(187 days)
Not Found
No
The summary describes a standard video endoscope and its components, with no mention of AI/ML capabilities, image processing beyond display, or data sets for training/testing AI/ML models.
No
The device is described as an instrument for "endoscopic diagnosis" to display images and aid observation, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is for "endoscopic diagnosis." The device's function is to provide video images from within the body to aid in diagnosis.
No
The device description explicitly details hardware components such as video connection sections, light guide connectors, control sections, and insertion sections, and the performance studies include hardware-related testing like reprocessing validation, biocompatibility, electrical safety, EMC, and bench performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "endoscopic diagnosis" within the nasal lumens and airway anatomy. This involves direct visualization of internal body structures.
- Device Description: The description details an endoscope used for visualizing internal anatomy with a video system, light source, and controls for manipulation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on such specimens. It is a tool for in vivo (within the body) visualization.
The device is clearly an endoscope used for direct visual examination of the respiratory tract, which falls under the category of medical devices used for imaging and visualization, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
EOB, NWB
Device Description
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).
It mainly consists of four functional parts:
- video connection section including a video connector and video cable that connects the endoscope to the video system center for displaying images on compatible video monitors.
- light guide connector section that links the endoscope with light source and transmits light to the distal end of the endoscope.
- control section that operates endoscope such as controlling angulation to guide insertion and observation.
- insertion section that goes through and contacts with the nasal lumens and airway anatomy (including nasopharynx and trachea) under light guide.
Principle of Operation
-
a. Basic principle
-
Illumination light supply
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. -
Image construction
The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in CCD at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen. -
Bending operation
The UP/DOWN angulation control lever and bending section are connected with each other by 2 independent wires. It is possible to bend the bending section to the UP/DOWN direction by operating the UP/DOWN angulation control lever.
b. Technological characteristics
-
New control section
The new control section of ENF-VH2 and ENF-V4 consists of a pistol grip shape. The new control section reduces the angle of the wrist and enables the insertion section to be directed to the nasal cavity of sitting patient even when the wrist and arm of the physician is in a relaxed situation. -
New layout of switches
By arranging the 3 switches of new ENT control section, physicians can easily push the 3 switches with only an index finger -
Reduced total weight
Newly developed configuration of control section and thinner and lighter universal cord leads to a reduction in the handling mass of the endoscope control section.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
-
Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the ENF-VH2 and ENF-V4 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling". -
Biocompatibility testing
Biocompatibility testing for the ENF-VH2 and ENF-V4 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay
- Intracutaneous Study in Rabbits
- Guinea Pig Maximization Sensitization Test
-
Software verification and validation testing
Software verification and validation testing for the ENF-VH2 and ENF-V4 were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "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". -
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the ENF-VH2 and ENF-V4. The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC. -
Performance testing - Bench
Bench testing for the ENF-VH2 and ENF-V4 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Thermal safety test
- Mechanical durability test
- Optical performance test
- Color performance test
-
Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence. -
Performance testing - Clinical
Clinical testing for ENF-VH2 and ENF-V4 as listed below was conducted to support the market claims.
- Evaluation for supporting evidence of marketing claim
- Meta-analysis
- Risk analysis
Risk analysis for the ENF-VH2 and ENF-V4 was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2019
Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K182102
Trade/Device Name: Rhino-laryngo Videoscope Olympus ENF-VH2, Rhino-laryngo Videoscope Olympus ENF-V4 Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB, NWB Dated: January 4, 2019 Received: January 7, 2019
Dear Sheri Musgnung:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182102
Device Name RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
Indications for Use (Describe)
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).
| 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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3
Image /page/3/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. There is a yellow line underneath the word. The registered trademark symbol is located in the upper right corner of the image.
February 4, 2019
510(k) Summary
1 GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Sheri L. Musgnung Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com
2 DEVICE IDENTIFICATION
- Device Name RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 ■ Common Name RHINO-LARYNGO VIDEOSCOPE ■ Regulation Number 874.4760, 876.1500 ■ Regulation Name Nasopharyngoscope (flexible or rigid) and accessories, Endoscope and accessories. ■ Regulatory Class II ■ Product Code EOB. NWB
- Classification Panel Ear Nose & Throat
4
3 PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| VISERA RHINO-LARYNGO | ||
| VIDEOSCOPE PLYMPUS ENF | ||
| TYPE V2 | ||
| (EVIS EXERA II CV-180 SYSTEM) | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K061313 |
4 DEVICE DESCRIPTION
- General Description of the subject device
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).
It mainly consists of four functional parts:
- video connection section including a video connector and video cable that connects the endoscope to the video system center for displaying images on compatible video monitors.
- light guide connector section that links the endoscope with light source and transmits light to the distal end of the endoscope.
- control section that operates endoscope such as controlling angulation to guide insertion and observation.
- insertion section that goes through and contacts with the nasal lumens and airway anatomy (including nasopharynx and trachea) under light guide.
Principle of Operation
- a. Basic principle
5
- Illumination light supply
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.
- Image construction
The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in CCD at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen.
