OtoSight Middle Ear Scope

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September 26, 2022 PhotoniCare, Inc Ryan Shelton CEO 1902 Fox Drive, Suite F Champaign, Illinois 61820 Re: K222655 Trade/Device Name: OtoSight Middle Ear Scope Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: QJG Dated: August 31, 2022 Received: September 2, 2022 Dear Ryan Shelton: 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. 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Sincerely, Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K222655 Device Name OtoSight Middle Ear Scope #### Indications for Use (Describe) The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Information Page | Date Prepared: | August 31, 2022 | |-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | Submitted by: | PhotoniCare, Inc. | | Web: | https://photoni.care/ | | Address: | PhotoniCare Inc.<br>1902 Fox Drive, Suite F<br>Champaign, IL 61820 | | Contact Person: | Ryan Shelton PhD | | Phone Number: | (866) 411 3277 | | Common Name: | Optical Coherence Tomography (OCT)<br>Imaging Otoscope | | Proprietary Name: | OtoSight Middle Ear Scope | | Classification: | | | Regulation Numbers: | 21 CFR 892.1560 | | Name: | Device System, Imaging, Tympanic<br>Membrane and Middle Ear | | Code: | QJG | | Class: | 2 | | Predicate Device(s): | | | Model Name: | TOMiScope (cleared under K191804 as the<br>TOMiScope but commercialized now as<br>OtoSight Middle Ear Scope) | | Common Name: | Optical Coherence Tomography Scanner | | 510(k) # | K191804 | | Manufacturer: | PhotoniCare, Inc. | | Clearance Date: | December 5, 2019 | | The predicate device has not been subject to a design-related recall. | | {4}------------------------------------------------ ## 2. Device Description The OtoSight Middle Ear Scope is a multiple use, non-sterile device which provides a surface view of the eardrum, equivalent to the functionality of a video otoscope. Additionally, the OtoSight Middle Ear Scope provides a view through the surface to visualize the contents of the middle ear using Low-Coherence Interferometry (LCI). LCI is an implementation of OCT which. rather than generating 2-D or 3-D images, is limited to the generation of a one-dimensional in-depth density profile displayed over time, which reveals the optical reflective property of the tympanic membrane (TM), as well as the content(s) which are present behind the TM. The OtoSight Middle Ear Scope has a form factor which allows for ease of imaging the middle ear by the clinician, who will utilize disposable speculum tips and position the OtoSight Middle Ear Scope in the external ear canal in the same way routinely utilized for the current gold standard otoscopy. A push-button on the handheld is used to put the device into active recording mode, capturing both surface and LCI images simultaneously. Scan data is saved on the device with the option to export a summary of the scan over a Wi-Fi network. The device incorporates a battery that provides 7 hours of use under a typical usage scenario to facilitate convenient use in a practice. Image /page/4/Picture/4 description: The image shows a medical device called OtoSight Middle Ear Scope. The device has a screen displaying two images, one showing a view inside the ear and the other showing a scan. The screen also displays text such as 'Laser Enabled', 'Patient ID', 'Exam 10212', and instructions for using the device's buttons. The device also has a handheld component attached to the side. #### 2.1 Intended Use/Indications The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. {5}------------------------------------------------ ## 2.2 Technology ### Video Otoscopy To provide a similar viewing experience to the clinician, and to guide LCI signal acquisition, video otoscopy is also integrated. These images are captured by a CCD camera. The otoscopy provides the true color surface image of the ear canal and the TM. ### Low-Coherence Interferometry (LCI) To visualize the in-depth density of human TM, the OtoSight Middle Ear Scope utilizes LCI, a noninvasive, optical imaging technique analogous to ultrasound imaging. Instead of using sound as in ultrasound imaging. LCI uses near infrared light. It is a non-scanning implementation of the more well-known OCT. In academia, LCI specifically refers to OCT technology that doesn't repeatedly steer the imaging optical beam perpendicular to the beam direction. Where OCT utilizes scanning components to steer the in-depth profiling beam which can generate 2-D or 3-D images, the OtoSight Middle Ear Scope does not use a beam steering component because the in-depth density along the beam direction is sufficient to reveal the middle ear content. LCI, or rather one-dimensional OCT, uses a stationary beam instead to generate a one-dimensional in-depth density profile, over time. LCI reveals the