Who is the manufacturer of RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP?

Olympus Medical Systems Corp. filed the 510(k) submission for RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (K221660).

What is the FDA product code for RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP?

EOB. It is classified under 21 CFR 874.4760 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP

Q: What are the predicate devices for RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP?

RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 (K181240).

K221660 · Olympus Medical Systems Corp. · EOB · Dec 28, 2022 · Ear, Nose, Throat

Device Facts

Record ID	K221660
Device Name	RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
Applicant	Olympus Medical Systems Corp.
Product Code	EOB · Ear, Nose, Throat
Decision Date	Dec 28, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4760
Device Class	Class 2

Intended Use

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

Device Story

The Rhino-Laryngofiberscope Olympus ENF Type XP is a flexible fiberscope used for endoscopic diagnosis of the nasal and nasopharyngeal lumen. It functions by transmitting light from an external source through optical fiber bundles to the distal end to illuminate the target area. The reflected image is captured by an objective lens and transmitted via image fiber bundles to an eyepiece. The observer can view the image directly through the eyepiece or via a monitor when connected to a video processor and camera head. The device is operated by clinicians in a clinical setting. It provides visual access to the nasal and nasopharyngeal anatomy, aiding in diagnosis. The device is a passive optical instrument; it does not contain software or automated analysis algorithms.

Clinical Evidence

No clinical data was provided. Substantial equivalence was supported by non-clinical bench testing, including thermal safety, durability, color performance, image intensity, resolution, photobiological safety, and verification of optical specifications (FOV, direction of view). Biocompatibility was evaluated per ISO 10993-1.

Technological Characteristics

Flexible fiberscope; optical fiber bundles for illumination and image transmission; 0° forward viewing; 75° field of view; 2.5-50 mm depth of field; 1.8 mm distal end diameter; 2.2 mm insertion tube diameter; 300 mm working length; 130° up/down angulation. Sterilization via EO gas. No software or electronic components integral to the scope itself.

Indications for Use

Indicated for use within the nasal and nasopharyngeal lumen for endoscopic diagnosis in patients requiring such procedures.

Regulatory Classification

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

RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 (K181240)

Reference Devices

OER-Pro (K103264)
OER-Mini (K120357)
OER-Elite (K201920)

