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.

AI/ML Overview

The Meddusa Bipolar System is an electrosurgical device. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and a study proving the device meets them in the traditional sense of a clinical trial with predefined performance metrics. The submission focuses on demonstrating safety and effectiveness through comparisons of physical and performance characteristics with existing devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria are not explicitly stated in the document, as this is a 510(k) summary focused on substantial equivalence. Instead, the performance is evaluated by demonstrating similarity to predicate devices in terms of thermal effects and safety.

Aspect of Performance	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Must be biocompatible	Passed biocompatibility testing
Dielectric Testing	Must pass dielectric testing	Passed dielectric testing
Thermal Effect (Tissue)	Perform similarly to predicate devices in terms of width and depth of thermally damaged zones in ex vivo tissue.	Performed similarly to predicate devices as demonstrated by measuring width and depth of thermally damaged zones in relation to tissue type, intensity setting, and duration of activation.
Temperature Profile (Applicator & Cable)	Maximum applicator surface area and maximum cable surface temperature will be safe to the user and/or patient during maximum energy delivery.	Temperature profile recorded during simulation use for maximum energy delivery duration at maximum power demonstrates safety.
Peak Temperatures (Electrode Tips & Target Tissue/Vessels)	Safe peak temperatures during maximum recommended duration and generator output settings.	Peak temperatures compared, implicitly found to be safe and effective.

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

Sample Size for Test Set: Not explicitly stated as a numerical value for a "test set" in the context of a clinical trial. The testing was done on ex vivo tissue, specifically liver, kidney, and muscle tissue. The quantity or number of samples of these tissues is not quantified.
Data Provenance: The data is from bench tests using ex vivo tissue. The country of origin of this tissue or the testing location is not specified, but it can be inferred to be part of the manufacturer's testing process. The study is retrospective in the sense that it's laboratory testing on prepared samples, not observations from a live patient study.

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

There is no mention of "experts" establishing ground truth in the context of radiologists or similar medical professionals for image interpretation. This device is not an imaging device that requires interpretation. The "ground truth" for the thermal effect would have been established through direct measurement and observation by the engineering or scientific personnel conducting the bench tests. No specific number or qualifications of these individuals are provided.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical trial with human observers or an "adjudication method" in the traditional sense. The performance data comes from direct measurements and observations during bench testing.

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. The Meddusa Bipolar System is an electrosurgical device, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant or performed.

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

Not applicable. This is a hardware medical device used by a physician, not an algorithm. The "standalone performance" is essentially the device's physical and functional performance during the bench tests, which were conducted without direct human control of the outcome metrics, but rather under controlled experimental conditions.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would be:

Direct Physical Measurements/Observations: For thermal damage (width and depth of thermally damaged zones), temperature profiles, and peak temperatures. These are objective measurements rather than subjective interpretations or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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

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: (516) 277-9000 Fax: (516) 277-9001 www.elliquence.com

OCT 0 8 2013

Establishment Registration for Elliquence, LLC is 3007024186.

Contact Information:

John Pikramenos - Product Development Director Phone: (516) 277-9012 Fax: (516) 277-9025 Email: johnp@elliquence.com

Paul Buhrke - Product Development Manager Phone: (516) 277-9010 Fax: (516) 277-9011 Email: pbuhrke@elliquence.com

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 classified as Sterile, Surgically Invasive, Active Device, with intended patient contact for a period for <1hr (Transient).

Intended Use

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 coaqulation. Thorascopic coagulation, Neurosurgical coaqulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

Technological Characteristics

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

The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics.

Performance Data

The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate devices. Bench tests used ex vivo tissue that included liver, kidney, and muscle tissue. The subject device and predicate devices were compared to demonstrate the thermal effect on tissue by measuring the width and depth of the thermally damaged zones in relation to tissue type, intensity setting, and duration of activation. The temperature profile of the subject device applicator and cable was recorded during simulation use for the maximum energy delivery duration at the maximum power to demonstrate the maximum applicator surface area and maximum cable surface temperature will be safe to the user and/or to the patient. The peak temperatures of the electrode tips and target tissue/vessels when the device is used for the maximum recommended duration and generator output settings was compared. Based on the results of the various bench tests, it was determined that the subject device is safe and effective.

Conclusion

We conclude that the subject device is safe and effective as the predicate device.

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

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G604 Silver Spring, MD 20993-0002

Elliquence Innovative Medical Solutions Mr. John Pikramenos Product Development Director 2455 Grand Avenue Baldwin, New York 11510

Re: K130110

Trade/Device Name: Meddusa Bipolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 13, 2013 Received: September 17, 2013

Dear Mr. Pikramenos:

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 10 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 docs 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

October 8, 2013

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

Page 2 - Mr. John Pikramenos

forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K130110

Device Name: Meddusa Bipolar System.

Indications For Use:

Throat coagulation.

Prescription Use
(Part 21 CFR 801 Subpart D)

✓

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H.
Chen -A

342.19200300.100.1.1 = 1 1003499056

for MXM

(Division Sign-off) Division of Surgical Devices 510(k) Number K130110

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.