OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER

K951994 · Olympus America, Inc. · IYO · Apr 15, 1996 · Radiology

Device Facts

• Record ID: K951994
• Device Name: OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
• Applicant: Olympus America, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

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 Story

System processes ultrasonic signals from compatible endoscopes/probes (7.5, 12.0, 20.0 MHz transducers); generates B-Mode images for monitor display. Used in clinical settings by physicians; integrates with EVIS-100/200 video systems for simultaneous ultrasonic/video sub-screen viewing. Supports peripherals: keyboard, monitor, printer, VCR, foot switch, magnetic card reader. Facilitates real-time visualization of GI anatomy and adjacent structures to aid diagnostic decision-making.

Clinical Evidence

Bench testing only. Compliance with IEC-601-1 (Class-I, Type BF) and FDA 510(k) Diagnostic Ultrasound Guidance (1993/1985) confirmed.

Technological Characteristics

Pulsed echo ultrasonic imaging system. Transducer frequencies: 7.5, 12.0, 20.0 MHz. B-Mode display. Connectivity: keyboard, monitor, video printer, VCR, EVIS video system, foot switch, magnetic card reader. Electrical safety: IEC-601-1, Class-I, Type BF.

Indications for Use

Indicated for real-time ultrasonic imaging of the upper and lower GI tract and adjacent structures in patients undergoing endoscopic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Olympus EU-M20 (K926514)
• Aloka SSD-550

Submission Summary (Full Text)

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K951994 P 2

510 (k) SUMMARY

APR 15 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
[phone] |
| 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, 12.0 MHz, 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.

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K951994 p. 2d2

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.

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