Related Devices

K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT · The Olympus Optical Co. · Jul 25, 2001
K013591 — XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT · Olympus Optical Co., Ltd. · Dec 26, 2001
K181240 — Rhino-Laryngo Fiberscope Olympus ENF-GP2 · Olympus Medical Systems Corp. · Oct 4, 2018
K221638 — Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 · Olympus Medical Systems Corp. · Sep 19, 2022
K021073 — VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V · Olympus America, Inc. · May 1, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 28, 2022 Olympus Medical Systems Corp. % Steven Keenan Program Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581 Re: K221660 Trade/Device Name: Rhino-Laryngofiberscope Olympus ENF Type XP Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: November 21, 2022 Received: November 21, 2022 Dear Steven Keenan: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Joyce C. Lin -S for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221660 Device Name RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP Indications for Use (Describe) RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image displays the word "OLYMPUS" in a bold, sans-serif font. The text is a dark blue color, which contrasts with the white background. A registered trademark symbol is located to the right of the word. ### K221660 - 510(k) Summary For ## RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP | General Information | | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Phone: (+81) 42-642-2694 Fax: (+81) 42-642-2307 Establishment Registration Number: 8010047 | | Manufacturer: | Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan Phone: (+81) 242-28-2111 Fax: (+81) 242-26-4234 Establishment Registration Number: 9610595 | | 510(k) Submitter: | Olympus Corporation of the Americas 800 West Park Drive Westborough, MA 01518 USA | | Establishment Registration Number: | 2429304 | | Contact Person: | Steven Keenan Program Manager Mobile: (508)-523-5004 Email: Steven.Keenan@olymus.com | | Date Prepared: | June 3, 2022 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. A registered trademark symbol is located to the right of the letter "S". ### Device Description | Model No. | Device/Trade Name | Product Classification | |-----------|------------------------------------------------|------------------------| | ENF-XP | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP | EOB (874.4760) | Classification Name: Generic/Common Name: Regulation Number: Regulatory Class: Product Codes: Review Panel: Nasopharyngoscope (flexible or rigid) and accessories Rhino-Laryngo Fiberscope 874.4760 Class II EOB Ear Nose & Throat ### Predicate Device | Predicate Device | 510(k) No. | |------------------------------------------|------------| | RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 | K181240 | ### Product Description RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen. ### Comparison of Technological Characteristics Table 5-1 compares RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP to the predicate device with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence. ### Table 5-1: Comparison of the technological characteristics of ENF-XP to predicate device | Feature/ Technological Characteristics | Subject Device ENF-XP | Predicate Device ENF-GP2 | Comparison | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory | | | | | Device Name | RHINO- LARYNGOFIBE RSCOPE OLYMPUS ENF TYPE XP | Rhino-Laryngo Fiberscope ENF- GP2 | Different model names. | | Regulatory Decision | This submission | K181240 | N/A | | Feature/ Technological Characteristics | Subject Device ENF-XP | Predicate Device ENF-GP2 | Comparison | | Product Code | EOB | EOB | Same as predicate. | | Regulation Number | 874.4760 | 874.4760 | Same as predicate. | | Regulation Name | Nasopharyngosco pe (flexible or rigid) and accessories | Nasopharyngosco pe (flexible or rigid) and accessories | Same as predicate. | | Intended Use | RHINO- LARYNGOFIBE RSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO- LARYNGOFIBE RSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen. | This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen. | Similar to predicate. Device name and model number are now included in the Indications for Use statement. The intended use is identical to predicate. | | Feature/ Technological Characteristics | Subject Device ENF-XP | Predicate Device ENF-GP2 | Comparison | | Mode of Action | When observing nasal or nasopharyngeal lumen, the light emitted from light source enters into the fiberscope via apparatus on connector section and is eventually transmitted and released from examination light outlet in the distal end to supply light by optical fiber bundles. Subsequently the illuminated image reflected into objective lens is sent to the eyepiece section by image fiber bundles. The observer can observe the image directly in the eyepiece section or alternatively, the image can be observed on a monitor generated by a video processor and a camera head attached on the eyepiece. | When observing nasal or nasopharyngeal lumen, the light emitted from light source enters into the fiberscope via apparatus on connector section and is eventually transmitted and released from examination light outlet in the distal end to supply light by optical fiber bundles. Subsequently the illuminated image reflected into objective lens is sent to the eyepiece section by image fiber bundles. The observer can observe the image directly in the eyepiece section or alternatively, the image can be observed on a monitor generated by a video processor and a camera head attached on the eyepiece. | Same as predicate. | | Optical System Parameters | | | | | Field of View | 75° | 85° | Although the field of view is different from PD, the area within the view can be adjusted by the advance or retreat of the endoscope. Therefore, the difference in FOV does not affect the safety and effectiveness of the subject device. | | Direction of View | 0° (Forward viewing) | 0° (Forward viewing) | Same as predicate. | | Feature/ Technological Characteristics | Subject Device ENF-XP | Predicate Device ENF-GP2 | Comparison | | Depth of Field | 2.5-50 mm | 5-50 mm | The increased range of depth of field covers the PD's depth of field. In addition, although the subject device is compatible with various processors, light sources, and camera heads, this specification is not affected by the variation of the systems. | | | Bending Section | | | | Angulation range | Up 130° / Down 130° | Up 130° / Down 130° | Same as predicate. | | | Insertion section | | | | Insertion Tube Diameter – Distal End | 1.8 mm | 3.1 mm | The difference in tube diameter of the distal end for the subject device does not alter or change the indications for use or result in a new intended use. | | Insertion Tube Diameter – Flexible Outer Diameter | 2.2mm | 3.5mm | The difference in flexible outer diameter of the insertion tube for the subject device does not alter or change the indications for use or result in a new intended use. | | Insertion Section Working Length | 300 mm | 300 mm | Same as predicate. | | | Connection to Light Source | | | | Configuration | Light Guide (LG) cable is not detachable | LG cable is detachable | Cable configuration does not directly affect the safety and effectiveness of the subject device. | | | Venting Connector | | | | Venting Connector Position | On LG connector | On control body | Venting connector position does not directly affect the safety and effectiveness of the subject device. | | | Sterilization | | | | EO | Available | Available | Same as predicate. | | | Other | | | | Suction Function | Not provided | Not provided | Same as predicate. | | Total Length | 530 mm | 550 mm | Due to the difference in the shape of the control section, the subject device has a 20mm shorter total length compared with the predicate device. This difference does not alter or change the indications for use or result in a new intended use. | | Feature/ Technological Characteristics | Subject Device ENF-XP | Predicate Device ENF-GP2 | Comparison | | Compatible Processor | OTV-S200/S300 (with light source function) | OTV-SC/SC2 OTV-S7V CV-170 OTV-S7Pro OTV-S190 | Compatibility of ENF- XP with OTV- S200/S300 was demonstrated with bench performance testing in Section 18 confirm that these additional processors do not raise any new questions of safety or effectiveness. | | Compatible Light Source | OTV-S200/S300 (with light source function) | CLV-S190 CLV-S40Pro CLH-SC CLL-V1 CLL-S1 CV-170 | Compatibility of ENF- XP with OTV- S200/S300 (with light source function) was demonstrated with bench performance testing in Section 18 confirm that these additional light sources do not raise any new questions of safety or effectiveness. | | Compatible Monitor | OEV-262H LMD-X310ST* *This can only be combined with OTV-S300. | OEV-141 OEV-142 OEV-143 OEV-201 OEV-202 OEV-203 OEV-181H OEV-191 OEV-191H OEV-261H | Compatibility of ENF- XP with OEV- 262H and LMD-X310ST was demonstrated with bench performance testing in Section 18 confirm that these additional monitors do not raise any new questions of safety or effectiveness. | | Compatible Camera Head | CH-S200-XZ-EA CH-S200-XZ-EB | OTV-S7H-1NA- 10E/12E OTV-S7H- 1N/1NA OTV-S7ProH- HD-10E/12E | Compatibility of ENF- XP with CH- S200-XZ-EA and CH-S200-XZ-EB camera heads was demonstrated with bench performance testing in Section 18 confirm that these additional camera heads do not raise any new questions of safety or effectiveness. | {5}------------------------------------------------ # OLYMPUS® #### Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP {6}------------------------------------------------ # OLYMPUS® #### Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the right of the word. {8}------------------------------------------------ #### Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP ### Indications for Use RHINO-LARYNGOFIBROSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBROSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen. ### Compliance to Voluntary Standards The following voluntary standards have been applied to the subject devices respectively: | Standard | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI AAMI ES 60601- 1:2005+A1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | | IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | | IEC 62471:2006 | Photobiological safety of lamps and lamp systems | | ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | | ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotox…