OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER

K043275 · Olympus Medical Systems Corporation · IYO · Dec 9, 2004 · Radiology

Device Facts

• Record ID: K043275
• Device Name: OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
• Applicant: Olympus Medical Systems Corporation
• Product Code: IYO · Radiology
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs; Intraluminal ultrasound for upper airways and tracheobronchial tree; Urinary tract; Female reproductive tract; 3D imaging.

Device Story

EU-M60 EUS EXERA Endoscopic Ultrasound Center acquires/displays high-resolution, real-time B-mode 2D and 3D ultrasound images. System utilizes endoscopes or ultrasonic probes inserted into body cavities; piezoelectric transducers transmit sound waves and convert reflected echoes into electrical signals for processing/display. Used in clinical settings by physicians for visualization of internal structures. Output assists in diagnostic decision-making and patient assessment. Device is an evolution of the predicate EU-M60 (K011886) with identical mechanical scanning principles.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on identical technological characteristics and intended use to the predicate device.

Technological Characteristics

Mechanical scanning ultrasound system. Piezoelectric transducer material. B-mode 2D and 3D imaging. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, and CISPR11 standards.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the GI tract, biliary/pancreatic ducts, surrounding organs, upper airways, tracheobronchial tree, urinary tract, and female reproductive tract. Includes 3D imaging. Prescription use only.

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-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER (K011886)
• ATL HDI 5000 Ultrasound System (K961459)

Submission Summary (Full Text)

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K0+3275

DEC = 9 2004

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

### A. GENERAL INFORMATION

- 1. Applicant: Olympus Medical Systems Corp. (Former Name: Olympus Corporation) Hinode Plant Address: 34-3 Hirai, Hinode-machi, Nishitama-gun Tokyo, Japan, 190-0182 Establishment Registration No.: 3003637092

| 2. Submission Correspondent: Takashi Yagi | |
|-------------------------------------------|---------------------------------------------------------------------|
| | Olympus Medical Systems Corp.<br>(Former Name: Olympus Corporation) |
| Address: | 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, Japan |
| Telephone: | 81-426-42-2891 |
| Facsimile: | 81-426-42-3174 |
| E-mail address: | [e-mail] |
| Establishment Registration No.: | 8010047 |

| 3. Official Correspondent: | Laura Storms-Tyler |
|---------------------------------|-----------------------------------------------------|
| Title: | Director, Regulatory Affairs and Quality Assurance |
| | OLYMPUS AMERICA INC. |
| Address: | Two Corporate Center Drive, Melville, NY 11747-9058 |
| Telephone: | 631-844-5688 |
| Facsimile: | 631-844-5554 |
| E-mail address: | [e-mail] |
| Establishment Registration No.: | 2429304 |

#### B. Device Name, Common Name

- 1. Common/Usual Name
Diagnostic Ultrasound System with Accessories

- 2. Device Name
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER

#### 3.Classification Name

| | FR Number | Product Code | Class |
|---------------------------------------|-----------|--------------|-------|
| Endoscope and accessories | 876.1500 | 78KOG | II |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90IYO | II |

## C. Identification of the predicate or legally marketed device

The following devices information demonstrates that this device is considered substantially equivalent to a legally marketed, predicate medical device.

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### 1. Ultrasound System

| Device Name | #K |
|-------------------------------------------------------|---------|
| OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER | K011886 |
| ATL HDI 5000 Ultrasound System | K961459 |

### D. Device Description

### 1. Summary

The OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode 2D and 3D images.

### 2. Design

The EU-M60 is designed to comply with the standards listed below.

| IEC 60601-1 | 1988 : Amendment 1 (1992) and Amendment (1995) |
|----------------|------------------------------------------------|
| IEC 60601-1-1 | 2000 |
| IEC 60601-1-2 | 1993 |
| IEC 60601-2-18 | 1996 |
| CISPR11 | 1990 |

### E. Intended Use:

The intended uses of the EU-M60, as defined by FDA guidance documents, are:

| Transesophageal | Transrectal |
|--------------------------------------------------------------------------------|---------------|
| Transvaginal | Transurethral |
| Other | |
| 1) Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs | |
| 2) Intraluminal ultrasound for upper airways and tracheobronchial tree | |
| 3) Urinary tract | |
| 4) Female reproductive tract | |
| 5) 3D imaging | |

### F. Technological Characteristics:

This device operates identically to the predicate devices in that the transducer of the endoscope or the ultrasonic probe that is inserted into the body cavity mechanically scans the targeted site. The piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images.

