MEDDUSA BIPOLAR SYSTEM

• K Number: K130110
• Device Name: MEDDUSA BIPOLAR SYSTEM
• Manufacturer: ELLIQUENCE LLC
• Date Cleared: 2013-10-08 ( 265 days)
• Product Code: GEI
• Regulation Number: 878.4400

Intended Use

The Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-Max® RF Generators (510(k) K100390). For optimal performance the Surgi-Max® Plus generator (510(k) K100390) is recommended. The Meddusa™ Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Laryngeal coagulation, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

Device Description

The Meddusa Bipolar System is a disposable device manufacturer of medical grade Stainless Steel, ABS plastic and TEFLON heat shrink tubing. The category of contact as classified by ISO 10993-1:2003 are that the device is an (1) External Communicating Device, (2) Contact Area: Tissue, Bone, Dentin, (3) Contact Duration <24 hrs. The Meddusa Bipolar System is classified as Sterile, Surgically Invasive, Active Device, with intended patient contact for a period for <1hr (Transient). The Meddusa Bipolar System is intended to be used with the elliguence Surgi-Max Plus Radiofrequency generator (510(k) K100390). The Surgi-Max emits high frequency, lowtemperature radiowaves which is directed to the Meddusa Bipolar System tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The timevarying voltage produced by the electrical power source vields a predetermined electrosurgical effect, such as tissue cutting or coagulation.

Predicate Devices

K003126, K052859, K052241

Reference Devices

K100390

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrosurgical bipolar system and does not mention any AI or ML capabilities. The performance studies focus on thermal effects and temperature profiles, not algorithmic performance.

Therapeutic

Yes
The device is described as being used for "coagulation/contraction of soft tissue" and "tissue cutting or coagulation" in various surgical procedures, which are therapeutic actions to treat or manage a condition.

Diagnostic

No

The device is described as a surgical tool used for coagulation of soft tissue with electrosurgery, not for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "disposable device manufacturer of medical grade Stainless Steel, ABS plastic and TEFLON heat shrink tubing," indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states it's for surgical procedures involving coagulation/contraction of soft tissue using electrosurgery. This is a therapeutic and surgical application, not a diagnostic one performed on samples outside the body.
• Device Description: The description details a disposable device used with an RF generator to deliver electrical power to tissue at a surgical site for cutting or coagulation. This is a direct intervention on the patient's body.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue samples, etc.) outside the body to diagnose a condition or provide information about a patient's health status. The device directly interacts with the patient's tissue during surgery.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Meddusa Bipolar System is a surgical tool used on the patient during a procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-Max® RF Generators (510(k) K100390). For optimal performance the Surgi-Max® Plus generator (510(k) K100390) is recommended.

The Meddusa™ Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Laryngeal coagulation, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

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

GEI

Device Description

The Meddusa Bipolar System is a disposable device manufacturer of medical grade Stainless Steel, ABS plastic and TEFLON heat shrink tubing. The category of contact as classified by ISO 10993-1:2003 are that the device is an (1) External Communicating Device, (2) Contact Area: Tissue, Bone, Dentin, (3) Contact Duration

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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K130110 Page 1 of 3

510 (k) Summary

(As Required By 21 CFR 807.92(a))

Date Prepared

January 10, 2013

Submitter's Information

Company Name and Address:

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

OCT 0 8 2013

Establishment Registration for Elliquence, LLC is 3007024186.

Contact Information:

John Pikramenos - Product Development Director Phone: [phone] Fax: [phone] Email: [e-mail]

Paul Buhrke - Product Development Manager Phone: [phone] Fax: [phone] Email: [e-mail]

Trade Name

Device Trade Name is Meddusa Bipolar System

Device Common, Usual, or Classification Names

Electrosurgical Cutting and Coagulation Device and Accessories.

Classification Panel

Classification of this device would fall under the responsibility of the Division of General, Restorative, and Neurological Devices.

1

Class

Classification: Class 2. Product Code: GEI, 21 CFR 878.4400

Predicate Device

• Bipolar Trigger-Flex Probe (510(k) K003126) .
• Aquamantys 2.3 Bipolar Sealer (510(k) K052859) .
• . Disc-FX System (510(k) K052241)

Description of the Device

The Meddusa Bipolar System is a disposable device manufacturer of medical grade Stainless Steel, ABS plastic and TEFLON heat shrink tubing. The category of contact as classified by ISO 10993-1:2003 are that the device is an (1) External Communicating Device, (2) Contact Area: Tissue, Bone, Dentin, (3) Contact Duration