(59 days)
Not Found
No
The description details a standard electrosurgical instrument that uses radiofrequency energy for cutting and coagulation, with no mention of AI or ML capabilities.
Yes
The device is described as a "Tissue Dissector" used for "tissue cutting or coagulation" in various surgical procedures, which are therapeutic actions directed at treating a condition.
No
Explanation: The device is described as an electrosurgical instrument intended for tissue cutting or coagulation, which are therapeutic procedures. It is not designed to diagnose any condition.
No
The device is a physical electrosurgical instrument with a handpiece, electrode, cable, and plug, intended for use with a separate RF generator. It is explicitly described as a "single-use, sterile, monopolar electrosurgical instrument."
Based on the provided information, the Cobbra RF Tissue Dissector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for use in surgical procedures on soft tissue for resection, incision, and hemostasis. This involves direct interaction with the patient's body during surgery.
- Device Description: The description details a surgical instrument that uses radiofrequency energy to cut and coagulate tissue. This is a therapeutic and surgical function, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not directly on the body during a surgical procedure. The Cobbra RF Tissue Dissector is a surgical tool used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Cobbra RF Tissue Dissector is intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Cobbra™ RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrument intended for use exclusively with the elliquence Surgi-Max® Plus radiofrequency generator (510(k) K100390). The basic design of the device is a plastic handpiece, a partiallyinsulated electrode with an uninsulated, active edge, and a cable and plug. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active edge of the Cobbra™ RF Tissue Dissector's electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation.
The Cobbra™ RF Tissue Dissector is classified as a sterile, surgically-invasive, active device with an intended patient contact period of
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2016
Elliquence LLC. Mr. Paul Buhrke IV QA/RA Manager 2455 Grand Avenue Baldwin, New York 11510
Re: K160041
Trade/Device Name: Cobbra RF Tissue Dissector Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 6, 2016 Received: January 8, 2016
Dear Mr. Buhrke:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160041
Device Name Cobbra RF Tissue Dissector
Indications for Use (Describe)
The Cobbra RF Tissue Dissector is intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (k) Summary
(As required by 21 CFR 807.92(a))
Date Prepared
January 6, 2016
Submitter's Information (807.92(a)(1))
Company Name and Address:
Elliquence, LLC. 2455 Grand Avenue Baldwin, NY 11510 Phone: (516) 277-9000 Fax: (516) 277-9001 www.elliquence.com
Establishment Registration for Elliquence, LLC is 3007024186.
Contact Information:
Daniel Connell - Regulatory Affairs Associate Phone: (516) 277-9036 Fax: (516) 277-9011 Email: dconnell@eliquence.com
Paul Buhrke – QA/RA Manager Phone: (516) 277-9010 Fax: (516) 277-9011 Email: pbuhrke@elliquence.com
Device Information (807.92(a)(2))
Trade Name Cobbra™ RF Tissue Dissector
Common/Usual Name Monopolar electrosurgical device
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Classification Name and Regulation Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400.
Class FDA Classification: Class II FDA Product Code: GEI
Predicate Devices (807.92(a)(3))
Device Description (807.92(a)(4))
The Cobbra™ RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrument intended for use exclusively with the elliquence Surgi-Max® Plus radiofrequency generator (510(k) K100390). The basic design of the device is a plastic handpiece, a partiallyinsulated electrode with an uninsulated, active edge, and a cable and plug. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active edge of the Cobbra™ RF Tissue Dissector's electrode. The time-varying voltage produced by RF electrical power source vields a predetermined electrosurgical effect, such as tissue cutting or coagulation.
The Cobbra™ RF Tissue Dissector is classified as a sterile, surgically-invasive, active device with an intended patient contact period of