The Estech Cobra Adhere Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Device Description

The Cobra Adhere Surgical System is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.

AI/ML Overview

This 510(k) submission does not contain a study to prove acceptance criteria for device performance. Instead, it relies on a "substantial equivalence" argument by asserting that the device is identical to an already legally marketed predicate device.

Here's why and what's present in the provided text:

No Acceptance Criteria or Performance Data: The submission explicitly states: "No data supporting equivalence between the Estech Cobra Adhere Surgical System and the Boston Scientific Cobra Adhere Surgical System is necessary because both are the same device." This indicates that no new performance studies (and therefore no new acceptance criteria) were established for this specific device because it is considered a re-branding of an existing one.
Reliance on Predicate Device: The core of the submission is the claim that the "Estech Cobra Adhere Surgical System is identical in nearly every way to the Boston Scientific Cobra Adhere Surgical System." The only difference cited is "labeling changes necessary to list a different final manufacturer." This implies that the Estech device inherits the performance and safety profile of the predicate device.

Given this, I cannot fill out the table and answer the study-specific questions as they pertain to a new performance study. However, I can summarize the information provided in the context of this "substantial equivalence" claim:

Summary of Device Equivalence Claim

The Estech Cobra Adhere Surgical System claims substantial equivalence to the Boston Scientific Cobra Adhere Surgical System. The basis for this claim is outlined below:

Feature/Aspect	Estech Cobra Adhere Surgical System	Boston Scientific Cobra Adhere Surgical System (Predicate)	Comparison/Comment
Acceptance Criteria	Not explicitly defined (A new study was not performed).	Assumed to be met by the predicate device's prior marketing clearance.	The acceptance criteria for the Estech device are implicitly met by its claim of being identical to the predicate device, which had already established its safety and effectiveness. No new performance endpoints or targets were set for this 510(k).
Reported Device Performance	Not reported directly for this device.	Assumed to be the same as the predicate device.	Since the devices are asserted to be identical, the performance of the Estech device is considered to be the same as the Boston Scientific device. No new performance data is presented.

Study-Specific Information (Based on the "Identical Device" Claim)

Sample sized used for the test set and the data provenance: Not applicable. No new test set or data provenance is mentioned as this device is stated to be identical to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set was performed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set for performance comparison was conducted.
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. This device is an electrosurgical probe, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical probe, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No primary ground truth was established for this submission, as it relies on the predicate device's established safety and effectiveness.
The sample size for the training set: Not applicable. This device is an electrosurgical probe; there is no mention of a "training set" in the context of machine learning or algorithms.
How the ground truth for the training set was established: Not applicable.

Explanation of the "Identical Device" Argument:

Manufacturing: "Both devices are manufactured by Boston Scientific on the same assembly line in San Jose of the exact same materials, processes and specifications."
Sterilization: "Both are EtO sterilized in processes validated to ISO 11135."
Indications for Use: "Both devices have identical indications for use."

Therefore, the review process for this device did not involve new performance studies against acceptance criteria but rather a verification of its sameness to the predicate device.

Summary

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JUL 2 7 2004 SECTION 2 -- 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Information:

Category	Comments
Sponsor:	Estech4135 Blackhawk Plaza Circle.Suite 150Danville, CA 94506Tel: 925-648-3500
Correspondent:	Art BertoleroChief Executive OfficerEstech4135 Blackhawk Plaza Circle.Suite 150Danville, CA 94506Tel: 925-648-3500
Contact Information:	Fax: 925-648-3507
Device Common Name:	Electrosurgical Probe
Device Proprietary Name:	Cobra Adhere Surgical System
Device Classification:	21 CFR 878.4400

Predicate Device Information:

Predicate Device:	Cobra Adhere Surgical System
Predicate Device Manufacturer:	Boston Scientific Corporation
Predicate Device Common Name:	Electrosurgical Probe
Predicate Device Classification:	21 CFR 878.4400
Predicate Device Classification Number:	Class II

b. Date Summary Prepared

July 7, 2004

c. Description of Device

d. Intended Use

The intended use for the Cobra Adhere Surgical System is as follows: The Estech Cobra Adhere Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

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e. Comparison to Predicate Device

The Estech Cobra Adhere Surgical System is identical in nearly every way to the Boston Scientific Cobra Adhere Surgical System. The only difference between the two systems is the labeling changes necessary to list a different final manufacturer.

Both devices are manufactured by Boston Scientific on the same assembly line in San Jose of the exact same materials, processes and specifications. Both are EtO sterilized in processes validated to ISO 11135. Both devices have identical indications for use.

f. Summary of Supporting Data

No data supporting equivalence between the Estech Cobra Adhere Surgical System and the Boston Scientific Cobra Adhere Surgical System is necessary because both are the same device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Estech, Inc. c/o Mr. Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, CA 94501

Re: K041599

Trade/Device Name: Estech Cobra Adhere Surgical System™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, GEI Dated: June 7, 2004 Received: June 21, 2004

FEB 2 1 2008

Dear Mr. Coombs:

This letter corrects our substantially equivalent letter of July 27, 2004.

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 (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.

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.

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Page 2 - Mr. Craig Coombs

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

elimal

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041599

Estech Cobra Adhere Surgical System™ Device Name:

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Miriam C. Provost

Page 1 of

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.