(182 days)
Not Found
No
The description focuses on RF energy delivery and temperature control, with no mention of AI/ML terms or functionalities.
Yes
The device is described as "intended for the coagulation of soft tissue during general surgery" and "used to coagulate blood and soft tissue to produce hemostasis," which are therapeutic actions.
No
The device is described as being used for coagulation of soft tissue and blood, and for producing hemostasis, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is comprised of a reusable surgical clamp and a sterile, single-use insert that transmits RF energy, indicating it is a hardware device with physical 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 soft tissue during general surgery" and "to coagulate blood and soft tissue to produce hemostasis." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a surgical clamp and an insert that transmits radiofrequency energy to coagulate tissue. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Cobra Bipolar System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
Product codes
GEI
Device Description
The Cobra Bipolar System device is comprised of two components; a reusable surgical clamp and an associated coagulating device BSC/ EP Technologies has named the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues. The Bipolar Clamp will be used with a Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz RF energy to selected Bipolar Clamp electrodes, modulates the RF energy to keep all selected Bipolar Clamp electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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 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
510(K) SUMMARY
| Category: | Comments |
|---|---|
| Sponsor: | Boston Scientific Corporation/EP Technologies, Inc. |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Correspondent: | April Malmborg |
| Specialist II, Regulatory Affairs | |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Contact Numbers: | Phone: 408.895.3637 |
| Fax: 408.895.2202 | |
| Email: malmbora@bsci.com | |
| Device Common Name | Electrosurgical Probe |
| Device Proprietary Name | Cobra Bipolar System |
| Device Classification | 21 CFR 878.4400; Class II |
| Predicate Device | Cobra Electrosurgical Probe |
| Predicate Device Manufacturer(s) | BSC/ EP Technologies, Inc. |
| Predicate Device Proprietary Name(s) | Eelectrosurgical Probes |
| Predicate Device Classification(s) | 21 CFR 8778.4400; Class II |
Date Summary Was Prepared:
April 3, 2003
Description of the Device:
The Cobra Bipolar System device is comprised of two components; a reusable surgical clamp and an associated coagulating device BSC/ EP Technologies has named the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues. The Bipolar Clamp will be used with a Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz RF energy to selected Bipolar Clamp electrodes, modulates the RF energy to keep all selected Bipolar Clamp electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.
Intended Use:
The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
Comparison to Predicate Devices:
CONFIDENTIAL
1
K023288 – Response to FDA Questions - April 2, 2003
Cobra Bipolar System
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | K013783 | K023288 |
| Intended Use | Coagulation of soft tissues | Same |
| Device Description | Electrosurgical Probe | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | BSC/ EP Technologies | Same |
| Device | ||
| Classification | Class II, GEI; 21 CFR §878.4400 | Same |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a row. The profiles are connected and form a continuous, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top of the design.
APR - 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. April Malmborg Regulatory Affairs Specialist II Boston Scientific 2710 Orchard Parkway San Jose, California 95134
Re: K023288
Trade/Device Name: Cobra Bipolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 30, 2002 Received: January 2, 2003
Dear Ms. Malmborg:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. April Malmborg
This letter will allow you to begin 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K023288 - Response to FDA Questions - April 2, 2003 Cobra Bipolar System
INTENDED USE STATEMENT
510(k) Number: K023288
Device Name: Cobra Bipolar System
Indication for Use:
្រុះបា
The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the Counter Use_ (Per 21 CFR $801.109)
Miriam C. Provost
Division of General, Restorative and Neurologica! Devices
510(k) Number K023288