(76 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on RF energy for tissue coagulation.
Yes
The device is intended for the coagulation of cardiac and soft tissues to produce hemostasis, which is a therapeutic intervention.
No
The device is described as a surgical system intended for coagulation of tissues. While it includes a "Bipolar Recording Electrode" and mentions "mapping" in a predicate device, the primary intended use is therapeutic (coagulation) rather than diagnostic analysis for disease detection or characterization. The recording electrode likely assists in guiding the therapeutic ablation, rather than providing a standalone diagnostic output.
No
The device description explicitly states the system includes RF Ablation Probes, an Electrosurgical Unit (ESU), and other accessories, which are hardware components.
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 cardiac and soft tissues using radiofrequency energy during surgery. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a surgical system including probes and an electrosurgical unit used by surgeons during open surgical procedures. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is to directly treat tissue within the body.
N/A
Intended Use / 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.
Product codes
GEI, OCL
Device Description
The Estech Cobra Surgical System is a family of devices including RF Ablation Probes, with either a malleable or flexible shafts, used in conjunction with the Cobra Electrosurgical Unit (ESU) and other accessories, including the Estech Cobra Bipolar Recording Electrode. The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue, soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
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)
No biocompatibility data is necessary since the materials in the modified ablation probes (XL and Surgical I root) are receited to those in the ablation probes.
Preclinical performance data is supplied to demonstrate that the XL version of the cooled Precimical performance data is supplied to usine pertinent specifications as the predicate version.
No performance data is necessary for the Estech Cobra Surgical Probe since it is identical No performance catand manufacture to the predicate device.
Preclinical performance data is supplied to demonstrate that the Estech Cobra Bipolar Recording Electrode operates as intended.
Additionally, Estech certifies that the accessories are in compliance with the pertinent Additionally, Estech certifics that the accessive are arrest HF-18: Electrosurgical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Endoscopic Technologies, Inc.
ESTECH Cobra System Model Amendma Premarket Notification
SECTION 1 - GENERAL DESCRIPTION 510(k) Notification Information Collection
Sponsor Endoscopic Technologies, Inc.; d/b/a Estech
K 051749
Person Responsible for File Art Bertolero Chief Executive Officer Estech Technologies
Device Trade Name Estech Cobra Surgical System™ Accessories presented in this premarket notification: Estech Cobra Adhere XL Surgical System Estech Cobra Surgical Probe Estech Cobra Bipolar Recording Electrode
Common Name Electrosurgical Probes and accessories
Classification Name
Classification Name
Class II, Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400);
Product Code GEI
Establishment Registration Number 2953686
Address of Manufacturing Facility and Sterilization Site:
| Manufacturing Facility | Sterilization Site |
|---|---|
| 4135 Blackhawk Plaza Circle | |
| Suite 150 | |
| Danville, CA 94506 | Sterigenics |
| 5725 W. Harold Gatty Dr. | |
| Salt Lake City, UT 84116 | |
| Tel: 925-648-3500 | Tel: 801-328-9901 |
| Contact: Art Bertolero | Fax: 801-328-9002 |
| Establishment Registration: | |
| 2953686 | Establishment Registration: |
| 1721676 |
1
SECTION 2 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Category | Comments |
|---|---|
| Sponsor: | Estech |
| 4135 Blackhawk Plaza Circle . | |
| Suite 150 | |
| Danville, CA 94506 | |
| Tel: 925-648-3500 | |
| Correspondent: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Contact Information: | Tel: 510-337-0140 |
| Fax: 510-337-0416 | |
| Device Common Name: | Electrosurgical Probe |
| Device Proprietary Name: | Estech Cobra Surgical System™ |
| Device Classification: | 21 CFR 878.4400 |
e Information:
Predicate Device Information:
| Predicate Devices: | Electrosurgical Probe (K981981)
Cobra Adhere Surgical System (K041599)
Detect Mapping and Pacing Tool (K040812) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Predicate Device Manufacturers: | Boston Scientific Corporation
Endoscopic Technologies
Medtronic |
| Predicate Device Common Name: | Electrosurgical Probe |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification Number: | Class II |
b. Date Summary Prepared
July 22, 2005
c. Description of Device
The Estech Cobra Surgical System is a family of devices including RF Ablation Probes, with either a malleable or flexible shafts, used in conjunction with the Cobra Electrosurgical Unit (ESU) and other accessories, including the Estech Cobra Bipolar Recording Electrode. The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
d. Intended Use
The intended use for the Estech Cobra Surgical System is as follows: 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
2
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
e. Comparison to Predicate Device
The XL version of the Estech Cobra Surgical System is substantially equivalent in intended use, technology, design and materials to the predicate device. The XL version intended use, technology, design and materials works. The original promarket notification
has up to seventeen electrodes on the ablation world it's in size and handle has up to seventeen electrodes on the abliated process differ in size and handle
device had an upper limit of seven electrodes. The Stabilizers add hament of the device had an upper mint of seven sieet. See of cilitate the placement of the System.
The Estech Cobra Surgical Probe is substantially equivalent in intended use, technology, I he Estech Cobra Surgical I rove is substantially.
design and materials to the predicate system. The Cobra Surgical Probed it does not design and materials to the predicate systems be run through the shaft and it does not the capability for a coomig steam of water to be country works.
interface with a Stabilizer. This version of the Cobra Surgical Probe is identical to the Boston Scientific Electrosurgical Probe.
The Estech Cobra Bipolar Recording Electrode is substantially equivalent to the surgical The Estech Cobra Bipolar Recording Blocared is the predicate device. Both are handintended use, sellsing and pacing characterial in an open surgical field. They are not implantable.
f. Summary of Supporting Data
f. Summary of Supporting Data
No biocompatibility data is necessary since the materials in the modified ablation probes No biocompatibility data is necessary only and described in the predicate 510(k)s. The (XL and Surgical I root) are receited to those in the ablation probes.
Preclinical performance data is supplied to demonstrate that the XL version of the cooled Precimical performance data is supplied to usine pertinent specifications as the predicate version.
No performance data is necessary for the Estech Cobra Surgical Probe since it is identical No performance catand manufacture to the predicate device.
Preclinical performance data is supplied to demonstrate that the Estech Cobra Bipolar Recording Electrode operates as intended.
Additionally, Estech certifies that the accessories are in compliance with the pertinent Additionally, Estech certifics that the accessive are arrest HF-18: Electrosurgical devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine, but it is rendered in a more abstract and modern design.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Estech, Inc. c/o Mr. Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, CA 94501
Re: K051749
Trade/Device Name: Estech Cobra Surgical System™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, GEL Dated: June 27, 2005 Received: July 7, 2005
Dear Mr. Coombs:
This letter corrects our substantially equivalent letter of September 13, 2005.
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.
4
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.
ellmoll
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
051749
Estech Cobra Surgical System™ Device Name:
Indications For Use:
The Estech Cobra Surgical System is intended for the coagulation The Estech Oobra Surgiour System Systems (RF) energy during cardiac of cardiac tissue doing factor of the system can be used during general surgery to surgery. The System can be used daning goneral bangulate coagulate oft 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)
| Barbare concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | Page 1 of ______ | |
| Division of General, Restorative, | ||
| and Neurological Devices | ||
| CONFIDENTIAL | Page 1-5 | |
| 510(k) Number | K051749 |