(87 days)
Not Found
No
The description focuses on the mechanical and electrical function of the device for cutting and coagulation, with no mention of AI or ML capabilities.
No.
The device is intended to cut tissue and control bleeding through coagulation, which are surgical functions, not therapeutic ones in the sense of treating a disease or condition.
No
Explanation: The device is described as an electrosurgical instrument intended to cut tissue and control bleeding through coagulation during surgical procedures. Its function is to perform surgical actions (cutting, coagulating) rather than to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components like an instrument handle, scissors blades, disposable cartridges, and an electrosurgical generator, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: The description details a surgical instrument (scissors) that uses electrical current to cut and coagulate tissue. This is a therapeutic and surgical device, not a diagnostic one.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not interact with specimens in this way.
Therefore, the OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.
Product codes
GEI
Device Description
The OSCAR™ Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the OSCAR™ Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows between the electrodes in the cartridges and the stainless steel cutting surfaces of the blades. The electrosurgical generator controls the flow of the electric current down the electrode. The overall length of the device is between 4 and 11 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are between 1 and 2 inches in length.
The surgeon places the opened scissors across the tissue to be cut and closes the scissors handle while moving the scissors across the tissue. Energizing the electrosurgical generator via the generator's footswitch, the surgeon can simultaneously cut and coagulate the target tissue. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting for the OSCAR™ Bipolar Scissors is 20-30 watts.
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
surgeon, open surgical procedures and in general 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K951387, K945975, K955001, K963930, K960476, K973173, K972558
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
K981219
OSCAR
TM Bipolar Scissors 510(k)
JUN 2 9 1998
510(k) SUMMARY OSCAR™ BIPOLAR SCISSORS WITH OSCAR™ BIPOLAR DISPOSABLE CARTRIDGES 981219 510(k) NOTIFICATION K
GENERAL INFORMATION
Manufacturer:
ENABLE Medical Corporation 6345 Centre Park Drive West Chester, OH 45069-3863 (513) 755-7600 (513) 755-7676 Est. Reg. No. 1530251
Contact Person:
Mark L. Friedman, PhD Directory, Ouality Assurance/Regulatory Affairs ENABLE Medical Corporation
Date Prepared:
DEVICE DESCRIPTION
Classification:
Trade Name:
OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges
Generic/Common Name:
Electrosurgical cutting and coagulation device and accessories 21CFR878.4400
PREDICATED DEVICES
-
- Symbiosis Bipolar Scissors (K951387)
- Everest Medical Bipolar Scissors (K945975 and K955001) 2.
- CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 3.
Class II
1
INTENDED USE
The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.
PRODUCT DESCRIPTION
The OSCAR™ Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the OSCAR™ Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows between the electrodes in the cartridges and the stainless steel cutting surfaces of the blades. The electrosurgical generator controls the flow of the electric current down the electrode. The overall length of the device is between 4 and 11 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are between 1 and 2 inches in length.
The surgeon places the opened scissors across the tissue to be cut and closes the scissors handle while moving the scissors across the tissue. Energizing the electrosurgical generator via the generator's footswitch, the surgeon can simultaneously cut and coagulate the target tissue. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting for the OSCAR™ Bipolar Scissors is 20-30 watts.
The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are substantially equivalent to the above-identified predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method. ENABLE, CardioThoracic, Symbiosis, Everest and Ethicon devices are all bipolar scissors that cut tissue and coagulate soft tissue through the use of bipolar technology. All the bipolar scissors are connected to the same or similar electrosurgical generators and use similar power ranges for operation.
SUMMARY
As contained in this 510(k) summary, the OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges are substantially equivalent to the predicate devices identified.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 29 1998
Mark L. Friedman, Ph.D. Director Ouality Assurance and Regulatory Affairs Enable Medical Corporation 6345 Centre Park Drive West Chester, Ohio 45069-3863
Re: K981219
Trade Name: Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges Regulatory Class: II Product Code: GEI Dated: March 27, 1998 Received: April 3, 1998
Dear Dr. Friedman:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Dr. Friedman
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
OSCAR™ Bipolar Scissors 510(k) Premarket Notification
STATEMENT OF INDICATIONS OF USE
The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.
Prescription Use
(Per 21 CFR 801.109)
ccodo
510k