OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
Device Facts
| Record ID | K093395 |
|---|---|
| Device Name | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE |
| Applicant | Olympus Medical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Jun 17, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment. This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Device Story
The Olympus GF-UCT180 is an ultrasonic gastrovideoscope used in conjunction with the Aloka SSD-α 10 ultrasound system. It functions as an endoscope equipped with an integrated ultrasound transducer. During procedures, the device is inserted into the upper gastrointestinal tract to provide real-time ultrasound imaging and facilitate ultrasound-guided needle aspiration. It is operated by physicians in a clinical setting. The device captures ultrasound signals, which are processed by the connected ultrasound system to produce images on a monitor. These images assist the clinician in visualizing internal structures and guiding biopsy needles for tissue sampling. The device supports diagnostic and therapeutic endoscopic procedures, potentially benefiting patients by enabling minimally invasive tissue acquisition and visualization of the GI tract and surrounding organs.
Clinical Evidence
No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.
Technological Characteristics
Ultrasonic gastrovideoscope featuring an integrated ultrasound transducer. Operates as an ultrasonic pulsed doppler imaging system. Designed for use with external video system centers, light sources, and the Aloka SSD-α 10 ultrasound system. Connectivity via standard endoscopic and ultrasound interfaces. Class II device.
Indications for Use
Indicated for endoscopic real-time ultrasound imaging, ultrasound-guided needle aspiration, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
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
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
Olympus Medical Systems Corporation % Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610
JUL 2 7 2013
Re: K093395
> Trade/Device Name: Olympus GF Type UCT180, Olympus GF Type UST180 Evis Exera II Ultrasound Gastrovideoscope used with ALOKA SSD-α 10 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, ODG and NWB Dated (Date on orig SE ltr): May 26, 2010
Received (Date on orig SE ltr): May 27, 2010
Dear Ms. Kluesner,
This letter corrects our substantially equivalent letter of June 17, 2010.
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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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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# Indications for Use
510(k) Number (if known): K093395
Device Name: OLYMPUS GF-UCT180
Indications For Use:
This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.
This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S.N.B.
(Division Sign-On)
Division of Radiological Devices
Health Diagnostic Device Evaluation and Safety
Page 1 of
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1.3.1 Diagnostic Ultrasound Indications for Use Form
## OLYMPUS GF TYPE UCT180 ULTRASOUND·GASTROVIDEOSCOPE used with the ALOKA SSD-a10 ULTRASOUND SYSTEM
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) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | N | N | N | | N | N | | |
| | 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 | N | | N | N | | |
| | Musculo-skel. (Convent.) | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (spec.)<br>(Note 1) | | N | N | N | | N | N | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (card.) | | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | 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 and Surrounding Organs
(Division Sign On) Division of Radiological De gnostic Device Evalue Office of in Vits
K093395
\$10K
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## ULTRASOUND SYSTEM SSD-a10
| Clinical Application | | Mode of Operation | | | | | | | | | |
|--------------------------------|---------------------------------------|-------------------|----|---|-----|-----|------------------|----------------------|---------------------|------------------|--|
| General<br>(Track I<br>only) | Specific<br>(Tracks I & III) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmi<br>c | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | (Note 3) | | |
| | Abdominal | | P | P | P | | P | P | (Note 3) | | |
| | Intra-operative (specify)<br>(Note 4) | | P | P | P | | P | P | (Note 3) | | |
| | Intraoperative (Neuro.) | | | | | | | | | | |
| Fetal<br>Imaging<br>&<br>Other | Laparoscopic | | | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | (Note 3) | | |
| | Small Organ (specify)<br>(Note 4) | | P | P | P | | P | P | (Note 3) | | |
| | Neonatal Cephalic | | P | P | P | | P | P | (Note 3) | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | ·P | P | P | | P | P | (Note 3) | | |
| | Trans-vaginal | | P | P | P | | P | P | (Note 3) | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | P | P | P | | P | P | (Note 2) | | |
| | Musculo-skel. (Convent.) | | .P | P | P | | P | P | (Note 3) | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | | |
| | Other (spec.)<br>(Note 1) | | P | P | P | | P | P | (Note 2) | | |
| Cardiac | Cardiac | | P | P | P | | P | P | (Note 3) | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | (Note 3) | | |
| | 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:
Note 1: Specification for "Other" :
Airways and tracheobronchial tree, Upper Gastrointestinal Tract and Surrounding Organs
Note 2: Specification for "Combined mode operation" includes:B/M,B/PWD,B/CD/PWD
Note 3: Specification for "Combined mode operation" includes :
B/M, P/PWD, M/CD, B/CD/PWD, B/CWD, B/CD/CWD
Note 4: Specification for "Small Organ" and "Intraoperative" :
Small Parts-breast/ testes/ thyroid, ·
Intra-operative-liver/ pancreas/ gall-bladder/ abdominal, gynecological, fetal, neonatal, cardiac.
cardiac.
