(26 days)
No
The description focuses on electrosurgical cutting, coagulation, grasping, and dissection using bipolar energy, and explicitly states the modification has not altered the fundamental technology of the predicate device. There is no mention of AI or ML.
Yes
The device is used for electrosurgical cutting and coagulation, and mechanical grasping and dissection of tissue, which are procedures intended to treat or manage a medical condition, thus qualifying it as a therapeutic device.
No
The device is described as electrosurgical cutting and coagulation forceps used for surgical procedures (grasping and dissection), which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a bipolar dissecting forceps, which is a physical hardware device used in surgical procedures. It describes the construction, materials, and electrical isolation of the jaws, all indicative of a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Electrosurgical cutting and coagulation, mechanical grasping and dissection of tissue Droving the performance of laparoscopic and general surgical procedures." This describes a device used during a surgical procedure on a patient's body.
- Device Description: The description details a surgical instrument (forceps) used for cutting, coagulation, grasping, and dissection. It talks about electrodes and energy sources used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The device described is a surgical instrument used directly on a patient during a procedure, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Electrosurgical cutting and coagulation, mechanical grasping and dissection of tissue Droving the performance of laparoscopic and general surgical procedures.
Product codes
GEI
Device Description
The PK ZIP WING Cutting Dissecting forceps is a modification to the predicate devices cleared under K904993. The bipolar dissecting forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The dissector 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 a cutting electrode mounted in one of the jaws is electrically isolated from the dissector jaw enabling the jaw to act as a return electrode. The modification has not altered the fundamental technology of the predicate devices cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
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.
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F: 510(k) Summary
October 16, 2002
NOV 1 3 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: | PK ZIP WING Cutting Dissector |
The device is a Class II medical device. The PK ZIP WING Cutting Dissecting forceps is a modification to the predicate devices cleared under K904993. The bipolar dissecting forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The dissector 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 a cutting electrode mounted in one of the jaws is electrically isolated from the dissector jaw enabling the jaw to act as a return electrode. The modification has not altered the fundamental technology of the predicate devices cleared under K904993. The intended use: Electrosurgical cutting and coagulation, grasping and dissection during surgical procedures is identical when compared to the predicate devices. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
In conclusion, as the design, materials of construction, function and intended use of the PK ZIP Wing Cutting Dissector 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
t and Drug Administration Cornorate Boulevard kville MD: 20850
Gyrus Medical, Inc. Frederick G. Mades Regulatory Affairs Manager 6655 Wedgwood Road Maple Grove, Minnesota 55311
Re: K023493
Trade/Device Name: PK ZIP WING Cutting Dissector Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: Class II Product Code: GEI Dated: October 16, 2002 Received: October 18, 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 (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.
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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" (21 CFR 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.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Parret
كَ كَ 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
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Page 1 of 1
ી ર 0 234 510(k) Number (if known): PK ZIP WING Dissector Device Name:
Indications for Use:
Electrosurgical cutting and coagulation, mechanical grasping and dissection of tissue Droving the performance of laparoscopic and general surgical procedures.
Prescription Use
(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)
Miriam C. Phoret
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023493