(11 days)
Not Found
No
The summary describes a standard bipolar RF surgical clamp and does not mention any AI or ML components or functionalities.
No
The device is intended for coagulation and hemostasis during surgery, which are active treatments to soft tissue and blood, classifying it as a therapeutic device.
No
The device description states it is used for "coagulation of soft tissue" and to "produce hemostasis" by guiding RF energy to target tissue. There is no mention of it being used to identify or diagnose any conditions or diseases.
No
The device description clearly states it 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." This describes a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of soft tissue during general surgery" and "to coagulate blood and soft tissue to produce hemostasis." This describes a surgical procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device is a "surgical clamp style device" that delivers RF energy to tissue. This is a therapeutic device used for treatment, not a diagnostic device used for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly modify tissue through coagulation.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K133017
SECTION 5: Special 510(k) Summary of Safety and Effectiveness
| A. Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Endoscopic Technologies, Inc., (dba |
| Estech) | |
| 2603 Camino Ramon | |
| Suite 100 | |
| San Ramon, CA 94583 | |
| Tel: 925-543-2110 | |
| Correspondent: | Tamer Ibrahim |
| Vice President | |
| ESTECH, Inc | |
| Contact Information: | Tel: 925-543-2110 |
| Fax: 925-866-7117 | |
| Device Common Name: | Electrosurgical cutting and coagulation |
| device 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 coagulation
device 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
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.
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.
1
E. Comparison to Predicate Device
1
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.
2
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
3
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
4
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 of |
| for MXM | |
| (Division Sign-Off) | |
| Division of Surgical Devices | |
| 510 (k) Number: K133017 |
Section 4, Page 1