(105 days)
No
The summary describes a standard endoscope and its accessories, focusing on physical and performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is strictly for "endoscopic diagnosis" and does not mention any therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "intended for endoscopic diagnosis."
No
The device description and performance studies clearly indicate this is a hardware device (videoscope) with associated software, not a software-only medical device. The studies include bench testing for physical properties, biocompatibility, sterilization, and electrical safety, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The description clearly states that the RHINO-LARYNGO VIDEOSCOPEs are used for "endoscopic diagnosis" within the "nasal lumens and airway anatomy." This involves directly visualizing internal body structures.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the patient. The device is used for direct observation.
Therefore, this device is an endoscopic device used for direct visualization and diagnosis within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH are intended to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).
Product codes (comma separated list FDA assigned to the subject device)
EOB, NWB
Device Description
Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (CCD)
Anatomical Site
nasal lumens and airway anatomy (including nasopharynx and trachea)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. NonClinical Bench Testing
- Thermal Safety: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH, Thermal safety performance test verified compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009-08.
- Composite Durability: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH, Durability test against composite stress of mechanical stress demonstrates the subject device retains its safety and effectiveness against the stresses expected in its use-life.
- Noise and Dynamic Range: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH, The substantial equivalence of Noise and Dynamic range between the subject device and predicate device connected with Video System Center / Light Source was confirmed and verified compliant to ISO 15739:2017.
- Color Performance: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH, The color performance of the subject devices is confirmed as substantially equivalent to the predicate devices in the WLI and NBI observation mode.
- Image Intensity Uniformity: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH, The image intensity uniformity of the subject devices is confirmed as substantially equivalent to the predicate devices.
- Resolution: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH, The resolution of the subject device is confirmed as substantially equivalent to the predicate device.
- Photobiological Safety: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH, The photobiological safety test verified compliance to IEC 32471:2006-07 and confirms the light emitted from subject devices connected to each light source is low enough not to cause injury to the skin and eve.
2. Animal Test: Animal testing was not applicable and not performed.
3. Biocompatibility Evaluation: Biocompatibility evaluation of the patient contacting materials of the RHINO-LARYNGO VIDEOSCOPES OLYMPUS ENF-V3 and ENF-VH (categorized as a surface medical device with mucosal membrane contact and limited contact (≤24 hours)) was successfully validated by testing on the subject devices according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. The overall conclusion is that the Biological Risk associated with this device is acceptable for the intended use.
4. Sterilization, Shelf Life, Reprocessing: RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH and their reusable accessories are not sterilized before shipment. Before using these instruments for the first time and after using the endoscopes, the devices must be reprocessed according to the instructions given in the subject endoscope's companion Reprocessing Manual. All cleaning. disinfection, and sterilization methods were validated pursuant to Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015. The reprocessing validation was conducted. ENF-VH/V3 are validated as safe and effective for reprocessing with the following: Manual Cleaning using FlexClean895, Manual Cleaning using Endozime AW, Manual Cleaning with pre-soaking using Endozime AW, Manual Disinfection (2-3.5% glutaraldehyde), OER-Pro (K103264), OER-Mini (K120357), OER-Elite (K201920), Sterilization with EO Gas, Sterilization with STERRAD NX, Sterilization with STERRAD 100S.
5. Electrical Safety and Electromagnetic Compatibility (EMC): Electrical safety and EMC performance testing have been confirmed for the subject devices. RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH were found to be in compliance with the relevant requirements noted below.
6. Software Verification and Validation Testing: Software testing has been performed and documented to be in compliance with the FDA guidance "Guidance for the Content of Premarket Submissions for Software contained in medical devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
7. Risk Analysis: Risk management has been performed in accordance with ISO 14971:2007. In the risk management process, Olympus determined that human factors validation testing was not required for the subject device in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Refer to the risk management table for the RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH. To date, with respect to perceivable conditions in which the device would be subjected to a worst-case environmental for human error scenario, Olympus believes that the outcomes of these risks are considered acceptable within the context of ISO 14971:2007 and that all potential risks have been mitigated to the lowest form.
8. Clinical Testing: Clinical testing was not applicable and not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
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.(b)
Classification. Class II.