Technological Characteristics of this device is identical to the predicated devices identified in item C.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC - 9 2004

Olympus Medical Systems Corp. % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K043275

Trade Name: Olympus EU-M60 EUS EXERA Endoscopic Ultrasound Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Product Code: 78 KOG Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II

Product Code: 90 IYO and ITX

Dated: November 23, 2004

Received: November 26, 2004

#### Dear Mr. Devine:

We have reviewed your Section 510(k) premarket 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 following transducers intended for use with the Olympus EU-M60 EUS EXTERA Endoscopic Ultrasound Center, as described in vour premarket notification:

#### Transducer Model Number

GF Type UM160 UM-DP12/20-35R

### UM-2R/3R GF UM 130

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 nredicate 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marv Sacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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

Sincerely yours,

David le. Lazaro

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# 4.3.1 Indications for Use Form for 4.5.1 maileations for SSC Formal :
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER

# Diagnostic Ultrasound Indications for Use Form

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>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | P | | | | | | | | Note2(E) | |
| Transrectal | | P | | | | | | | | Note2(E) | |
| Transvaginal | | P | | | | | | | | Note2(E) | |
| Transurethral | | P | | | | | | | | Note2(E) | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify)<br>Note1 | | P | | | | | | | | Note2(E) | |

Other (specif)
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E

Additional Comments:

| Note1: Specification for "Other": |
|--------------------------------------------------------------------------|
| Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. |
| Intraluminal ultrasound for upper airways and tracheobronchial tree |
| Urinary tract |
| Female reproductive tract: |
| Note2:3D Imaging |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Seymour

(Division Sion-Off Division and Radiolor 510(k) Num

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## 4.3.2 Indications for U se Form for EUS EXERA Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UM160

## Diagnostic Ultrasound Indications for Use Form

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>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | P | | | | | | | | Note2(E) |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | Note1 | P | | | | | | | | Note2(E) |

N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E

Additional Comments:

Note1: Specification for "Other"

Gastrointestinal fract billiary, pancreatic duct and surrounding organs, Note2:3D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Daniel A. Legum

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number _

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## 4.3.3 Indications for U se Form for OLYMPUS UM-DP12/20-35R Ultrasonic Probes

# Diagnostic Uitrasound Indications for Use Form

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>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | P | | | | | | | | Note2(E) | |
| Transrectal | | P | | | | | | | | Note2(E) | |
| Transvaginal | | P | | | | | | | | Note2(E) | |
| Transurethral | | P | | | | | | | | Note2(E) | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify)<br>Note1 | | P | | | | | | | | Note2(E) | |

Other (epocition; P= previously cleared by FDA in K011886; E= added under Appendix E

Additional Comments:

Note1: Specification for "Other" :

| Gastrointestinal tract, biliary, pancreatic duct and surround organs |
|----------------------------------------------------------------------|
| Intraluminal ultrasound for upper airways and tracheobronchial tree |
| Urinary tract |
| Female reproductive tract: |
| Note2:3D Imaging |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David Ch. Seegman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

{7}------------------------------------------------

# 4.3.4 Indications for U se For OLYMPUS UM-2R/3R Ultrasonic Probes

# Diagnostic Ultrasound Indications for Use Form

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>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | P | | | | | | | | Note2(E) | | |
| Transrectal | | P | | | | | | | | Note2(E) | | |
| Transvaginal | | P | | | | | | | | Note2(E) | | |
| Transurethral | | P | | | | | | | | Note2(E) | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Note 1<br>Other (specify) | | P | | | | | | | | Note2(E) | | |

N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E

Additional Comments:

| Note1: Specification for "Other": | |
|----------------------------------------------------------------------|--|
| Gastrointestinal tract, biliary, pancreatic duct and surround organs | |
| Intraluminal ultrasound for upper airways and tracheobronchial tree | |
| Urinary tract | |
| Female reproductive tract: | |
| Note2:3D Imaging | |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Logam

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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### 4.3.5 Indications for U se for OLYMPUS GF UM130 Ultrasound Gastrovideoscope

# Diagnostic Ultrasound Indications for Use Form

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>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | P | | | | | | | | Note2(E) |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Note1<br>Other (specify) | | P | | | | | | | | Note2(E) |

N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E

Additional Comments:

Note1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Note2:3D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ... ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Daniel A. Leyson

(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________