(84 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard electrosurgical functions.
Yes
The device is used for electrosurgery, which involves cutting and coagulation of tissue, making it a therapeutic intervention.
No
The device is described as an "Electrosurgical System" for "cutting and coagulation," which are therapeutic procedures, not diagnostic ones. Its "Intended Use" also specifies its role in "electrosurgery."
No
The device description explicitly states "Olympus UES-20 Electrosurgical System and its associated accessories," indicating a hardware system, not a software-only device.
Based on the provided information, the Olympus UES-20 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general and endoscopic electrosurgery (cutting and coagulation)". This is a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: It's described as an "Electrosurgical System and its associated accessories," which are tools used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Olympus UES-20's function is to perform surgical procedures.
N/A
Intended Use / Indications for Use
The Olympus UES-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
Product codes
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Device Description
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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
trained physician, medical facilities
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
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Key Metrics
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Predicate Device(s)
Olympus UES-10 Electrosurgical Unit (K911904)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
APR 11 1997
510 (k) SUMMARY OLYMPUS UES-20 ELECTROSURGICAL SYSTEM
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
| Device Name: | Olympus UES-20 Electrosurgical System and its associated accessories. |
|---|---|
| Common/Usual Name: | Electrosurgical Units |
| Classification Name: | 21 CFR 878.440, Class II |
| Electrosurgical Cutting and Coagulation Device and | |
| Accessories. | |
| 21 CFR 876.4300, Class II | |
| Endoscopic Electrosurgical Unit and Accessories. | |
| Predicate Devices: | Olympus UES-10 Electrosurgical Unit (K911904) |
| Prepared & Submitted By: | |
| (Contact Person) | Mr. Subhash Patel |
| Olympus America Inc. | |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| (516) 844-5481 | |
| Summary Preparation | |
| Date: | January 15, 1997 |
Statement of Intended Use:
UES-20 Electrosurgical Unit
The Olympus UES-20 has been designed for use in medical facilities under the supervision of a trained physician. It has been designed for general and endoscopic electrosurgery (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light sources and ancillary equipment. Do not use the instrument for any purpose other than its intended use.
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