OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE

K063683 · Olympus Medical Systems Corporation · IYN · Feb 8, 2007 · Radiology

Device Facts

• Record ID: K063683
• Device Name: OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE
• Applicant: Olympus Medical Systems Corporation
• Product Code: IYN · Radiology
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal, Transurethral, Transesophageal(non-cardiac), Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree, 3-D Imaging

Device Story

The XEU-M60A Endoscopic Ultrasound Center, used with compatible ultrasonic probes and gastrovideoscopes, acquires and displays real-time, high-resolution B-mode endoscopic ultrasound images. The system utilizes piezoelectric transducers to transmit ultrasound waves into the body; reflected waves are converted into electrical signals, processed, and displayed. The device supports Color Flow and spectrum analysis for blood flow assessment. It is intended for use by clinicians in endoscopic procedures to visualize the gastrointestinal tract, biliary system, pancreatic duct, and surrounding structures. The output assists physicians in diagnostic decision-making by providing real-time anatomical and vascular information, potentially improving diagnostic accuracy for intraluminal and surrounding organ pathologies.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System uses piezoelectric transducers for ultrasound transmission/reception. Supports B-mode imaging, Color Flow, and spectrum analysis. Connectivity includes endoscopic interface for probes/gastrovideoscopes. Software performs signal processing to convert reflected waves into visual images.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, specifically for transrectal, transurethral, transesophageal (non-cardiac), gastrointestinal tract, biliary, pancreatic duct, surrounding organs, and intraluminal ultrasound for upper airways and tracheobronchial tree. Includes 3-D imaging.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER (K043275)
• EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER (K010591)
• UM-2R/3R ULTRASONIC PROBES (K944610, K982323, K982610)
• GF-UM130 ULTRASONIC GASTROVIDEOSCOPE (K971660, K011886)
• GF-UM160 EUS EXERA ULTRASONIC GASTROVIDEOSCOPE (K011886)
• GF-UE160-AL5 ULTRASONIC GASTROVIDEOSCOPE (K051541)
• GF-UC140P-AL5 ULTRASONIC GASTROVIDEOSCOPE (K011314)
• GF-UCT140-AL5 ULTRASONIC GASTROVIDEOSCOPE (K012080)

Submission Summary (Full Text)

{0}------------------------------------------------

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

Olympus Medical Systems Corporation % Ms. Laura Storms-Tyler Olympus America, Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610

JUL 2 7 2015

Re: K063683

Trade/Device Name: XEU-M60A Endoscopic Ultrasound Center Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and ODG Dated (Date on orig SE ltr): December 5, 2006 Received (Date on orig SE ltr): December 14, 2006

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of February 8, 2007.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/ReportalProblem/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 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

# XEU-M60A ENDOSCOPIC ULTRASOUND CENTER

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

| | Clinical Application | | Mode of Operation | | | | | |
|---------------------------|------------------------------|---|-------------------|-----|-----|------------------|---------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (specify) | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | | | | N | | Note 2 |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | N | | | | N | | Note 2 |
| | Trans-esoph. (non-Card.) | N | | | | N | | Note 2 |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.) (Note 1) | N | | | | N | | Note 2. |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Note 2: 3-D Imaging

David A. Simpson

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

Prescription Use (Per 21 CFR 801.109)

{3}------------------------------------------------

## 4.3.2 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

### UM-2R / 3R ULTRASONIC PROBES

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

| | Clinical Application | | | | | | Mode of Operation | | | |
|--|---------------------------|------------------------------|---|---|-----|-----|-------------------|---------------------|------------------|--|
| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | |
| | Ophthalmic | Ophthalmic | | | | | | | | |
| | | Fetal | | | | | | | | |
| | | Abdominal | | | | | | | | |
| | | Intra-operative (specify) | | | | | | | | |
| | | Intraoperative (Neuro.) | | | | | | | | |
| | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | | Pediatric | | | | | | | | |
| | | Small Organ (specify) | | | | | | | | |
| | | Neonatal Cephalic | | | | | | | | |
| | | Adult Cephalic | | | | | | | | |
| | | Trans-rectal | N | | | | | | | |
| | | Trans-vaginal | | | | | | | | |
| | | Trans-urethral | N | | | | | | | |
| | | Trans-esoph. (non-Card.) | N | | | | | | | |
| | | Musculo-skel. (Convent.) | | | | | | | | |
| | | Musculo-skel. (Superfic.) | | | | | | | | |
| | | Other (spec.) (Note 1) | N | | | | | | | |
| | | Cardiac Adult | | | | | | | | |
| | Cardiac | Cardiac Pediatric | | | | | | | | |
| | | Trans-esophageal (card.) | | | | | | | | |
| | | Other (spec.). | | | | | | | | |
| | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | | Other (spec.) | | | | | | | | |

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

Additional Comments:

.

