(105 days)
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).
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).
The provided text describes a 510(k) premarket notification for two new medical devices, the Olympus RHINO-LARYNGO VIDEOSCOPE ENF-VH and ENF-V3. The primary goal of this submission is to demonstrate that these new devices are substantially equivalent to already legally marketed predicate devices (Olympus ENF-VH2 and ENF-V4).
It is crucial to understand that this document describes a submission for substantial equivalence of new endoscopes to existing predicate endoscopes. It is not a study proving the performance of an AI-powered diagnostic device against specific acceptance criteria for diagnostic accuracy. Therefore, many of the requested elements for an AI/ML-based device will not be found in this document.
The document focuses on demonstrating that the new endoscopes (ENF-VH and ENF-V3) have similar technological characteristics, intended use, and safety/effectiveness profiles to their respective predicate devices (ENF-VH2 and ENF-V4). The "performance testing" described is primarily bench testing to ensure the new endoscopes meet established medical device standards and perform comparably to the predicates in terms of physical and optical properties.
Here's an attempt to answer your questions based on the provided text, highlighting where the requested information for an AI/ML diagnostic study is not applicable or not present in this type of device submission:
1. Table of acceptance criteria and the reported device performance
For these endoscopes, the "acceptance criteria" are generally based on meeting established medical device standards and demonstrating performance comparable to the predicate devices. The "reported device performance" refers to the results of various bench tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | |
| - Similar Indications for Use | Stated as "Similar to predicate. Device name and model number are now included in the Indications for Use statement. The actual intended use is identical." (Tables 5-1 and 5-2) |
| - Similar Mode of Action | Stated as "Same as predicate" (Tables 5-1 and 5-2) |
| - Similar Optical System Parameters (Field of View, Direction of View, Depth of Field) | Stated as "Same as predicate" (Tables 5-1 and 5-2) |
| - Similar Imaging System (Type of Chip, No. of Image Sensor Chip, NBI observation) | Stated as "Same as predicate" (Tables 5-1 and 5-2) |
| - Similar Physical Dimensions (e.g., Insertion Tube Diameter, Working Length) | Stated as "Same as predicate" for most. Minor total length difference noted for control section design change, but deemed not to alter indications for use or safety/effectiveness. (Tables 5-1 and 5-2) |
| - Similar Sterilization Compatibility | Stated as "Available, Same as predicate" for EO, STERRAD NX, STERRAD 100S. (Tables 5-1 and 5-2) Reprocessing validation was conducted and devices validated as safe and effective for listed methods. |
| Compliance with Voluntary Standards (Section 10) | Stated "The following voluntary standards have been applied to the subject devices respectively" with a comprehensive list of standards met (e.g., IEC 60601 series, ISO 10993 series, ISO 14971). |
| Specific Performance Bench Testing (Section 12) | |
| - Thermal Safety | Verified compliance to IEC 60601-2-18:2009-08 ("Protection against excessive temperature and other safety hazards"). |
| - Composite Durability | Demonstrated subject device retains safety and effectiveness against expected use-life stresses. |
| - Noise and Dynamic Range | Confirmed "substantially equivalent to the predicate device" and "compliant to ISO 15739:2017." |
| - Color Performance | Confirmed "substantially equivalent to the predicate devices in the WLI and NBI observation mode." |
| - Image Intensity Uniformity | Confirmed "substantially equivalent to the predicate devices." |
| - Resolution | Confirmed "substantially equivalent to the predicate device." |
| - Photobiological Safety | Verified compliance to IEC 32471:2006-07; confirmed light emitted is low enough not to cause injury. |
| - Biocompatibility | "Successfully validated by testing on the subject devices according to ISO 10993-1" for mucosal membrane contact. "Biological Risk associated with this device is acceptable." |
| - Electrical Safety and EMC | Found to be in compliance with relevant IEC 60601 series requirements. |
| - Software Verification and Validation Testing | Performed and documented to be in compliance with relevant FDA guidance. |
| - Risk Analysis | Performed in accordance with ISO 14971:2007. Outcomes considered acceptable. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an "AI test set." The testing described is primarily bench testing of physical device properties and adherence to manufacturing and safety standards. For example, durability tests would involve a certain number of units, but this is not a "data set" in the AI sense.
