(22 days)
Not Found
No
The 510(k) summary describes a standard electrosurgical bipolar forceps and does not mention any AI or ML capabilities.
No
The device is described as a surgical instrument (forceps) used for grasping, coagulating, and transecting tissues during laparoscopic procedures, which are considered interventional tools rather than therapeutic devices.
No
The device is described as a surgical instrument for grasping, coagulating, and transecting tissues during laparoscopic procedures, not for identifying a disease or condition.
No
The device description clearly states it is a "laparocopic grasping, coagulating, and transecting bipolar forceps," which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a laparoscopic bipolar forceps used during a surgical procedure to grasp, coagulate, and transect tissues within the body. This is an in vivo (within the body) procedure.
The device is a surgical instrument, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic bipolar procedures, to grasp, coagulate and transect tissues.
Product codes
GEI
Device Description
The Dexide Bipolar Forceps II** device is a laparocopic grasping, coagulating, and transecting bipolar forceps, which is intended to be passed down a laparoscopic cannula. The device is intended to be used with the bipolar outputs of compatible electrosurgical generators.
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
The Dexide Bipolar Forceps II** device is in compliance with ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993.
Key Metrics
Not Found
Predicate Device(s)
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
JUN 23 1999
Dexide Bipolar Forceps II** Device
KG918Sq
IX. 510(k)_Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical
150 Glover Avenue
Norwalk, CT 06856 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Christopher A. Graham |
| DATE PREPARED: | May 27, 1999 |
| CLASSIFICATION NAME: | Electrosurgical cutting and coagulation device and accessories |
| COMMON NAME: | Bipolar Forceps |
| PROPRIETARY NAME: | Dexide Bipolar Forceps II** device |
| PREDICATE DEVICES: | Minisite* Bipolar Forceps** device (K972415) |
| DEVICE DESCRIPTION: | The Dexide Bipolar Forceps II** device is a laparocopic
grasping, coagulating, and transecting bipolar forceps, which is
intended to be passed down a laparoscopic cannula. The
device is intended to be used with the bipolar outputs of
compatible electrosurgical generators. |
| INTENDED USE: | The Dexide Bipolar Forceps II** device is indicated for use in
laparoscopic bipolar procedures, to grasp, coagulate and
transect tissues. |
| MATERIALS: | All component materials of the Dexide Bipolar Forceps II**
device are comprised of materials which are in accordance with
ISO Standard # 10993-1. |
| PERFORMANCE DATA: | The Dexide Bipolar Forceps II** device is in compliance with
ANSI/AAMI American National Standard for Electrosurgical
Devices HF-18/1993. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Mr. Christopher A. Graham Senior Associate, Regulatory Affairs United States Surgical Corp. 150 Glover Avenue Norwalk, Connecticut 06856
Re: K991859 Trade Name: Dexide Bipolar Forceps II Regulatory Class: II Product Code: GEI Dated: May 27, 1999 Received: June 1, 1999
Dear Mr.Graham:
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 regulation may result in regulatory 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 regulations.
2
Page 2 - Mr. Christopher A. Graham
This letter will allow you to begin marketing your device as described in your 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 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,
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
3
Dexide Bipolar Forceps II** Device
IV. Indications For Use:
ﺰ
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Name: Dexide Bipolar Forceps II** device
Indications For Use:
The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic bipolar procedures, to grasp, coagulate and transect tissues.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)
OR Over-The-Counter Use:_ Prescription Use: (Per 21 CFR §801.109)
Pocotalo
Sign-Off) (Division Division of General Restorative Devices 510(k) Number .