← Product Code [EOB](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB) · K021073 # VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K021073) _Olympus America, Inc. · EOB · May 1, 2002 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K021073 ## Device Facts - **Applicant:** Olympus America, Inc. - **Product Code:** [EOB](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB.md) - **Decision Date:** May 1, 2002 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 874.4760 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumens. ## Device Story The Olympus ENF-V is a flexible nasopharyngoscope used for visualization and treatment of nasal and nasopharyngeal lumens. It captures visual data via a distal CCD sensor, replacing the traditional image guide used in the predicate device. The device connects to an Olympus video system center, light source, and display monitor, allowing the clinician to view real-time images on a monitor. The improved optical system provides higher resolution and a wider field of view compared to the predicate. It is operated by a physician or trained clinician in a clinical setting. The output assists in the diagnosis and treatment of nasal/nasopharyngeal conditions. ## Clinical Evidence Bench testing only. Comparison of technical specifications (field of view, resolution, dimensions) provided to demonstrate equivalence to the predicate device. ## Technological Characteristics Flexible nasopharyngoscope featuring a CCD optical system. Key specs: 90° field of view, 5-50 mm depth of field, 3.9 mm insertion tube diameter, 365 mm working length. Operates with external video system center, light source, and monitor. Reprocessing methods are identical to the predicate. ## Regulatory Identification A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier. ## Predicate Devices - XENF-TP ([K013591](/device/K013591.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # MAY 0-1 2002 ## SMDA 510(k) SUMMARY ### VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V #### A. Submitter's Name, Address, Phone and Fax Numbers | Name & Address of manufacturer: | Olympus Optical Co., Ltd. | |---------------------------------|----------------------------------------| | | 2-3-1 Shinjuku Monolis Nishi-Shinjuku, | | | Shinjuku-ku Tokyo, Tokyo 163-0914 | | | Japan | | Registration No.: | 8010047 | | Address, Phone and Fax Numbers: | 2951 Ishikawa-Cho, | | | Hachioji-shi, Tokyo 192-8507 | | | Japan | | | TEL 81-426-42-2891 | | | FAX 81-426-46-5613 | #### B. Name of Contact Person | Name: | Laura Storms-Tyler | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Address, Phone and Fax Numbers: | Olympus America Inc.
Two Corporate Center Drive
Melville, New York 11747-3157
TEL: (631) 844-5688
FAX: (631) 844-5416 | # C. Device Name, Common Name, Classification Name and Predicate Devices | Trade Name: | VISERA RHINO-LARYNGOVIDEOSCOPE
OLYMPUS ENF-TYPE V | |-------------------|---------------------------------------------------------------------------| | Common Name: | Nasopharyngoscope (flexible) and accessories | | Classification: | 21 CFR 874.4760 Nasopharyngoscope (flexible) and
accessories, Class II | | Predicate Device: | XENF-TP (K# 013591) | #### D. Description of the Device(s) The subject device is used for endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens. The optical system is modified from the image guide to CCD and the resolution is improved. {1}------------------------------------------------ Following is the comparison table between the subject ENF-V and the predicate XENF-TP. | Specifications | Subject Device | Predicate Device | |----------------------------------|--------------------------------|--------------------------------| | | ENF-V | XENF-TP | | Field of view | 90° | 85° | | Direction of view | 0° (Forward) | 0° (Forward) | | Depth of field | 5-50 mm | 3-50 mm | | Insertion tube working length | 365mm | 365mm | | Insertion tube outer diameter | $\phi$ 3.9mm | $\phi$ 5.0mm | | Bending section angulation range | Up 130°, Down130° | Up 130°, Down130° | | Total length | 593mm | 620mm | | Optical system | CCD | Image guide | | Resolution (Max, Minimum) | 12.6 Lines/mm
12.6 Lines/mm | 5.62 Lines/mm
0.70 Lines/mm | - ー - Field of view is wider. - - Total length is shorter. - Optical system is CCD which provides observation on a monitor. - Resolution is improved. - The subject device, ENF-V, has the following similarities to the predicate device which has received 510(k) clearance. - The same intended use . - The same operating principle except for the optical system ● - The same reprocessing method . - The same basic endoscope design except for the optical system . - The same body contacting materials 8 In summary, the subject device, ENF-V, described in this substantially equivalent to the predicate device_ ### E. Intended Use of the Device(s) This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAY 0-1 2002 Olympus America Inc. c/o Laura Storms-Tyler Two Corporate Center Drive Melville, NY 11747 Re: K021073 Trade/Device Name: Olympus ENF Type V Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible) and accessories Regulatory Class: Class II Product Code: EOB Dated: March 29, 2002 Received: March 2, 2002 Dear Ms. Storms-Tyler: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be 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); 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. {3}------------------------------------------------ # Page 2 - Laura Storms-Tyler This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 (301) 594-4613. Additionally, for questions on the promotion and advertising of Compinance at (301) 29 - 1 t the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Indications for Use Statement # K021073 510(k) Number(if known): ____Not assigned yet._ Device Name: YISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V # Indications for Use: This instrument has been designed to be used with an Olympus vadeo system source, documentation equipment, display monitor, and other center, light ancillary equipment for endoscopic diagnosis within the nasal and nasopharyngeal lumens. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
Analyst
| |--------------------------------------------------------|-----------------------------------------------------| | | (Division Sign-Off) | | | Division of Ophthalmic Ear, Nose and Throat Devices | | Prescription Use |
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| | (Prescription 21 CFR 801.109) | OR | | | 510(k) Number: K021073 | | | Over-The-Counter Use | (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K021073](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K021073) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com