OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE

K994069 · Olympus America, Inc. · ITX · Jun 2, 2000 · Radiology

Device Facts

• Record ID: K994069
• Device Name: OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE
• Applicant: Olympus America, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jun 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.

Device Story

The Olympus UM-S30-25R is an ultrasonic probe designed for intraluminal imaging of the urinary tract. It functions as part of a system including an Olympus Endoscopic Ultrasound center (EU-M30) and a Probe Driving Unit (MH-240). The probe is inserted through an endoscope channel; the driving unit controls the rotation of the transducer. It utilizes a 30MHz ultrasonic frequency to perform 360-degree mechanical/radial B-mode scanning of tissue using de-aerated water immersion or balloon methods. The device is operated by a clinician in a clinical setting. The resulting ultrasound images are displayed for the clinician to visualize internal urinary tract structures, aiding in diagnostic assessment.

Clinical Evidence

Bench testing only. The device was tested for electromagnetic compatibility (IEC 60601-1-2) and general safety/performance requirements (IEC 60601-1 and FDA Diagnostic Ultrasound Guidance). No clinical data was required or provided.

Technological Characteristics

Ultrasonic probe with 30MHz frequency; 2.4mm outer diameter; 2050mm length. Mechanical/radial scanning (360 degrees). B-mode operation. Uses de-aerated water immersion or balloon method. Complies with IEC 60601-1 and IEC 60601-1-2. Materials identical to predicate.

Indications for Use

Indicated for diagnostic ultrasound imaging of the urinary tract in adult patients. Used in conjunction with an endoscope, endoscopic ultrasound center, and probe driving unit.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Ultrasonic Probe UM-2R (K982610)
• Ultrasonic Probe UM-3R (K982610)
• Endoscopic Ultrasound Center EU-M30 (K982610)
• Probe Driving Unit MH-240 (K982610)
• Balloon Sheath MH-246 (K982734)

Submission Summary (Full Text)

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K994069
Page 1 of 3

# 510(k) SUMMARY OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY TRACT USE

## A. Submitter's Name, Address, Phone and Fax Numbers

## 1. Manufacturer of the subject devices

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division

Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishishinjyuku Shinjuku-ku, Tokyo, Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL [phone] FAX [phone]

#### B. Name of Contact Person

Name: Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 TEL: [phone] FAX: [phone]

#### C. Device Name, Common Name, Classification Name and Predicate Devices

| Device Name: | Ultrasonic Probe UM-S30-25R<br>Endoscopic Ultrasound Center EU-M30<br>Probe Driving Unit MH-240 |
|----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Ultrasonic Probe |
| Classification Name: | 21 CFR892.1570 Diagnostic Ultrasonic transducer |

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K994069.
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Predicate Device:

| MODEL | NAME | 510(k)# |
|--------|------------------------------|------------------------|
| UM-2R | Ultrasonic Probe | K982610 |
| UM-3R | Ultrasonic Probe | K982610 |
| EU-M30 | Endoscopic Ultrasound Center | K982610 |
| MH-240 | Probe Driving Unit | K982610 |
| MH-246 | Balloon Sheath | K982734 (for UM-2R/3R) |

#### D. Description of the Device(s)

The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.

The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer.

UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probeoffers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.

## E. Intended Use of the Device(s)

The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.

## F. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)

Ultrasonic Frequency

The ultrasonic frequency is changed to 30MHz.

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K994069
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## G. Summary including a Brief Discussion of Non-clinical Tests and How their Results support Determination of Substantial Equivalence

#### 1. Design

Endoscopic Ultrasound Center EU-M30 and Probe Driving Unit MH-240 have been designed, manufactured and tested in compliance with IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995. It meets the requirements of IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995.

Ultrasonic Probe UM-S30-25R has been tested to verify electromagnetic compatibility (EMC) with IEC 60601-1-2. It meets the requirements of IEC 6060-1-1-2.

#### 2. Materials

The patient contacting materials are identical to predicate device.

#### H. Summary including Conclusions drawn from Non-clinical Tests

When compared to the predicate device, the Olympus UM-S30-25R Ultrasonic probe and associated ancillary equipment do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.

Public Health Service

JUN - 2 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157

Re: K994069

UM-S30-25R Ultrasonic Probe Regulatory Class: II Product Code: 90 ITX/21 CFR 892.1570 Dated: March 23, 2000 Received: March 29, 2000

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the UM-S30-25R Ultrasonic Probe intended for use with the Olympus EU-M30 Endoscopic Ultrasound Center as described in your premarket notification.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 – Ms. Laura Storms-Tyler

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and rr you desire specific as reviews and the see contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers on your responsive manaber [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Mr. Rodrigo C. Perez at [phone].

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Appendix F

### Diagnostic Ultrasound Indications for Use Form OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER (ancillary system) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows:

| | Mode of Operation | | | | | | | | | |
|--------------------------------------------------|-------------------|---|---|-----|-----|----------------------|------------------------------|--------------------------------------|-------------------------------|------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppl<br>er | Amplit<br>ude<br>Dopple<br>r | Color<br>Veloc<br>ity<br>Imagi<br>ng | Combin<br>ed<br>(Speci<br>fy) | Other<br>(Speci<br>fy) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic<br>Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

N = new indication: P = previously cleared by EDA: E = added under Appendix FN = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:

the urinary tract.

(PLEASE DO NOT WRITE BELOW THE LINE-CONTIINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evalution (ODE) | |
|-------------------------------------------------------|--|
|-------------------------------------------------------|--|

Prescription Use (Per 21 CFR 801.109)

F-3

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K94406

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Appendix F

### Diagnostic Ultrasound Indications for Use Form OLYMPUS UM-S30-25R ULTRASONIC PROBE (Subject Device) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows:

Intended Use. Diagnostic ultrasound imaging or fluid flow analysis of the human Body as follows:

| | Mode of Operation | | | | | | | | | |
|--------------------------------------------------|-------------------|---|---|-----|-----|----------------------|------------------------------|--------------------------------------|-------------------------------|------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppl<br>er | Amplit<br>ude<br>Dopple<br>r | Color<br>Veloc<br>ity<br>Imagi<br>ng | Combin<br>ed<br>(Speci<br>fy) | Other<br>(Speci<br>fy) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | N | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic<br>Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (Specify) | | N | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments: the urinary tract.

(PLEASE DO NOT WRITE BELOW THE LINE CONTIN

(PLEASE DO NOT WRITE BELOW THE LINE-CONTIINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalution (ODE)

Prescription Use (Per 21 CFR 801.109)

F-3

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radialasia

Radiological Devices
510(k) Number K994069