TOMi Scope

K191804 · Photonicare, Inc. · QJG · Dec 5, 2019 · Radiology

Device Facts

• Record ID: K191804
• Device Name: TOMi Scope
• Applicant: Photonicare, Inc.
• Product Code: QJG · Radiology
• Decision Date: Dec 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TOMi 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 TOMi Scope is used to visualize the fluid density. The TOMi 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 Story

The TOMi Scope is a handheld, non-sterile imaging device used by clinicians in healthcare facilities to visualize the tympanic membrane and middle ear. It integrates two modalities: video otoscopy (using a CCD camera for surface images) and Low-Coherence Interferometry (LCI). LCI, a non-scanning, one-dimensional implementation of OCT, uses a near-infrared SLED light source to generate an in-depth density profile of the tympanic membrane and underlying middle ear contents. The clinician positions the device in the ear canal using disposable specula tips and triggers recording via a push-button. The system displays both surface video and LCI density profiles on a base unit touchscreen. This information assists clinicians in assessing middle ear fluid presence and density, aiding clinical decision-making regarding ear health. The device benefits patients by providing non-invasive, real-time visualization of middle ear conditions.

Clinical Evidence

A 26-subject, single-site observational study was conducted in pediatric and otolaryngology clinics. The study evaluated the ability to collect images of the human tympanic membrane and middle ear space. Endpoints: 1) Successful collection of bilateral images from at least 25 subjects (achieved); 2) At least 80% of collected images considered readable by a trained reader (achieved). No adverse events were reported.

Technological Characteristics

The device uses a near-infrared SLED (700-1400 nm) for LCI and a CCD camera for video otoscopy. It features a handheld probe with disposable specula tips, a base unit with a touchscreen, and an opto-electrical cable. It conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), IEC 62471 (photobiological safety), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for use in children and adults for real-time visualization of the human tympanic membrane and middle ear space (fluid or air) and for surface imaging of the ear canal.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Foresee (4C) Imaging System (K133209)

Reference Devices

• AIO HD Otoscope (K123821)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

December 5, 2019

PhotoniCare, Inc. Ryan Shelton, Ph.D. CEO 60 Hazelwood Dr. Champaign, Illinois 61820

Re: K191804

Trade/Device Name: TOMi Scope Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: QJG Dated: October 25, 2019 Received: November 5, 2019

Dear Dr. 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia 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) K191804

Device Name TOMi Scope

Indications for Use (Describe)

The TOMi 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 TOM Scope is used to visualize the fluid density. The TOMi 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):

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## Section 5-510(k) Summary

Provided in accordance with 21 CFR 807.92

#### General Provisions 1.

## Date Prepared:

December 5, 2019

Submitted by:

PhotoniCare, Inc.

Web: https://photoni.care/

### Contact Person:

Ryan Shelton PhD, CEO and Co-founder PhotoniCare, Inc.

### Common Name:

Optical Coherence Tomography (OCT) Imaging otoscope

### Trade/Proprietary Name:

Model 34R TOMi Scope

### Establishment Registration Number:

N/A

### Classification:

Regulation Numbers: 21 CFR 892.1560 Name: Ultrasonic pulsed echo imaging system Product code: QJG

Class II

### Predicate Device:

| (Primary) | |
|---------------|--------------------------------------|
| Model Name: | Foresee (4C) Imaging System |
| Common Name: | Optical Coherence Tomography Scanner |
| 510(k) # | K133209 |
| Manufacturer: | Diagnostic Photonics, Inc. |
| Submitted: | October 17, 2013 |

### Reference Device:

Model Name: AIO HD Otoscope Common Name: Otoscope 510(k) #K123821 Manufacturer: Blue Focus Submitted: December 12, 2012

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To our knowledge, the predicate and reference devices have not been subject to a design-related recall.

#### 2. Description and Use

Model 34R TOMi 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 TOMi Scope provides a view through the surface to visualize the contents of the middle ear using Low-Coherence Interferometry (LC). LCI is an implementation of OCT which, rather than generating 2-D or 3-D images, is limited to the generation of a onedimensional 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 TOMi Scope has a form factor which allows for ease of imaging the middle ear by the clinician, who will utilize disposable specula tips and position the TOMi 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.