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September 19, 2022
Olympus Medical Systems Corp. % Brenda Geary Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K221638
Trade/Device Name: Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB, NWB Dated: August 9, 2022 Received: August 18, 2022
Dear Brenda Geary:
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.
1
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 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 (QS) 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 medical devices and radiation-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,
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and Ear, Nose and Throat Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) TBD
Device Name
RHINO-LARYNGO VIDEOSCOPE, OLYMPUS MODEL: ENF-VH RHINO-LARYNGO VIDEOSCOPE, OLYMPUS MODEL: ENF-V3
Indications for Use (Describe)
RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH are intended to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGO VIDEOSCOPEs OLY MPUS ENF-V3 and ENF-VH is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3
| 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: | Shirakawa Olympus Co., Ltd. |
| 3-1 Okamiyama, Odakura, Nishigo-mura, | |
| Nishishirakawa-gun, Fukushima 961-8061, | |
| Japan | |
| Phone: (+81) 248-27-2239 | |
| Fax: (+81) 248-27-2429 | |
| Establishment Registration Number: | |
| 3002808148 | |
| Aizu Olympus Co., Ltd., | |
| 500 Muranishi, Niidera, Monden-machi, | |
| Aizuwakamatsu-shi, Fukushima 965-8520, | |
| Japan | |
| Phone: (+81) 242-28-2111 | |
| Fax: (+81) 81-242-26-4234 | |
| Establishment Registration Number: 9610595 | |
| 510(k) Submitter: | Olympus Corporation of the Americas |
| 800 West Park Drive | |
| Westborough, MA 01581 USA | |
| Establishment Registration Number: | 2429304 |
| Contact Person: | Brenda M Geary |
| Manager, Regulatory Affairs | |
| Mobile: (508) 683-9561 | |
| Email: brenda.geary@olympus.com | |
| Date Prepared: | 3 June 2022 |
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Device Description
| Model No. | Device/Trade Name | Product Classification |
|---|---|---|
| ENF-VH | RHINO-LARYNGO VIDEOSCOPE | EOB (874.4760) |
| ENF-V3 | RHINO-LARYNGO VIDEOSCOPE | NWB |
| Classification Name: | Nasopharyngoscope (flexible or rigid) and accessories,
Endoscope and accessories | |
|----------------------|-------------------------------------------------------------------------------------|--|
| Generic/Common Name: | Rhino-Laryngo Videoscope | |
| Regulation Number: | 874.4760 | |
| Regulatory Class: | Class II | |
| Product Codes: | EOB, NWB | |
| Review Panel: | Ear Nose & Throat | |
Predicate Devices
| Predicate Device | 510(k) No. |
|---|---|
| RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V4 | K182102 |
Product Description
Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).
Comparison of Technological Characteristics
Table 5-1 compares ENF-VH 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.
| Feature/Technological
Characteristics | Subject Device
ENF-VH | Predicate Device
ENF-VH2 | Comparison |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Device Name
(Model) | Rhino-Laryngo
Videoscope
(ENF-VH) | Rhino-Laryngo
Videoscope
(ENF-VH2) | Model names differ. |
| Regulatory Decision | This submission | K182102 | N/A |
| Product Code | EOB, NWB | EOB, NWB | Same as predicate |
| Regulation Number | 874.4760, | 874.4760, | Same as predicate |
| Regulation Name | Nasopharyngoscope
(flexible or rigid) and
accessories, Endoscope
and accessories | Nasopharyngoscope
(flexible or rigid) and
accessories, Endoscope
and accessories | Same as predicate |
| Feature/Technological
Characteristics | Subject Device
ENF-VH | Predicate Device
ENF-VH2 | Comparison |
| Intended Use | RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS ENF-VH
is intended to be used
with an Olympus video
system center, light
source, documentation
equipment, display
monitor, and other
ancillary equipment for
endoscopic diagnosis.
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS ENF-VH is
indicated for use within
the nasal lumens and
airway anatomy
(including nasopharynx
and trachea). | This instrument is intended
to be used with an
Olympus video system
center, light source,
documentation equipment,
display monitor, and other
ancillary equipment for
endoscopic diagnosis. This
instrument is indicated for
use within the nasal lumens
and airway anatomy
(including nasopharynx
and trachea). | Similar to predicate.
