(90 days)
No
The summary describes a standard electrosurgical device with no mention of AI or ML capabilities, data processing, or performance metrics typically associated with such technologies.
Yes
The device is intended to "cut tissue and control bleeding through coagulation during general surgery," which are therapeutic actions.
No
The device is described as an electrosurgical instrument intended to cut tissue and control bleeding through coagulation during general surgery, not to diagnose a condition.
No
The device description clearly outlines a physical, reusable electrosurgical instrument with blades, a handle, and a connection to an electrosurgical generator. It describes the physical dimensions and how the device is used to cut and coagulate tissue using electric current. This 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 general surgery." This describes a surgical instrument used directly on a patient's tissue in vivo (within the living body).
- Device Description: The description details a surgical tool with blades, a handle, and a connection to an electrosurgical generator. It describes how the device is used to physically cut and coagulate tissue during a surgical procedure.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the body (like blood, urine, tissue biopsies) to diagnose diseases or conditions. This device does not perform any such testing on samples.
Therefore, the ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during general surgery.
Product codes
GEI
Device Description
The ENABLE Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the ENABLE Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows from the electrodes in the cartridges to 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 ENABLE 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
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)
K951387, K945975, K955001, K963930, K960476
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
0CT - 7 1997
510(k) SUMMARY BIPOLAR SCISSORS WITH ENABLE BIPOLAR DISPOSABLE CARTRIDGES 510(k) NOTIFICATION K_9725558
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: | Michael D. Hooven
President/CEO
ENABLE Medical Corporation |
| Date Prepared: | -------- |
| DEVICE DESCRIPTION | |
| Classification: | Class II |
| Trade Name: | ENABLE Bipolar Scissors with ENABLE Bipolar
Disposable Cartridges |
| Generic/Common Name: | Electrosurgical cutting and coagulation device and
accessories
21CFR878.4400 |
PREDICATED DEVICES
-
- Symbiosis Bipolar Scissors (K951387)
-
- CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930)
-
- Ethicon PowerStar Bipolar Scissors (K960476)
1
INTENDED USE
The ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during general surgery.
PRODUCT DESCRIPTION
The ENABLE Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the ENABLE Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows from the electrodes in the cartridges to 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 ENABLE Bipolar Scissors is 20-30 watts.
The ENABLE Bipolar Scissors with ENABLE 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 ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges are substantially equivalent to the predicate devices identified.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0CT - 7 1997
Mr. Michael D. Hooven President ENABLE Medical Corporation 6345 Centre Park Drive West Chester, Ohio 45069-3863
Re: K972558 ENABLE Bipolar Scissors with ENABLE Disposable Cartridges Requlatory Class: II Product Code: GEI Dated: July 7, 1997 Received: July 9, 1997
Dear Mr. Hooven:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 requlations.
3
Page 2 - Mr. Michael D. Hooven
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (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 yours,
Colia M. Witton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
(
(
Bipolar Scissors 510(k) Premarket Notification
STATEMENT OF INDICATIONS OF USE
The ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during general surgery.
Prescription Use X
(Per 21 CFR 801.109)
Acolla
(Divis