(353 days)
Not Found
No
The description focuses on basic image acquisition, display, and connectivity features typical of ultrasound systems from that era. There is no mention of advanced image analysis, pattern recognition, or learning algorithms.
No
The device is described as an Endoscopic Ultrasound Center for observation of real-time, ultrasonic images, indicating it is for diagnostic imaging rather than therapy.
Yes
The device is explicitly designed for "observation of real-time, ultrasonic images" of internal body structures, which is a diagnostic purpose. It produces "ultrasonic images" and provides a "B-Mode display," which are tools used by medical professionals to diagnose conditions.
No
The device description clearly outlines hardware components such as a center unit, connectors for various peripherals (keyboard, monitor, printer, VCR, etc.), and the ability to connect to ultrasonic endoscopes and probes. It produces ultrasonic images using transducers and provides a B-Mode display, all indicative of a hardware-based system.
Based on the provided information, the Olympus EU-M30 Endoscopic Ultrasound center is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the EU-M30 is used for real-time, ultrasonic imaging of internal anatomical structures (upper GI tract, lower GI tract, and adjacent structures) using ultrasonic endoscopes and probes.
- The device description explicitly states that "No components of the Olympus EU-M30 Endoscopic Ultrasound Center (Standard Set) come in contact with patient." While the probes and endoscopes used with it do contact the patient, the core unit itself does not. IVD devices typically involve the analysis of samples outside the body.
The Olympus EU-M30 is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo diagnostic imaging rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
Olympus EU-M30 Endoscopic Ultrasound center is designed to be used in combination with the Olympus GF-UM20/JF-UM20/CF-UM20 ultrasonic endoscopes, Olympus UM-2R/UM-3R ultrasonic probes, and Olympus MH-908 esophageal ultrasonic probe for observation of real-time, ultrasonic images of upper GI tract, lower GI tract, and adjacent structures.
Product codes
Not Found
Device Description
The EU-M30 Endoscopic Ultrasound Center allows the connection of a keyboard, monitor, video printer, video cassette recorder (VCR), Endoscopic Video Image System (EVIS), foot switch, and magnetic card reader. The front panel of the EU-M30 allows the connection of endoscope via a specially designed connector. It produces ultrasonic images using the 7.5MHz. or 20.0 MHz transducers and provides a B-Mode display on a monitor. The EU-M30 is recommended to be used in conjunction with the Olympus GF-UM20/JF-UM-20/CF-UM20 ultrasonic endoscopes, UM-2R/UM-3R ultrasonic probe, and MH-908 esophageal ultrasonic probe. When Olympus EVIS-100 or EVIS-200 Video System is connected to the EU-M30 Center, it offers a sub-screen feature that allows the user to view both ultrasonic and video images simultaneously on a monitor. It also provides the ability to switch between ultrasonic and video images, as desired.
No components of the Olympus EU-M30 Endoscopic Ultrasound Center (Standard Set) come in contact with patient. For instructions on operation and maintenance, the user must refer to the Instruction Manual accompanied with the equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic images
Anatomical Site
upper GI tract, lower GI tract, and adjacent structures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Olympus EU-M20 (K926514), Aloka SSD-550
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
151994 P q
510 (k) SU MMARY
APR 1 5 1996
Olympus EU-M30 Endoscopic Ultrasound Center
| Device Name: | Olympus EU-M30 Endoscopic Ultrasound Center and ancillary equipment |
|---|---|
| Common/Usual Name: | Endoscopic Ultrasound System |
| Classification Name: | System, Imaging, Pulsed Echo, Ultrasonic Endoscope and/or Accessories |
| Predicate Devices: | Olympus EU-M20 (K926514) Aloka SSD-550 |
| Submitted By: | |
| (Contact Person) | Mr. Barry Sands Olympus America Inc. Medical Instrument Division 4 Nevada Drive Lake Success, NY 11042 (516) 488-0513 |
| Summary Preparation Date: | April 18, 1995 |
Statement of Intended Use
Olympus EU-M30 Endoscopic Ultrasound center is designed to be used in combination with the Olympus GF-UM20/JF-UM20/CF-UM20 ultrasonic endoscopes, Olympus UM-2R/UM-3R ultrasonic probes, and Olympus MH-908 esophageal ultrasonic probe for observation of real-time, ultrasonic images of upper GI tract, lower GI tract, and adjacent structures.
Device Description
The EU-M30 Endoscopic Ultrasound Center allows the connection of a keyboard, monitor, video printer, video cassette recorder (VCR), Endoscopic Video Image System (EVIS), foot switch, and magnetic card reader. The front panel of the EU-M30 allows the connection of endoscope via a specially designed connector. It produces ultrasonic images using the 7.5MHz. or 20.0 MHz transducers and provides a B-Mode display on a monitor. The EU-M30 is recommended to be used in conjunction with the Olympus GF-UM20/JF-UM-20/CF-UM20 ultrasonic endoscopes, UM-2R/UM-3R ultrasonic probe, and MH-908 esophageal ultrasonic probe. When Olympus EVIS-100 or EVIS-200 Video System is connected to the EU-M30 Center, it offers a sub-screen feature that allows the user to view both ultrasonic and video images simultaneously on a monitor. It also provides the ability to switch between ultrasonic and video images, as desired.
No components of the Olympus EU-M30 Endoscopic Ultrasound Center (Standard Set) come in contact with patient. For instructions on operation and maintenance, the user must refer to the Instruction Manual accompanied with the equipment.
1
P. 2d, 2 (951994
The Olympus EU-M30 Endoscopic Ultrasound Center is substantially equivalent in design, material, intended use, operation, performance, and energy source to the Olympus EU-M20 Endoscopic Ultrasound Center which was cleared in 510(k) # K926514. Additionally, it is also substantially equivalent to the Aloka SSD-550 Ultrasound System marketed by Corometics Medical System. The 510(k) # for the Aloka SSD-550 Ultrasound System is not known to Olympus America Inc.
Safety:
The Olympus EU-M30 Endoscopic Ultrasound Center is designed, manufactured and tested in compliance with the requirements of IEC-601-1, Class-I, Type BF. The ultrasound characteristics of Olympus EU-M30 Endoscopic Ultrasound Center meets the requirements of FDA's 510(k) Diagnostic Ultrasound Guidance for 1993 and 1985.
When compared to the predicate Olympus EU-M20 Endoscopic Ultrasound Center and Aloka SSD-550 Ultrasound System, the Olympus EU-M30 Endoscopic Ultrasound Center does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety or effectiveness.