(310 days)
The ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
The ENTity WiFi Video Nasopharyngoscope System is a complete video nasopharyngoscopy system that includes a rechargeable, battery-powered, flexible videoscope with an integral LED light source and WiFi connectivity; a video processor box that receives WiFi signals from the videoscope and provides HDMI output to a video monitor; image management and user interface software; a battery charger accessory for the videoscope; and an active touchscreen monitor accessory that can be used to view images and/or to communicate with the software user interface. Light generated by the LED light source located in the videoscope handle is transmitted through glass fiber optic bundles to the distal tip of the scope, where it illuminates the anatomy to be examined. A CMOS image sensor (camera chip) located at the distal tip of the videoscope captures still or video images in the form of electrical signals, which are wirelessly transmitted to the ENTity WiFi Video Processor. The video processor incorporates user interface and image management software. Still and/or video images may be viewed on the ENTity WiFi Active Touchscreen Monitor; the touchscreen features on the monitor can also be used to interact with the ENTity WiFi Video Processor.
The provided text describes the ENTity WiFi Video Nasopharyngoscope System and its substantial equivalence to a predicate device. However, it does not contain a specific study proving the device meets particular clinical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for identifying specific conditions). The document focuses on showing substantial equivalence based on technical characteristics, non-clinical performance data, and compliance with various engineering and safety standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I detail a study that proves such criteria were met, as that information is not present in the provided text.
I can, however, extract information about the non-clinical performance and testing performed to demonstrate safety and technical equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with clinical acceptance criteria (e.g., diagnostic sensitivity/specificity) and corresponding device performance data for ENTity WiFi Video Nasopharyngoscope System. Instead, it lists technical features and compliance with standards.
Here's a table based on the technical comparison and performance verification mentioned, rather than clinical acceptance criteria for diagnostic efficacy.
| Acceptance Criteria (Technical/Performance Standard) | Reported Device Performance (Compliance/Result) |
|---|---|
| Biocompatibility (ISO 10993-1, -5, -10) | Evaluation and testing performed; passed cytotoxicity, sensitization, and intracutaneous irritation tests. |
| Reprocessing Validation (FDA guidance, AAMI TIR 12, TIR 30, ASTM E1837) | Validated for manual cleaning and high-level disinfection. |
| Software Life Cycle Processes (IEC 62304) | Compliant with IEC 62304. |
| Cybersecurity Risk Management (FDA 2014 Guidance) | Risks assessed and mitigated. |
| Wireless Communication Performance (FDA 2013 Guidance, AAMI TIR69, ANSI C63.27) | WPA2 encrypted 2.4 GHz WLAN 802.11 communication; wireless coexistence testing conducted. |
| End-to-End (E2E) Latency | Comparable to predicate device + reference device; measured >160ms and <200ms. |
| Dimensional Accuracy | Met design specifications. |
| Optical Measurement | Met design specifications. |
| Surface Temperature Measurement | Met design specifications. |
| Color Performance | Met design specifications. |
| Limiting Spatial Resolution | Met design specifications. |
| Modulation Transfer Function (MTF) | Met design specifications. |
| Distortion | Met design specifications. |
| Image Intensity Uniformity | Met design specifications. |
| Signal to Noise Ratio | Met design specifications. |
| Dynamic Range | Met design specifications. |
| Rechargeable Battery & Charger Performance | Performance verification conducted. |
| Camera Performance | Evaluation conducted. |
| Videoscope Moisture Resistance | Testing conducted. |
| Hazard Mitigations | Verification conducted. |
| System Performance Evaluation | Evaluation conducted. |
| Electrical Safety (IEC 60601-1, IEC 60601-2-18) | Tested in accordance with these standards. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Tested in accordance with this standard. |
| Usability (IEC 62366-1, FDA 2016 Guidance) | Usability evaluated in a user validation study. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance testing and compliance with standards. It does not specify sample sizes for test sets related to human data or diagnostic performance. Details like country of origin or retrospective/prospective nature are not provided for the described tests, as they are largely engineering and bench testing rather than clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document because it does not detail a study involving expert-established ground truth for diagnostic accuracy. The testing described is overwhelmingly technical and engineering-focused.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as there is no described clinical study involving human judgment and adjudication.
