(310 days)
No
The summary describes standard video processing and wireless communication for a nasopharyngoscope. There is no mention of AI, ML, or any related concepts like training data, algorithms for analysis, or automated interpretation of images.
No.
The device is intended for examination and visualization (diagnostic purposes) rather than for treating a disease or condition.
Yes
The device is intended for the "examination of the upper airway," which is a diagnostic purpose to visualize and assess the anatomy for potential medical conditions.
No
The device description explicitly lists multiple hardware components including a flexible videoscope, video processor box, battery charger, and touchscreen monitor, in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The ENTity WiFi Video Nasopharyngoscope System is used for the direct visual examination of the upper airway inside the body. It captures images of the anatomy.
- Intended Use: The intended use is for "oral or nasal introduction for the examination of the upper airway." This is a diagnostic procedure performed in vivo (inside the body), not a test on a sample in vitro.
The device is a medical imaging device used for direct visualization, not for performing laboratory tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EOB
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video images captured by a CMOS image sensor
Anatomical Site
upper airway from the nasal passage to the vocal cords
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, clinic, medical office
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)
The ENTity WiFi Video Nasopharyngoscope has been tested in accordance with FDA-recognized consensus standards and guidance documents to confirm that the product meets design specifications for physical characteristics, performance, and safety.
Biocompatibility: evaluation and testing performed in accordance with ISO 10993-1:2009. The videoscope insertion tube was tested for cytotoxicity in accordance with ISO 10993-5:2009, and for sensitization and intracutaneous irritation and ISO 10993-10:2010.
Reprocessing Validation: Validated reprocessing instructions for manual cleaning and high-level disinfection 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, AAMI TIR 30:2011/R2016, and ASTM E1837-96.
Software: Software life cycle processes are compliant with IEC 62304. Software documentation provided in accordance with FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Cybersecurity risks assessed and mitigated according to FDA's 2014 Guidance for the Content of Premarket Submissions Management of Cybersecurity in Medical Devices.
Wireless Communication: 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 conducted using a test plan based on AAMI TIR69 and ANSI C63.27.
Dimensional, Functional, and Performance Testing: 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.
Key Result: 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.
Safety and Performance Standards: Tested in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-18.
Usability: Usability 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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 Road |
| Sturbridge, MA 01566 USA | |
| FDA Registration #: | 1218141 |
| Regulation: | 21 CFR 874.4760 |
| Contact: | Jenna Lipka, QA Manager |
| Contact Information: | Tel: 508-347-5100 |
| Fax: 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 upper |
| airway 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 airway |
| anatomy, and is intended to provide visualization via a video | |
| monitor | |
| Reference Device | |
| Trade Name: | NDS Surgical Imaging, LLC ZeroWire Duo Wireless HD |
| Video 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 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 |
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 Video
Nasopharyngoscope System
(subject device) | Karl Storz CMOS Video
Rhino-Laryngoscope System;
K103467 (predicate device) | Similarities and
Differences |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Common Name | Flexible Nasopharyngoscope
System | Flexible Nasopharyngoscope
System | 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 for
the examination of the upper
airway from the nasal passage to
the vocal cords | For endoscopic diagnosis within
the nasal lumens and airway
anatomy; intended to provide
visualization via a videomonitor | Same |
| Use Environment | Hospital, clinic, medical office | Hospital, clinic, medical office | Same |
| Principle of Operation | CMOS videoscope with integral
battery and LED illumination
light source; video processor
with user interface and image
management capabilities; WiFi
data transfer between videoscope
and video processor | CMOS videoscope with integral
battery and LED illumination
light source; video processor
with user interface and image
management capabilities; wired
connection between videoscope
and video processor | Different |
| System Components &
Accessories | ENTity WiFi Video
Nasopharyngoscope; ENTity
Video Processor with ENTity
ICS Software; Active
Touchscreen Monitor;
Videoscope Battery Charger | Karl Storz CMOS Video
Rhino-Laryngoscope scope;
Karl Storz C-MAC Monitor | Different |
| Device Design -
Videoscope | Flexible videoscope with
integrated LED light source | Flexible videoscope with
integrated LED light source | Same |
| Scope Insertion Tube
OD | 4.0 mm (distal tip)
3.8 mm (shaft) | 3.7 mm | Similar |
| Scope Insertion Tube
Length | 300 mm | 300 mm | Same |
| Feature | ENTity WiFi Video
Nasopharyngoscope System
(subject device) | Karl Storz CMOS Video
Rhino-Laryngoscope System;
K103467 (predicate device) | Similarities and
Differences |
| Scope Internal Channel | None | None | Same |
| Scope Direction of
View | 0° | 0° | Same |
| Scope Field of View | 85° | 85° | Same |
| Scope Distal Tip
Articulation | 135° up / down | 140° up / down | Similar |
| Scope Image Sensor
(camera) Type | CMOS | CMOS | Same |
| Scope Power Source | Rechargeable Li-ion battery
located in scope handpiece | Wired connection between
videoscope and monitor | Different |
| Illumination Light
Source Type | LED | LED | Same |
| Illumination Light
Output (min) | 6 Lumens | Unknown | Unknown |
| Light Source
Photobiological Safety | IEC 62471 | Unknown | Unknown |
| Video Processor
Functionality | Image processing for display
on monitor; wireless
communication with
videoscope; image
management and storage | Image processing for display
on monitor; image
management and storage | Different |
| Video Processor
Software Functionality | User interface; set/change
scope button assignment, white
balance & light output; image
management | Unknown | Unknown |
| Scope – Video
Processor Connection | Wireless (WiFi) | Wired | Different |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Scope Reprocessing | Manual cleaning followed by
High-Level Disinfection
(AAMI TIR 12, AAMI TIR
30, ASTM E1837) | Manual cleaning followed by
High-Level Disinfection
(AAMI TIR 12, AAMI TIR
30, ASTM E1837) | Same |
| Scope Patient-
Contacting Materials | 303 stainless steel; glass;
polyurethane;
polyetheretherketone (PEEK);
fluorocarbon rubber; epoxy | Glass; metal; plastic | Similar |
| Electrical Safety &
Scope Safety
Performance | IEC 60601-1
IRC 60601-2-18 | IEC 60601-1
IRC 60601-2-18 | Same |
| Electromagnetic
Compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Scope Optics | IEC 8600-x | IEC 8600-x | Same |
6
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.
7
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" (