Note 1: Specification for "Other" :

Gastrointestinal tract, billiary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree

Dennis K. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

Prescription Use (Per 21 CFR 801 109)

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# 4.3.3 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

## UM-DP12/20-25R ULTRASONIC PROBES

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

| Clinical Application | | | | | | Mode of Operation | | | | |
|---------------------------|------------------------------|---|---|-----|-----|-------------------|---------------------|------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (specify) | | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | | |
| Fetal Imaging.<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | N | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | N | | | | | | | | |
| | Trans-esoph. (non-Card.) | N | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Other (spec.) (Note 1) | N | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | | |

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

Additional Comments:

Note 1: Specification for "Other" :

Gastrointestinal tract, billary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree

David B. Leggison

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

Prescription Use (Per 21 CFR 801.109) -

. .

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## 4.3.4 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

# ULTRASONIC GASTROVIDEOSCOPE GF TYPE UM130

| Clinical Application | | | | | | Mode of Operation | | | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|---------------------|------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal<br>Abdominal<br>Intra-operative (specify)<br>Intraoperative (Neuro.)<br>Laparoscopic<br>Pediatric<br>Small Organ (specify)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Card.)<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Other (spec.) (Note 1) | N | | | | | | | | |
| Cardiac | Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (card.)<br>Other (spec.) | N | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel<br>Other (spec.) | | | | | | | | | |

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

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

Additional Comments:

Note1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

Daniela Segmen

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

Prescription Use (Per 21 CFR 801, 109)

.

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# 4.3.5 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

# EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (specify) | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.) (Note 1) | N | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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.

Daniel R. Seymore

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

Prescription Use (Per 21 CFR 801.109)

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

# 4.3.6 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

## ULTRASONIC GASTROVIDEOSCOPE OLYMPUS XGF TYPE UM180

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

| | Clinical Application | | | | | | Mode of Operation | | | |
|--|---------------------------|------------------------------|---|---|-----|-----|-------------------|---------------------|------------------|--|
| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | |
| | Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal Imaging<br>& Other | Fetal | | | | | | | | |
| | | Abdominal | | | | | | | | |
| | | Intra-operative (specify) | | | | | | | | |
| | | Intraoperative (Neuro.) | | | | | | | | |
| | | Laparoscopic | | | | | | | | |
| | | Pediatric | | | | | | | | |
| | | Small Organ (specify) | | | | | | | | |
| | | Neonatal Cephalic | | | | | | | | |
| | | Adult Cephalic | | | | | | | | |
| | | Trans-rectal | | | | | | | | |
| | | Trans-vaginal | | | | | | | | |
| | | Trans-urethral | | | | | | | | |
| | | Trans-esoph. (non-Card.) | N | | | | | | | |
| | | Musculo-skel. (Convent.) | | | | | | | | |
| | | Musculo-skel. (Superfic.) | | | | | | | | |
| | | Other (spec.) (Note 1) | N | | | | | | | |
| | Cardiac | Cardiac Adult | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | |
| | | Trans-esophageal (card.) | | | | | | | | |
| | | Other (spec.) | | | | | | | | |
| | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | | Other (spec.) | | | | | | | | |

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.

David h. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

{8}------------------------------------------------

# 4.3.7 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (specify) | | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | N | | | | N | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Other (spec.) (Note 1). | N | | | | N | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Other (spec.) (Note 1) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |

## GF-UE160-AL5 ULTRASONIC GASTROVIDEOSCOPE

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

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.

David h. Segerson

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

Prescription Use (Per 21 CFR 801.109)

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

### 4.3.9 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

## GF-UCT140-AL5 ULTRASONIC GASTROVIDEOSCOPE

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (specify) | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | | | | N | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.) (Note 1) | N | | | | N | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Note1: Specification for "Other"

mana ana mana mana mana mananta na mana d

Gastrointestinal tract, billiary, pancreatic duct and surrounding organs.

Gerral H. Leggott

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices ്ച് 1 | 14:1 Pumber .........................................................................................................................................................

Prescription Use (Per 21 CFR 801 109)

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

## 4.3.8 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

### GF-UC140P-AL5 ULTRASONIC GASTROVIDEOSCOPE

Intended Use: Diagnostic utrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|--------------------------|---------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| (Track I only) | (Tracks I & II) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (specify) | | | | | | | |
| | Intraoperative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | | | | N | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.) (Note 1) | N | | | | N | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Note1: Specification for "Other"

Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.

David A. Seppon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 11

Prescription Use (Per 21 CFR 801.109)

. .

