (1) FlexTrode Malleable Electrodes, (2) Depth Gauge FlexTrodes, (3) Clear-Vu Bayonet Electrodes, (4) Empire microlncision Needle Electrodes, (5) MicroFibre Electrode, (6) Standard Electrode, (7) Medical Electrode, and (8) Surg-e Tip Electrode. The electrode tips are available in three fundamental configurations:

• (1) loop (round loop, diamond loop, and triangle loop)
• (2) ball
• (3) blade (fine wire, needle, and spatula)

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

physician

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)

Bench Tests/Performance Testing:

• Hipot Test → Pass
• Drop Test → Pass
• Pull Test → Pass
• Lateral heat spread test → Pass. Testing performed on ex vivo bovine tissue. Liver, kidney, and muscle tissue were o evaluated with representative samples of the Monopolar Electrodes (ball, loop, spatula). Minimum, default, and maximum settings were performed in triplicate. Measurements of the thermal damage zone were obtained. Results did not raise any new issues of safety or efficacy.
• Bend test → Pass

Biocompatibility:

• ISO10993
  • Cytotoxicity → Pass
  • Sensitization → Pass O
  • Irritation / intracutaneous reactivity → Pass O

Electrical Safety:

• IEC 60601-1: Part 1: General requirements for basic safety and essential performance → . Pass
• IEC 60601-1-2: Part 1-2: General Requirements for Basic Safety and Essential ● Performance, Collateral Standard: Electromagnetic Compatibility → Pass
• IEC 60601-2-2: Part 2: Particular requirements for the basic safety and essential . performance of high frequency surgical equipment and high frequency surgical accessories → Pass

Sterility / Shelf Life:

• ISO 11135-1: Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements . for development, validation and routine control of a sterilization process for medical devices → Meets standard
• ISO 11137-1: Sterilization of health care products -- Radiation -- Part 1: Requirements for ● development, validation and routine control of a sterilization process for medical devices → Meets standard
• Simulated use test subsequent to accelerated aging → Pass
• Seal integrity testing subsequent to accelerated aging → Pass

Clinical testing was not performed for the elliquence electrodes. The elliquence electrodes do not differ from the predicate devices in fundamental scientific technology or intended use.

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

Not Found

Predicate Device(s)

K082786, K962044, K964602

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 30, 2015

Elliquence LLC Mr. Paul D. Buhrke IV Quality Assurance/Regulatory Affairs Manger 2455 Grand Avenue Balwin, New York 11510

Re: K142410

Trade/Device Name: Elliquence Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 5, 2015 Received: October 6, 2015

Dear Paul Buhrke:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K142410

Device Name Elliquence Electrodes

Indications for Use (Describe)

The Elliquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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510 (k) Summary

510K K142410 page 1 of 5

(As Required By 21 CFR 807.92(a))

Date Prepared

October 1, 2015

Submitter's Information (807.92(a)(1))

Company Name and Address:

Elliquence, LLC. 2455 Grand Avenue Baldwin, NY 11510 Phone: [phone] Fax: [phone] www.elliquence.com

Establishment Registration for Elliquence, LLC is 3007024186.

Contact Information:

Daniel Connell - Regulatory Affairs Associate Phone: [phone] Fax: [phone] Email: [e-mail]

Paul Buhrke - QA/RA Manager Phone: [phone] Fax: [phone] Email: [e-mail]

Device Information (807.92(a)(2))

Trade Name

elliquence Electrodes (encompassing the following product lines: FlexTrode Malleable Electrodes, Depth Gauge FlexTrodes, Clear-Vu Bayonet Electrodes, Empire microIncision Needle Electrodes, MicroFibre Electrode, Standard Electrode Set, Medical Electrode Set, Surg-e Tip Electrode)

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Image /page/4/Picture/0 description: The image shows the logo for "elliquence Innovative Medical Solutions". The word "elliquence" is written in a stylized font, with the "e" resembling a circle with a dot inside. Below the word "elliquence" is the phrase "Innovative Medical Solutions" in a smaller, sans-serif font. The logo is in black and white.

510K K142410 page 2 of 5

Common/Usual Name Electrosurgical Cutting and Coagulation Device and Accessories

Classification Name Electrosurgical Cutting and Coagulation Device and Accessories: 21 CFR 878.4400

Class FDA Classification: Class 2 FDA Product Code: GEI

Predicate Devices (807.92(a)(3))

• PEAK Surgery System (510(k) K082786)
• Valleylab Coated Electrodes (510(k) K962044)
• . Davis Bayonet Electrodes (510(k) K964602)

Device Description (807.92(a)(4))

The elliguence family of electrodes is a collection of monopolar electrodes which are used in association with an electrosurgical generator, elliquence Surgi-Max (K100390). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active tip of the electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coaqulation.

