OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,

K011886 · Olympus America, Inc. · ODG · Aug 27, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011886
• Device Name: OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
• Applicant: Olympus America, Inc.
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Aug 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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

Device Story

The Olympus EU-M60 EUS Exera Endoscopic Ultrasound Center, used with the GF TYPE UM160 gastrovideoscope and UM-DP12/20-35R probes, provides real-time, high-resolution B-mode ultrasound imaging. The system utilizes a mechanical scanning transducer inserted into body cavities. Piezoelectric material transmits ultrasound waves into the tissue; reflected echoes are captured by the transducer and converted into electrical signals. These signals are processed by the center to generate B-mode images for display. The device is operated by physicians in clinical settings to visualize internal structures, aiding in diagnostic assessment of the GI tract, biliary/pancreatic ducts, airways, and reproductive/urinary tracts. The output allows clinicians to evaluate anatomy and pathology, supporting clinical decision-making during endoscopic procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed on the new patient-contacting material used in the distal portion of the UM-DP12/20-35R probes to ensure safety.

Technological Characteristics

System uses mechanical scanning with piezoelectric transducers. Materials include a new biocompatible material for the distal portion of the UM-DP12/20-35R probe. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, and CISPR11. Operates as a B-mode ultrasound imaging system.

Indications for Use

Indicated for diagnostic ultrasound imaging of the gastrointestinal tract, biliary tree, pancreatic duct, surrounding organs, upper airways, tracheobronchial tree, urinary tract, and female reproductive tract. For use in transesophageal, transrectal, transvaginal, and transurethral procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Olympus EU-M30 Endoscopic Ultrasound Center (K951994)
• Olympus GF TYPE UM130 Ultrasound Gastrovideoscope (K971660)
• Olympus UM-2R/3R Ultrasonic Probes (K944610)
• Olympus UM-2R/3R Ultrasonic Probes (K982323)
• Olympus UM-2R/3R Ultrasonic Probes (K982610)
• Olympus UM-2R/3R Ultrasonic Probe (K001203)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JUL 2 7 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K011886 Trade/Device Name: Olympus EU-M60 EUS Exera Endoscopic Ultrasound Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG, FET, IYO Dated (Date on orig SE ltr): June 15, 2001 Received (Date on orig SE Itr): June 18, 2001

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of August 27, 2001.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 -

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4.3.1 Indications for Use Form for Indications for Use i onii 16:
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 | | N | | | | | | | | |
| Transrectal | | N | | | | | | | | |
| Transvaginal | | N | | | | | | | | |
| Transurethrai | | N | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Note1<br>Other (specify) | | N | | | | | | | | |

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

Additional Comments:

| Note 1: Specification for "Other": |
|------------------------------------|
|------------------------------------|

| Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. |
|--------------------------------------------------------------------------|
| Intraluminal ultrasound for upper airways and tracheobronchial tree |
| Urinary tract |
| Female reproductive tract: |

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ---------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancyc broglor

(Division Sign-Off)
Division of Reproduction, Abddel,
and Radiological Devices K011886

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# 4.3.2 Indications for Use 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 | | N | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | N | | | | | | | | | |

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

Additional Comments:

Note1: Specification for "Other"

Gastrointestinal tract billiary pancreatic duct and surrounding organs.

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ---------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy L. Ingalson

510(k) Numb

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# 4.3.3 Indications for Use Form for OLYMPUS UM-DP12/20-35R 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 | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | N | | | | | | | | |
| Transrectal | | N | | | | | | | | |
| Transvaginal | | N | | | | | | | | |
| Transurethral | | N | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Note1<br>Other (specify) | | N | | | | | | | | |

Other (Specify)

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: | |

IPLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON - ANQTHER PAGE IS NEEDEDI Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brazion

(Division Sign-Division of Reproduc and Radiological Devices 510(k) Number

{5}------------------------------------------------

#### 4.3.4 Indications for Use 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:

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|--------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | P | | | | | | | | |
| Transrectal | | P | | | | | | | | |
| Transvaginal | | P | | | | | | | | |
| Transurethral | | P | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | | P | | | | | | | | |

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

Additional Comments:

Note1: 510(k) control numbers for the previously cleared indications

Gastrointestinal tract wall, billiary, pancreatie duct and surround organs. : K944610