- Data Provenance: Not applicable for an AI data set. The "data" here comes from results of physical and electrical safety testing, as well as characterization of optical properties, performed by Olympus. The countries of origin for manufacturing facilities are listed as Japan (Shirakawa Olympus Co., Ltd. and Aizu Olympus Co., Ltd.). The testing is presumably prospective as it's for a new product submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" to be established by experts for a diagnostic AI model. The device is a direct visualization endoscope, not an AI diagnostic tool. The "truth" is whether the physical and optical properties meet specifications and are comparable to predicate devices, verified through engineering and laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human reader studies or expert labeling for AI training/testing data, neither of which are described for these endoscopes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an endoscope for direct visualization, not an AI-assisted diagnostic tool. No MRMC study or assessment of human reader improvement with AI assistance was performed or needed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This refers to AI algorithm performance. The device is a traditional endoscope.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a medical device like an endoscope, "ground truth" relates to its physical, optical, and safety specifications being met, and its performance being comparable to a legally marketed predicate. This is confirmed through engineering testing and compliance with recognized standards.
8. The sample size for the training set
- Not applicable. There is no AI model or "training set" for this submission as it's for a physical endoscope.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, the provided document is a regulatory submission for medical device clearance (510(k)) that focuses on demonstrating "substantial equivalence" of new endoscopes to existing ones. It is not about an AI/ML-based diagnostic device, and therefore the criteria for evaluating such a device (e.g., AI performance, expert ground truth, reader studies) are not present or applicable here.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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. Underneath the blue square, the words "U.S. Food & Drug Administration" are written in blue.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, creating a solid block of text. A registered trademark symbol is located to the right of the word.
510(k) Summary
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3
| General Information | |
|---|---|
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507Phone: (+81) 42-642-2694Fax: (+81) 42-642-2307Establishment Registration Number: 8010047 |
| Manufacturer: | Shirakawa Olympus Co., Ltd.3-1 Okamiyama, Odakura, Nishigo-mura,Nishishirakawa-gun, Fukushima 961-8061,JapanPhone: (+81) 248-27-2239Fax: (+81) 248-27-2429Establishment Registration Number:3002808148 |
| Aizu Olympus Co., Ltd.,500 Muranishi, Niidera, Monden-machi,Aizuwakamatsu-shi, Fukushima 965-8520,JapanPhone: (+81) 242-28-2111Fax: (+81) 81-242-26-4234Establishment Registration Number: 9610595 | |
| 510(k) Submitter: | Olympus Corporation of the Americas800 West Park DriveWestborough, MA 01581 USA |
| Establishment Registration Number: | 2429304 |
| Contact Person: | Brenda M GearyManager, Regulatory AffairsMobile: (508) 683-9561Email: brenda.geary@olympus.com |
| Date Prepared: | 3 June 2022 |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the right of the word. The background is white.
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/TechnologicalCharacteristics | Subject DeviceENF-VH | Predicate DeviceENF-VH2 | Comparison |
|---|---|---|---|
| Regulatory | |||
| Device Name(Model) | Rhino-LaryngoVideoscope(ENF-VH) | Rhino-LaryngoVideoscope(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) andaccessories, Endoscopeand accessories | Nasopharyngoscope(flexible or rigid) andaccessories, Endoscopeand accessories | Same as predicate |
| Feature/TechnologicalCharacteristics | Subject DeviceENF-VH | Predicate DeviceENF-VH2 | Comparison |
