OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER

K010591 · Olympus Optical Co., Ltd. · ODG · Mar 15, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K010591
• Device Name: OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
• Applicant: Olympus Optical Co., Ltd.
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Mar 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Laparoscopic, Intraoperative (abdominal organs and vascular), Abdominal, Small Organ (breast, thyroid, testicle), Trans-vaginal, Trans-rectal, Other (1) Gastrointestinal tract and the surrounding Organs (2) The airways and tracheobronchial tree, Musculo-skeletal (conventional), Musculo-skeletal (superficial), Neonatal Cephalic, Pediatric, Cardiac-(adult and pediatric), Trans-esophageal (non-cardiac), Peripheral Vessel.

Device Story

The Olympus EU-C60 EUS EXERA is a compact, software-controlled diagnostic ultrasound system. It processes ultrasound signals received from compatible transducers (SonoSite or Olympus) to generate 2D, Color Power Doppler, and PowerMap™ Directional Color Power Doppler images. Used in clinical settings, it allows physicians to visualize anatomical structures, perform measurements, and conduct EUS-guided fine needle aspiration (FNA) via specialized gastrovideoscopes. The system displays processed images on a monitor, aiding clinicians in diagnostic decision-making and biopsy guidance. Patient benefits include non-invasive or minimally invasive visualization of internal organs and vascular flow.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, intended use, and compliance with safety standards (IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-18, CISPR11). Biocompatibility testing was performed for new patient-contacting materials (balloon).

Technological Characteristics

Compact, software-controlled ultrasound system. Piezoelectric transducer technology for ultrasound transmission/reception. Modes: 2D, Color Power Doppler, PowerMap™ Directional Color Power Doppler, combined modes. Compliance: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11. Biocompatible balloon material used.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring examination of the abdomen, fetal, small organs, musculoskeletal, neonatal/pediatric, cardiac, peripheral vascular, and endoscopic (GI tract, airways, tracheobronchial tree) structures. Prescription use only.

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

• SonoSite Hand-Carried Ultrasound System (K003399)
• SonoSite SonoHerat Hand-Carried Echocardiography System (K994096)
• Advanced Technology Laboratories(ALT) HDI 5000 Ultrasound System (K961459)
• Olympus GF Type UM30P Ultrasonic Gastrofiberscope (K963023)
• Olympus GF Type UM130 Ultrasonic Gastrovideoscope (K971660)
• Olympus UM-2R/UM-3R Ultrasonic Probes (K982323)
• Olympus BF Type 240 Bronchovideoscopes (K963033)
• Olympus GIF-1T140 Video Gastroscope (K954451)
• Pentax FG-36UX, Ultrasound Upper GI Fiberscope (K961974)

Submission Summary (Full Text)

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

JUL 2 7 2015

Olympus America, Inc. % Mark Job Program Manager . TUV Product Service 1775 Old Highway 8 N.W., Suite 104 New Brighton, MN 55112-1891

K010591 Re:

> Trade/Device Name: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ODG Dated (Date on orig SE Itr): February 27, 2001 Received (Date on orig SE ltr): February 28, 2001

Dear Mr. Job.

This letter corrects our substantially equivalent letter of March 15, 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 (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/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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System: Olympus EU-C60 EUS EXERA Compact 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 | N | N | | | | B+M | Note 1 |
| | Abdominal | N | N | | | | B+M | Note 1 |
| | Intra-operative (Abdominal<br>organs and vascular) | N | N | | | | B+M | Note 1 |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | N | N | | | | B+M | Note 1 |
| | Pediatric | N | N | | | | B+M | Note 1 |
| | Small Organ (breast,<br>thyroid, testicles.) | N | N | | | | B+M | Note 1 |
| | Neonatal Cephalic | N | N | | | | B+M | Note 1 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | | | | B+M | Note 1 |
| | Trans-vaginal | N | N | | | | B+M | Note 1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | N | | | | B+M | Note 1 |
| | Musculo-skel. (Convent.) | N | N | | | | B+M | Note 1 |
| | Musculo-skel. (Superfic.) | N | N | | | | B+M | Note 1 |
| | Other (spec.) (Note2) | N | N | | | | B+M | Note 1 |
| | Cardiac Adult | N | N | | | | B+M | Note 1 |
| Cardiac | Cardiac Pediatric | N | N | | | | B+M | Note 1 |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | | | | B+M | Note 1 |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Note 1: Other includes Color Power Doppier, combined B and Color Power Doppler, Note 1. Other Includes Only Fower Deppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.