### Device Components/Accessories

The TOMi Scope System includes the following components:

- Base unit with touch screen ●
- Handheld piece with visual display ●
- Opto-electrical connection cable .
- . Stand
- Power cord

The TOMi Scope utilizes software which is responsible for the user interface. The user interface consists of both user inputs and displayed information.

The following accessories are available for the TOMi Scope:

- TOMi Adult Speculum Tip ●
- TOMi Pediatric Speculum Tip .

### Environment of Use

The TOMi Scope is intended to be used in a healthcare facility by qualified users.

#### 3. Intended Use / Indications Statement:

The Tomi 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 TOMi Scope is used to visualize the fluid density. The TOMi Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.

While the Indications for Use Statement for the TOMi Scope is not identical to the predicate device, the differences do not alter the intended use of the device nor do they affect the safety and/or effectiveness of the device relative to the predicate. Both the subject device and the primary predicate device utilize equivalent technology to produce images which are intended to be evaluated by the clinician. (Note: The video otoscopy functionality of the TOMi Scope is currently considered to be Class 1, 510(k) exempt.)

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#### 4. Technological Characteristics

The TOMi Scope includes two fundamental modes of operation; video otoscopy and LCI. These technologies are described below.

### Video Otoscopy

In order 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.

(Note: The video otoscopy functionality of the TOMi Scope is currently considered to be Class 1, 510(k) exempt. The AIO HD Otoscope which was cleared under K123821 is included in this submission as a Reference Device.)

### Low-Coherence Interferometry (LCI)

To visualize the density profile of the TM and middle ear contents, the TOMi Scope utilizes LCI, a non-invasive, optical imaging technique analogous to ultrasound imaging. Instead of using sound as in ultrasound imaging, LCI uses near infrared light. It is a nonscanning implementation of the more well-known OCT technology.