- Bending operation
The UP/DOWN angulation control lever and bending section are connected with each other by 2 independent wires. It is possible to bend the bending section to the UP/DOWN direction by operating the UP/DOWN angulation control lever.
b. Technological characteristics
- New control section
The new control section of ENF-VH2 and ENF-V4 consists of a pistol grip shape. The new control section reduces the angle of the wrist and enables the insertion section to be directed to the nasal cavity of sitting patient even when the wrist and arm of the physician is in a relaxed situation.
- New layout of switches
By arranging the 3 switches of new ENT control section, physicians can easily push the 3 switches with only an index finger
- Reduced total weight
Newly developed configuration of control section and thinner and lighter universal cord leads to a reduction in the handling mass of the endoscope control section.
6
Image /page/6/Picture/1 description: The image displays the word "OLYMPUS" in bold, blue letters. The registered trademark symbol is located to the right of the word. A yellow line is located underneath the word.
List of compatible equipment -
| Model name | 510(k) number | |
|---|---|---|
| Endoscopes | ENF-V4 | K182102 (this submission) |
| ENF-VH2 | K182102 (this submission) | |
| VISERA ELITE video system center | OTV-S190 | K111425 |
| Video system center | CV-170 | K122831 |
| VISERA ELITE xenon light source | CLV-S190 | K111425 |
| Strobe LED Light source | CLL-S1 | EXEMPT from Premarket Notification |
| Video monitors | OEV262H | K102379 |
| OEV261H | K954451 | |
| OEV191H | K954451 |
Table 1 Compatible equipment
7
Image /page/7/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 word.
5 INDICATIONS FOR USE
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).
6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The ENF-VH2 and ENF-V4 have the same technological characteristics and design as the predicate device except for the following new features:
- Changes on optical system parameters (total number of pixels, resolution, etc.) -
- Configuration modification of control section to improve operability -
- -Dimensional and material changes on the insertion section
- Extension of reprocessing methods -
- Software implementation to correct the pixel defect -
All other technological characteristics of both the subject and predicate devices are identical.
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
8
Image /page/8/Picture/0 description: The image contains the word "OLYMPUS" in a bold, sans-serif font. The word is in all capital letters and is a dark blue color. There is a registered trademark symbol to the right of the word.
| Features |
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS
ENF-VH2
#K182102 |
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS ENF-V4
#K182102 |
VISERA
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS ENF
TYPE V2
#K061313 |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | 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). | 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). | This instrument has
been designed to be
used with an Olympus
video system center,
light source,
documentation
equipment, display
monitor, and other
ancillary equipment
for endoscopic within
the nasal lumens and
airway anatomy
(including
nasopharyngeal and
trachea). |
| Field of View | 110° | 90° | 90° |
| Depth of Field | 5-50mm | 3.5-50mm | 5-50mm |
| Direction of
Forward View | 0°(Forward viewing) | 0°(Forward viewing) | 0°(Forward viewing) |
| Outer Diameter
of Distal End | φ3.9mm | φ2.6mm | φ3.2mm |
| Outer Diameter
of Insertion
Tube | φ3.6mm | φ2.9mm | φ3.4mm |
| Bending
Section
Angulation | UP:130°
DOWN:130° | UP:130°
DOWN:130° | UP:130°
DOWN:130° |
| Working
Length of
insertion | 300mm | 300mm | 300mm |
| Features |
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS
ENF-VH2
#K182102 |
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS ENF-V4
#K182102 |
VISERA
RHINO-LARYNGO
VIDEOSCOPE
OLYMPUS ENF
TYPE V2
#K061313 |
| Configuration
of Control
section and
location of
scope switch | Image: Subject Device 1 control section | Image: Subject Device 2 control section | Image: Predicate Device control section |
| NBI
observation | Available | Available | Available |
| Reprocess with
OER-Pro | available | available | unavailable |
| Sterilization
with
STERRAD | available | available | unavailable |
| Sterilization
with V-PRO | available | available | unavailable |
Table 2 Device Comparison Table
9
Image /page/9/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a strong visual impact. A registered trademark symbol is present in the upper right corner of the image.
K182102 Traditional 510(k) Notification RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V4
7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the ENF-VH2 and ENF-V4 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
2) Biocompatibility testing
Biocompatibility testing for the ENF-VH2 and ENF-V4 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of
10
International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay ।
- Intracutaneous Study in Rabbits ।
- Guinea Pig Maximization Sensitization Test ।
3) Software verification and validation testing
Software verification and validation testing for the ENF-VH2 and ENF-V4 were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "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".
4) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the ENF-VH2 and ENF-V4. The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
5) Performance testing - Bench
Bench testing for the ENF-VH2 and ENF-V4 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Thermal safety test
- Mechanical durability test
- Optical performance test
- Color performance test
6) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
7) Performance testing - Clinical
Clinical testing for ENF-VH2 and ENF-V4 as listed below was conducted to support the market claims.
- Evaluation for supporting evidence of marketing claim
- Meta-analysis
8) Risk analysis
Risk analysis for the ENF-VH2 and ENF-V4 was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result
11
Image /page/11/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. The word is likely a logo or brand name, given its prominent display and the presence of the registered trademark symbol next to the letter "S".
of this risk analysis assessment.
8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the ENF-VH2 and ENF-V4 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.