| Intended Use | RHINO-LARYNGOVIDEOSCOPEOLYMPUS ENF-VHis intended to be usedwith an Olympus videosystem center, lightsource, documentationequipment, displaymonitor, and otherancillary equipment forendoscopic diagnosis.RHINO-LARYNGOVIDEOSCOPEOLYMPUS ENF-VH isindicated for use withinthe nasal lumens andairway anatomy(including nasopharynxand trachea). | This instrument is intendedto be used with anOlympus video systemcenter, light source,documentation equipment,display monitor, and otherancillary equipment forendoscopic diagnosis. Thisinstrument is indicated foruse within the nasal lumensand airway anatomy(including nasopharynxand trachea). | Similar to predicate.Device name and modelnumber are nowincluded in theIndications for Usestatement. The actualintended use is identical. |
| Mode of Action | The endoscope receivesthe illumination lightfrom the light source bylight guide connectorconnected to the lightsource device. Theillumination light istransferred to the distalend through the opticalfiber bundle inside of theendoscope andilluminates the inside ofthe patient body throughthe illumination lens atthe distal end. Theendoscope receives thereflected light from theinner lumen of a patientby objective lens at thedistal end. | The endoscope receivesthe illumination light fromthe light source by lightguide connectorconnected to the lightsource device. Theillumination light istransferred to the distalend through the opticalfiber bundle inside of theendoscope and illuminatesthe inside of the patientbody through theillumination lens at thedistal end. The endoscopereceives the reflected lightfrom the inner lumen of apatient by objective lensat 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 Attachment12-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 SensorChip | 1 | 1 | Same as predicate |
| NBI observation | Available | Available | Same as predicate |
| Control Section | |||
| Feature/TechnologicalCharacteristics | Subject DeviceENF-VH | Predicate DeviceENF-VH2 | Comparison |
| Control Section | Image: Subject Device ENF-VH | Image: Predicate Device ENF-VH2 | The control section ofthe Rhino-LaryngoVideoscopes (ENF-VH/V3) were designedhave the same controlmechanism howeverthey are designed to behandled with up-rightfunctionality rather thana pistol and trigger grip.The difference in theergonomic design doesnot raise new questionsof safety andeffectivenessThis difference does notalter or change theindications for use orresult in a new intendeduse. |
| Total Length | 510 mm | 500 mm | SimilarTotal length difference isdue to change in designof the control section forthe subject device. Thisdifference does not alteror change the indicationsfor use or result in a newintended use. |
| Insertion section | |||
| Insertion TubeDiameter - Distal End | 3.9 mm | 3.9 mm | Same as predicate |
| Insertion TubeDiameter - FlexibleOuter Tube | 3.6 mm | 3.6 mm | Same as predicate |
| Insertion Section WorkingLength | 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) cableis not detachable | Light guide (LG) cableis 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/TechnologicalCharacteristics | Subject DeviceENF-VH | Predicate DeviceENF-VH2 | Comparison |
| Compatible Processor | OTV-S200/S300OTV-S190CV-170 | OTV-S190CV-170 | For VH- qualifiedadditional processorsOTV-S200/S300.Compatibility of ENF-VH with OTV-S200/S300 wasdemonstrated with benchperformance testing inSection 18 confirm thatthese additionalprocessors do not raiseany new questions ofsafety or effectiveness. |
| Compatible LightSource | CLV-S190CLL-S1 | CLV-S190CLL-S1 | Same as predicate |
| Compatible Monitor | OEV262HLMD-X310ST**This can only becombined with OTV-S300. | OEV262HOEV-261HOEV-191H | For VH- qualifiedLMD-X310ST.Compatibility of ENF-VH with LMD-XS310ST wasdemonstrated duringelectrical safety andelectromagneticcompatibility testingdescribed in Section 17confirm that this monitordoes not raise newquestions of safety oreffectiveness. |
Table 5-1: Comparison of the technological characteristics of ENF-VH to predicate device
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows 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 "S".
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-VH, ENF-V3
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are sans-serif and appear to be a custom font. A registered trademark symbol is located to the right of the letter "S".
Traditional 510(k) Notification RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. A small registered trademark symbol is located to the right of the letter "S".
