(44 days)
Not in text
GK380R, GK383R
No
The description focuses on the mechanical and electrical components of a surgical electrode and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is described for use in endoscopic surgery for coagulation and dissection of selected tissue, which are therapeutic actions.
No
The device is described as being used for "coagulation and dissection of selected tissue" in surgical procedures, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical hardware components (insulated handle, insulated shaft, working tip) that are reusable and disassemble for cleaning and sterilization. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation and dissection of selected tissue" during endoscopic surgery. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical instrument (electrodes) used for physical manipulation of tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modular Monopolar Electrodes presented in this submission are intended for use in endoscopic surgery (laparoscopy, thoracoscopy) for coagulation and dissection of selected tissue.
Product codes
Not Found
Device Description
The Modular Monopolar Electrodes are made up of 3 separate components: an insulated handle (GK382R), an insulated shaft (GK380R) and a working tip. The working tips come in several different styles (i.e. J-shaped hook electrode GK383R) which can be used interchangeably. All components are reusable and disassemble for cleaning and sterilization.
The assembled electrodes are 5 mm in diameter and 450 mm in length. They have no suction/irrigation feature.
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
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Modular Monopolar Electrodes comply with the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.)
The Modular Monopolar Electrodes will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.
Key Metrics
Not Found
Predicate Device(s)
To be inferred from "shares similar features and function with corresponding devices distributed by Aesculap, Brimfield and Marlow."
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
MAR 2 8 1997
K970541
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Aescular Modular Monopolar Electrodes
February 11, 1997
Submitted by:
Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden (415) 876-7000 x348 Phone: (415) 589-3007 FAX:
Aesculap Modular Monopolar Electrodes Product:
Common Name: Monopolar Electrodes
Intended Use
The Modular Monopolar Electrodes presented in this submission are intended for use in endoscopic surgery (laparoscopy, thoracoscopy) for coagulation and dissection of selected tissue.
Technological Characteristics
Aesculap currently markets a line of non-modular endoscopic monopolar electrodes and a line of modular endoscopic monopolar scissiors and forceps which are subject to 510(k) clearance. This submission represents the following design changes:
- Change electrodes from a non-modular design to a modular design.
- Change in tip insulation material. .
- Change in shaft insulation material. .
The Modular Monopolar Electrodes are made up of 3 separate components: an insulated handle (GK382R), an insulated shaft (GK380R) and a working tip. The working tips come in several different styles (i.e. J-shaped hook electrode GK383R) which can be used interchangeably. All components are reusable and disassemble for cleaning and sterilization.
The assembled electrodes are 5 mm in diameter and 450 mm in length. They have no suction/irrigation feature.
1
Performance Standards
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Modular Monopolar Electrodes comply with the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.)
The Modular Monopolar Electrodes will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.
Sterilization
The Modular Monopolar Electrodes are provided non-sterile and must be sterilized prior to use. The devices may be sterilized by steam sterilization.
Substantial Equivalence
Aesculap's Modular Monopolar Electrodes shares similar features and function with corresponding devices distributed by Aesculap, Brimfield and Marlow.
المقابل المنتدى المنتدى المنتدى المنتدى المنتدى المنتدى المنتخب