(43 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical probe and unit for tissue coagulation, with no mention of AI, ML, or related concepts like image processing or data analysis for decision-making.
Yes.
The device is intended for the coagulation of cardiac and soft tissues using radiofrequency (RF) energy, which is a therapeutic intervention aimed at treating medical conditions such as bleeding (hemostasis) during surgery.
No
The device description indicates its purpose is for coagulation and hemostasis using radiofrequency energy, which are therapeutic actions, not diagnostic ones. There is no mention of it being used to identify or analyze conditions or diseases.
No
The device description explicitly states it is an Electrosurgical Probe used in conjunction with an Electrosurgical Unit (ESU), indicating it includes hardware components.
Based on the provided information, the Estech Cobra Adhere Surgical System 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 direct surgical intervention on the patient's body.
- Device Description: The device is an electrosurgical probe used in conjunction with an electrosurgical unit. This is a surgical tool.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device operates directly on the patient's tissues inside the body.
The description clearly indicates a surgical device used for therapeutic purposes (coagulation and hemostasis) during surgical procedures, not a diagnostic device that analyzes samples in a lab setting.
N/A
Intended Use / Indications for Use
The Estech Cobra Adhere 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 (comma separated list FDA assigned to the subject device)
OCL, GEI
Device Description
The Cobra Adhere Surgical System is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac, 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No data supporting equivalence between the Estech Cobra Adhere Surgical System and the Boston Scientific Cobra Adhere Surgical System is necessary because both are the same device.
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.
Not Found
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).
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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.
0
JUL 2 7 2004 SECTION 2 -- 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Estech |
| 4135 Blackhawk Plaza Circle. | |
| Suite 150 | |
| Danville, CA 94506 | |
| Tel: 925-648-3500 | |
| Correspondent: | Art Bertolero |
| Chief Executive Officer | |
| Estech | |
| 4135 Blackhawk Plaza Circle. | |
| Suite 150 | |
| Danville, CA 94506 | |
| Tel: 925-648-3500 | |
| Contact Information: | Fax: 925-648-3507 |
| Device Common Name: | Electrosurgical Probe |
| Device Proprietary Name: | Cobra Adhere Surgical System |
| Device Classification: | 21 CFR 878.4400 |
Predicate Device Information:
| Predicate Device: | Cobra Adhere Surgical System |
|---|---|
| Predicate Device Manufacturer: | Boston Scientific Corporation |
| Predicate Device Common Name: | Electrosurgical Probe |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification Number: | Class II |
b. Date Summary Prepared
July 7, 2004
c. Description of Device
The Cobra Adhere Surgical System is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). 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 Cobra Adhere Surgical System is as follows: The Estech Cobra Adhere 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.
1
e. Comparison to Predicate Device
The Estech Cobra Adhere Surgical System is identical in nearly every way to the Boston Scientific Cobra Adhere Surgical System. The only difference between the two systems is the labeling changes necessary to list a different final manufacturer.
Both devices are manufactured by Boston Scientific on the same assembly line in San Jose of the exact same materials, processes and specifications. Both are EtO sterilized in processes validated to ISO 11135. Both devices have identical indications for use.
f. Summary of Supporting Data
No data supporting equivalence between the Estech Cobra Adhere Surgical System and the Boston Scientific Cobra Adhere Surgical System is necessary because both are the same device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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: K041599
Trade/Device Name: Estech Cobra Adhere Surgical System™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, GEI Dated: June 7, 2004 Received: June 21, 2004
FEB 2 1 2008
Dear Mr. Coombs:
This letter corrects our substantially equivalent letter of July 27, 2004.
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 yours,
elimal
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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Indications for Use
510(k) Number (if known): K041599
Estech Cobra Adhere Surgical System™ Device Name:
Indications For Use:
The Estech Cobra Adhere 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.
× Prescription Use (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 ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page 1 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________