(76 days)
The KSEA Thermocoagulator is intended to be used for the laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels and separation of adhesions.
The KSEA Thermocoagulator is composed of a generator unit, a footswitch, a cord to connect the unit to a power supply, and a cord to connect the unit to the thermocoagulation probes. The Thermocoagulator contains no are no patient contact materials. Coagulation time can be set by the end user for 10-70 seconds, and the instrument temperature can be set by the end user for 70-130°C. The
This document is a 510(k) summary for the KSEA Thermocoagulator (model 265100 20), a gynecologic electrocautery generator. It outlines the device's identification, indication, description, and claims of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document focuses on regulatory submission information rather than detailed performance study results.
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Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CRF 807.92. All data included in this documents are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Contact:
Manager, Regulatory Affairs
Betty M. Johnson
Device Identification:
Common Name gynecologic electrocautery generator
Trade Name (optional) KSEA Thermocoagulator (model 265100 20)
Indication: The KSEA Thermocoagulator is intended to be used for the laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels and separation of adhesions.
Device Description: The KSEA Thermocoagulator is composed of a generator unit, a footswitch, a cord to connect the unit to a power supply, and a cord to connect the unit to the thermocoagulation probes. The Thermocoagulator contains no are no patient contact materials. Coagulation time can be set by the end user for 10-70 seconds, and the instrument temperature can be set by the end user for 70-130°C. The safety features include a number of audio signals and alarms.
Substantial Equivalence: The KSEA Thermocoagulator (model 265100 20) is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Thermocoagulator and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of this device.
Signed:
Betty M. Johnson Manager, Regulatory Affairs
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).