optical reflective property of the TM, as well as the contents present behind. ## 3. Description of changes The OtoSiaht Middle Ear Scope predicate has been available on the US market since October 2020. In that time, it has been used thousands of times. As part of reqular interactions with users, feedback has indicated that a more mobile product would benefit use within a typical primary care practice. In particular, it was noted that bringing the product to the exam room and finding a power outlet within reach of the patient was impactice workflow. This design change is intended to reduce the impact of the device on the practice workflow by supporting use while on battery power. Table 1 is a summary of the changes included within the project that is resulting in the application of a Special 510(k) for the modification of the OtoSight Middle Ear Scope. The proposed device was developed according to existing risk management and development processes. All new and existing risks have been appropriately mitigated and residual risk is acceptable. | Area impacted | Description of changes | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | Device is operable under battery power for up to 7 hours. Internal<br>battery is a non-user replaceable 74Wh li-ion battery. | | Risk Analysis | Risk Management File has been updated to reflect new risks and<br>mitigations introduced into product as part of device changes | | Labeling | IFU, Quick Start Guide and device labeling updated to reflect<br>operation under battery power and compliance with additional<br>standards. | Table 1. List of changes to the device included within this special 510k submission {6}------------------------------------------------ ## 4. Non-Clinical Performance Testing The OtoSight Middle Ear Scope has been tested using appropriate bench testing methods to ensure safety as well as performance aspects. Test results of the subject device have demonstrated that the device performs within its design specifications and equivalently to the predicate device. Design changes were completed according to the internal PhotoniCare design controls standard operating procedure with appropriate verification and validation completed. For changes that may have impacted conformity to recognized standards, verification was completed to ensure the device remains compliant. Design control procedures provided reasonable assurance of safety and effectiveness and that the modifications did not affect the intended use. As applicable, the verification and validation testing completed for the design change was equivalent to verification and validation activities completed for the predicate device. Table 2 provide a nonexhaustive summary verification and validation activities completed for the subject device. | Verification/Validation Method | Acceptance Criteria | Summary of results | |------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------| | IEC 60601-<br>1:2005+AMD1:2012 CSV | Compliant with IEC 60601-1 ed3.1 | PASS | | IEC 62133-2:2017 | Compliant with IEC 62133-2:2017 | PASS | | IEC 60601-1-2 4th edition | Compliant with IEC 60601-1-2 4th<br>edition | PASS | | Verification of existing and<br>new design inputs according to<br>existing protocols equivalent to<br>used in K191804. | Equivalent to acceptance criteria used<br>in K191804, as applicable. | PASS | | Validation of existing and new<br>user needs according to<br>equivalent protocol used in<br>K191804. | Equivalent to acceptance criteria used<br>in K191804, as applicable. | PASS | Table 2 - Summary of non-clinical performance testing of subject device ## 5. Substantial Equivalence The OtoSight Middle Ear Scope has the same intended use, indications for use and fundamental technology as the predicate. The design change included in the submission impacts only the use of the device on battery, and associated design and labeling changes to facilitate the change in operation. Verification and validation activities have shown adherence to the original design inputs and user needs using the same methods and acceptance criteria, as applicable, with substantially equivalent performance to the predicate. ## 6. Conclusion The OtoSight Middle Ear Scope is substantially equivalent in intended use and fundamental scientific technology to its predicate. The OtoSight Middle Ear Scope is considered as safe and effective as the predicate device for its intended use when used in accordance with its Instructions {7}------------------------------------------------ for Use. The rechargeable battery does not introduce different issues of safety and effectiveness of the device. Non-clinical performance data, conformity to standards, and risk analysis provides evidence to support reasonable assurance of safety and effectiveness per its intended use and is substantially equivalent to the predicate.