(64 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics related to algorithmic analysis strongly suggest this is a traditional electrosurgical electrode without AI/ML capabilities.
No
The device description states that the product is an "accessory" that fits other surgical tools and offers "tissue interaction tips," which suggests it assists in surgical procedures rather than directly administering therapy. Its predicate is also another electrosurgical electrode and not a therapeutic device.
No
Explanation: The device is described as an accessory that offers a variety of tissue interaction tips for surgical applications, indicating its use in treatment rather than diagnosis.
No
The device description explicitly states it is an accessory that fits commercially available resectoscopes, cystoscopes, laproscopes, and hysteroscopes, pencil grips, and pistol grips, and has different configurations of tissue interaction tips. This indicates a physical, hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a strong indicator that the device's primary function is not diagnostic testing.
- Device Description: The description clearly states that the device is an accessory for surgical instruments (resectoscopes, cystoscopes, laproscopes, hysteroscopes, etc.) and is used for "tissue interaction tips depending on the specific surgical application." This points towards a surgical tool used during a procedure, not for analyzing samples in vitro.
- Lack of IVD-related information: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic tests, or any other activities typically associated with IVD devices.
Therefore, the ENDOcare Electrosurgical Electrodes are surgical accessories used for electrosurgical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue.
Product codes
Not Found
Device Description
The ENDOcare Electrosurgical Electrodes are accessories that fit commercially available resectoscopes, cystoscopes, laproscopes and hysteroscopes, pencil grips and pistol grips. Each model has a different configuration which offers the surgeon a variety of tissue interaction tips depending on the specific surgical application.
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)
Not Found
Reference Device(s)
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
Section 2.0 - SMDA 1990 Requirements
Image /page/0/Picture/1 description: The image shows a document with handwritten and printed text. The handwritten text at the top reads 'P1N2' and 'K965243'. The printed text at the bottom reads 'FEB 25 1997', indicating a date. The document appears to be some kind of record or form with an identification number and a date.
510(k) Summary 2.1
Device Description
The ENDOcare Electrosurgical Electrodes are accessories that fit commercially available resectoscopes, cystoscopes, laproscopes and hysteroscopes, pencil grips and pistol grips. Each model has a different configuration which offers the surgeon a variety of tissue interaction tips depending on the specific surgical application.
Biocompatibility
The biocompatibility requirements were determined through use of the International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The ENDOcare Electrosurgical Electrode has the same material, manufacturing process, chemical composition, body contact and sterilization method as the currently marketed electrode. Therefore, per the FDA matrix, the biocompatibility requirements were met and no additional testing was performed.
Substantial Equivalence Support
The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue. The ENDOcare Electrosurgical Electrodes are substantially equivalent to the ENDOcare Electrosurgical Electrodes (reference K954321) which were found to be substantially equivalent to the Unimed Electrodes (reference K944540 and K945191) on October 13, 1995.
Sterilization Methodology
This electrode may be shipped as a non-sterile, reusable device. The following are the recommended cleaning and sterilization instructions:
(1) Cleaning
- Wipe all debris from the electrode with a moistened sponge or gauze pad. .
- Rinse with cold tap water for approximately 30 seconds. .
- Place the electrode in a warm bath of tap water and detergent and scrub with the . appropriate brush, taking care to keep the electrode totally immersed at all times.
1
K9658243
PL972
- Rinse with warm tap water for approximately 20 seconds to remove any debris or . detergent. If necessary, place in an ultrasonic bath containing sonic detergent for 10 minutes at 60 hz. Remove and rinse with tap water for approximately 20 seconds.
- . Rough dry.
- (2) Sterilization
- Check the electrode for particulate contamination. If necessary, wipe down the . electrode with a clean gauze pad.
- Wrap the electrode in sterilization wrap using a standard hospital square wrap. .
- Autoclave in a pre-vacuum cycle using the following parameters: ●
Exposure Temperature 132°C Exposure Time 8 minutes 42 to 44 PSIA Pressure Dry Time 5 minutes