(47 days)
Not Found
No
The description focuses on electrosurgical technology and modifications to a predicate device, with no mention of AI or ML.
No.
The device's described functions (electrosurgical coagulation, cutting, dissection) are interventional and perform a physical action on tissue, which does not align with the definition of a therapeutic device that typically treats a condition.
No
The device description clearly states its functions are electrosurgical coagulation, cutting, tissue dissection, irrigation, and aspiration during surgical procedures. These are all therapeutic and procedural actions, not diagnostic ones.
No
The device description explicitly states it is a "Bipolar L Hook" and describes physical components like "forceps jaws" and "shaft length," indicating it is a hardware device used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed on the patient (electrosurgical coagulation, cutting, dissection, irrigation, and aspiration). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The description details a surgical instrument used for direct interaction with tissue during surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device is a surgical instrument used during procedures, not an IVD.
N/A
Intended Use / Indications for Use
Electrosurgical coagulation, electrosurgical cutting, dissection of tissue, irrigation and aspiration during the performance of laparoscopic and general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Bipolar L Hook is a modification to the predicate device cleared under K904993. The Bipolar L Hook is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. 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. The modification has not altered the fundamental technology of the predicate device cleared under K904993.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
| F: 510(k) Summary |
|---|
| ------------------- |
| K 031082 | |
|---|---|
| -- | ---------- |
March 31, 2003
| Company: | Gyrus Medical, Inc.
6655Wedgwood Road
Maple Grove, MN
55311-3602
Tel. No. (763) 416-3000
FAX. No. (763) 416-3070 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mercedes Bayani
Director, Regulatory Affairs |
| Common/Usual Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical Cutting and Coagulation Device
and Accessories (21 CFR 878.4400) |
| Proprietary Name: | Everest Bipolar L Hook and Gyrus Bipolar L Hook |
The device is a Class II medical device. The Bipolar L Hook is a modification to the predicate device cleared under K904993. The Bipolar L Hook is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a refurn electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation, grasping and dissection of the tissue during surgical procedures is similar to the predicate devices cleared under K904993. 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 modified Bipolar L Hook 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
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
MAY 21 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mercedes Bayani Director, Regulatory Affairs Gyrus Medical, Inc. 6655 Wedgwood Road Maple Grove, Minnesota 55311
Re: K031082
Trade/Device Name: Everest Bipolar L Hook and Gyrus Bipolar L Hook Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 31, 2003 Received: April 24, 2003
Dear Ms. Bayani:
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.
2
Page 2 - Ms. Mercedes Bayani
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), 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) you may obtain. 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 vours.
Sincerely yours,
Mark A. Millbern
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
3
Page 1 of 1
510(k) Number (if known): 139082 Device Name: Everest Bipolar L Hook & Gyrus Bipolar L Hook Indications for Use:
Electrosurgical coagulation, electrosurgical cutting, dissection of tissue, irrigation and aspiration during the performance of laparoscopic and general surgical procedures.
(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)
Mark N. Milliken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031082