(67 days)
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No
The summary describes a manual, reusable surgical instrument for tissue coagulation and makes no mention of AI or ML.
No
The device is used to coagulate tissue during surgery, which is a surgical tool function, not a therapeutic function for treating a disease or condition.
No
Explanation: The KSEA Bipolar Coagulating Forceps are described as surgical devices used to coagulate tissue with high-frequency electrical current during ENT surgical procedures. Their function is therapeutic (coagulation), not diagnostic (identifying a disease or condition).
No
The device description clearly states it is a manual reusable surgical device made of surgical grade stainless steel and insulated materials, 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 "coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures" using high frequency electrical current. This is a therapeutic/surgical function performed directly on the patient's tissue, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a manual surgical instrument used for direct intervention during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely surgical and therapeutic.
N/A
Intended Use / Indications for Use
The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The KSEA Bipolar Coagulating Forceps are manual reusable surgical devices. The KSEA Bipolar Coagulating Forceps are long enough to gain access to the surgical area and are designed to be used as accessories to endoscopes. The body contact material is surgical grade stainless steel. The Bipolar Coagulating Forceps are insulated with commonly used materials.
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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§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
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 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 | K962396 |
|------------------------|---------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist | AUG 27 1996 |
| Device Identification: | Common Name:
Bipolar Forceps | |
| | Trade Name: (optional)
KSEA Bipolar Coagulating Forceps | |
Indication: The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.
Device Description: The KSEA Bipolar Coagulating Forceps are manual reusable surgical devices. The KSEA Bipolar Coagulating Forceps are long enough to gain access to the surgical area and are designed to be used as accessories to endoscopes. The body contact material is surgical grade stainless steel. The Bipolar Coagulating Forceps are insulated with commonly used materials.
Substantial Equivalence: The KSEA Bipolar Coagulating Forceps for endoscopic and non endoscopic ENT surgical procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Bipolar Coagulating Forceps 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:
Kevin Kennan
Regulatory Affairs Specialist
000048