Intraluminal ultrasound for upper ainways and trached to the later 14.982323

Urinary tract: K982610

Female reproductive tract: K001203

These oreviously control numbers were classified as the combination with the Olymous previous endoscopic ultrasound system EU-M80(K951894) EUS-20(K926514) and EU-M3(K882061) The feature, efficiency, and acoustic outout of UM-2R/3R are not changed when they, are combined with the new system EU-M60.

| (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)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _

{6}------------------------------------------------

### 4.3.5 Indications for Use for Indications 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:

| Clinical Application | Mode of Operation | | | | | | | | | |
|--------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | 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 | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | | P | | | | | | | | |

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

Additional Comments:

Note1: 510(k) control numbers for the previously cleared indications

Gastrointestinal wall, billiary, pancreatic duct, and surrounding organs: K971660 ___ Gastrontestinal wall. Dillary, parcleant good and the Olymous previous endoscopic ultrasound system EU-M30(K951994). EU-20(K926514) and EU-M31K882061). The feature officiency. and acoustic output of UM-2R/3R are not changed when they are combined with the new system EU-M60,

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON --- ANOTHER PAGE E NEEDEDI Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-C Division of Reproduct Division ological Devices E 1 Not Number

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

K911886

#### 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. Submitter's name, address, telephone number, initial importer, contact person

#### 1. Manufacturer of the subject device

Name & Address of Manufacturer; Olympus Optical Co,. Ltd. 2-3-1 Shinjukuku Monolis Nishi-Shinjuku Shiniuku-ku, Tokyo, 163-0914 Japan Registration Number : 810047 2951 Ishikawa-cho Address. Phone and Fax Hachioii-shi, Tokyo 192-8507 of R & D Department Japan Endoscope Division TEL [phone] FAX [phone]

#### 2. Initial Importer

Name: Address:

Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL [phone] FAX [phone]

#### 3. Name of Contact Person

| Name: | Laura Storms-Tyler |
|----------------------------------------------------|--------------------|
| Director, Regulatory affairs, Olympus America Inc. | |

Address, Phone and Fax:

Two Corporate Center Drive Melville, NY 11747-3157 TEL [phone] FAX [phone]

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#### B. Device Name, Common Name

#### 1. Common/Usual Name

Diagnostic Ultrasound System with Accessories

#### 2. Device Name

- O NOS NAMO EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
- · EUS EXERA Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UM160
- Ultrasonic Probes OLYMPUS UM-DP12/20-35R .

# 3.Classification Name

| | FR Number | Product<br>Code | Class |
|---------------------------------------|-----------|-----------------|-------|
| Endoscope and accessories | 876.1500 | KOG | II |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | IYO | II |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX | II |

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

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

#### 1. Ultrasound System

| Device Name | #K |
|---------------------------------------------|---------|
| Olympus EU-M30 Endoscopic Ultrasound Center | K951994 |

#### 2. Ultrasonic Gastrovideoscope and Probes

| Device Name | #K |
|----------------------------------------------------------------------------------------------|---------|
| Olympus GF TYPE UM130 Ultrasound Gastrovideoscope | K971660 |
| Olympus UM-2R/3R Ultrasonic Probes and associated<br>ancillary equipment for Gl | K944610 |
| Olympus UM-2R/3R Ultrasonic Probes and associated<br>ancillary equipment (for bronchial use) | K982323 |
| Olympus UM-2R/3R Ultrasonic Probes and associated<br>ancillary equipment (for urinary tract) | K982610 |
| Olympus UM-2R/3R Ultrasonic Probe and associated ancillary<br>equipment (Ob/Gyn) | K001203 |

{9}------------------------------------------------

### D. Device Description

#### 1. Summary

The combination of OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER, Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UM160, and Ultrasonic probe OLYMPUS UM-DP12/20-35R makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode images.

#### 2. Design

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

| IEC 60601-1 |
|----------------|
| IEC 60601-1-1 |
| IEC 60601-1-2 |
| IEC 60601-2-18 |
| CISPR11 |

#### 3. Materials

The material of the distal portion for MAJ-356RJ outer sheath of OLYMPUS UM-DP 12/20-35R Ultrasonic Probes is a new patient-contacting material. The biocompatibility test reports of the new material show that the new material is safe for its intended use.

#### E. Intended Use:

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

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

#### 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.

{10}------------------------------------------------

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

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