The Cobbra RF Tissue Dissector is 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 Cobbra™ RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrument intended for use exclusively with the elliquence Surgi-Max® Plus radiofrequency generator (510(k) K100390). The basic design of the device is a plastic handpiece, a partially-insulated electrode with an uninsulated, active edge, and a cable and plug. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active edge of the Cobbra™ RF Tissue Dissector's electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation.

The Cobbra™ RF Tissue Dissector is classified as a sterile, surgically-invasive, active device with an intended patient contact period of <1hr (transient). It is composed of 17-4PH medical-grade stainless steel, ABS plastic, PFA, PVC, and copper. The biocompatibility of patient contacting materials has been assured through appropriate testing in accordance with ISO 10993-1.

The Cobbra™ RF Tissue Dissector is individually-packaged and supplied EtO-sterilized for single use. It is available in five models which differ only by the diameter of the electrode: RF-COBB/XS (0.25 in.), RF-COBB/S (0.375 in.), RF-COBB/M (0.5 in.), RF-COBB/L (1.0 in.), and RF-COBB/XL (1.5 in.).

AI/ML Overview

The provided document does not contain information regarding detailed acceptance criteria, the specific study that proves the device meets those criteria, or the detailed aspects of a study typically associated with AI/ML-driven devices. This document is a 510(k) premarket notification for a medical device called the "Cobbra RF Tissue Dissector," which is an electrosurgical cutting and coagulation device.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

Intended use
Technology/principle of operation
Materials
Performance (through non-clinical bench testing)

Here's a breakdown of what is available in the document related to performance and testing, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Various performance tests including mechanical testing, thermal damage measurements, and simulated use tests" were conducted. However, it does not provide a table with specific acceptance criteria (e.g., maximum allowed thermal damage, specific mechanical strength thresholds) or the reported device performance against these criteria.

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

This information is not provided. The testing described is "non-clinical bench testing," which typically involves laboratory conditions rather than human data. There is no mention of "test sets" in the context of patient data, nor country of origin or retrospective/prospective nature.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and therefore not provided. The device is not an AI/ML diagnostic tool that relies on expert interpretation for ground truth.

4. Adjudication Method:

This information is not applicable and therefore not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted or reported. The device is an electrosurgical tool, and its effectiveness is not assessed through comparative human reader studies.

6. Standalone (Algorithm only) Performance:

This is not applicable as the device is a physical electrosurgical instrument, not a software algorithm.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/ML validation (e.g., pathology, outcomes data) is not applicable here. The performance is assessed through engineering and biological safety tests. For instance, "thermal damage measurements" would have a physical ground truth related to tissue effects.

8. Sample Size for the Training Set:

This is not applicable as the device is not an AI/ML algorithm that is trained on a dataset.

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

This is not applicable.

Summary of available information related to performance and testing:

Acceptance Criteria & Reported Performance: Not explicitly detailed in a table. The document states that "Various performance tests including mechanical testing, thermal damage measurements, and simulated use tests" were performed, along with biocompatibility, electrical safety, EMC, shelf-life, and sterility testing. These tests implicitly have acceptance criteria (e.g., passing results for biocompatibility, meeting electrical safety standards), but the specifics are not enumerated.
Study Type: Non-clinical bench testing.
Clinical Testing: The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
Testing Categories:
- Mechanical testing
- Thermal damage measurements
- Simulated use tests
- Biocompatibility (in accordance with ISO 10993-1)
- Electrical safety and electromagnetic compatibility (in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2)
- Shelf-life determination
- Sterility validation

The document establishes that the device is "as safe and effective as the predicate devices" based on these non-clinical tests and comparisons of intended use, technological characteristics, and materials.

Summary

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

March 7, 2016

Elliquence LLC. Mr. Paul Buhrke IV QA/RA Manager 2455 Grand Avenue Baldwin, New York 11510

Re: K160041

Trade/Device Name: Cobbra RF Tissue Dissector Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 6, 2016 Received: January 8, 2016

Dear Mr. 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 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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K160041

Device Name Cobbra RF Tissue Dissector

Indications for Use (Describe)

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)

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510 (k) Summary

(As required by 21 CFR 807.92(a))

Date Prepared

January 6, 2016

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

Company Name and Address:

Elliquence, LLC. 2455 Grand Avenue Baldwin, NY 11510 Phone: (516) 277-9000 Fax: (516) 277-9001 www.elliquence.com

Establishment Registration for Elliquence, LLC is 3007024186.

Contact Information:

Daniel Connell - Regulatory Affairs Associate Phone: (516) 277-9036 Fax: (516) 277-9011 Email: dconnell@eliquence.com

Paul Buhrke – QA/RA Manager Phone: (516) 277-9010 Fax: (516) 277-9011 Email: pbuhrke@elliquence.com

Device Information (807.92(a)(2))

Trade Name Cobbra™ RF Tissue Dissector

Common/Usual Name Monopolar electrosurgical device

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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 bold, sans-serif font, with the "e" at the beginning stylized as a circle with a dot inside. Below "elliquence" is the phrase "Innovative Medical Solutions" in a smaller, sans-serif font. The logo is in black and white.

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Classification Name and Regulation Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400.

Class FDA Classification: Class II FDA Product Code: GEI

Predicate Devices (807.92(a)(3))

Elliquence Electrodes (510(k) K142410)
PEAK Surgery System (510(k) K082786) .

Device Description (807.92(a)(4))

The Cobbra™ RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrument intended for use exclusively with the elliquence Surgi-Max® Plus radiofrequency generator (510(k) K100390). The basic design of the device is a plastic handpiece, a partiallyinsulated electrode with an uninsulated, active edge, and a cable and plug. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active edge of the Cobbra™ RF Tissue Dissector's electrode. The time-varying voltage produced by RF electrical power source vields a predetermined electrosurgical effect, such as tissue cutting or coagulation.

Intended Use (807.92(a)(5))

The Cobbra™ RF Tissue Dissector is intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open

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Image /page/5/Picture/0 description: The image is a company logo for "elliquence Innovative Medical Solutions". The logo is in black font and the words "Innovative Medical Solutions" are smaller than the company name. Below the logo is the text "510(k) K160041 Page 3 of 3".

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

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

The Cobbra™ RF Tissue Dissector is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the two chosen predicate devices:

(1) elliquence Electrodes (510(k) K142410)
(2) PEAK Surgery System (510(k) K082786)

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

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

Bench testing performed to support substantial equivalence included:

Various performance tests including mechanical testing, thermal damage measurements, . and simulated use tests
Applicable biocompatibility tests conducted in accordance with ISO 10993-1 ●
. Electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2
. Testing to support the shelf life determination and sterility of the product

Clinical Testing (807.92(b)(2))

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

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.

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.