(38 days)
No
The summary describes a standard electrosurgical probe and handle for tissue excision and coagulation, with no mention of AI or ML capabilities.
Yes
The device is described as being used to "excise tissue and coagulate tissue," which are medical procedures aimed at treating or alleviating a condition, thus classifying it as a therapeutic device.
No
The device description states its function is to "excise tissue and coagulate bleeding," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is an "Endoscopic Electrosurgical Probe and Handle," which are physical hardware components used in conjunction with an electrical generator. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Excise tissue and coagulate tissue." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is an "Endoscopic Electrosurgical Probe and Handle" used in conjunction with an electrical generator. This is a surgical instrument used for cutting and controlling bleeding during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The provided description does not mention any analysis of specimens.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Excise tissue and coagulate tissue.
Product codes
Not Found
Device Description
Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle is used in coniunction with an electrical generator to excise tissue and coagulate bleeding.
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 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
Smith & Nephew Endoscopy, Inc.
160 Dascomb Road Andover, MA 01810 U.S.A. Telephone (508) 470-2800 Fax (508) 470-2227
Smith - Nephew
NOV - 4 1996
510(k) Summary Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle
Substantial Equivalence :
The Smith & Nephew Endoscopy Disposable Endoscopic Elecrosurgical Probe and Handle were originaly determined to be substantially equivalent to pre-amendment devices under 510(k) K901505..
Predicate Device :
The change discussed in this 510(k) does not affect the method of use, or intended use, of the device. The additonal labeling of a voltage limit is a European requirement for CE marking. Other changes to this device are user convenience features only.
Summary of Device Function :
Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle is used in coniunction with an electrical generator to excise tissue and coagulate bleeding.
Intended Use of Device :
Excise tissue and coagulate tissue.
Comparison of Technological Characteristics of Predicate Device :
The design technologies and function of the items refered to in this 510(k) notification are identical to those listed in the previous Electrosurgery Probe 510(k) submitted by Smith & Nephew Endoscopy, Inc.
Elizabeth A. Ryan
Elizabeth A. Rvan Regulatory Affairs