EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC

{0}------------------------------------------------ # SMDA 510(k) SUMMARY EVIS EXERA Bronchovideoscope Olympus XBF-1T160Y3AC, XBF-160Y3AC, XBF-Q160Y2AC, its accessories and ancillary equipment This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92. # 1. GENERAL INFORMATION | Applicant | Olympus Corporation<br>34-3 Hirai Hinode-machi,<br>Nishitama-gun, Tokyo, 190-0182, Japan<br>Establishment Registration No.: 3003637092 | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission Correspondent | Akiko Fukagawa<br>Olympus Corporation<br>2951 Ishikawa-cho,<br>Hachioji-shi, Tokyo, 192-8507, Japan<br>Phone: +81-426-2891<br>Fax: +81-426-3174<br>E-mail: akiko_fukagawa@ot.olympus.co.jp<br>Establishment Registration No.: 8010047 | | Official Correspondent | Tina Steffanie-Oak<br>Associate Manager, Regulatory Affairs/Clinical Monitor<br>Olympus America Inc.<br>Two Corporate Center Drive, Melville,<br>NY 11747-9058<br>Phone: 631-844-5477<br>Fax: 631-844-5554<br>Establishment Registration No.: 2429304 | ### 2. Device Identification | Trade Name: | EVIS EXERA Bronchovideoscope Olympus XBF-160Y3AC,<br>XBF-1T160Y3AC, XBF-Q160Y2AC, its accessories and ancillary<br>equipment | |--------------------|------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Bronchoscope | | Regulation Name: | Bronchoscope (flexible or rigid) and accessories | | Regulation Number: | 21 CFR 874.4680 | | Class: | II | | Product Code: | EOQ | {1}------------------------------------------------ ### 3. Predicate Device | Predicate Device Name | Manufacturer | 510(k) Number | |-------------------------------------------------------|---------------------------|---------------| | EVIS EXERA Bronchovideoscope<br>Olympus BF type 160 | Olympus Corporation | K023984 | | EVIS EXERA Bronchovideoscope<br>Olympus BF type 1T160 | Olympus Corporation | K023984 | | Olympus Sterilization Trays | Olympus Winter & Ibe GMBH | K033222 | ## 4. Device Description The subject devices, Olympus EVIS EXERA Bronchovideoscope XBF-160Y3AC, XBF-1T160Y3AC, and I XBF-Q160Y2AC are identical to the predicate devices, BF-160 and BF-1T160, in intended use. These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. As for the device specifications, they are basically identical to the BF-160 and BF-1T160 with the exception that the subject devices are now compatible with steam sterilization (autoclave) in addition to ETO gas sterilization. The XBF-Q160Y2AC is loaded with higher pixels in the CCD compared to the predicate device, BF-160. The increase of the number of pixels has contributed to the expansion of image size. However, the resolution at optimum working distance of the XBF-Q160Y2AC is basically the same as that of the predicate device. Therefore, optical performance of the XBF-Q160Y2AC before and after clinical use is identical to the predicate device. In addition to the above scopes, this submission also includes the following devices: - XMAJ-178 (Sterilization Tray) MAJ-1214 (Water-resistant Cap) FB-52C-1 Biopsy Forceps FG-36D Grasping Forceps IE-2P Magnetic Extractor NM-8L-1 Injector NM-9L-1 Injector M1-1G Measuring Device M2-1C Measuring Device M2-2C Measuring Device ## 5. Intended Use of the device ### EVIS EXERA Bronchovideoscope These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. ### Accessories to the EVIS EXERA Bronchovideoscope ### XMAJ-178 (Sterilization Tray) The XMAJ-178 is a sterilization tray intended for use in medical facilities to accommodate the Olympus autoclavable Bronchovideoscopes during autoclaving. {2}------------------------------------------------ #### MAJ-1214 (Water-resistant Cap) The MAJ-1214 is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing. #### FB-52C-1 (Biopsy Forceps) The FB-52C-1 has been designed to be used with an Olympus endoscope to collect tissue within the thoracic and abdominal cavities and the airways and tracheobrochial tree. #### FG-36D (Grasping Forceps) This instrument has been designed to be used with Olympus endoscopes to retrieve foreign r not morth has been specimens from the digestive tract, urinary tract, female reproductive tract and respiratory organs. #### IE-2P (Magnetic Extractor) The Olympus IE-2P magnetic Extractor has been specially designed to be used within the airways and tracheobrochial tree. #### NM-8L-1/NM-9L-1 (Injector) These instruments have been designed to be used with an Olympus endoscope to perform r noo internaments have bomucosal injection within the thoracic and abdominal cavities and the airways and tracheobrochial tree. #### M1-1C/M2-1C/M2-2C (Measuring Device) These measuring devices have been designed for measuring leisions within the thoracic and abdominal cavities and the airways and tracheobochial tree. ## 6. Comparison of Technological Characteristics Below is the comparison table between the subject devices and predicate device. | Specifications | Subject Device<br>XBF-160Y3AC | Subject Device<br>XBF-1T160Y3AC | Subject Device<br>XBF-Q160Y2AC | Predicate Device<br>BF-160 (K023984) | |----------------------------------|-------------------------------|---------------------------------|--------------------------------|--------------------------------------| | Reprocessing | ETO/Autoclaving | ETO/Autoclaving | ETO/Autoclaving | ETO | | Distal end Outer<br>Diameter | $\phi$ 4.9 mm | $\phi$ 5.9 mm | $\phi$ 5.5 mm | $\phi$ 5.3 mm | | Insertion Tube<br>Outer Diameter | $\phi$ 4.9 mm | $\phi$ 6.0 mm | $\phi$ 5.3 mm | $\phi$ 5.2 mm | | Inner Channel<br>Diameter | $\phi$ 2.0 mm | $\phi$ 2.8 mm* | $\phi$ 2.0 mm | $\phi$ 2.0 mm | *Inner Channel Diameter of XBF-1T160Y3AC is identical to that of the other predicate device, BF-1T160. ### 7. Materials Biocompatibility testing was performed in accordance with Japan's Ministry of Health and Welfare notification "GUIDELINES FOR BASIC BIOLOGICAL EVALUATION OF MEDICAL DEVICES" (issued on June 27 1995), YAKKI No.99. {3}------------------------------------------------ ## 8. Conclusion When compared to the predicate device, XBF-160Y3AC, XBF-1T160Y3AC and XBF-Q160Y2AC vvien oompared the prodicant changes in intended use, method of operation, material, or do hot most portule any organisativeness. Therefore, clinical data is not necessary for its evaluation of safety and efficacy.