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
There is no mention of an MRMC comparative effectiveness study, nor any AI assistance in the context of this device. The device is a "Video Nasopharyngoscope System," implying a direct visualization tool, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device described is a video nasopharyngoscope system for direct visualization, not an algorithm or AI system for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance and safety testing, the "ground truth" was established by engineering specifications, recognized consensus standards, and guidance documents. For example, the ground truth for biocompatibility was adherence to ISO 10993-1, and for electrical safety, it was compliance with IEC 60601-1. There is no mention of clinical ground truth (e.g., pathology, outcomes data) as this document focuses on technical and safety equivalence.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
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January 13, 2021
Optim, LLC % Pamela Papineau Consultant Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K200609
Trade/Device Name: ENTity WiFi Video Nasopharyngoscope System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: December 4, 2020 Received: December 14, 2020
Dear Pamela Papineau:
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/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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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.
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200609
Device Name
ENTity WiFi Video Nasopharyngoscope System
Indications for Use (Describe)
The ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 – 510(k) Summary (K200609)
A. General Information
| 510(k) Sponsor | Optim, LLC |
|---|---|
| Address: | 64 Technology Park RoadSturbridge, MA 01566 USA |
| FDA Registration #: | 1218141 |
| Regulation: | 21 CFR 874.4760 |
| Contact: | Jenna Lipka, QA Manager |
| Contact Information: | Tel: 508-347-5100Fax: 508-347-2380 |
| Date Prepared: | 12 January 2021 |
B. Device Identification
| Subject Device | |
|---|---|
| Trade Name: | ENTity WiFi Video Nasopharyngoscope System |
| Common Name: | Flexible Nasopharyngoscope |
| Classification Name: | Nasopharyngoscope (flexible or rigid) |
| Regulation: | 21 CFR 874.4760 |
| Product Code: | EOB |
| Device Classification: | Class II |
| Reviewing Panel: | Ear, Nose & Throat Devices |
| Indications for Use: | For oral or nasal introduction for the examination of the upperairway from the nasal passage to the vocal cords |
| Predicate Device | |
| Trade Name: | Karl Storz CMOS Video Rhino-Laryngoscope System |
| Common Name: | Flexible Nasopharyngoscope |
| Classification Name: | Nasopharyngoscope (flexible or rigid) |
| Regulation: | 21 CFR 874.4760 |
| Product Code: | EOB |
| Device Classification: | Class II |
| Reviewing Panel: | Ear, Nose & Throat Devices |
| 510(k) Number: | K103467 |
| Indications for Use: | For endoscopic diagnosis within the nasal lumens and airwayanatomy, and is intended to provide visualization via a videomonitor |
| Reference Device | |
| Trade Name: | NDS Surgical Imaging, LLC ZeroWire Duo Wireless HDVideo Transfer System G2 (“ZeroWire G2") |
| Common Name: | Wireless Device |
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| Classification Name: | Endoscope and accessories |
|---|---|
| Regulation: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Device Classification: | Class II |
| Reviewing Panel: | General & Plastic Surgery Devices |
| 510(k) Number: | K151609 |
| Indications for Use: | For the delivery of video signals from a source such as anendoscopy camera/processor, or other video source over aradio-frequency link to a ZeroWire Receiver for display ofimages during endoscopic and general surgical procedures |
C. Device Description
The ENTity WiFi Video Nasopharyngoscope System is a complete video nasopharyngoscopy system that includes a rechargeable, battery-powered, flexible videoscope with an integral LED light source and WiFi connectivity; a video processor box that receives WiFi signals from the videoscope and provides HDMI output to a video monitor; image management and user interface software; a battery charger accessory for the videoscope; and an active touchscreen monitor accessory that can be used to view images and/or to communicate with the software user interface. Light generated by the LED light source located in the videoscope handle is transmitted through glass fiber optic bundles to the distal tip of the scope, where it illuminates the anatomy to be examined. A CMOS image sensor (camera chip) located at the distal tip of the videoscope captures still or video images in the form of electrical signals, which are wirelessly transmitted to the ENTity WiFi Video Processor. The video processor incorporates user interface and image management software. Still and/or video images may be viewed on the ENTity WiFi Active Touchscreen Monitor; the touchscreen features on the monitor can also be used to interact with the ENTity WiFi Video Processor.
D. Indications for Use
The indications for use of the ENTity WiFi Video Nasopharyngoscope (for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords) and the predicate Karl Storz CMOS Video Rhino-Laryngoscope System cleared in K103467 (for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor) are the same with minor differences in wording. The indications for use for the ZeroWire G2 reference device (for the delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures) describe the same type of wireless communication found in the ENTity WiFi System.
