(71 days)
The ESTECH Cobra Bipolar II System 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.
The ESTECH Cobra Bipolar System is 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.
The provided text does not describe a study involving a medical device with acceptance criteria and reported performance in the context of an AI/algorithm-based system. Instead, it is a 510(k) premarket notification for a traditional medical device, the ESTECH Cobra Bipolar II System.
The document states that the new device is "identical in indications for use, technology, manufacture, packaging and sterilization" to a predicate device (ESTECH Cobra Bipolar System, K053100). The "acceptance criteria" and "study" described are primarily related to demonstrating equivalence to the predicate device and ensuring the safety and basic functionality of the new design.
Therefore, many of the requested fields are not applicable to this type of submission. Below is a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Category/Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Adequacy for use of joints and other mechanical aspects. | "The bench testing supplied in Section 18 demonstrates that the joints and other mechanical aspects of the design of the ESTECH Cobra Bipolar II System are adequate for use." |
| Electrode Performance | Performance equivalent to the predicate device (ESTECH Cobra Bipolar System). | "Additionally, the data demonstrates that the performance of the ESTECH Cobra Bipolar II System electrodes is equivalent to that of the predicate." |
| Biocompatibility | Conformance with ISO 10993: Biological Evaluation of Medical Devices. | "The patient contacting materials of the ESTECH Cobra Bipolar II System have been demonstrated to be biocompatible, in accordance with ISO 10993: Biological Evaluation of Medical Devices..." |
| Electrical Safety | Conformance with pertinent sections of IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment. | "...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." |
| Substantial Equivalence (Overall) | The device is "identical in indications for use, technology, manufacture, packaging and sterilization" to the predicate, with design differences not altering performance. | "ESTECH concludes that the ESTECH Cobra Bipolar II System is substantially equivalent to the predicate ESTECH Cobra Bipolar System (K053100)." (FDA concurred with this conclusion). |
2. Sample size used for the test set and the data provenance: Not applicable. The "study" here involves bench testing of device components and performance characteristics, not a clinical study with a "test set" of patient data or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical "test set" is not relevant for this type of device submission. The "ground truth" for the device's performance is established by established engineering and international standards (e.g., ISO, IEC).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is based on established engineering principles, international standards (ISO 10993 for biocompatibility, IEC 60601-2-2 for electrical safety), and comparison to the well-understood performance of the predicate device.
8. The sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.
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Endoscopic Technologies, Inc.
APR - 7 2010 ESTECH Cobra Bipolar II Special Premarket Notification
SECTION 5: Special 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 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 Bipolar II System |
| Device Classification: | Class II, GEI (21 CFR 878.4400) |
Device Information:
ﺬ
Predicate Device Information:
| Predicate Devices: | ESTECH Cobra Bipolar System (K053100) |
|---|---|
| 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, GEI |
b. Date Summary Prepared
22 January 2010
c. Description of Device
The ESTECH Cobra Bipolar System is 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.
d. Intended Use
The ESTECH Cobra Bipolar II System 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.
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Endoscopic Technologies, Inc.
ESTECH Cobra Bipolar II Svstem Special Premarket Notification
e. Comparison to Predicate Device
The ESTECH Cobra Bipolar II System is identical in indications for use, technology, manufacture, packaging and sterilization to the predicate ESTECH Cobra Bipolar System (K053100).
There are small design differences between the application and predicate devices. These design differences (rotatable jaws, single use clamp) provide a convenience for the physician, but do not alter the performance profile seen in the predicate device.
ESTECH concludes that the ESTECH Cobra Bipolar II System is substantially equivalent to the predicate ESTECH Cobra Bipolar System.
f. Summary of Supporting Data
The bench testing supplied in Section 18 demonstrates that the joints and other mechanical aspects of the design of the ESTECH Cobra Bipolar II System are adequate for use. Additionally, the data demonstrates that the performance of the ESTECH Cobra Bipolar II System electrodes is equivalent to that of the predicate.
The patient contacting materials of the ESTECH Cobra Bipolar II System 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.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 7 2010
Estech, Inc. % Coombs Medical Device Consulting, Inc. Mr. Craig Coombs, President - -1193 Sherman Street Alameda, California 94501
Re: K100224
Trade/Device Name: Estech Cobra™ Bipolar II System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 14, 2010 Received: March 18, 2010
Dear Mr. Coombs:
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
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Page 2 - Mr. Craig Coombs, President
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, pleasenote 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
ely yours,
For
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ESTECH Cobra Bipolar II System Special Premarket Notification
K100224 Section 4: Indications for Use
510(k) Number (if known):
4.77
K100224
ESTECH Cobra Bipolar II System Device Name:
Indications For Use:
The ESTECH Cobra Bipolar II System 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 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ZuihkeQal for num Page 1 of
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100224
CONFIDENTIAL
§ 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.