(36 days)
The Estech Cobra Cardiac Electrosurgical System is intended for the coaqulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissue. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
The Estech Cobra Cardiac Electrosurgical Unit and Estech Cable comprise a system that is identical to the Boston Scientific Cobra Cardiae Electrosurgical System. Both Systems are comprised of three components: the (radiofrequency) RF Probe, Flectrosurgical Unit (ESU) and Instrument (Cobra) Cable is an accessory to the ESC. The Estech RF Probes have been the subject of previous premarket notifications. The ESU is a software controlled high frequency electronic instrument, provided with controls for set temperature, power limit, and number of active electrodes. The ESU delivers 460 kHz of RF energy to selected Probe electrodes. The ESU measures temperatures from the Probe thermocouples and modulates the RF encrgy to keep all sclected electrodes' temperatures essentially the same; it adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point. The ESU has readouts for temperature, time of energy delivery, and delivered power. Front panel connectors include connections for the Instrument Cable, and third party dispersive or indifferent (DIP) electrodes. The Instrument Cable (Cobra Cable) connects the ESU to the RF Probe. It is supplied sterile to the user. The User can resterilize the Cable.
This document describes a 510(k) submission for the Estech Cobra Cardiac Electrosurgical Unit and Cable. The submission argues for substantial equivalence to a predicate device, the Boston Scientific Cobra Cardiac Electrosurgical System (K013873), rather than presenting a study with specific acceptance criteria and performance data for the Estech device itself. Therefore, many of the requested categories are not applicable to this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission asserts identity to a predicate device, meaning it is considered to have the same performance characteristics as the predicate. No new performance data or acceptance criteria are provided or required for this type of 510(k).
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new test set data was generated for the Estech device as it is asserted to be identical to the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. See point 2.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. See point 2.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (electrosurgical unit and cable), not an algorithm or AI system.
7. The Type of Ground Truth Used
Not applicable. See point 2. The "ground truth" for this submission is the established performance and safety profile of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI or machine learning system that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
Summary of the Acceptance Criteria and Study (as presented in the document):
The Estech Cobra Cardiac Electrosurgical Unit and Cable passed acceptance criteria by demonstrating substantial equivalence to a previously cleared predicate device, the Boston Scientific Cobra Cardiac Electrosurgical System (K013873).
The "study" in this context is the comparison of the new device to the predicate device, which concluded they are identical.
Key points from the document regarding this "study":
- Acceptance Criteria (Implicit): The primary acceptance criterion was that the Estech device be identical in intended use, technology, design, materials, manufacture, and packaging to the Boston Scientific Cobra Cardiac Electrosurgical System.
- Reported Device Performance (Implicit): Since the device is stated to be identical to the predicate, its performance is assumed to be identical to the predicate device, which had already met FDA requirements.
- Supporting Data: The submission explicitly states, "Supporting data is not necessary to support this submission since the Estech Cobra Cardiac FSU is identical to the predicate device..." This means no new tests, clinical trials, or performance studies were conducted for the Estech device. The FDA's 510(k) clearance confirms their agreement with this assessment of substantial equivalence.
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Endoscopic Technologies, Inc.
| Device Information: | JAN 6 2006 |
|---|---|
| Category | Comments |
| Sponsor: | Estech |
| 4135 Blackhawk Plaza Circle. | |
| Suite 150 | |
| Danville, CA 94506 | |
| Tel: 925-648-3500 | |
| Correspondent ContactInformation: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140Fax: 510-337-0416 | |
| Device Common Name: | Electrosurgical Unit and Accessories |
| Device Classification & Code: | Class II, GEI (21 CFR 878.4400) |
| Device Classification Name: | Electrosurgical cutting and coagulation device andaccessories |
| Device Proprietary Name: | Estech Cobra Cardiac Electrosurgical Unit |
| Estech Cobra Cable |
Section 5: 510(k) Summary
Predicate Device Information:
| Predicate Devices: | Cobra Cardiac Electrosurgical System(K013873) |
|---|---|
| Predicate Device Manufacturers: | Boston Scientific |
| Predicate Device Common Name: | Electrosurgical Unit and Accessories |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification & Code: | Class II, GEI |
b. Date Summary Prepared
28 December 2005
c. Description of Device
The Estech Cobra Cardiac Electrosurgical Unit and Estech Cable comprise a system that is identical to the Boston Scientific Cobra Cardiae Electrosurgical System.
Both Systems are comprised of three components: the (radiofrequency) RF Probe, Flectrosurgical Unit (ESU) and Instrument (Cobra) Cable is an accessory to the ESC. The Estech RF Probes have been the subject of previous premarket notifications.
The ESU is a software controlled high frequency electronic instrument, provided with controls for set temperature, power limit, and number of active electrodes. The ESU delivers 460 kHz of RF energy to selected Probe electrodes. The ESU measures
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Endoscopic Technologies, Inc.
temperatures from the Probe thermocouples and modulates the RF encrgy to keep all sclected electrodes' temperatures essentially the same; it adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point. The ESU has readouts for temperature, time of energy delivery, and delivered power. Front panel connectors include connections for the Instrument Cable, and third party dispersive or indifferent (DIP) electrodes.
The Instrument Cable (Cobra Cable) connects the ESU to the RF Probe. It is supplied sterile to the user. The User can resterilize the Cable.
d. Intended Use
The Estech Cobra Cardiac Electrosurgical 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 tissue. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
e. Comparison to Predicate Device
The Estech Cobra Cardiac Electrosurgical Unit is identical in intended use, technology. design, materials, manufacture, and packaging to that of the Boston Scientific Cobra Cardiac Electrosurgical System (K013873). The Instrument/Cobra Cables arc accessories to their respective ESU's. They, too, are identical to each other.
Estech concludes that the Estech Cobra Cardiac Electrosurgical Unit is substantially equivalent to the Boston Scientific ESU of the Cobra Cardiac Electrosurgical System.
f. Summary of Supporting Data
Supporting data is not necessary to support this submission since the Estech Cobra Cardiac FSU is identical to the predicate device, the Boston Scientific ESU of the Cobra Cardiac Electrosurgical System (K013873).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Estech, Endoscopic Technologies, Inc. c/o Mr. Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, CA 94501
Re: K053326
Trade/Device Name: Estech Cobra Cardiac Electrosurgical Unit & Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and Coagulation device and accessories. Regulatory Class: II (two) Product Code: OCL, GEI Dated: November 30, 2005 Received: December 12, 2005
Dear Mr. Coombs:
This letter corrects our substantially equivalent letter of January 6, 2006.
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 vours.
eqmee
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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Section 4: Indications for Use Statement
510(k) Number (if known):
KO53326
Estech Cobra Cardiac Electrosurgical Unit; Cobra Cable Device Name:
Indications For Use:
The Estech Cobra Cardiac Electrosurgical System is intended for the coaqulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissue. 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)
| Javare Bnemand for MKM | |
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| (Division Sign-Off) |
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K053326 |
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§ 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.