(46 days)
Not Found
No
The description focuses on RF energy delivery and temperature modulation, with no mention of AI or ML terms or functionalities.
Yes
The device is used to coagulate soft tissue and blood to produce hemostasis during general surgery, which are therapeutic actions.
No
Explanation: The device is intended for coagulation of soft tissue during general surgery to produce hemostasis, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is comprised of a reusable surgical clamp and a single-use bipolar insert, which are hardware components. It also mentions use with an electrosurgical unit (ESU), another hardware component.
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 for hemostasis. This is a therapeutic/surgical function performed directly on the patient's body.
- Device Description: The device is a surgical system (clamp and insert) that transmits radiofrequency energy to coagulate tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) 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 does not fit that description.
N/A
Intended Use / Indications for Use
The ESTECH Cobra Bipolar 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.
Product codes
GEI
Device Description
The Estech Cobra Bipolar System is identical to the Boston Scientific Cobra Bipolar System.
Both Bipolar Systems are comprised of two components: a reusable surgical clamp an associated coagulating device known as the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues and fits in a jaw of the clamp. The Bipolar System will be used with the Boston Scientific Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz of RF energy to selected Bipolar Insert electrodes, modulates the RF energy to keep all selected Bipolar Insert electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Supporting data is not necessary to support this submission since the Estech Cobra Bipolar System is identical to the predicate device, the Boston Scientific Cobra Bipolar System (K023288).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
· ESTECH Cobra Bipolar System Premarket Notification
| Section 10: Executive Summary | |
|---|---|
| K053100 | |
| Device Information: | |
| Category | Comments |
| Sponsor: | Estech |
| 4135 Blackhawk Plaza Circle. | |
| Suite 150 | |
| Danville, CA 94506 | |
| Tel: 925-648-3500 | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Electrosurgical Probe |
| Device Classification & Code: | Class II, GEI (21 CFR 870.4420) |
| Device Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories | |
| Device Proprietary Name: | Estech Cobra Bipolar System |
Predicate Device Information:
| Predicate Devices: | Cobra Bipolar System (K023288) |
|---|---|
| Predicate Device Manufacturers: | Boston Scientific |
| Predicate Device Common Name: | Electrosurgical Probe |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification & Code: | Class II, GEI |
b. Date Summary Prepared
October 31, 2005
c. Description of Device
The Estech Cobra Bipolar System is identical to the Boston Scientific Cobra Bipolar System.
Both Bipolar Systems are comprised of two components: a reusable surgical clamp an associated coagulating device known as the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues and fits in a jaw of the clamp. The Bipolar System will be used with the Boston Scientific Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz of RF energy to selected Bipolar Insert electrodes, modulates the RF energy to keep all selected Bipolar Insert electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.
1
C 503100
Endoscopic Technologies, Inc.
Image /page/1/Picture/2 description: The image shows the text "Page 2 of 2 ESTECH Cobra Bipolar System Premarket Notification". The word "Page" is written in cursive. The number "2" appears three times in the image, twice written in cursive and once circled.
d. Intended Use
The ESTECH Cohra Bipolar 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.
e. Comparison to Predicate Device
The Estech Cobra Bipolar System is identical in intended use, technology, design, materials, manufacture, packaging and sterilization to the predicate Boston Scientific Cobra Bipolar System.
This 510(k) is being filed to transfer sales and responsibility of this portion of Boston Scientifics' product line over to Estech. For the time being Boston Scientific will continue to manufacture the device. Estech will add additional contract manufacturers as needed.
Estech concludes that the Estech Cobra Bipolar System is substantially equivalent to the Boston Scientific Cobra Bipolar System.
f. Summary of Supporting Data
Supporting data is not necessary to support this submission since the Estech Cobra Bipolar System is identical to the predicate device, the Boston Scientific Cobra Bipolar System (K023288).
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2005
Endoscopic Technologies, Inc. % Mr. Craig Coombs President Coombs Medical Device Consulting 1193 Sherman Street Alameda, California 94501
Re: K053100
Trade/Device Name: Estech Cobra Bipolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and Coagulation device and accessories. Regulatory Class: II Product Code: GEI Dated: November 2, 2005 Received: November 8, 2005
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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.
3
This letter will allow you to begin 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chateaumichin)
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
KO53100 510(k) Number (if known):
Device Name: ESTECH Cobra Bipolar System
Indications For Use:
The ESTECH Cobra Bipolar 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 |
|---|---|
| (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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | to MXM |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K053100 |
| Page 1 of |
CONFIDENTIAL