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/ TechnologicalCharacteristics | Subject DeviceENF-V3 | Predicate DeviceENF-V4 | Comparison |
|---|---|---|---|
| Regulatory | |||
| Device Name(Model) | Rhino-LaryngoVideoscope(ENF-V3) | Rhino-LaryngoVideoscope(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) andaccessories, Endoscopeand accessories. | Same as predicate |
| Intended Use | RHINO-LARYNGOVIDEOSCOPE | This instrument isintended 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 |
|---|
| ------------------------------------------------------------------------------------------ |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image features the word "OLYMPUS" in a bold, sans-serif font. The word is displayed in a dark blue color, which contrasts with the white background. 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/ TechnologicalCharacteristics | Subject DeviceENF-V3 | Predicate DeviceENF-V4 | Comparison |
|---|---|---|---|
| OLYMPUS ENF-V3 isintended to be used withan Olympus videosystem center, lightsource, documentationequipment, displaymonitor, and otherancillary equipment forendoscopic diagnosis.RHINO-LARYNGOVIDEOSCOPEOLYMPUS ENF-V3 isindicated for use withinthe nasal lumens andairway anatomy(including nasopharynxand trachea). | an Olympus video systemcenter, light source,documentation equipment,display monitor, and otherancillary equipment forendoscopic diagnosis. Thisinstrument is indicated foruse within the nasallumens and airwayanatomy (includingnasopharynx and trachea). | number are now includedin the Indications for Usestatement. The actualintended use is identical. | |
| Mode of Action | The endoscope receivesthe illumination lightfrom the light source bylight guide connectorconnected to the lightsource device. Theillumination light istransferred to the distalend through the opticalfiber bundle inside ofthe endoscope andilluminates the inside ofthe patient body throughthe illumination lens atthe distal end. Theendoscope receives thereflected light from theinner lumen of a patientby objective lens at thedistal end. | The endoscope receivesthe illumination light fromthe light source by lightguide connector connectedto the light source device.The illumination light istransferred to the distalend through the opticalfiber bundle inside of theendoscope and illuminatesthe inside of the patientbody through theillumination lens at thedistal end. The endoscopereceives the reflected lightfrom the inner lumen of apatient by objective lens atthe 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 Attachment12-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 ImageSensor 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/ TechnologicalCharacteristics | Subject DeviceENF-V3 | Predicate DeviceENF-V4 | Comparison |
|---|---|---|---|
| Control Section | |||
| Control Section | Image: ENF-V3 Control Section | Image: ENF-V4 Control Section | The control section of theRhino-LaryngoVideoscopes (ENF-VH/V3) were designedhave the same controlmechanism however theyare designed to behandled with up-rightfunctionality rather than apistol and trigger grip.The difference in theergonomic design doesnot raise new questionsof safety andeffectivenessThis difference does notalter or change theindications for use orresult in a new intendeduse. |
| Total Length | 510 mm | 500mm | Total length difference isdue to change in designof the control section forthe subject device.This difference does notalter or change theindications for use orresult in a new intendeduse. |
| Insertion section | |||
| Insertion TubeDiameter - Distal End | 2.6 mm | 2.6 mm | Same as predicate |
| Insertion TubeDiameter - FlexibleOuter Tube | 2.9 mm | 2.9 mm | Same as predicate |
| Insertion SectionWorking 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/ TechnologicalCharacteristics | Subject DeviceENF-V3 | Predicate DeviceENF-V4 | Comparison |
|---|---|---|---|
| Compatible Processor | OTV-S200/S300OTV-S190CV-170 | OTV-S190CV-170 | For V3- qualifiedadditional processorOTV-S200/S300.Compatibility of ENF-V3 with OTV-S200/S300was demonstrated withbench performancetesting in Section 18confirm that theseadditional processors donot raise any newquestions of safety oreffectiveness. |
| Compatible LightSource | CLV-S190CLL-S1 | CLV-S190CLL-S1 | Same as predicate |
| Compatible Monitor | OEV-262HLMD-X310ST** This can be combinedwith only OTV-S300. | OEV-262HOEV-261HOEV-191H | For V3- qualifiedLMD-X310ST.Compatibility ofENF-V3 with LMD-XS310ST wasdemonstrated duringelectrical safety andelectromagneticcompatibility testingdescribed in Section 17confirm that this monitordoes not raise newquestions of safety oreffectiveness. |
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: Particularrequirements for the basic safety and essentialperformance of endoscopic equipment |
| ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3) |
| ISO 15739:2017 | Photography - Electronic still-picture imaging – Noisemeasurements |
| 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: Testsfor in vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices – Part 10: Testsfor 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 materialswithin a risk management process |
| ISO 11135:2014 | Sterilization of health care products – Ethylene Oxide –requirements for development, validation and routinecontrol 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 tomedical devices |
| FDA Device Specific Guidance | |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and LabelingGuidance for Industry and Food and Drug Administration Staff | |
| FDA Guidance Use of International Standard ISO 10993-1, ‘Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a risk management process | |
| Guidance for the Content of Premarket Submissions for Software contained in MedicalDevices | |
| 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: Generalrequirements for basic safety and essential performance |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particularrequirements for the basic safety and essentialperformance of endoscopic equipment |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: Generalrequirements 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.
§ 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.