(64 days)
No
The device description focuses on mechanical and electrical components for surgical manipulation and energy delivery, with no mention of AI/ML terms or functionalities.
No.
The device is used to grasp, hold, coagulate, and cut tissue, which are surgical functions rather than therapeutic ones aimed at treating a disease or condition.
No
The device is described as being used to "grasp, hold, coagulate, and cut tissue" during surgical procedures, indicating its function as a therapeutic or surgical tool, not for diagnosis.
No
The device description clearly outlines physical components such as tip inserts, cartridges, reusable tubes, and a handle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MEG Laparoscopic Electrodes are surgical instruments used directly on tissue within the body during a surgical procedure. They are used for grasping, holding, coagulating, and cutting tissue.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the body. Its function is entirely focused on interacting with tissue in situ.
Therefore, the intended use and device description clearly indicate that this is a surgical device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MEG Laparoscopic Electrodes are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures.
Product codes
GEI
Device Description
Laparoscopic Electrodes are surgical instruments with single use or reusable interchangeable tin inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:
•. A removable insert allows for easier cleaning and disinfection of the instrument components.
• Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
• Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.
Laparoscopic Electrodes consist of:
• I ) Tip Inserts (pre-sterilized single use and non-sterile reusable) that interchangeably fit into a reusable tube.
• 2) Cartridges (pre-sterilized single use) that fit directly into a reusable handle.
• 3) Reusable Tubes (non-sterile, rcusable) that fit directly into a reusable handle and accommodates a variety of tip inserts.
Radiofrequency energy is delivered to the tip through the handle by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle (cleared in 510k # K062337) is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.
Reusable Laparoscopic Electrodes are provided non-sterile and must be sterilized prior to use using steam sterilization.
Single use Laparoscopic Electrodes are provided sterilized using ethylene oxide gas.
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
K081431
510(k) SUMMARY (per CFR21 807.92(c))
GENERAL INFORMATION:
JUL 2 4 2008
510k Owner's Name Address
Bovie Medical 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs Telephone #: (727) 384-2323 FAX Number: (727) 347-9144
Date Prepared:
Contact Person
May 19, 2008
DEVICE DESCRIPTION:
Trade Name: Common Name: Classification Name:
, ( / . Modular Ergonomic Instrument (MEG)
Laparoscopic Electrodes
Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878.4400; Class II; Product Code: GEI)
1
510(k) SUMMARY (per CFR21 807.92(c))
DEVICE DESCRIPTION:
Predicate Devices:
Aaron Medical: Modular Monopolar Electrodes
INTENDED USE:
Laparoscopic Electrodes are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures.
DEVICE COMPONENTS AND OPERATION:
Laparoscopic electrodes are surgical instruments with single use or reusable interchangeable tin inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:
- . A removable insert allows for easier cleaning and disinfection of the instrument components.
- Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
- Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.
Laparoscopic Electrodes consist of:
- I ) Tip Inserts (pre-sterilized single use and non-sterile reusable) that interchangeably fit into a reusable tube.
-
- Cartridges (pre-sterilized single use) that fit directly into a reusable handle.
-
- Reusable Tubes (non-sterile, rcusable) that fit directly into a reusable handle and accommodates a variety of tip inserts.
Radiofrequency energy is delivered to the tip through the handle by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle (cleared in 510k # K062337) is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.
2
510(k) SUMMARY (per CFR21 807.92(c))
These devices use technology that is substantially equivalent to Aaron Modular Monopolar Electrodes (K062337). Both consist of a series of electrodes that are used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.
Reusable Laparoscopic Electrodes are provided non-sterile and must be sterilized prior to use using steam sterilization.
Single use Laparoscopic Electrodes are provided sterilized using ethylene oxide gas.
Laparoscopic Electrodes conform to particular requirements of electrical safety standards ANSI/AAMI/ISO HF-18: 2001 Electrosurgical Devices and IEC 60601-2-2- 2006, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
There are no significant differences in technology, performance, or intended use between Bovie Laparoscopic Electrodes and the given predicate devices. There are no new questions raised regarding safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2008
Bovie Medical % Mr. Richard A. Kozloff VP, QA/RA 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Re: K081431
Trade/Device Name: MEG Laparoscopic Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 19, 2008 Received: May 21, 2008
Dear Mr. Kozloff:
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.
4
Page 2 - Mr. Richard A. Kozloff
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 1408143 |
Device Name: MEG Laparoscopic Electrodes
Indications for Use:
MEG Laparoscopic Electrodes are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures.
Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number L061431
04-2