| Areas of<br>Comparison | Subject Device:<br>TOMI Scope | Primary<br>Predicate<br>Device:<br>Foresee (4C)<br>Imaging<br>System<br>(K133209) | Similarities and<br>Differences |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement<br>Technology | Low-Coherence<br>Interferometry (LCI,<br>one-dimensional<br>Optical Coherence<br>Tomography, 1D-<br>OCT) | Optical<br>Coherence<br>Tomography<br>(OCT) | Equivalent<br>LCI is a non-<br>scanning<br>implementation of<br>the more well-known<br>OCT. OCT utilizes<br>scanning<br>components to steer<br>the in-depth profiling<br>beam which can<br>generate 2-D or 3-D<br>images. LCI, or<br>rather one-<br>dimensional OCT,<br>uses a stationary<br>beam instead to<br>generate a one-<br>dimensional, in-<br>depth density profile,<br>displayed over time.<br>LCI reveals optical<br>reflective property of |
| Areas<br>of<br>Comparison | Subject Device:<br>TOMI Scope | Primary<br>Predicate<br>Device:<br>Foresee (4C)<br>Imaging<br>System<br>(K133209) | Similarities and<br>Differences |
| | | | the tympanic<br>membrane, as well<br>as contents present<br>behind. |
| Light Source | Superluminescent<br>Light Emitting Diode<br>(SLED) | Swept Laser<br>Source | Equivalent<br>Both light sources<br>are suitable for OCT |
| Radiation<br>Type | Near-Infrared Low-<br>Coherence Beam<br>(700 nm - 1400 nm) | Near-Infrared<br>Low-<br>Coherence<br>Beam (700 nm<br>- 1400 nm) | Same<br>Same optical<br>radiation band |
| Optical<br>Radiation<br>Safety<br>Cont. from<br>above. | Class 3R | Class 1 | Different<br>While the subject<br>device has a higher<br>laser classification<br>than the primary<br>predicate device, the<br>subject TOMi Scope<br>also follows IEC<br>60825-1 Laser<br>safety standards and<br>employs the<br>following controls:<br>• unintentional<br>exposures would<br>rarely reflect worst-<br>case conditions of<br>(e.g.) beam<br>alignment with a<br>large pupil and<br>worst-case<br>accommodation with<br>the entire beam<br>energy entering the<br>eye,<br>• inherent reduction<br>factor (safety<br>margin) in the<br>Maximal Permissible<br>Exposure |
| Areas of<br>Comparison | Subject Device:<br>TOMI Scope | Primary Predicate Device:<br>Foresee (4C) Imaging System<br>(K133209) | Similarities and<br>Differences |
| | | | There is a radiation label near the Laser aperture with the warning phrase to avoid eye exposure. The label is readily visible when operating the handheld probe, where the Laser beam is emitting; There is a Laser-ON indicator to warn the operator when the Laser is turned on; There are instructions in the Instruction for Use (IFU), which asks the operator to avoid pointing the handheld probe towards the eye; While the TOMi Scope uses a laser in the near infrared wavelength range, there are LEDs in the visible wavelengths for illumination of the tympanic membrane. The illumination is ON when the Laser is turned on. Such illumination causes natural aversion behavior of human eye to avoid bright light exposure. |
| Areas<br>of<br>Comparison | Subject Device:<br>TOMI Scope | Primary<br>Predicate<br>Device:<br>Foresee (4C)<br>Imaging<br>System<br>(K133209) | Similarities<br>and<br>Differences |
| Reference<br>Arm | Fixed reference arm | Fixed reference<br>arm | Same |
| Optical<br>Signal<br>Detection | Frequency-domain<br>signal acquisition | Frequency-<br>domain signal<br>acquisition | Same |
| Axial<br>Resolution | ≤ 47μm (in air) | < 20 μm (in air) | Equivalent<br>OCT devices have a<br>trade-off between<br>the axial resolution<br>and the axial<br>imaging range. For<br>TOMi Scope we<br>accept a lower axial<br>resolution, which is<br>still sufficient to<br>represent the<br>eardrum thickness<br>on the order of one<br>hundred microns.<br>We designed a<br>longer axial imaging<br>range which makes<br>the device more user<br>friendly in the<br>tortuous ear canal.<br>Nevertheless, the<br>two parameters are<br>on the same order of<br>magnitude. |
| Axial<br>Imaging<br>Range | ≥ 3mm (in air) | ≥ 2.1mm (in air) | Equivalent<br>OCT devices have a<br>trade-off between<br>the axial resolution<br>and the axial<br>imaging range. For<br>the TOMi Scope we<br>accept a lower axial<br>resolution, which is<br>still sufficient to<br>represent the<br>eardrum thickness<br>on the order of one<br>hundred microns. |
| Areas<br>of<br>Comparison | Subject Device:<br>TOMi Scope | Primary<br>Predicate<br>Device:<br>Foresee<br>Imaging<br>System<br>(K133209) | Similarities<br>and<br>Differences |
| | | | We design a longer<br>axial imaging range<br>which makes the<br>device more user<br>friendly in the<br>tortuous ear canal.<br>Nevertheless, the<br>two parameters are<br>on the same order of<br>magnitude as the<br>predicate device. |
| Lateral<br>Resolution | ≤ 50µm | < 20µm | Equivalent<br>The comparison of<br>the lateral resolution<br>and lateral scanning<br>range is a<br>comparison between<br>general OCT versus<br>LCI. Lateral direction<br>is perpendicular to<br>the beam direction.<br>Because LCI does<br>not scan laterally or<br>identify lateral<br>features, the lateral<br>resolution is less<br>critical for the TOMi<br>Scope.<br>Nevertheless, the<br>two lateral<br>resolutions are on<br>the same order of<br>magnitude. |
| Lateral<br>Scanning<br>Range | None (1D-OCT) | 9.6mm | Different<br>The comparison of<br>the lateral resolution<br>and lateral scanning<br>range is a<br>comparison between<br>general OCT versus<br>LCI. Lateral direction<br>is perpendicular to<br>the beam direction. |
| Areas<br>of<br>Comparison | Subject Device:<br>TOMI Scope | Primary<br>Predicate<br>Device:<br>Foresee (4C)<br>Imaging<br>System<br>(K133209) | Similarities<br>and<br>Differences |
| | | | LCI does not scan<br>laterally, because<br>the features of<br>interest in the ear<br>application are in the<br>axial dimension,<br>rather than the<br>lateral dimension, so<br>the TOMi Scope was<br>designed without<br>lateral scanning to<br>simplify the usability<br>and design<br>complexity. Despite<br>this technological<br>difference from the<br>predicate device,<br>bench and clinical<br>testing demonstrated<br>the PhotoniCare<br>TOMI Scope<br>performs as<br>intended. |
| Power<br>Supply | 120/240V, 50/60Hz | 120/240V,<br>50/60Hz | Same |
| Luminance<br>Measurement<br>and Light<br>Intensity | 10 cm: 125 lux<br>15 cm: 84 lux<br>20 cm: 49 lux | N/A | Equivalent<br>TOMI Scope uses<br>lower luminance<br>than the AIO HD<br>otoscope.<br>Nevertheless, the<br>luminance is on the<br>same order of<br>magnitude. |
| LED<br>Operating<br>Voltage | 4V | N/A | Equivalent<br>TOMI Scope uses a<br>lower voltage for<br>electronic parts<br>inside the hand-held<br>unit which includes<br>the APPLIED PART<br>(speculum tip) |
| Areas of Comparison | Subject Device: TOMI Scope | Primary Predicate Device:<br>Foresee (4C) Imaging System<br>(K133209) | Similarities and Differences |
| Contact Temperature | 34.4 °C (93.92 F) | N/A | Equivalent<br>The TOMi Scope contact temperature is slightly higher than the AIO HD otoscope but is within a comfortable range which does not pose additional risks. |

