This instrument has been designed to be used with an OLYMPUS compact endoscopic ultrasound center, video system center, light source, documentation equipment, video monitor, Endo-therapy accessories and other ancillary equipment for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.
Device Story
Ultrasonic endoscope (BF type UC160F-OL8) used for real-time ultrasonic imaging and ultrasound-guided fine needle aspiration (FNA). Device inputs: ultrasonic signals reflected from body tissues; optical images from internal CCD. Operation: transducer transmits piezoelectric pulses into body; reflected waves processed into ultrasonic images; fiber bundle and CCD capture endoscopic video. Used in clinical settings by physicians. Output: real-time ultrasonic and endoscopic video displayed on monitor. Assists in biopsy guidance and visualization of airway/GI tract structures. Benefits: enables minimally invasive diagnostic imaging and tissue sampling.
Clinical Evidence
Bench testing only. No clinical data required as the device does not incorporate significant changes in intended use, method of operation, or design compared to legally marketed predicate devices.
Technological Characteristics
Ultrasonic endoscope with integrated CCD and fiber bundle. Transducer surface uses biocompatible material. Operates with OLYMPUS EU-C60 EUS EXERA center. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, and CISPR11 standards.
Indications for Use
Indicated for patients requiring endoscopic real-time ultrasonic imaging, ultrasound-guided needle aspiration, and endoscopic procedures within the airway, tracheobronchial tree, gastrointestinal tract, and surrounding organs.
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
Ultrasonic Bronchofiberscope BF type UM40 (K021204)
EU-C60 Compact Endoscopic ultrasound Center (EVIS EXERA Ultrasonic Gasrovideoscope GF type UC160P-OL5) (K010591)
Ultrasonic Gasrovideoscope GF type UC160P-AT8 (K031347)
Submission Summary (Full Text)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002
Olympus Corporation
% Mr. Derwyn Reuber
Vice President
Intertek Testing Services NA, Inc.
70 Codman Hill Road
Boxborough, MA 01719
JUL 27 2015
Re: K042140
Trade/Device Name: EVIS EXERA Ultrasonic Bronchofibervideoscope
OLYMPUS BF Type UC160F-OL8, OLYMPUS EU-C60 EUS
EXERA Compact Endoscopic Ultrasound Center
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: ODG, FDS, EOQ and ITX
Dated (Date on orig SE ltr): August 4, 2004
Received (Date on orig SE ltr): August 9, 2004
Dear Mr. Reuber,
This letter corrects our substantially equivalent letter of August 18, 2004.
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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# 4.3.2 OLYMPUS EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center
## 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 | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Abdominal organs and vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, 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.) (Note 2) | N | N | | | | B+M | Note 1 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other"
(1) the gastrointestinal tract and the surrounding organs.
(2) the airways and tracheobronchial tree.
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)
Section 4.2 Page 5
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# 4.3 Indication for use :
## 4.3.1 EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF type UC160F-OL8 Diagnostic Ultrasound Indications for Use Form
Intended Use: Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:
| Clinical Application | | Mode of Operation | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Abdominal organs and vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, 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.) (Note 2) | N | N | | | | B+M | Note 1 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other"
(1) the gastrointestinal tract and the surrounding organs.
(2) the airways and tracheobronchial tree.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 601.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
610(k) Number
K642140
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AUG 18 2004
K042140
Page 1 of 3
May 11, 2004
# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
## A. Applicant, Submission Correspondent, Initial Importer, Official Correspondent
1. Applicant & Manufacture :
OLYMPUS CORPORATION
34-3 Hirai Hinode-machi,
Nishitama-gun, Tokyo, 190-0182 ,Japan
(Registration Number : 3003637092)
2. Submission Correspondent :
Masao Wada
OLYMPUS CORPORATION
2951 Ishikawa-cho, Hachiouji-shi, Tokyo
192- 8507, Japan
Telephone :81-426-42-2891
Facsimile : 81-426-42-2291
E-mail : m_wada@ot.olympus.co.jp
(Registration Number : 8010047)
3. Initial Importer :
OLYMPUS AMERICA INC.
Two Corporate Center Drive, Melville,
NY 11747-3157
(Registration Number : 2429304)
4. Official Correspondent :
Tina-Steffanie-Oak
Associate Manager Regulatory Affair
Clinical Monitor
OLYMPUS AMERICA INC.
Two Corporate Center Drive, Melville,
NY 11747-3157
Telephone :631-844-5477
Facsimile : 631-844-5416
E-mail : Tina, Steffainie-Oak@olympus.com
(Registration Number :2429304)
## B. Device Name, Common Name
1. Common/Usual Name
Ultrasonic endoscope
50
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142140
143
## 2. Device Name
- EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF type UC160F-OL8
## 3. Classification Name
| | CFR Number | Product Code | Class |
| --- | --- | --- | --- |
| Endoscope and accessories | 876.1500 | KOG | II |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX | II |
## C. Identification of the predicate or legally marketed device
The following devices are the predicate medical devices.
| Device Name | #K |
| --- | --- |
| Ultrasonic Bronchofiberscope BF type UM40 | K021204 |
| EVIS EXERA Ultrasonic Bronchofibervideoscope BF typeXP160F | K033225 |
| EU-C60 Compact Endoscopic ultrasound Center (EVIS EXERA Ultrasonic Gasrovideoscope GF type UC160P-OL5) | K010591 |
| Ultrasonic Gasrovideoscope GF type UC160P-AT8 | K031347 |
## D. Device Description
### 1. Summary
The subject device has been designed to be used with the OLYMPUS EU-C60 EUS EXERA Compact Endoscopic ultrasound center, OLYMPUS video system center, light source, documentation equipment, display monitor, Endo-therapy accessories such as an aspiration biopsy needle.
The subject device is designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airways and trancheobronchial tree and the gastrointestinal tract.
### 2. Design
The subject device 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 for transducer surface of the subject device has a new patient-contacting material. The Biocompatibility test reports of the new material show that the new material is safe for its intended use.
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Page 3 of 3
## E. Intended Use:
The intended use of these devices, as defined by FDA guidance documents is:
This instrument has been designed to be used with an OLYMPUS compact endoscopic ultrasound center, video system center, light source, documentation equipment, video monitor, Endo-therapy accessories and other ancillary equipment for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.
## F. Comparison Technological Characteristics:
The subject device operates identically to the predicate device (K010591) 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 ultrasonic images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis.
The subject device is basically identical to the predicate device (K021024), except that the subject device is equipped with the CCD in the control section, as well as the fiber bundle in the insertion tube. Images are transmitted through the fiber bundle and the CCD in the control section changes them to video signals. then, the endoscopic image is displayed on the monitor. This is identical with EVIS EXERA Ultrasonic Bronchofibervideoscope (K033225).
## G. Conclusion
When compared to the predicate device, the BF type UC160F-OL8 does not incorporate any significant changes in the intended use, method of operation, or design that could affect safety and effectiveness. Therefore, clinical data is not necessary for evaluation of safety and efficacy.