{11}------------------------------------------------

# 11063683

#### 510(k) SUMMARY

#### 8 2007 FEB

#### December X, 2006

#### ﮩ General information

- 트 Applicant:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507

Establishment Registration No: 8010047

- 를 Official Correspondent:
Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: [phone] FAX: [phone] Email:[e-mail] Establishment Registration No: 2429304

Manufacturer: 트

OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT 34-3 Hirai Hinode-Machi, Nishitama-gun, Tokyo Japan, 190-0182 Establishment Registration No:8010047

#### 2 Device Identification

- Device Trade Name:

| Model Name | Device Name |
|----------------|---------------------------------------|
| XEU-M60A | ENDOSCOPIC ULTRASOUND CENTER |
| UM-2R/3R | ULTRASONIC PROBES |
| UM-DP12/20-25R | ULTRASONIC PROBES |
| GF-UM130 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UM160 | EUS EXERA ULTRASONIC GASTROVIDEOSCOPE |
| XGF-UM180 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UE160-AL5 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UC140P-AL5 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UCT140-AL5 | ULTRASONIC GASTROVIDEOSCOPE |

- Common Name: 版
#### Diagnostic Ultrasound System

II

Regulation Number: 트

892.1550 Ultrasound Puised Doppler Imaging System 892.1560 Ultrasonic Pulsed Echo Imaging System 892.1570 Diagnostic Ultrasound Transducer 876.1500 Endoscope and Accessories

Regulatory Class:

{12}------------------------------------------------

#### I Product Code:

.

.

## 90-1YN/90-1YO/90-1TX/78-KOG

## 3 Predicate Device Information

:

### Ultrasound System

| Subject device | Predicate device | |
|---------------------------------------------|----------------------------------------------------------------|-------------------|
| | Name | Control<br>number |
| XEU-M60A<br>ENDOSCOPIC ULTRASOUND<br>CENTER | EU-M60<br>EUS EXERA ENDOSCOPIC<br>ULTRASOUND CENTER | K043275 |
| | EU-C60<br>EUS EXERA COMPACT<br>ENDOSCOPIC ULTRASOUND<br>CENTER | K010591 |

## Ultrasonic Gastrovideoscopes and Probes

| Subject device | Predicate device Name | Control number |
|------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| UM-2R/3R<br>ULTRASONIC PROBES | UM-2R/3R<br>ULTRASONIC PROBES | K944610<br>K982323<br>K982610 |
| UM-DP12/20-25R<br>ULTRASONIC PROBES | UM-2R/3R<br>ULTRASONIC PROBES | Based<br>upon<br>K944610,<br>K982323,<br>K982610,<br>Olympus<br>determined<br>that no<br>510(k) was<br>required<br>for device<br>changes. |
| GF-UM130<br>ULTRASONIC<br>GASTROVIDEOSCOPE | GF-UM130<br>ULTRASONIC GASTROVIDEOSCOPE | K971660<br>K011886 |
| GF-UM160<br>EUS EXERA ULTRASONIC<br>GASTROVIDEOSCOPE | GF-UM160<br>EUS EXERA ULTRASONIC<br>GASTROVIDEOSCOPE | K011886 |
| XGF-UM180<br>ULTRASONIC<br>GASTROVIDEOSCOPE | GF-UM160<br>ULTRASONIC GASTROVIDEOSCOPE | This<br>submission |
| GF-UE160-AL5<br>ULTRASONIC<br>GASTROVIDEOSCOPE | GF-UE160-AL5<br>ULTRASONIC GASTROVIDEOSCOPE | K051541 |
| GF-UC140P-AL5<br>ULTRASONIC<br>GASTROVIDEOSCOPE | GF-UC140P-AL5<br>ULTRASONIC GASTROVIDEOSCOPE | K011314 |
| GF-UCT140-AL5<br>ULTRASONIC<br>GASTROVIDEOSCOPE | GF-UCT140-AL5<br>ULTRASONIC GASTROVIDEOSCOPE | K012080 |

{13}------------------------------------------------

#### 4 Device Description

The combination of the XEU-M60A Endoscopic Ultrasound Center, UM-2R/3R Ultrasonic Probes, UM-DP12/20-25R Ultrasonic Probes, GF-UM130 Ultrasonic Gastrovideoscope, GF-UM160 Ultrasonic Gastrovideoscope, XGF-UM180 Ultrasonic Gastrovideoscope, GF-UE160-AL5 Uftrasonic Gastrovideoscope, GF-UC140P-AL5 Ultrasonic Gastrovideoscope, and GF-UCT140-AL5 Ultrasonic Gastrovideoscope enables the acquisition and display of high-resolution and high-penetration, real-time ultrasound B-mode endoscopic images,

#### 5 Indications for Use

The indications for use for the XEU-M60A Endoscopic Ultrasound Center are as follows:

- Transrectal 제
- 1 Transurethral
- 199 Transesophageal(non-cardiac) .
- 17 Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
- Intraluminal ultrasound for upper airways and tracheobronchial tree 1
- 18 3-D Imaging

#### ర్ Comparison of Technological Characteristics

The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis.

Technological Characteristics of this device is identical to the predicate devices identified in item 3.