RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
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 |
Indications for 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
Submission Summary (Full Text)
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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
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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
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## 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)
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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### K221660 - 510(k) Summary
For
## RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
| General Information | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan<br>192-8507<br>Phone: (+81) 42-642-2694<br>Fax: (+81) 42-642-2307<br>Establishment Registration Number: 8010047 |
| Manufacturer: | Aizu Olympus Co., Ltd.,<br>500 Muranishi, Niidera, Monden-machi,<br>Aizuwakamatsu-shi, Fukushima 965-8520,<br>Japan<br>Phone: (+81) 242-28-2111<br>Fax: (+81) 242-26-4234<br>Establishment Registration Number: 9610595 |
| 510(k) Submitter: | Olympus Corporation of the Americas<br>800 West Park Drive<br>Westborough, MA 01518 USA |
| Establishment Registration Number: | 2429304 |
| Contact Person: | Steven Keenan<br>Program Manager<br>Mobile: (508)-523-5004<br>Email: Steven.Keenan@olymus.com |
| Date Prepared: | June 3, 2022 |
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### Device Description
| Model No. | Device/Trade Name | Product Classification |
|-----------|------------------------------------------------|------------------------|
| ENF-XP | RHINO-LARYNGOFIBERSCOPE<br>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/<br>Technological<br>Characteristics | Subject Device<br>ENF-XP | Predicate Device<br>ENF-GP2 | Comparison |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Device Name | RHINO-<br>LARYNGOFIBE<br>RSCOPE<br>OLYMPUS ENF<br>TYPE XP | Rhino-Laryngo<br>Fiberscope ENF-<br>GP2 | Different model names. |
| Regulatory Decision | This submission | K181240 | N/A |
| Feature/<br>Technological<br>Characteristics | Subject Device<br>ENF-XP | Predicate Device<br>ENF-GP2 | Comparison |
| Product Code | EOB | EOB | Same as predicate. |
| Regulation Number | 874.4760 | 874.4760 | Same as predicate. |
| Regulation Name | Nasopharyngosco<br>pe (flexible or<br>rigid) and<br>accessories | Nasopharyngosco<br>pe (flexible or<br>rigid) and<br>accessories | Same as predicate. |
| Intended Use | RHINO-<br>LARYNGOFIBE<br>RSCOPE<br>OLYMPUS ENF<br>TYPE XP is<br>intended to be<br>used with an<br>Olympus video<br>system center,<br>documentation<br>equipment,<br>display monitor,<br>and other<br>ancillary<br>equipment for<br>endoscopic<br>diagnosis.<br>RHINO-<br>LARYNGOFIBE<br>RSCOPE<br>OLYMPUS ENF<br>TYPE XP is<br>indicated for use<br>within the nasal<br>and<br>nasopharyngeal<br>lumen. | This instrument is<br>intended to be<br>used with an<br>Olympus light<br>source,<br>documentation<br>equipment,<br>display monitor<br>and other<br>ancillary<br>equipment for<br>endoscopic<br>diagnosis. This<br>instrument is<br>indicated for use<br>within the nasal<br>and<br>nasopharyngeal<br>lumen. | Similar to predicate. Device name<br>and model number are now<br>included in the Indications for Use<br>statement. The intended use is<br>identical to predicate. |
| Feature/<br>Technological<br>Characteristics | Subject Device<br>ENF-XP | Predicate Device<br>ENF-GP2 | Comparison |
| Mode of Action | When observing<br>nasal or<br>nasopharyngeal<br>lumen, the light<br>emitted from light<br>source enters into<br>the fiberscope via<br>apparatus on<br>connector section<br>and is eventually<br>transmitted and<br>released from<br>examination light<br>outlet in the distal<br>end to supply<br>light by optical<br>fiber bundles.<br>Subsequently the<br>illuminated image<br>reflected into<br>objective lens is<br>sent to the<br>eyepiece section<br>by image fiber<br>bundles. The<br>observer can<br>observe the image<br>directly in the<br>eyepiece section<br>or alternatively,<br>the image can be<br>observed on a<br>monitor generated<br>by a video<br>processor and a<br>camera head<br>attached on the<br>eyepiece. | When observing<br>nasal or<br>nasopharyngeal<br>lumen, the light<br>emitted from light<br>source enters into<br>the fiberscope via<br>apparatus on<br>connector section<br>and is eventually<br>transmitted and<br>released from<br>examination light<br>outlet in the distal<br>end to supply light<br>by optical fiber<br>bundles.<br>Subsequently the<br>illuminated image<br>reflected into<br>objective lens is<br>sent to the<br>eyepiece section<br>by image fiber<br>bundles. The<br>observer can<br>observe the image<br>directly in the<br>eyepiece section<br>or alternatively,<br>the image can be<br>observed on a<br>monitor generated<br>by a video<br>processor and a<br>camera head<br>attached on the<br>eyepiece. | Same as predicate. |