Note 2:

- (1) the gastrointestinal tract and the surrounding organs.
(2) the airways and tracheobronchial tree.

Prescription Use (Per 21 CFR 801.109)

Hinid li. Slym

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

510(k) Number.

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#### System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

### Transducer: ICT/7-4 7.0-4.0 MHz Intracavitary Transducer

| 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 | P | P | | | | B+M | Note 3 |
| | Abdominal | | | | | | | |
| | Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>thyroid, testicles.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | | | | B+M | Note 3 |
| | Trans-vaginal | P | P | | | | B+M | Note 3 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| 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 3: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K003399.

Prescription Use (Per 21 CFR 801.109)

Voriel Ci. Sgomm
(Division Sign-Off)

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

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### System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

#### Transducer: L38/10-5 10.0-5:0 MHz Linear Array

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 | P | P | | | | B+M | Note 3 |
| | Abdominal | P | P | | | | B+M | Note 3 |
| | Intra-operative (Abdominal<br>organs and vascular) | P | P | | | | B+M | Note 3 |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | P | P | | | | B+M | Note 3 |
| | Pediatric. | P | P | | | | B+M | Note 3 |
| | Small Organ (breast,<br>thyroid, testicles.) | P | P | | | | B+M | Note 3 |
| | Neonatal Cephalic | P | P | | | | B+M | Note 3 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | | | | B+M | Note 3 |
| | Musculo-skel. (Superfic.) | P | P | | | | B+M | Note 3 |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | - | - | | | | | |
| Cardiac | Cardiac Pediatric | P | P | | | | B+M | Note 3 |
| | Trans-esophageal (card:) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel. | P | P | | | | B+M | Note 3 |
| | Other (spec.) | | | | | | | |

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

#### Additional Comments:

Note 3: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(K) K003399. Prescription Use (Per 21 CFR 801.109)

Vimil C. Symon
Division Sign-Off

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

Prescription Use (Per 21 CFR 801.109)

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#### System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

#### Transducer: C60/5-2 5.0-2.0 MHz Curved Array

### 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 | P | P | | | | B+M | Note 3 |
| | Abdominal | P | P | | | | B+M | Note 3 |
| | Intra-operative (Abdominal<br>organs and vascular) | P | P | | | | B+M | Note 3 |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | | | | B+M | Note 3 |
| | Small Organ (breast,<br>thyroid, testicles.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | | | | B+M | Note 3 |
| | Cardiac Pediatric | P | P | | | | B+M | Note 3 |
| | 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 3: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(K) K003399. Prescription Use (Per 21 CFR 801.109)

Gird li. Slysion

(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

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### System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

### Transducer: C15/4-2 MHz Curved Array

| 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 | P | P | | | | B+M | Note3 |
| | Abdominal | P | P | | | | B+M | Note3 |
| | Intra-operative (Abdominal<br>organs and vascular) | P | P | | | | B+M | Note3 |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | | | | B+M | Note3 |
| | Small Organ (breast,<br>thyroid, testicles.) | P | P | | | | B+M | Note3 |
| | Neonatal Cephalic | P | P | | | | B+M | Note3 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | | | | B+M | Note3 |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | P | P | | | | B+M | Note3 |
| Cardiac | Cardiac Pediatric | P | P | | | | B+M | Note3 |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | | | | B+M | Note3 |
| | 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:

Note3: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, S-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510() K00339. Prescription Use {Per 21 CFR 801.109}

Yorid C. Nygren

(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

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System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

### Transducer: Olympus GF TYPE UC160P-OL5 EUS EXERA 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 | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>thyroid, testicles.) | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | N | | | | B+M | Note 1 |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.)<br>(Note 2) | N | N | | | | B+M | Note 1 |
| | 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: Other Includes Color Power Doppier, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging for guidance of biopsy.

Note 2:

- (1) the gastrointestinal tract and the surrounding organs.
- (2) the airways and tracheobronchial tree.

Prescription Use (Per 21 CFR 801.109)

Yionil Ci. Veymm

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Device 510(k) Number .

