The Estech COBRA® Genesis Bipolar Clamp is intended for the coagulation of soft tissue during general surgery. The system may also be used to coagulate blood and soft tissue to produce hemostasis.

Device Description

The Estech COBRA® Genesis Bipolar Clamp is a sterile, single-use device designed to guide RF energy to the target tissue via electrodes in the jaws of a surgical clamp style device. RF energy is delivered in a bipolar mode, with one jaw of the device as the ablative electrode and the other jaw as the indifferent electrode.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Estech COBRA® Genesis Bipolar Clamp:

Please note: The provided document is a 510(k) summary, which is typically a high-level overview. It states that detailed testing information is available in "Section 18" and "Sections 15 and 17," but these sections are not included in the provided text. Therefore, several of the requested details about specific study methodologies (like sample sizes for specific tests, expert qualifications, adjudication methods, or MRMC studies) are not present in this summary.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list performance acceptance criteria in a quantifiable table format. Instead, it asserts that the device is "substantially equivalent" to a predicate device (Estech COBRA Bipolar System II, K100224) based on various assessments. The "acceptance criteria" are implicitly met by demonstrating this substantial equivalence.

Here's a table summarizing the areas of comparison:

Acceptance Criterion (Implicit)	Reported Device Performance (Estech COBRA® Genesis)
Indications for Use Equivalence	Identical to predicate device (coagulation of soft tissue during general surgery; coagulation of blood and soft tissue for hemostasis).
Technology Equivalence	Identical to predicate device (RF energy delivered in bipolar mode, one jaw ablative, other indifferent). Minor design differences (non-rotatable jaws, single active electrode) do not alter performance.
Manufacturing Process Equivalence	Identical to predicate device.
Packaging Equivalence	Identical to predicate device.
Sterilization Method Equivalence	Identical to predicate device.
Mechanical Integrity	Joints and other mechanical aspects are "adequate for use" (demonstrated in Section 18, not provided).
Ablation Performance Equivalence	"Equivalent to that of the predicate" (demonstrated in Section 18, not provided).
Biocompatibility	Patient contacting materials "demonstrated to be biocompatible" in accordance with ISO 10993 (testing in Sections 15 and 17, not provided).
Electrical Safety (High Frequency Surgical Equipment)	Conforms to pertinent sections of IEC 60601-2-2 (testing in Sections 15 and 17, not provided).

Details of the Study/Testing That Proves the Device Meets Acceptance Criteria:

The provided document describes the types of studies performed but lacks specific quantitative details about their methodology, sample sizes, or outcomes.

Sample sizes used for the test set and the data provenance:
- Mechanical Integrity & Ablation Performance: The document states "The testing supplied in Section 18 demonstrates that the joints and other mechanical aspects... are adequate for use. Additionally, the data demonstrates that the ablation performance... is equivalent to that of the predicate."
  - Sample Size: Not specified in this summary. The detailed report in "Section 18" would contain this information.
  - Data Provenance: Not specified (e.g., in-vitro, ex-vivo, animal model, specific country, etc.). This would likely be found in "Section 18."
  - Retrospective/Prospective: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. For mechanical and ablation performance, "ground truth" would likely be established through objective measurements against predefined standards or comparative measurements against the predicate device, rather than expert consensus on a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not specified for mechanical and ablation performance testing described. These are typically objective measurements.
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:
- No, an MRMC study is not mentioned or applicable. This device is an electrosurgical clamp, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device. The "standalone" performance would be its direct mechanical and electrical function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Mechanical Integrity and Ablation Performance: Ground truth would likely be established through objective physical and functional measurements and comparisons to the predicate device's established performance specifications, rather than clinical outcomes or pathology.
- For Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and specific biological testing (e.g., cytotoxicity, sensitization, irritation).
- For Electrical Safety: Ground truth is established by adherence to IEC 60601-2-2 standards and electrical testing.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established based on engineering principles and regulatory standards.
How the ground truth for the training set was established:
- Not applicable for this type of device.

