(76 days)
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No
The summary describes a device with user-settable parameters (time and temperature) and safety features, but there is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The KSEA Thermocoagulator is used for the treatment of various medical conditions, including endometriosis, hemostasis, and coagulation of blood vessels, which are therapeutic interventions.
No
The device description and intended use indicate it is an active surgical tool used for coagulation and tissue manipulation, not for diagnosis. It does not mention any diagnostic functionalities like imaging, sensing, or analysis of bodily conditions.
No
The device description explicitly lists hardware components such as a generator unit, footswitch, and cords, indicating it is not a software-only device.
Based on the provided information, the KSEA Thermocoagulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- KSEA Thermocoagulator Function: The description clearly states the KSEA Thermocoagulator is used for laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels, and separation of adhesions. These are all procedures performed directly on or within the patient's body (in vivo). It uses heat to achieve these effects.
The device's function is therapeutic and surgical, not diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/0 description: The image shows a black and white abstract pattern. The pattern is concentrated in the center of the image, with the density of black pixels decreasing as you move away from the center. The overall effect is a textured, somewhat chaotic visual with a gradient of darkness.
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
Image /page/0/Picture/4 description: The image shows the text "K963852" in what appears to be handwritten text. Below this text is the number "10 1996". The text is black and the background is white. The image is a close-up of the text.
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