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E. Substantial Equivalence Comparison
Substantial equivalence for the ENTity WiFi Video Nasopharyngoscope System is primarily based on a comparison of design features and performance characteristics to those of the Karl Storz CMOS Video Rhino-Laryngoscope System cleared in K103467. This comparison is supported by non-clinical testing to confirm that the ENTity WiFi System meets design specifications for physical characteristics, performance, and safety. Wherever possible, test methods and acceptance criteria were based on FDA-recognized consensus standards and guidance documents. The NDS Surgical Imaging, LLC ZeroWire Duo Wireless HD Video Transfer System G2 (the "ZeroWire G2") cleared in K151609 is cited as a reference device to establish substantial equivalence of the wireless video image transmission capabilities of the ENTity WiFi Video Nasopharyngoscope System.
F. Comparison of Technical Characteristics with the Predicate Device
A summary of the differences between the subject and predicate devices is provided in accordance with 21 CFR 807.92(a)(6).
| Feature | ENTity WiFi VideoNasopharyngoscope System(subject device) | Karl Storz CMOS VideoRhino-Laryngoscope System;K103467 (predicate device) | Similarities andDifferences |
|---|---|---|---|
| Common Name | Flexible NasopharyngoscopeSystem | Flexible NasopharyngoscopeSystem | Same |
| Classification Name | Nasopharyngoscope(flexible or rigid) | Nasopharyngoscope(flexible or rigid) | Same |
| Device Class | Class II | Class II | Same |
| Regulation | 21 CFR 874.4760 | 21 CFR 874.4760 | Same |
| Product Code | EOB | EOB | Same |
| Indications for Use | For oral ornasal introduction forthe examination of the upperairway from the nasal passage tothe vocal cords | For endoscopic diagnosis withinthe nasal lumens and airwayanatomy; intended to providevisualization via a videomonitor | Same |
| Use Environment | Hospital, clinic, medical office | Hospital, clinic, medical office | Same |
| Principle of Operation | CMOS videoscope with integralbattery and LED illuminationlight source; video processorwith user interface and imagemanagement capabilities; WiFidata transfer between videoscopeand video processor | CMOS videoscope with integralbattery and LED illuminationlight source; video processorwith user interface and imagemanagement capabilities; wiredconnection between videoscopeand video processor | Different |
| System Components &Accessories | ENTity WiFi VideoNasopharyngoscope; ENTityVideo Processor with ENTityICS Software; ActiveTouchscreen Monitor;Videoscope Battery Charger | Karl Storz CMOS VideoRhino-Laryngoscope scope;Karl Storz C-MAC Monitor | Different |
| Device Design -Videoscope | Flexible videoscope withintegrated LED light source | Flexible videoscope withintegrated LED light source | Same |
| Scope Insertion TubeOD | 4.0 mm (distal tip)3.8 mm (shaft) | 3.7 mm | Similar |
| Scope Insertion TubeLength | 300 mm | 300 mm | Same |
| Feature | ENTity WiFi VideoNasopharyngoscope System(subject device) | Karl Storz CMOS VideoRhino-Laryngoscope System;K103467 (predicate device) | Similarities andDifferences |
| Scope Internal Channel | None | None | Same |
| Scope Direction ofView | 0° | 0° | Same |
| Scope Field of View | 85° | 85° | Same |
| Scope Distal TipArticulation | 135° up / down | 140° up / down | Similar |
| Scope Image Sensor(camera) Type | CMOS | CMOS | Same |
| Scope Power Source | Rechargeable Li-ion batterylocated in scope handpiece | Wired connection betweenvideoscope and monitor | Different |
| Illumination LightSource Type | LED | LED | Same |
| Illumination LightOutput (min) | 6 Lumens | Unknown | Unknown |
| Light SourcePhotobiological Safety | IEC 62471 | Unknown | Unknown |
| Video ProcessorFunctionality | Image processing for displayon monitor; wirelesscommunication withvideoscope; imagemanagement and storage | Image processing for displayon monitor; imagemanagement and storage | Different |
| Video ProcessorSoftware Functionality | User interface; set/changescope button assignment, whitebalance & light output; imagemanagement | Unknown | Unknown |
| Scope – VideoProcessor Connection | Wireless (WiFi) | Wired | Different |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Scope Reprocessing | Manual cleaning followed byHigh-Level Disinfection(AAMI TIR 12, AAMI TIR30, ASTM E1837) | Manual cleaning followed byHigh-Level Disinfection(AAMI TIR 12, AAMI TIR30, ASTM E1837) | Same |
| Scope Patient-Contacting Materials | 303 stainless steel; glass;polyurethane;polyetheretherketone (PEEK);fluorocarbon rubber; epoxy | Glass; metal; plastic | Similar |
| Electrical Safety &Scope SafetyPerformance | IEC 60601-1IRC 60601-2-18 | IEC 60601-1IRC 60601-2-18 | Same |
| ElectromagneticCompatibility | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Scope Optics | IEC 8600-x | IEC 8600-x | Same |
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G. Non-Clinical Performance Data
The ENTity WiFi Video Nasopharyngoscope has been tested in accordance with FDArecognized consensus standards and guidance documents to confirm that the product meets design specifications for physical characteristics, performance, and safety.