| Optical System Parameters | | | |
| Field of View | 75° | 85° | Although the field of view is<br>different from PD, the area within<br>the view can be adjusted by the<br>advance or retreat of the endoscope.<br>Therefore, the difference in FOV<br>does not affect the safety and<br>effectiveness of the subject device. |
| Direction of View | 0° (Forward<br>viewing) | 0° (Forward<br>viewing) | Same as predicate. |
| Feature/<br>Technological<br>Characteristics | Subject Device<br>ENF-XP | Predicate Device<br>ENF-GP2 | Comparison |
| Depth of Field | 2.5-50 mm | 5-50 mm | The increased range of depth of<br>field covers the PD's depth of field.<br>In addition, although the subject<br>device is compatible with various<br>processors, light sources, and<br>camera heads, this specification is<br>not affected by the variation of the<br>systems. |
| | Bending Section | | |
| Angulation range | Up 130° / Down<br>130° | Up 130° / Down<br>130° | Same as predicate. |
| | Insertion section | | |
| Insertion Tube<br>Diameter – Distal<br>End | 1.8 mm | 3.1 mm | The difference in tube diameter of<br>the distal end for the subject<br>device does not alter or change the<br>indications for use or result in a<br>new intended use. |
| Insertion Tube<br>Diameter –<br>Flexible Outer<br>Diameter | 2.2mm | 3.5mm | The difference in flexible outer<br>diameter of the insertion tube for<br>the subject device does not alter or<br>change the indications for use or<br>result in a new intended use. |
| Insertion Section<br>Working Length | 300 mm | 300 mm | Same as predicate. |
| | Connection to Light Source | | |
| Configuration | Light Guide (LG)<br>cable is not<br>detachable | LG cable is<br>detachable | Cable configuration does not<br>directly affect the safety and<br>effectiveness of the subject device. |
| | Venting Connector | | |
| Venting<br>Connector<br>Position | On LG connector | On control body | Venting connector position does<br>not directly affect the safety and<br>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<br>of the control section, the subject<br>device has a 20mm shorter total<br>length compared with the predicate<br>device. This difference does not<br>alter or change the indications for<br>use or result in a new intended use. |
| Feature/<br>Technological<br>Characteristics | Subject Device<br>ENF-XP | Predicate Device<br>ENF-GP2 | Comparison |
| Compatible<br>Processor | OTV-S200/S300<br>(with light source<br>function) | OTV-SC/SC2<br>OTV-S7V<br>CV-170<br>OTV-S7Pro<br>OTV-S190 | Compatibility of ENF- XP with OTV-<br>S200/S300 was demonstrated with<br>bench performance testing in Section<br>18 confirm that these additional<br>processors do not raise any new<br>questions of safety or effectiveness. |
| Compatible Light<br>Source | OTV-S200/S300<br>(with light source<br>function) | CLV-S190<br>CLV-S40Pro<br>CLH-SC<br>CLL-V1<br>CLL-S1<br>CV-170 | Compatibility of ENF- XP with OTV-<br>S200/S300 (with light source<br>function) was demonstrated with<br>bench performance testing in Section<br>18 confirm that these additional light<br>sources do not raise any new<br>questions of safety or effectiveness. |
| Compatible<br>Monitor | OEV-262H<br>LMD-X310ST*<br>*This can only be<br>combined with<br>OTV-S300. | OEV-141<br>OEV-142<br>OEV-143<br>OEV-201<br>OEV-202<br>OEV-203<br>OEV-181H<br>OEV-191<br>OEV-191H<br>OEV-261H | Compatibility of ENF- XP with OEV-<br>262H and LMD-X310ST was<br>demonstrated with bench performance<br>testing in Section 18 confirm that<br>these additional monitors do not raise<br>any new questions of safety or<br>effectiveness. |
| Compatible<br>Camera Head | CH-S200-XZ-EA<br>CH-S200-XZ-EB | OTV-S7H-1NA-<br>10E/12E<br>OTV-S7H-<br>1N/1NA<br>OTV-S7ProH-<br>HD-10E/12E | Compatibility of ENF- XP with CH-<br>S200-XZ-EA and CH-S200-XZ-EB<br>camera heads was demonstrated with<br>bench performance testing in Section<br>18 confirm that these additional<br>camera heads do not raise any new<br>questions of safety or effectiveness. |
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# OLYMPUS®
#### Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
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# OLYMPUS®
#### Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
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#### 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-<br>1:2005+A1:2012 | Medical electrical equipment – Part 1: General<br>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…
