(119 days)
Not Found
No
The document describes a device for cardiac ablation and temporary pacing/sensing, with no mention of AI or ML capabilities in its function or description.
Yes
The device is described as being used for ablation of cardiac tissue and for temporary cardiac pacing, sensing, recording, and stimulation, all of which are therapeutic interventions.
Yes
The device is intended for "sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery," which are diagnostic functions.
No
The device description clearly states it is a "sterile, single use device intended for the ablation of The Esteon CODIA Cranel to deliver RF energy to the target tissue via electrodes in the device". This describes a physical hardware device with electrodes, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to "ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy". This is a therapeutic procedure performed directly on the patient's tissue. The secondary use is for "temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery". While this involves evaluating the heart's electrical activity, it's still a direct interaction with the patient's body during surgery, not an analysis of a sample taken from the body.
- Device Description: The device delivers RF energy to tissue via electrodes and can be connected to a pacemaker or recording device for direct interaction with the heart's electrical signals.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) taken from the body. IVDs are designed to perform tests on these types of samples to provide information about a patient's health status.
The device is clearly intended for direct surgical intervention and physiological monitoring in vivo (within the living body), which is the opposite of in vitro (in glass, or outside the living body).
N/A
Intended Use / Indications for Use
The ESTECH Cobra Adhere XL2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical Unit (ESU).
The ESTECH Cobra Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external pacemaker or recording device.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The Estech COBRA Adhere XL 2 is a sterile, single use device intended for the ablation of The Esteon CODIA Cranel to deliver RF energy to the target tissue via electrodes in the device when connected to the COBRA Electrosurgical Unit (ESU).
When the COBRA Adhere XL 2 is connected to an auxiliary temporary external pacemaker or recording device it can be used to provide temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery. The COBRA Adhere XL 2 must be disconnected from the ESU and connected to a temporary external pacemaker or recording device using the accessory cable provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
during cardiac surgery
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)
Appropriate testing, included in this application, has been performed to ensure that the ESTECH COBRA Adhere XL 2 meets its product specifications. The data demonstrates substantial equivalence to the predicate devices. In-vitro and in-vivo testing demonstrate that the COBRA Adhere XL2 is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the predicate devices.
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
KIT3445
SECTION 5: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 2 0 2012
Device Information:
| Category | Comments |
|---|---|
| Sponsor: | ESTECH, Inc. |
| 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: | Surgical Device, For Ablation of Cardiac |
| Tissue | |
| Device Proprietary Name: | Estech COBRA Adhere XL 2 |
| Device Classification: | Class II, OCL (21 CFR 878.4400) |
Predicate Device Information:
| Predicate Devices: | Estech COBRA Adhere XL (K051749)
Estech COBRA Bipolar Recording Electrode
(K051749) |
|-----------------------------------------|-------------------------------------------------------------------------------------------|
| Predicate Device Manufacturers: | Endoscopic Technologies, Inc (dba Estech) |
| Predicate Device Common Name: | Surgical Device, For Ablation of Cardiac
Tissue |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification Number: | Class II, OCL |
Predicate Device Information:
| Predicate Devices: | Multifunctional Linear Pen (K100501) |
|---|---|
| Predicate Device Manufacturers: | AtriCure, Inc. |
| Predicate Device Common Name: | Surgical Device, For Ablation of Cardiac |
| Tissue | |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification Number: | Class II, OCL |
b. Date Summary Prepared
21 November 2011 (Updated 22Feb2012)
c. Description of Device
The Estech COBRA Adhere XL 2 is a sterile, single use device intended for the ablation of The Esteon CODIA Cranel to deliver RF energy to the target tissue via electrodes in the device when connected to the COBRA Electrosurgical Unit (ESU).
1
When the COBRA Adhere XL 2 is connected to an auxiliary temporary external pacemaker or recording device it can be used to provide temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery. The COBRA Adhere XL 2 must be disconnected from the ESU and connected to a temporary external pacemaker or recording device using the accessory cable provided.
d. Intended Use
The ESTECH COBRA Adhere XL 2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
The ESTECH COBRA Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
e. Comparison to Predicate Device and Summary of Technological Characteristics
The ESTECH COBRA Adhere XL2 has the identical intended use and the same technological characteristics as the predicate devices. There have been no significant changes in technological characteristics with respect to the predicate device including materials, design, energy sources, or other features from the predicate device.
The COBRA Adhere XL 2 and predicate COBRA Adhere XL both comprise a vacuum stabilizer to maintain contact between the ablation probe and target tissue to be ablated. These vacuum te hilizers are flexible. The COBRA Adhere XL 2 further comprises an internal ribeage which gives the device the ability to conform into various shapes while providing the flexible suction stabilizer with structural integrity. The predicate COBRA Adhere XL has a vacuum stabilizer with a centrally located series of electrodes. The COBRA Adhere XL 2 has a vacuum stabilizer with a laterally located series of electrodes. As the vacuum stabilizers form a seal with the tissue, while is drawn into the device creating contact between tissue to be ablated and the electrodes.
Both the COBRA Adhere XL2 and predicate COBRA Adhere XL include temperature controlled Doar are of endicate and application devices each have multiple active RF electrodes that are individually selectable and controlled by the ESU (generator). Predicate and application devices each have two (2) thermocouples attached to each active RF electrode. The COBRA Adhere XL2 also comprises an integrated indifferent electrode. With the COBRA Adhere XL 2, RF energy is directed from the active electrode to the integrated indifferent electrode or to the indifferent electrode placed on the patient's back, depending on the mode the device is in, as selected by the surgeon. The surgeon depresses the button on the device handle and the switch in serveted by the bargeon. I am enables or disables the integrated indifferent electrode.
The COBRA Adhere XL 2 also provides transient pacing/sensing capability when connected to an auxiliary temporary external pacemaker or recording device like the predicate devices.
2
f. Summary of Nonclincal Testing
Appropriate testing, included in this application, has been performed to ensure that the ESTECH COBRA Adhere XL 2 meets its product specifications. The data demonstrates substantial equivalence to the predicate devices. In-vitro and in-vivo testing demonstrate that the COBRA Adhere XL2 is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the predicate devices.
The patient contacting materials of the ESTECH COBRA Adhere XL 2 have been tested in accordance with ISO 10993: Biological Evaluation of Medical Device to ensure biocompatibility. The safety of the electrical design has been tested per and is in conformance with the pertinent sections of IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests and IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
g. Summary of Substantial Equivalence
Estech concludes that the COBRA Adhere XL 2 is substantially equivalent to the predicate devices. The indications for use, basic overall function, materials, packaging, and sterilization methods are identical or substantially equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 0 2012
Endoscopic Technologies, Inc. C/O Mr. Tamer Ibrahim 2603 Camino Ramon, Suite 100 San Ramon, CA 94583
Re: K113475
Trade/Device Name: ESTECH Cobra Adhere XL 2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OCL Dated: February 21, 2012 Received: February 22, 2012
Dear Mr. Ibrahim:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premailer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regally manatiment date of the Medical Device Amendments, or to commence prior to May 20, 1970, the enaounter with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allu Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The You may, therefore, market me device, basjever to assements for annual registration, listing of general controls provisions of the fielding, and prohibitions against misbranding and devices, good manufacturing practice, tabeling, and information related to contract liability adulteration. Please note: CDNT docs not overance increases and misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) finitials affecting your device can be may be subject to additional controls. "Internal Regulations, "In addition, FDA may lound in the Code of I each. Regarders
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 Please be advised that FDA s issualled of a bays of a be requirements of the Act
that FDA has made a determination that your device complies with on any must that FDA has made a decernmanch and Joan Seeel by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not issuesting of m comply with all the Act 3 requirements, incruaing, our access of the subsiting of medical
4
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1100 for regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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,
Ronn D. Zuckerman, M.D.
Bram D. Zackerman, 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): K113475
Device Name: ESTECH Cobra Adhere XL 2
Indications For Use:
The ESTECH Cobra Adhere XL2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical Unit (ESU).
The ESTECH Cobra Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external pacemaker or recording device.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | A13475 |
| Page 1 |
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