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Biocompatibilitv
Biocompatibility of the patient contacting materials contained in the ENTity WiFi Videoscope was established through evaluation and testing performed in accordance with ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA's June 2016 guidance for the use of ISO 10993-1. The videoscope insertion tube has direct contact with the mucosal surfaces in the nasal passages and the nasopharynx; the duration of contact category according to ISO 10993-1 is "limited" (< 24 hours). The endoscope insertion tube was tested for cytotoxicity in accordance with ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cvtotoxicity, and for sensitization and intracutaneous irritation and ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for in irritation and skin sensitization.
Reprocessing Validation
The ENTity WiFi Videoscope is a reusable device for which validated reprocessing instructions and reprocessing validation data are required in accordance with the June 9, 2017 Federal Register Notice Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications. Detailed instructions for manual cleaning and high-level disinfection are included in the ENTity WiFi System labeling; these methods have been validated in accordance with FDA's 2015 Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling and recognized technical guidelines such as AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care settings: A guide for medical device manufacturers, AAMI TIR 30:2011/R2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and ASTM E1837-96 Standard test method to determine the efficacy of disinfection processes for medical devices (simulated use test).
Software
The ENTity ICS Software consists of user interface software that allows the user to enter and access patient data stored in the ENTity WiFi Video Processor, perform still image and streaming video capture during an examination, control some ENTity WiFi Videoscope settings, and to generate reports. Software life cycle processes are compliant with IEC 62304 Medical Device Software - Software Life Cycle Processes. Software documentation has been provided in accordance with FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Cybersecurity risks have been assessed and mitigated according to FDA's 2014 Guidance for the Content of Premarket Submissions Management of Cybersecurity in Medical Devices.
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Wireless Communication
The ENTity WiFi Videoscope and the ENTity WiFi Video Processor exchange data, including streaming image data, over a 2.4 GHz WLAN 802.11 wireless radio connection. All wireless data is encrypted using WPA2 technology for IEEE 802.11. FDA's 2013 Guidance for Industry and FDA Staff – Radio Frequency Wireless Technology in Medical Devices was applied for RF wireless technology design, documentation, and testing. Wireless coexistence testing was conducted using a test plan based on AAMI TIR69 and ANSI C63.27.
Dimensional, Functional, and Performance Testing
The ENTity WiFi System has been tested at the component and system level to ensure that all design specifications were met; testing included endoscope dimensional and optical measurement, endoscope surface temperature measurement, color performance, limiting spatial resolution, modulation transfer function (MTF), distortion, image intensity uniformity, signal to noise, dynamic range, rechargeable battery and battery charger performance verification, camera performance evaluation, videoscope moisture resistance testing, verification of hazards mitigations, and system performance evaluation. Comparative end-to-end (E2E) latency testing demonstrated that the E2E latency of the ENTity WiFi System is comparable to that of the predicate device system when used together with the reference device. The measured E2E latency of both the ENTity WiFi System and the predicate Karl Storz System with the reference NDS Surgical Imaging ZeroWire G2 was greater than 160ms and less than 200ms.
The ENTity WiFi System has been tested in accordance with IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance, IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility Requirements and Tests, IEC 60601-1-6 Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability, and IEC 60601-2-18 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Endoscopic Equipment.
Usability
The usability engineering principles contained in IEC 62366-1 Medical Devices – Application of Usability Engineering to Medical Devices were utilized in the design and development of the ENTity WiFi System. Usability has been evaluated in a user validation study designed and conducted in accordance with FDA's 2016 guidance Applying Human Factors and Usability Engineering to Medical Devices.
H. Conclusion
Based on a comparison of the proposed and predicate device systems in terms of indications for use, technology, physical characteristics and performance specifications, together with the results of performance testing conducted in accordance with FDA guidance documents and recognized standards, the ENTity WiFi System raises no new questions of safety and effectiveness, and is substantially equivalent to predicate device.
§ 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.