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.

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.

AI/ML Overview

The provided text describes a 510(k) submission (K222655) for the PhotoniCare OtoSight Middle Ear Scope. This submission is a Special 510(k) for a modification to an already cleared device (K191804). Special 510(k)s are used for changes that do not affect the intended use or fundamental scientific technology of a device, where the new design is validated through design controls.

Therefore, the study described in this document is primarily focused on non-clinical performance testing to demonstrate that the modified device remains safe and effective and substantially equivalent to its predicate, rather than a clinical study establishing the device's diagnostic performance from scratch. Clinical studies to establish the diagnostic performance (e.g., accuracy in detecting fluid vs. air in the middle ear) would typically have been performed for the original predicate device (K191804).

Based on the provided text, here's an analysis of the acceptance criteria and study details:

Nature of the Study: This submission is a Special 510(k), indicating that the device has undergone relatively minor changes (addition of battery operation). The "study" described is a series of non-clinical performance tests to ensure the modified device remains safe and effective and substantially equivalent to the original cleared device. It is not a clinical diagnostic performance study demonstrating efficacy in disease diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

Verification/Validation Method	Acceptance Criteria	Reported Device Performance
IEC 60601-1:2005+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 edition	PASS
Verification of existing and new design inputs according to existing protocols equivalent to used in K191804.	Equivalent to acceptance criteria used in K191804, as applicable.	PASS
Validation of existing and new user needs according to equivalent protocol used in K191804.	Equivalent to acceptance criteria used in K191804, as applicable.	PASS

2. Sample size used for the test set and data provenance:

For the non-clinical performance tests listed, the "sample size" refers to the number of devices or test conditions used for engineering verification and validation, not patient data. The document does not specify exact numbers of devices tested but generally refers to "appropriate bench testing methods."
Data Provenance: The document does not discuss the provenance of data in terms of country of origin or retrospective/prospective for patient data, as this 510(k) focuses on engineering changes and compliance with safety standards rather than clinical performance data. The device itself is manufactured by PhotoniCare, Inc. in Champaign, Illinois, USA.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

This information is not applicable to the non-clinical performance tests described. Ground truth for diagnostic accuracy would be established during clinical studies, which are not the focus of this Special 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable to the non-clinical performance tests.

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. The OtoSight Middle Ear Scope is an imaging tool for visualization, not an AI-assisted diagnostic device where human readers would interpret AI outputs. This document discusses engineering changes and safety compliance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is an imaging tool, not a standalone algorithm. The "LCI" (Low-Coherence Interferometry) part of the device processes optical signals to generate a one-dimensional in-depth density profile. Its performance is evaluated through its ability to provide this visualization, not as a diagnostic algorithm independent of human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests described, the "ground truth" or reference standard would be the specified engineering tolerances, recognized safety standards (IEC 60601 series, IEC 62133-2), and design inputs/user needs established for the device. For example, for battery performance, the ground truth would be that the battery operates for "up to 7 hours" under typical usage, or that it complies with the specified standard.

8. The sample size for the training set:

Not applicable. This submission is for device modification, not for the development of a machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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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. 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 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

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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 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

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Indications for Use

510(k) Number (if known) K222655

Device Name OtoSight Middle Ear Scope

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510k Summary K222655

1. Information Page

Date Prepared:	August 31, 2022
Submitted by:	PhotoniCare, Inc.
Web:	https://photoni.care/
Address:	PhotoniCare Inc.1902 Fox Drive, Suite FChampaign, IL 61820
Contact Person:	Ryan Shelton PhD
Phone Number:	(866) 411 3277
Common Name:	Optical Coherence Tomography (OCT)Imaging Otoscope
Proprietary Name:	OtoSight Middle Ear Scope
Classification:
Regulation Numbers:	21 CFR 892.1560
Name:	Device System, Imaging, TympanicMembrane and Middle Ear
Code:	QJG
Class:	2
Predicate Device(s):
Model Name:	TOMiScope (cleared under K191804 as theTOMiScope but commercialized now asOtoSight 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.

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2. Device Description

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.

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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
TechnologicalCharacteristics	Device is operable under battery power for up to 7 hours. Internalbattery is a non-user replaceable 74Wh li-ion battery.
Risk Analysis	Risk Management File has been updated to reflect new risks andmitigations introduced into product as part of device changes
Labeling	IFU, Quick Start Guide and device labeling updated to reflectoperation under battery power and compliance with additionalstandards.

Table 1. List of changes to the device included within this special 510k submission

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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 60601-1:2005+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 4thedition	PASS
Verification of existing andnew design inputs according toexisting protocols equivalent toused in K191804.	Equivalent to acceptance criteria usedin K191804, as applicable.	PASS
Validation of existing and newuser needs according toequivalent protocol used inK191804.	Equivalent to acceptance criteria usedin 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

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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.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.