SICK
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
6 of 77
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K093395
JUN 17 2010
## 510(k) SUMMARY
## March 9, 2010
## 1 General Information
| | | GF-UCT180 | SSD-a 10 |
|-------|-----------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| 1.2.1 | Manufacture's Name: | OLYMPUS MEDICAL SYSTEMS<br>CORP.<br>HINODE PLANT | ALOKA CO., LTD. |
| | Address: | 34-3 Hirai Hinode-Machi,<br>Nishitama-gun, Tokyo<br>190-0182, Japan | 6-22-1, Mure Mitaka-Shi<br>Tokyo 181-8622, Japan |
| | Corresponding Official: | Stacy Abbatiello Kluesner, RAC<br>Regulatory Affairs & Quality<br>Assurance | Richard J Cehovsky<br>RA/QA Coordinator |
| | Address: | Olympus America Inc.<br>3500 Corporate Parkway<br>PO Box 610<br>Center Valley, PA 18034-0610. | ALOKA CO. LTD USA<br>10 Fairfield blvd.<br>Wallingford, CT 06492 |
| | Telephone: | 484-896-5405 | 203-269-5088 |
| | Facsimile: | 484-896-7128 | |
| | E-mail: | stacy.kluesner@olympus.com | |
| | Applicant's Name: | OLYMPUS MEDICAL SYSTEMS<br>CORP. | |
| | Address: | 2951 Ishikawa-cho, Hachioji-shi,<br>Tokyo, Japan 192-8507 | |
| 1.2.2 | Initial Distributor<br>Name/Title/Firm: | Olympus America Inc. | |
| | Address: | 3500 Corporate Parkway<br>PO Box 610<br>Center Valley, PA 18034-0610, | |
| | Telephone: | 484-896-5688 | |
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#### 2 Device Identification
Device Trade Name:
EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180
| Common Name: | Ultrasonic Endoscope |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 892.1570 Diagnostic Ultrasound Transducer<br>892.1550 Ultrasonic Pulsed Doppler Imaging System<br>892.1560 Ultrasonic Echo Imaging System<br>876.1500 Endoscope and Accessories |
| Regulatory Class: | II |
- Product Code: ITX/ IYN/ KOG/ NWB/ IYO
#### 3 Predicate Device Information
#### Ultrasonic Endoscope
| Subject device | Predicate devices | |
|-----------------------------------------------------------|-------------------------------------------------|----------------|
| | Name | Control number |
| GF-UCT180<br>EVIS EXERA II ULTRASOUND<br>GASTROVIDEOSCOPE | GF-UC140P-AL5<br>ULTRASONIC<br>GASTROVIDEOSCOPE | K011314 |
| SSD-α 10 | ALOKA SSD-α 10 ULTRASOUND<br>SYSTEM | K043196 |
#### 4 Device Description
OLYMPUS GF-UCT180 EVIS EXERA II ULTRASOUND GASTRO VIDEOSCOPE have been designed to be used with the SSD-a10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, monitor, Endo-Therapy accessories such as aspiration biopsy needle and other ancillary equipment.
The subject devices are designed for endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
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#### 5 Indications for Use
This instrument has been designed to be used with an Olympus universal endoscopic ultrasound center or a diagnostic ultrasound system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment, This instrument is designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
### 6 Comparison of Technological Characteristics
When the OLYMPUS GF-UCT180 used with the ALOKA SSD-a10 ULTRASOUND SYSTEM is compared to its predicate device does not incorporate any significant changes in its intended use, method of operation, material or design that could affect the safety and effectiveness, Technological characteristics of ALOKA SSD-a10 ULTRASOUND SYSTEM is identical to the predicate devices identified in above item 3.
