(141 days)
K/DEN number: None
No
The summary describes standard electrosurgical instruments and does not mention any AI or ML components or functionalities.
Yes
The device is described as an electrosurgical instrument used to "grasp, manipulate, cut, and cauterize soft tissue" during endoscopic surgical procedures. These actions are directly therapeutic as they aim to treat or alleviate a medical condition by physically altering tissue. Also, the reference to "coagulation of tissue" further supports its therapeutic function.
No
Explanation: The device is described as an instrument for surgical procedures (grasping, manipulating, cutting, cauterizing tissue) and does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states it is made from "biocompatible plastic and stainless steel" and is a "family of instruments," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states the device is an endoscopic surgical instrument used to grasp, manipulate, cut, and cauterize soft tissue during surgical procedures. This is an in vivo (within the body) application.
- Intended Use: The intended use is for "Endoscopic surgical procedures," which are performed directly on the patient's body.
The device is a surgical instrument used for direct intervention on tissue within the body, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
GENICON Disposable Electrosurgical Instrumentation is indicated for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
Product codes
GEI
Device Description
The GENICON disposable electrosurgical instruments are single use sterile instruments made from biocompatible plastic and stainless steel with a working length of 33cm. Current may be supplied by an approved electrosurgical generator which provides the ability for the coagulation of tissue when used with an appropriate ground electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Where laparoscopic surgical techniques are indicated, but not for fallopian tube sterilization.
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
510(k) Summary
OCT 1 0 2006
(As Required By 21 CFR 807.93)
PreMarket Notification Summary
Image /page/0/Picture/5 description: The image shows a stack of books next to the words "See Related Information". The books are stacked on top of each other, and the words are in bold black font. The image is likely a button or icon that links to related information on a website or in a document. The background is white.
A 510(k) summary has been selected in lieu of a 510[k] statement.
Trade Name - GENICON Electrosurgical Instrumentation
Common Name - Electrosurgical Instrumentation
Classification Name - Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400, Product Code GEI)
Legally Marketed Device - Ethicon ENDOPATH (K984240)
Device Description - The GENICON disposable electrosurgical instruments are single use sterile instruments made from biocompatible plastic and stainless steel with a working length of 33cm. Current may be supplied by an approved electrosurgical generator which provides the ability for the coagulation of tissue when used with an appropriate ground electrode.
Intended Use - GENICON Disposable Electrosurgical Instrumentation is indicated for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
Technological Characteristics - The technological characteristics of the new device are the same as the predicate device.
Performance – There are no mandatory performance standards or special controls in existence for this device at the date of submittal. GENICON electrosurgical instruments were designed to meet the following voluntary standards:
AAMI/ANSI HF18:2001, Electrosurgical Devices
IEC 60601-2-2:2000, Medical electrical equipment - Particular requirements for the safety of high frequency surgical equipment
EN 12011:1998, Instrumentation to be used in association with non-active surgical implants - General requirements
ISO 7153-1:1991, Surgical Instruments -- Metallic Materials -- Part 1: Stainless Steel
ISO 4957:1999, Tool Steels
EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods EN 552:1994, Sterilization of medical devices - Validation and routine control of sterilization by irradiation
Conclusion - Based on the indications for use and technological characteristics, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OC1 1 0 2006
Genicon % Mr. Gary Haberland 6869 Stapoint Court, Suite 114 Winter Park, Florida 32792
Re: K061417
Trade/Device Name: Genicon Disposable Electrosurgical Instrumentation Regulation Number: 21 CFR 878.4400 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: GEI Dated: September 13, 2006 Received: September 14, 2006
Dear Mr. Haberland:
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 – Mr. Gary Haberland
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 vours.
Barbara Buettm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K061417
Device Name: Genicon Disposable Electrosurgical Instrumentation
Indications for Use:
Endoscopic surgical procedures. It is a family of instruments which includes graspers, Linsectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
Target population definition
Patients requiring laparoscopic surgical intervention where use of an electro-surgical cutting, manipulating, and/or coagulating device is indicated.
Anatomical sites
Where laparoscopic surgical techniques are indicated, but not for fallopian tube sterilization.
Prescription Use YES X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buettner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K191417