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

## System: Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

### Transducer: Olympus GF TYPE UCT160-OL5 EUS EXERA 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 (Abdominal<br>organs and vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>thyroid, testicles.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | N | N | | | | B+M | Note 1 |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other (spec.)<br>(Note 2) | N | N | | | | B+M | Note 1 |
| 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: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Power Directional Color Power Doppler, 3-D Imaging, Hamonic Imaging, and innaging, and imaging for guidance of biopsy.

Note 2:

(1) the gastrointestinal tract and the surrounding organs.

(2) the airways and tracheobronchial tree.

Prescription Use (Per 21 CFR 801.109)

David G. Layson

ivision of Reproductive, Abdominal. ENT and Radiological Devices 510(k) Number

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

### MAR 1 5 2001

### 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;

Registration Number : Address, Phone and Fax Of R & D Department Endoscope Division

Olympus Optical Co,. Ltd. 2-3-1 Shinjukuku Monolis Nishi-Shinjuku Shinjuku-ku, Tokyo, 163-0914 Japan 810047 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507 Japan 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 :

Tsuyoshi Yanai Manager Regulatory Affairs Quality Assurance Department Endoscope Division

Address, Phone and Fax :

2951 Ishikawa-cho Hachioji-shi, Tokyo 192-85 TEL [phone] FAX [phone]

י נורד התנועה ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצור ליצ

SKII

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#### B. Device Name, Common Name

### 1. Common/Usual Name

Diagnostic Ultrasound System with Accessories

#### 2. Device Name

Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center

#### 3.Classification Name

| | FR Number | Product<br>Code | Class |
|------------------------------------------|-----------|-----------------|-------|
| Bronchoscope and accessories | 874.4680 | KIT | II |
| Endoscope and accessories | 876.1500 | KOG | II |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN | 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 |
|------------------------------------------------------------------|---------|
| SonoSite™ Hand-Carried Ultrasound System | K003399 |
| SonoSite SonoHerat™ Hand-Carried Echocardiography System | K994096 |
| Advanced Technology Laboratories(ALT) HDI 5000 Ultrasound System | K961459 |

#### 2. Ultrasonic Gastrovideoscope

| Device Name | #K |
|---------------------------------------------------|---------|
| Olympus GF Type UM30P Ultrasonic Gastrofiberscope | K963023 |
| Olympus GF Type UM130 Ultrasonic Gastrovideoscope | K971660 |
| Olympus UM-2R/UM-3R Ultrasonic Probes | K982323 |
| Olympus BF Type 240 Bronchovideoscopes | K963033 |
| Olympus GIF-1T140 Video Gastroscope | K954451 |
| Pentax FG-36UX, Ultrasound Upper Gl Fiberscope | K961974 |

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#### D. Device Description

#### 1. Summary

The EU-C60 is a general purpose, compact, software-controlled, diagnostic ultrasound system. The EU-C60 has compatibility with SonoSite transducers (such as abdominal or intracavital transducers) and Olympus Ultrasound videoscope. Its function is to acquire ultrasound data and display it on a monitor in several modes.

( 2D, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes.)

The EU-C60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes.

The GF-UC160P-OL5/GF-UCT160-OL5 give the operator the ability to perform Endocopic Ultrasound(EUS) guided fine needle aspiration(FNA).

#### 2. Design

The EU-C60 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 Balloon3 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-C60, as defined by FDA guidance documents, are:

| Fetal - OB/GYN | Musculo-skeletal (conventional) |
|-----------------------------------------------------------------------------------------------------------|---------------------------------|
| Laparoscopic | Musculo-skeletal (superficial) |
| Intraoperative (abdominal organs and vascular) | Neonatal Cephalic |
| Abdominal | Pediatric |
| Small Organ (breast, thyroid, testicle) | Cardiac-(adult and pediatric) |
| Trans-vaginal | Trans-esophageal (non-cardiac) |
| Trans-rectal | Peripheral Vessel |
| Other<br>1) Gastrointestinal tract and the surrounding Organs<br>2) The airways and tracheobronchial tree | |

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### F. Technological Characteristics:

This device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves matomal in the body. Sound waves are reflected back to the transducer and converted to into the bough "Count are processed and displayed as images. Doppler shift crosed by blood flow is displayed as Color Flow, or as spectrum analysis.

Technological Characteristics of this device is identical to the predicated devicesidentified in item 3.