(67 days)
No
The 510(k) summary describes electrosurgical electrodes, which are passive accessories for surgical instruments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical configuration and intended surgical applications of the electrodes.
Yes.
The device is used for cutting, coagulation, resection, and vaporization of tissue, which are all therapeutic actions.
No
Explanation: The device is described as electrosurgical electrodes used for cutting, coagulation, resection, and vaporization of tissue, which are therapeutic rather than diagnostic functions.
No
The device description clearly states it is an accessory (electrode) that fits into other surgical instruments, indicating it is a physical hardware component used for cutting, coagulation, etc.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures (cutting, coagulation, resection, vaporization of tissue) within the body. IVDs are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health.
- Device Description: The description details accessories that fit into surgical instruments (resectoscopes, cystoscopes, etc.) for direct interaction with tissue during surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the ENDOcare Electrosurgical Electrodes are surgical devices, not IVDs.
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
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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
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Section 2.0 - SMDA 1990 Requirements
Plnz
2.1
Device Description
510(k) Summary
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 Monopolar Electrodes (reference K952587) which were found to be substantially equivalent to the Unimed Electrodes (reference K944540 and K945191) on July 17, 1995.
Sterilization Methodology
Two methods of sterilization may be employed for this device:
(1) Ethylene Oxide
Sterilization validation will be conducted utilizing an overkill method based on the recommendations in the current American Association for the Advancement of Medical Instrumentation (ANSI/AAMI/ISO 11135 1994) Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. A minimum Sterility Assurance Level (SAL) of 10 * will be achieved. Sterile barrier packaging will consist of standard disposable pouch containing a plastic film and a coated paper side. This is the same type of sterile barrier packaging that is used with the currently marketed device. Maximum levels of EtO residuals will not exceed:
1
11965118 パンの2
25 ppm for ethylene oxide 25 ppm for ethylene chlorohydrin 250 ppm for ethylene glycol
(2) Gamma Radiation
Sterilization will be based on the recommendations in the current American Association for the Advancement of Medical Instrumentation (ANSI/AAMI/ISO 11137-1994) Guideline for the Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization. A minimum Sterility Assurance Level (SAL) of 106 will be achieved. Sterile barrier packaging will consist of standard disposable pouch containing a plastic film and a coated paper side. This is the same type of sterile barrier packaging that is used with the currently marketed device.