Device name and model
number are now
included in the
Indications for Use
statement. The actual
intended use is identical. |
| Mode of Action | The endoscope receives
the illumination light
from the light source by
light guide connector
connected to the light
source device. The
illumination light is
transferred to the distal
end through the optical
fiber bundle inside of the
endoscope and
illuminates the inside of
the patient body through
the illumination lens at
the distal end. The
endoscope receives the
reflected light from the
inner lumen of a patient
by objective lens at the
distal end. | The endoscope receives
the illumination light from
the light source by light
guide connector
connected to the light
source device. The
illumination light is
transferred to the distal
end through the optical
fiber bundle inside of the
endoscope and illuminates
the inside of the patient
body through the
illumination lens at the
distal end. The endoscope
receives the reflected light
from the inner lumen of a
patient by objective lens
at the distal end. | Same as predicate |
| Optical System Parameters | | | |
| Field of View | 110° | 110° | Same as predicate |
| Direction of View | 0° forward viewing | 0° forward viewing | Same as predicate |
| Depth of Field
(Refer to Attachment
12-B for the definition) | 5-50 mm | 5-50 mm | Same as predicate |
| Imaging System | | | |
| Type of Chip | Color CCD | Color CCD | Same as predicate |
| No. of Image Sensor
Chip | 1 | 1 | Same as predicate |
| NBI observation | Available | Available | Same as predicate |
| Control Section | | | |
| Feature/Technological
Characteristics | Subject Device
ENF-VH | Predicate Device
ENF-VH2 | Comparison |
| Control Section | Image: Subject Device ENF-VH | Image: Predicate Device ENF-VH2 | The control section of
the Rhino-Laryngo
Videoscopes (ENF-
VH/V3) were designed
have the same control
mechanism however
they are designed to be
handled with up-right
functionality rather than
a pistol and trigger grip.
The difference in the
ergonomic design does
not raise new questions
of safety and
effectiveness
This difference does not
alter or change the
indications for use or
result in a new intended
use. |
| Total Length | 510 mm | 500 mm | Similar
Total length difference is
due to change in design
of the control section for
the subject device. This
difference does not alter
or change the indications
for use or result in a new
intended use. |
| Insertion section | | | |
| Insertion Tube
Diameter - Distal End | 3.9 mm | 3.9 mm | Same as predicate |
| Insertion Tube
Diameter - Flexible
Outer Tube | 3.6 mm | 3.6 mm | Same as predicate |
| Insertion Section Working
Length | 300 mm | 300 mm | Same as predicate |
| Bending section | | | |
| Angulation range | Up 130° / Down 130° | Up 130° / Down 130° | Same as predicate |
| Connection to Light Source | | | |
| Configuration | Light guide (LG) cable
is not detachable | Light guide (LG) cable
is not detachable | Same as predicate |
| Venting Connector | | | |
| Position | On LG connector | On LG connector | Same as predicate |
| Sterilization | | | |
| EO | Available | Available | Same as predicate |
| STERRAD NX | Available | Available | Same as predicate |
| STERRAD 100S | Available | Available | Same as predicate |
| Feature/Technological
Characteristics | Subject Device
ENF-VH | Predicate Device
ENF-VH2 | Comparison |
| Compatible Processor | OTV-S200/S300
OTV-S190
CV-170 | OTV-S190
CV-170 | For VH- qualified
additional processors
OTV-S200/S300.
Compatibility of ENF-
VH 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 | CLV-S190
CLL-S1 | CLV-S190
CLL-S1 | Same as predicate |
| Compatible Monitor | OEV262H
LMD-X310ST*
*This can only be
combined with OTV-S300. | OEV262H
OEV-261H
OEV-191H | For VH- qualified
LMD-X310ST.
