(175 days)
The Estech Cobra 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.
The ThermaShield is a flat, bell-shaped silicone pad that is designed to reliably fill the anatomic space between the target tissue of an RF ablation and adjacent non-target tissue. Its thickness and rounded edges provide tactile feedback to the surgeon and facilitates confidence in proper placement. The ThermaShield is primarily designed for use in open chest cardiac surgery. The addition of the ThermaShield to the ESTECH Cobra Surgical System provides a more convenient option for the physician to thermally insulate surrounding non-target tissue during RF ablations. The ThermaShield is intended to improve upon circumstances where no insulation is used or to replace the current use of a surgical glove as a thermal insulator between target and surrounding tissues.
The provided text describes an update to an existing medical device, the ESTECH Cobra Surgical System, with the addition of a ThermaShield accessory. This is a special 510(k) submission, meaning the changes are not significant enough to warrant a new full review but rather an amendment to an existing clearance. As such, the study described is a bench test to demonstrate substantial equivalence, not a clinical trial with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates the criteria were met by demonstrating the ThermaShield's performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Thermally insulate adjacent tissues during RF ablation | "Bench data provided in Section 18 demonstrates that the ThermaShield performs as intended" and "demonstrates that the ThermaShield technology is equivalent or better than surgical gloves, commonly used clinically, in thermally insulating adjacent tissues and is an improvement over having no insulation." |
| Not raise new types of safety or efficacy questions | "Bench data provided in Section 18 demonstrates that the ThermaShield performs as intended and does not raise new types of safety or efficacy questions." |
| Biocompatibility of patient-contacting materials | "The patient contacting materials of the ESTECH ThermaShield technology have been demonstrated to be biocompatible, in accordance with ISO 10993: Biological Evaluation of Medical Devices." |
| Safety of electrical design (Electromagnetic Compatibility) | "the safety of the electrical design is in conformance with the pertinent sections of IEC 60601-1-2, (Second Edition, 2001)... and IEC 60601-2-2." |
| Substantial Equivalence to Predicate Device | "ESTECH concludes that the ESTECH Cobra Surgical System with ThermaShield accessory is substantially equivalent to the predicate ESTECH Cobra Surgical System." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this was a bench test, not a clinical study involving human or animal subjects. The "bench data" would refer to a series of experimental setups to measure thermal insulation properties.
- Data Provenance: Bench test data, not explicitly stated origin (likely internal company testing). It is retrospective in the sense that it evaluates the performance of the newly designed accessory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an accessory to an electrosurgical system, and the evaluation was based on objective thermal insulation measurements, not expert interpretation of images or symptoms.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to bench testing, and data would be gathered and analyzed by technical personnel, not adjudicated by experts in the context of clinical interpretation.
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. This document describes a physical medical device accessory, not an AI-based diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an algorithm-based device. However, "standalone" in a different context could refer to the ThermaShield's performance when incorporated into the Cobra Surgical System, which was indeed evaluated in the bench tests.
7. The Type of Ground Truth Used
The ground truth used was objective physical measurements of thermal insulation properties during bench testing, as well as compliance with established biocompatibility and electrical safety standards. This is not ground truth in the pathology/outcomes sense.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based 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 an AI/ML model, no ground truth was established for it.
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K 440913 SEP 2 3 2011
Section 5: Special 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | ESTECH, Inc.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 Surgical System withThermaShield accessory |
| Device Classification: | Class II, OCL (21 CFR 878.4400) |
Predicate Device Information:
| Predicate Devices: | ESTECH Cobra Surgical System (K051749) |
|---|---|
| Predicate Device Manufacturers: | Endoscopic Technologies, Inc (akaESTECH) |
| Predicate Device Common Name: | Electrosurgical cutting and coagulationdevice and accessories |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification Number: | Class II, OCL |
b. Date Summary Prepared
31 March 2011
c. Description of Device
The ThermaShield is a flat, bell-shaped silicone pad that is designed to reliably fill the anatomic space between the target tissue of an RF ablation and adjacent non-target tissue. Its thickness and rounded edges provide tactile feedback to the surgeon and facilitates confidence in proper placement. The ThermaShield is primarily designed for use in open chest cardiac surgery.
The addition of the ThermaShield to the ESTECH Cobra Surgical System provides a more convenient option for the physician to thermally insulate surrounding non-target tissue during RF ablations. The ThermaShield is intended to improve upon
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circumstances where no insulation is used or to replace the current use of a surgical glove as a thermal insulator between target and surrounding tissues (Williams, 2004; article in TAB 5).
d. Intended Use
The Estech Cobra 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.
e. Comparison to Predicate Device
The application ESTECH Cobra Surgical System with ThermaShield Accessory is identical in nearly every way to the predicate device, the ESTECH Cobra Surgical System (K051749). The only difference between the two systems is that this application requests clearance for the addition of a thermal insulation pad, known as the ThermaShield.
This SPECIAL 510(k) is being submitted only to accommodate the inclusion of the ThermaShield. Estech is not requesting any change to the Indications for Use of the ESTECH Cobra Surgical System, nor are there any technological changes being submitted for the ESTECH Cobra Surgical System.
Bench data provided in Section 18 demonstrates that the ThermaShield performs as intended and does not raise new types of safety or efficacy questions.
ESTECH concludes that the ESTECH Cobra Surgical System with ThermaShield accessory is substantially equivalent to the predicate ESTECH Cobra Surgical System.
f. Summary of Supporting Data
The bench testing supplied in Section 18 demonstrates that the ThermaShield technology is equivalent or better than surgical gloves, commonly used clinically, in thermally insulating adjacent tissues and is an improvement over having no insulation of surrounding tissues during ablation with the previously cleared COBRA Surgical System.
The patient contacting materials of the ESTECH ThermaShield technology 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 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests and IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Endoscopic Technologies. Inc. D/b/a Estech c/o Mr. Tamer Ibrahim Vice President, R&D/RA/QA 2603 Camino Ramon Suite 100 San Ramon. CA. 94583
SEP 2 3 2011
Re: [510(k)] K110913
Trade/Device Name: Estech cobra surgical system with thermashield accessory Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: September 12, 2011 Received: September 12, 2011
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 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.
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Page 2 - Mr. Tamer Ibrahim
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Integrity, yob,
Bram D. Zyckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use
K 110943 510(k) Number (if known):
ESTECH Cobra Surgical System with ThermaShield Accessory Device Name:
Indications for Use:
The Estech Cobra 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.
Prescription Use X
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)
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| Division of Cardiovascular Devices510(k) Number | K110913 |
§ 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.