Summary

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K133017

SECTION 5: Special 510(k) Summary of Safety and Effectiveness

A. Device Information:
Category	Comments
Sponsor:	Endoscopic Technologies, Inc., (dbaEstech)2603 Camino RamonSuite 100San Ramon, CA 94583Tel: 925-543-2110
Correspondent:	Tamer IbrahimVice PresidentESTECH, Inc
Contact Information:	Tel: 925-543-2110Fax: 925-866-7117
Device Common Name:	Electrosurgical cutting and coagulationdevice and accessories
Device Proprietary Name:	Estech COBRA® Genesis Bipolar Clamp
Device Classification:	Class II, GEI (21 CFR 878.4400)

Predicate Device Information:

이

Predicate Devices:	Estech COBRA Bipolar System II(K100224)
Predicate Device Manufacturers:	Endoscopic Technologies, Inc (dba Estech)
Predicate Device Common Name:	Electrosurgical cutting and coagulationdevice and accessories
Predicate Device Classification:	21 CFR 878.4400
Predicate Device Classification Number:	Class II, GEI

B. Date Summary Prepared

25 September 2013

C. Description of Device

D. Intended Use

The Estech COBRA® Genesis Bipolar Clamp is intended for the coagulation of soft tissue during general surgery. The system may also be used to coagulate blood und soft tissue to produce hemostasis.

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E. Comparison to Predicate Device

The Estech COBRA® Genesis Bipolar Clamp is identical in indications for use, technology, manufacturing, packaging and sterilization to the predicate ESTECH Cobra Bipolar II System (K100224).

There are minor design differences between the application and predicate devices. These design differences (non-rotatable jaws, single active electrode) provide improved stability and ease of use for the physician, but do not alter the performance profile seen in the predicate device.

F. Summary of Supporting Data

The testing supplied in Section 18 demonstrates that the joints and other mechanical aspects of the design of the Estech COBRA® Genesis Bipolar Clamp are adequate for use. Additionally, the data demonstrates that the ablation performance of the Estech COBRA® Genesis Bipolar Clamp is equivalent to that of the predicate.

The patient contacting materials of the Estech COBRA® Genesis Bipolar Clamp have been demonstrated to be biocompatible, in accordance with ISO 10993: Biological Evaluation of Medical Devices, and the safety of the electrical design is in conformance with the pertinent sections of IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (see reference test reports in Sections 15 and 17).

G. Summary of Supporting Data

Estech concludes that the Estech COBRA® Genesis Bipolar Clamp is substantially equivalent to the predicate ESTECH Cobra Bipolar II System (K100224). The indications for use, technology, manufacturing, materials, packaging, and sterilization methods are identical to that of the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 7. 2013

Food and Drug Administration 10903 New Hampshife Avenue Document Control Center - WO06-G609 Silver Spring, MD 20993-0002

Endoscopic Technologies, Incorporated, dba Estech Mr. Tamer Ibrahim Vice President, R&D/RA/QA 2603 Camino Ramon, Suite 100 San Ramon, California 94583

Re: K133017

Trade/Device Name: Estech COBRA* Genesis Bipolar Clamp Regulation Number: 21 CFR 878,4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 25, 2013 Received: September 26, 2013

Dear Mr. Ibrahim:

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 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 cither 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 I'DA'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

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Page 2 - Mr. Tamer Ibrahim

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/ResourcesforYou/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/Safetw/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

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510(k) Number (if known): K133017

Device Name: Estech COBRA® Genesis Bipolar Clamp

Indications for Use:

The Estech COBRA® Genesis Bipolar Clamp is intended for the coagulation of soft tissue during general surgery. The system may also be used to coagulate blood and soft tissue to produce hemostasis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Lona H. :Chen -A	Page 1 offor MXM
(Division Sign-Off)
Division of Surgical Devices
510 (k) Number: K133017

Section 4, Page 1

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.