Compatibility of ENF-
VH with LMD-
XS310ST was
demonstrated during
electrical safety and
electromagnetic
compatibility testing
described in Section 17
confirm that this monitor
does not raise new
questions of safety or
effectiveness. |
Table 5-1: Comparison of the technological characteristics of ENF-VH to predicate device
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RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-VH, ENF-V3
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Traditional 510(k) Notification RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3
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Table 5-2 compares subject device ENF-V3 to the predicate device ENF-V4 with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
| Feature/ Technological
Characteristics | Subject Device
ENF-V3 | Predicate Device
ENF-V4 | Comparison |
|-------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------|
| Regulatory | | | |
| Device Name
(Model) | Rhino-Laryngo
Videoscope
(ENF-V3) | Rhino-Laryngo
Videoscope
(ENF-V4) | Model names differ |
| Regulatory Decision | This submission | K182102 | N/A |
| Product Code | Same as predicate | EOB, NWB | Same as predicate |
| Regulation Number | Same as predicate | 874.4760 | Same as predicate |
| Regulation Name | Same as predicate | Nasopharyngoscope
(flexible or rigid) and
accessories, Endoscope
and accessories. | Same as predicate |
| Intended Use | RHINO-LARYNGO
VIDEOSCOPE | This instrument is
intended to be used with | Similar to predicate.
Device name and model |
| Table 5-2: Comparison of the technological characteristics of ENF-V3 to predicate device |
|---|
| ------------------------------------------------------------------------------------------ |
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Traditional 510(k) Notification RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3
| Feature/ Technological
Characteristics | Subject Device
ENF-V3 | Predicate Device
ENF-V4 | Comparison |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | OLYMPUS ENF-V3 is
intended to be used with
an Olympus video
system center, light
source, documentation
equipment, display
monitor, and other
ancillary equipment for
endoscopic diagnosis.
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS ENF-V3 is
indicated for use within
the nasal lumens and
airway anatomy
(including nasopharynx
and trachea). | an Olympus video system
center, light source,
documentation equipment,
display monitor, and other
ancillary equipment for
endoscopic diagnosis. This
instrument is indicated for
use within the nasal
lumens and airway
anatomy (including
nasopharynx and trachea). | number are now included
in the Indications for Use
statement. The actual
intended use is identical. |
| Mode of Action | The endoscope receives
the illumination light
from the light source by
light guide connector
connected to the light
source device. The
illumination light is
transferred to the distal
end through the optical
fiber bundle inside of
the endoscope and
illuminates the inside of
the patient body through
the illumination lens at
the distal end. The
endoscope receives the
reflected light from the
inner lumen of a patient
by objective lens at the
distal end. | The endoscope receives
the illumination light from
the light source by light
guide connector connected
to the light source device.
The illumination light is
transferred to the distal
end through the optical
fiber bundle inside of the
endoscope and illuminates
the inside of the patient
body through the
illumination lens at the
distal end. The endoscope
receives the reflected light
from the inner lumen of a
patient by objective lens at
the distal end. | Same as predicate |
| Optical System Parameters | | | |
| Field of View | 90° | 90° | Same as predicate |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing | Same as predicate |
| Depth of Field
(Refer to Attachment
12-B for the definition) | *3.5-50 mm | *3.5-50 mm | Same as predicate |
| Imaging System | | | |
| Type of Chip | Color CCD | Color CCD | Same as predicate |
| Number of Image
Sensor Chip | 1 | 1 | Same as predicate |
| NBI Observation | Available | Available | Same as predicate |
9
Image /page/9/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The word is underlined by a thin, yellow line. A registered trademark symbol is located to the right of the word.
| Traditional 510(k) Notification | |
|---|---|
| RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3 |
| Feature/ Technological
Characteristics | Subject Device
ENF-V3 | Predicate Device
ENF-V4 | Comparison |
|-----------------------------------------------------|-------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control Section | | | |
| Control Section | Image: ENF-V3 Control Section | Image: ENF-V4 Control Section | The control section of the
Rhino-Laryngo
Videoscopes (ENF-
VH/V3) were designed
have the same control
mechanism however they
are designed to be
handled with up-right
functionality rather than a
pistol and trigger grip.
The difference in the
ergonomic design does
not raise new questions
of safety and
effectiveness
This difference does not
alter or change the
indications for use or
result in a new intended
use. |
| Total Length | 510 mm | 500mm | Total length difference is
due to change in design
of the control section for
the subject device.
