(67 days)
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 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.
The provided text describes an medical device 510(k) submission for "ENDOcare Electrosurgical Electrodes." However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance, clinical efficacy, or algorithm-based performance.
Instead, the document focuses on:
- Device Description: A general description of the electrosurgical electrodes and their intended uses.
- Biocompatibility: States that requirements were met based on ISO-10993 and substantial equivalence to a previously marketed device, without presenting new studies.
- Substantial Equivalence Support: Argues for substantial equivalence to existing predicate devices (K952587, K944540, K945191) based on intended use and device type, not performance metrics.
- Sterilization Methodology: Describes the methods (Ethylene Oxide and Gamma Radiation) and related guidelines (ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 11137) to achieve a specified Sterility Assurance Level (SAL), along with residual limits for EtO. This is about sterilization validation, not device performance.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving their fulfillment because such details are absent from the provided text.
Based on the prompt's expectation for details like "sample size," "ground truth," "MRMC," and "standalone performance," it seems the prompt is geared towards an AI/ML-driven medical device, which the ENDOcare Electrosurgical Electrodes are not. They are physical surgical instruments.
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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:
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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.
§ 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).