(343 days)
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No
The summary describes manually operated, reusable surgical instruments for thermal coagulation, with no mention of AI, ML, image processing, or any computational capabilities.
No
The device is used for thermal coagulation during surgical procedures, which is a surgical intervention rather than a therapeutic treatment for a disease.
No
Explanation: The device is described as a thermocoagulator used to "thermally coagulate tissue during laparoscopic surgical procedures". This is a therapeutic function (coagulation of tissue), not a diagnostic one (identifying a disease or condition).
No
The device description clearly states it is a manually operated, reusable surgical device made of surgical grade stainless steel, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "thermally coagulate tissue during laparoscopic surgical procedures in gynecology." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The device description details surgical instruments (point coagulator, crocodile forceps, myoma enucleator) used for physical manipulation and thermal coagulation of tissue in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.
Product codes
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Device Description
The KSEA thermocoagulator accessories are manually operated, reusable surgical devices consisting of a point coagulator, crocodile forceps and a myoma enucleator. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to laparoscopes. The body contact materials are surgical grade stainless steel.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 is a black and white abstract pattern. The left side of the image is dominated by a dense, dark area with a rough, textured appearance. The right side of the image is lighter, with scattered dark spots and streaks. There are also a few faint, horizontal lines in the upper right corner.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NOV 26 1999
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 CFR 807.92. All data included in this document 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: | Betty M. Johnson |
| Manager, Regulatory Affairs | |
| Device Identification: | Common Name |
| Laparoscopic Thermocoagulator accessories |
Trade Name Karl Storz Thermocoagulator accessories
Indication: The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.
Device Description: The KSEA thermocoagulator accessories are manually operated, reusable surgical devices consisting of a point coagulator, crocodile forceps and a myoma enucleator. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to laparoscopes. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA thermocoagulator accessories are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA thermocoagulator accessories and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed: Renate McPher for
Betty M. Johnson
Manager, Regulatory Affairs
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