# Technological Characteristic Comparison with Predicate Device

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#### 5. Performance Data

The TOMi Scope has been designed and tested to comply with all applicable FDA Recognized Standards. The following table provides a listing of the recognized standards to which TOMi Scope conforms.

| Standard ID # | Title | FDA<br>Recognition<br># |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| IEC 60601-<br>1:2005+AMD1:2012<br>CSV | Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance | 19-4 |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Electromagnetic disturbances -<br>Requirements and tests | 19-8 |
| IEC 60601-1-<br>6:2010+AMD1:2013<br>CSV | Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and<br>essential performance - Collateral standard:<br>Usability | 5-89 |
| IEC 60825-1:2007 | Safety of laser products - Part 1: Equipment<br>classification and requirements | 12-273 |
| IEC 62471:2006 | Photobiological safety of lamps and lamp<br>systems | 12-249 |
| IEC<br>62304:2006+AMD1:2015<br>CSV | Medical device software - Software life cycle<br>processes | 13-79 |
| ISO 10993-1:2009 | Biological evaluation of medical devices --<br>Part 1: Evaluation and testing within a risk<br>management process | 2-220 |

#### Non-Clinical Testing 6.

A non-clinical bench study using a phantom ear comprised of a model tympanic membrane and middle ear fluid of varying densities demonstrated that the TOMi Scope visualizes the phantom tympanic membrane and fluid as intended. Comprehensive verification and validation testing was also performed on the device in accordance with the requirements of regulation Part 21 CFR 820.30, in order to confirm that it is safe and functions as intended.

#### 7. Clinical Testing

The following non-clinical performance testing was submitted in support of the substantial equivalence determination.

PhotoniCare conducted a 26 subiect, single site clinical study involving both Pediatric and Otolaryngology clinics to illustrate the ability of the TOMi Scope to collect images of human

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tympanic membrane (TM; eardrum) and underlying middle ear space, from adult and child subjects in a clinical setting.

The intent of this observational study was to illustrate the ability of the TOMi Scope to collect images of human TM and underlying middle ear space in the proposed adult and child patient population.

The two endpoints for the study were:

- Endpoint 1: Obtain data illustrating the clinical use of the PhotoniCare TOMi Scope . to collect bilateral images of human TM and underlying middle ear space from at least 25 combined adult and child subjects.
- Endpoint 2: Obtain data illustrating TOMi Scope imageability of human middle ears, . wherein at least 80% of TOMi Scope images collected are considered readable by a trained reader.

Both endpoints were successfully achieved.

#### Summary/Conclusion 8.

Based upon conformity to applicable FDA recognized standards, non-clinical and clinical performance testing as well as the result of the risk assessment, the TOMi Scope was found to have a safety and effectiveness profile that is equivalent to the predicate device. Therefore, PhotoniCare, Inc. has demonstrated that the TOMi Scope is substantially equivalent to the stated predicate device and that the TOMi Scope is as safe and performs in an equivalent manner to the stated predicate device.