(141 days)
Not Found
No
The description focuses on the mechanical and electrosurgical functions of the device, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is used for surgical procedures like dissection, grasping, cutting, and coagulation, which are interventional rather than therapeutic.
No
The device is described as performing actions like dissection, grasping, cutting, and coagulation, all of which are interventional or surgical procedures, not diagnostic ones. Its purpose is to manipulate or alter tissue, not to obtain information about a patient's medical condition.
No
The device description clearly describes a physical surgical instrument (forceps) with grasping jaws, a handle, and integrated finger loops, designed for electrosurgical cutting and coagulation, grasping, and dissection. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding of tissue during open surgical procedures and in general surgery." This describes a device used on the patient's tissue during surgery, not a device used to test samples from the patient outside of the body.
- Device Description: The description details a surgical instrument with grasping jaws and electrosurgical capabilities. It functions by applying energy directly to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue samples, etc.), performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for direct intervention on tissue during a procedure.
N/A
Intended Use / Indications for Use
Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding of tissue during open surgical procedures and in general surgery.
Product codes
GEI
Device Description
The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for grasping, dissection, electrosurgical coagulation and cutting. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. In addition, one jaw contains a second electrically isolated electrode element to effect electrosurgical cutting.
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
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
JUL 1 3 2002
020585
G: 510(k) Summary
February 20, 2002
| Company: | Gyrus Medical, Inc.
6655Wedgwood Road
Maple Grove, MN
Tel. No. (763) 416-3000
FAX. No. (763) 416-3070 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact: | Frederick G. Mades
Regulatory Affairs Manager |
| Common/Usual Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical Cutting and Coagulation Device And Accessories
(21 CFR 878.4400) |
| Proprietary Name: | Zip Open Forceps with Electrosurgical Cut |
The device is a Class II medical device. The Zip Open Forceps with Electrosurgical Cut is a modification to the predicate device cleared under K000496. The Open Forceps is similar in construction and in component materials when compared to the predicate device. The indications for use are similar to the predicate devices cleared under K000496 and K904993. The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for grasping, dissection, electrosurgical coagulation and cutting. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The intended use of the device is to electrosurgically coagulate and cut tissue as well as to grasp and dissect tissue during the performance of open general surgical procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. In addition, one jaw contains a second electrically isolated electrode element to effect electrosurgical cutting.
In conclusion, as the design, materials of construction, function and intended use of the Zip Open Forceps with Electrosurgical Cut is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent.
Page 9 of 9
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2002
Mr. Frederick G. Mades Regulatory Affairs Manager Gyrus Medical, Inc. 6655Wedgwood Road Maple Grove, Minnesota 55311-3602
Re: K020585
Trade/Device Name: Zip Open Forceps with Electrosurgical Cut Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 11, 2002 Received: June 12, 2002
Dear Mr. Mades:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Frederick G. Mades
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.fida.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stylet Rlurcha
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K020585 ZIP Open Forceps with Electrosurgical Cut Device Name: Indications for Use:
Dissection, grasping, electrosurgical cutting, and electrosurgical coagulation to control bleeding of tissue during open surgical procedures and in general surgery.
Stupt Rhodes
(Division Sign-Off) Division of Gene 1, Restorative and Neurological Levices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE) (Optional Format 3-10-98)
(Posted July 1, 1998)