(153 days)
No
The summary describes the device's imaging technology (LCI and video otoscopy) and its intended use for visualization. There is no mention of AI or ML being used for image analysis, interpretation, or any other function. The performance studies focus on imageability and visualization, not algorithmic performance.
No.
The device is described as an "imaging tool for real-time visualization" and provides "surface images" and "a view through the surface to visualize the contents of the middle ear." Its purpose is diagnostic imaging, not therapeutic intervention or treatment.
Yes
The device 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, and to visualize fluid density in the presence of middle ear fluid. This capability to visualize and characterize internal body structures and conditions for medical assessment and diagnosis directly aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "multiple use, non-sterile device" with a "form factor which allows for ease of imaging the middle ear by the clinician" and a "push-button on the handheld". This indicates a physical hardware component beyond just software.
Based on the provided information, the TOMi Scope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- TOMi Scope's Intended Use: The TOMi Scope is intended for the real-time visualization of the human tympanic membrane and middle ear space in situ (within the body). It uses imaging modalities (LCI and video otoscopy) to directly view structures and fluid within the ear.
- No Specimen Examination: The device does not involve the collection or analysis of any biological specimens from the patient.
Therefore, the TOMi Scope falls under the category of a medical imaging device used for direct visualization within the body, rather than an IVD device that analyzes specimens outside the body.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
QJG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (Low-Coherence Interferometry, LCI, one-dimensional Optical Coherence Tomography, 1D-OCT), Video Otoscopy
Anatomical Site
human tympanic membrane and fluid or air within the middle ear space, ear canal
Indicated Patient Age Range
children and adults
Intended User / Care Setting
healthcare facility by qualified users
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PhotoniCare conducted a 26 subject, single site clinical study involving both Pediatric and Otolaryngology clinics to illustrate the ability of the TOMi Scope to collect images of human 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.
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
§ 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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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):
| 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
Provided in accordance with 21 CFR 807.92
General Provisions 1.
Date Prepared:
December 5, 2019
Submitted by:
PhotoniCare, Inc.
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
4
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
Comparison | Subject Device:
TOMI Scope | Primary
Predicate
Device:
Foresee (4C)
Imaging
System
(K133209) | Similarities and
Differences |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement
Technology | Low-Coherence
Interferometry (LCI,
one-dimensional
Optical Coherence
Tomography, 1D-
OCT) | Optical
Coherence
Tomography
(OCT) | Equivalent
LCI is a non-
scanning
implementation of
the more well-known
OCT. OCT utilizes
scanning
components to steer
the in-depth profiling
beam which can
generate 2-D or 3-D
images. LCI, or
rather one-
dimensional OCT,
uses a stationary
beam instead to
generate a one-
dimensional, in-
depth density profile,
displayed over time.
LCI reveals optical
reflective property of |
| Areas
of
Comparison | Subject Device:
TOMI Scope | Primary
Predicate
Device:
Foresee (4C)
Imaging
System
(K133209) | Similarities and
Differences |
| | | | the tympanic
membrane, as well
as contents present
behind. |
| Light Source | Superluminescent
Light Emitting Diode
(SLED) | Swept Laser
Source | Equivalent
Both light sources
are suitable for OCT |
| Radiation
Type | Near-Infrared Low-
Coherence Beam
(700 nm - 1400 nm) | Near-Infrared
Low-
Coherence
Beam (700 nm
- 1400 nm) | Same
Same optical
radiation band |
| Optical
Radiation
Safety
Cont. from
above. | Class 3R | Class 1 | Different
While the subject
device has a higher
laser classification
than the primary
predicate device, the
subject TOMi Scope
also follows IEC
60825-1 Laser
safety standards and
employs the
following controls:
• unintentional
exposures would
rarely reflect worst-
case conditions of
(e.g.) beam
alignment with a
large pupil and
worst-case
accommodation with
the entire beam
energy entering the
eye,
• inherent reduction
factor (safety
margin) in the
Maximal Permissible
Exposure |
| Areas of
Comparison | Subject Device:
TOMI Scope | Primary Predicate Device:
Foresee (4C) Imaging System
(K133209) | Similarities and
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
of
Comparison | Subject Device:
TOMI Scope | Primary
Predicate
Device:
Foresee (4C)
Imaging
System
(K133209) | Similarities
and
Differences |
| Reference
Arm | Fixed reference arm | Fixed reference
arm | Same |
| Optical
Signal
Detection | Frequency-domain
signal acquisition | Frequency-
domain signal
acquisition | Same |
| Axial
Resolution | ≤ 47μm (in air) |