(56 days)
Not Found
No
The device description focuses on mechanical and electrical components for surgical procedures and does not mention any AI/ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a surgical instrument used to grasp, hold, coagulate, and cut tissue, which are actions performed during a surgical procedure rather than for therapy.
No
The device is used to grasp, hold, coagulate, and cut tissue, which are therapeutic actions, not diagnostic. It does not gather information about a patient's condition.
No
The device description clearly outlines physical components (handle, tips, shaft, connector port, rotary knob) and their interaction with electrosurgical generators, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The description clearly states that the Laparoscopic Electrodes and Handle are used during laparoscopic surgical procedures to "grasp, hold, coagulate, and cut tissue." This is an in vivo (within the living body) surgical function.
- Lack of Diagnostic Testing: The device description focuses on surgical manipulation and energy delivery for therapeutic purposes (coagulation and cutting), not on analyzing samples for diagnostic information.
Therefore, this device falls under the category of a surgical instrument used for therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Laparoscopic electrodes and handles are surgical instruments with interchangeable tip 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.
The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle 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.
Laparoscopic electrodes are reusable and are resterilized using steam sterilization.
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
Physician or nurse / 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
Page 1 of 2
510(k) SUMMARY (per CFR21 807.92(c))
062337
- 5 2006
DEVICE DESCRIPTION:
Predicate Devices:
Aesculap USA: Modular Monopolar Electrodes K970541
ACMI Circon: Surgical Instrument for Minimally Invasive Surgery K914883
INTENDED USE:
Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures
DEVICE COMPONENTS AND OPERATION:
Laparoscopic electrodes and handles are surgical instruments with interchangeable tip 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.
The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle 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.
1
Image /page/1/Picture/0 description: The image shows the text "K062337" at the top, with a line underneath it. Below that is a blacked out section, followed by the text "510(k) SUMMARY (per CFR21 807.92(c))". The text appears to be part of a document or form, possibly related to a regulatory submission.
Page 2 q(2)
These devices use technology substantially equivalent to the Aesculap USA Modular Monopolar Electrodes (K970541) and the ACMI Circon Surgical Instrument for Minimally Invasive Surgery (K914883). Each consists of handles and a series of electrodes that are used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.
Laparoscopic electrodes are reusable and are resterilized using steam sterilization.
Aaron Laparoscopic Electrodes and Handle conform to the requirements of safety standard ANSI/AAMI HF-18 Electrosurgical Devices.
There are no significant differences in technology, performance, or intended use between the Aaron Laparoscopic Electrodes and Handle and the given predicate devices. There are no new questions raised regarding safety or effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 5 2006
Aaron Medical % Mr. Richard A. Kozloff Vice President, Quality Assurance Regulatory Affairs 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Re: K062337
Trade/Device Name: Laparoscopic Electrodes and Handle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 9, 2006 Received: August 10, 2006
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 complics 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.
3
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 Office of Compliance at (240) 276-0115. 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 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,
Karbay Buchner
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K062337
Laparoscopic Electrodes and Handle Device Name:
Indications for Use:
Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures
Prescription Use _ > (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)
Barbara Buchm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062337