The elliquence electrodes are composed of SUS 303 stainless steel, ABS plastic, TEFLON heat shrink tubing, tungsten, brass alloys, and PFA. The basic design of the electrodes consists of an insulated shaft with an uninsulated active tip.

All elliquence electrodes share the same materials, design principle, and operating principle, but are available in various shaft and tip configurations in order to satisfy different user preferences. There are eight shaft form "families" which vary in length (1.9 cm to 60 cm), shape (straight, angled, bayonet, and curved), diameter (1/16" and 3/32"), and malleability: (1) FlexTrode Malleable Electrodes, (2) Depth Gauge FlexTrodes, (3) Clear-Vu Bayonet Electrodes, (4) Empire microlncision Needle Electrodes, (5) MicroFibre Electrode, (6) Standard Electrode, (7) Medical Electrode, and (8) Surg-e Tip Electrode. The electrode tips are available in three

5

Image /page/5/Picture/0 description: The image shows the logo for "elliquence Innovative Medical Solutions". The word "elliquence" is written in a bold, sans-serif font, with the "e" stylized as a circle with a dot inside. Below the word "elliquence" is the phrase "Innovative Medical Solutions" in a smaller, sans-serif font. The logo is simple and modern, and the use of the color black gives it a professional look.

510K K142410 page 3 of 5

fundamental configurations:

• (1) loop (round loop, diamond loop, and triangle loop)
• (2) ball
• (3) blade (fine wire, needle, and spatula)

Intended Use (807.92(a)(5))

The Elliquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

Substantial Equivalence Comparison (807.92(a)(6))

The elliquence electrodes device family is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the three chosen predicate devices:

• (1) PEAK Surgery System (510(k) K082786)
• (2) Valleylab Coated Electrodes (510(k) K962044)
• (3) Davis Bayonet Electrodes (510(k) K964602)

An extensive comparison chart is provided within the 510(k) submission.

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510K K142410 page 4 of 5

Non-Clinical Testing (807.92(b)(1))

Bench Tests/Performance Testing

• Hipot Test → Pass ●
• Drop Test → Pass ●
• Pull Test → Pass ●
• . Lateral heat spread test → Pass
  • Testing performed on ex vivo bovine tissue. Liver, kidney, and muscle tissue were o evaluated with representative samples of the Monopolar Electrodes (ball, loop, spatula). Minimum, default, and maximum settings were performed in triplicate. Measurements of the thermal damage zone were obtained. Results did not raise any new issues of safety or efficacy.
• Bend test → Pass ●

Biocompatibility

• · ISO10993
  • o Cytotoxicity → Pass
  • Sensitization → Pass O
  • Irritation / intracutaneous reactivity → Pass O

Electrical Safety

• IEC 60601-1: Part 1: General requirements for basic safety and essential performance → . Pass
• IEC 60601-1-2: Part 1-2: General Requirements for Basic Safety and Essential ● Performance, Collateral Standard: Electromagnetic Compatibility → Pass
• IEC 60601-2-2: Part 2: Particular requirements for the basic safety and essential . performance of high frequency surgical equipment and high frequency surgical accessories → Pass

elliquence, LLC. 2455 Grand Avenue . Baldwin, New York 11510 [phone] · Fax: [phone] · www.elliquence.com

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510K K142410 page 5 of 5

Sterility / Shelf Life

• ISO 11135-1: Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements . for development, validation and routine control of a sterilization process for medical devices → Meets standard
• ISO 11137-1: Sterilization of health care products -- Radiation -- Part 1: Requirements for ● development, validation and routine control of a sterilization process for medical devices → Meets standard
• Simulated use test subsequent to accelerated aging → Pass ●
• Seal integrity testing subsequent to accelerated aging → Pass ●

Clinical Testing (807.92(b)(2))

Clinical testing was not performed for the elliquence electrodes. The elliquence electrodes do not differ from the predicate devices in fundamental scientific technology or intended use.

Conclusion (807.92(b)(3))

Based upon a comparison of the intended uses, technological characteristics, and performance testing, we have concluded that the subject device is as safe and effective as the predicate devices.

elliquence, LLC. 2455 Grand Avenue . Baldwin, New York 11510 [phone] · Fax: [phone] · www.elliquence.com