This difference does not
alter or change the
indications for use or
result in a new intended
use. |
| Insertion section | | | |
| Insertion Tube
Diameter - Distal End | 2.6 mm | 2.6 mm | Same as predicate |
| Insertion Tube
Diameter - Flexible
Outer Tube | 2.9 mm | 2.9 mm | Same as predicate |
| Insertion Section
Working Length | 300 mm | 300 mm | Same as predicate |
| Bending section | | | |
| Angulation Range | Up 130° / Down 130° | Up 130° / Down 130° | Same as predicate |
| Venting Connector | | | |
| Position | On LG connector | On LG connector | Same as predicate |
| Sterilization | | | |
| EO | Available | Available | Same as predicate |
| STERRAD NX | Available | Available | Same as predicate |
| STERRAD 100S | Available | Available | Same as predicate |
10
Image /page/10/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 small registered trademark symbol is located to the right of the letter "S".
| Traditional 510(k) Notification | ||
|---|---|---|
| RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3 |
| Feature/ Technological
Characteristics | Subject Device
ENF-V3 | Predicate Device
ENF-V4 | Comparison |
|-------------------------------------------|--------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible Processor | OTV-S200/S300
OTV-S190
CV-170 | OTV-S190
CV-170 | For V3- qualified
additional processor
OTV-S200/S300.
Compatibility of ENF-
V3 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 | CLV-S190
CLL-S1 | CLV-S190
CLL-S1 | Same as predicate |
| Compatible Monitor | OEV-262H
LMD-X310ST*
- This can be combined
with only OTV-S300. | OEV-262H
OEV-261H
OEV-191H | For V3- qualified
LMD-
X310ST.Compatibility of
ENF-V3 with LMD-
XS310ST was
demonstrated during
electrical safety and
electromagnetic
compatibility testing
described in Section 17
confirm that this monitor
does not raise new
questions of safety or
effectiveness. |
Indications for Use
RHINO-LARYNGO VIDEOSCOPES OLYMPUS ENF-V3 and ENF-VH are intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH are indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).
Compliance to Voluntary Standards
The following voluntary standards have been applied to the subject devices respectively:
| Standard | |
|---|---|
| ANSI AAMI ES 60601- | Medical electrical equipment – Part 1: General |
| 1:2005+A1:2012 | 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 | |
| ANSI AAMI IEC 60601-1- | |
| 2:2014 | Medical electrical equipment - Part 1-2: General |
| requirements for basic safety and essential performance - | |
| Collateral standard: Electromagnetic compatibility - | |
| Requirements and tests (Edition 3) | |
| ISO 15739:2017 | Photography - Electronic still-picture imaging – Noise |
| measurements | |
| 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 cytotoxicity | |
| ISO 10993-10:2010 | Biological evaluation of medical devices – Part 10: Tests |
| for irritation and skin sensitization | |
| ISO 10993-12:2012 | Biological evaluation of medical devices – Part 12: |
| Sample preparation and reference materials | |
| ISO 10993-17:2002 | Biological evaluation of medical devices – Part 17: |
| Establishment of allowable limits for leachable substances | |
| ISO 10993-18:2020 | Biological evaluation of medical devices – Part 18: |
| Chemical characterization of medical device materials | |
| within a risk management process | |
| ISO 11135:2014 | Sterilization of health care products – Ethylene Oxide – |
| requirements for development, validation and routine | |
| control of a sterilization process for medical devices | |
| ISO 10993-7: 2008 | Biological evaluation of medical devices – Part 7: |
| Ethylene oxide sterilization residuals [Including: | |
| Technical Corrigendum 1 (2009), AMENDMENT 1: | |
| Applicability of allowable limits for neonates and infants | |
| (2019) | |
| ISO 14971:2007 | Medical Devices – Application of risk management to |
| medical devices | |
| FDA Device Specific Guidance | |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling | |
| Guidance for Industry and Food and Drug Administration Staff | |
| FDA Guidance Use of International Standard ISO 10993-1, ‘Biological evaluation of | |
| medical devices - Part 1: Evaluation and testing within a risk management process | |
| Guidance for the Content of Premarket Submissions for Software contained in Medical | |
| Devices | |
| FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices |
11
Image /page/11/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The font is sans-serif and the letters are closely spaced together. A small registered trademark symbol is located to the right of the "S".
Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
12
1. NonClinical Bench Testing
| Item | Applicable Device | Contents |
|---|---|---|
| Thermal Safety | ENF-VH | Thermal safety performance test verified compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009-08. |
| ENF-V3 | ||
| Composite Durability | ENF-VH | The durability test against composite stress of mechanical stress demonstrates the subject device retains its safety and effectiveness against the stresses expected in its use-life. |
| ENF-V3 | ||
| Noise and Dynamic Range | ENF-VH | The substantial equivalence of Noise and Dynamic range between the subject device and predicate device connected with Video System Center / Light Source was confirmed and verified compliant to ISO 15739:2017. |
| ENF-V3 | ||
| Color Performance | ENF-VH | The color performance of the subject devices is confirmed as substantially equivalent to the predicate devices in the WLI and NBI observation mode. |
| ENF-V3 | ||
| Image Intensity Uniformity | ENF-VH | The image intensity uniformity of the subject devices is confirmed as substantially equivalent to the predicate devices. |
| ENF-V3 | ||
| Resolution | ENF-VH | The resolution of the subject device is confirmed as substantially equivalent to the predicate device. |
| ENF-V3 | ||
| Photobiological Safety | ENF-VH | The photobiological safety test verified compliance to IEC 32471:2006-07 and confirms the light emitted from subject devices connected to each light source is low enough not to cause injury to the skin and eve. |
| ENF-V3 |
2. Animal Test
Animal testing was not applicable and not performed.
3. Biocompatibility Evaluation
Biocompatibility evaluation of the patient contacting materials of the RHINO-LARYNGO VIDEOSCOPES OLYMPUS ENF-V3 and ENF-VH (categorized as a surface medical device with mucosal membrane contact and limited contact (≤24 hours)) was successfully validated by testing on the subject devices according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. The overall conclusion is that the Biological Risk associated with this device is acceptable for the intended use.
4. Sterilization, Shelf Life, Reprocessing
RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH and their reusable accessories are not sterilized before shipment. Before using these instruments for the first time and after using the endoscopes, the devices must be reprocessed according to the instructions given in the subject endoscope's companion Reprocessing Manual. All cleaning. disinfection, and sterilization methods were validated pursuant to Reprocessing Medical
13
Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015. The reprocessing validation was conducted. ENF-VH/V3 are validated as safe and effective for reprocessing with the following:
- Manual Cleaning using FlexClean895 ●
- Manual Cleaning using Endozime AW
- Manual Cleaning with pre-soaking using Endozime AW
- Manual Disinfection (2-3.5% glutaraldehyde) ●
- OER-Pro (K103264)
- . OER-Mini (K120357)
- OER-Elite (K201920)
- Sterilization with EO Gas
- Sterilization with STERRAD NX
- . Sterilization with STERRAD 100S
5. Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC performance testing have been confirmed for the subject devices. RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH were found to be in compliance with the relevant requirements noted below.
| Standards | |
|---|---|
| IEC 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 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General |
| requirements for basic safety and essential performance - | |
| Collateral standard: Electromagnetic compatibility - | |
| Requirements and tests (Edition 3) |
6. Software Verification and Validation Testing
Software testing has been performed and documented to be in compliance with the FDA guidance "Guidance for the Content of Premarket Submissions for Software contained in medical devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
7. Risk Analysis
Risk management has been performed in accordance with ISO 14971:2007. In the risk management process, Olympus determined that human factors validation testing was not required for the subject device in accordance with the FDA Guidance, "Applying Human
14
OLYMPUS
Factors and Usability Engineering to Medical Devices. " Refer to the risk management table for the RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH. To date, with respect to perceivable conditions in which the device would be subjected to a worst-case environmental for human error scenario, Olympus believes that the outcomes of these risks are considered acceptable within the context of ISO 14971:2007 and that all potential risks have been mitigated to the lowest form.
8. Clinical Testing
Clinical testing was not applicable and not performed.
Substantial Equivalence
It is concluded that the safety and effectiveness of RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH are substantially equivalent to the legally marketed predicate devices, Rhino-Laryngo Videoscopes Olympus ENF-VH2 and ENF-V4 (K182102), respectively. Olympus claims substantial equivalence to the predicate devices based on evaluation of the on similarities in indications for use, design, materials, principle of operation, technological and performance characteristics, and operational characteristics. Differences are summarized in Table 5-1 and 5-2 above,
Conclusion
In summary, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V3 and RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH are substantially equivalent to the predicate devices and present no new questions of safety or effectiveness.