Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Eustachi provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.

Device Description

The Eustachi device is a battery-operated device designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Eustachi device is activated by pressing and holding the power button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear.

Eustachi is provided non-sterile, and is designed for reuse with a single patient.

AI/ML Overview

The provided text describes the Eustachi Ear Pressure Relief Device (K203754) and its substantial equivalence to a predicate device. However, it does not include typical acceptance criteria tables or detailed study results that would be used to demonstrate device performance against specific metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. This type of information is generally found in studies for diagnostic devices or AI-powered medical devices.

The Eustachi device is a non-AI, mechanical device for relieving negative middle ear pressure. Therefore, the information requested regarding AI performance, expert ground truth, MRMC studies, or training set details is not applicable to this device submission.

Here's a breakdown of the available information regarding acceptance criteria and performance studies, addressing as many of the requested points as possible given the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the way one might expect for a diagnostic or AI device. Instead, "acceptance criteria" are implied by compliance with various standards and successful completion of specific tests. The "reported device performance" is the successful demonstration of this compliance and functionality.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Complies with ISO 10993-1:2018 (FDA recognition # 2-258) and FDA guidance for surface-contact devices (mucosal tissue, <24 hours duration).	Cytotoxicity: Tested and passed. Sensitization: Tested and passed. Irritation / Intracutaneous reactivity: Tested and passed. The nosepiece (ABS plastic) was evaluated for contact with mucosal tissue for limited cumulative duration.
Cleaning Validation: Effectively cleaned according to instructions, validated to AAMI TIR30:2011/(R)2016.	Cleaning validation was conducted and demonstrated effectiveness of the Eustachi cleaning instructions.
Electrical Safety: Complies with IEC 60601-1:2012 and IEC 60601-1-11:2015.	The device complies with applicable sections of IEC 60601-1: 2012 and IEC 60601-1-11: 2015 standards.
Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2 edition 4.	The device complies with IEC 60601-1-2 edition 4 for EMC.
Bench Testing (Dimensional, Pressure, Flow Rate, Drop Test): Validates intended performance.	Bench testing was conducted to validate: Dimensional verification: Successful. Pressure value verification: Achieved 31 – 41 kPa (4.5 to 6 PSI). Flow rate verification: Achieved 1.7 – 2.1 LPM. Drop test verification: Successful.
Usability Testing: Potential users can complete tasks following instructions for OTC home use (identifying appropriateness, understanding/completing tasks, knowing when to consult HCP), compliant with IEC 62366-1: 2016 and IEC 60601-1-6: 2013.	A study was conducted verifying the ability of potential users to identify appropriateness, understand/complete tasks, and understand when to consult a healthcare professional. This demonstrated the labeling is sufficient for OTC use by lay users without prior training.
Software Verification and Validation: (N/A)	The Eustachi device does not contain software, so no software verification or validation was required.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench Testing" and "Usability Testing" as performance data.

Bench Testing: No sample size is specified for dimensional, pressure, flow rate, or drop tests. These are typically engineering tests performed on a limited number of manufactured units.
Usability Testing: The document states "A study was conducted... to verify the ability of potential users to complete the following tasks..." The sample size for this usability study is not provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). Usability studies are typically prospective tests with a representative user group.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The Eustachi device is a mechanical device for therapeutic intervention, not a diagnostic device requiring expert interpretation for ground truth. Ground truth in this context is based on engineering specifications and user comprehension of instructions.

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

This question is not directly applicable. For engineering tests like bench testing, results are typically compared against pre-defined specifications without an "adjudication method" involving multiple human reviewers in the way it's used for AI or diagnostic studies. For usability testing, user performance and feedback are assessed against criteria, but a specific "adjudication method" like 2+1 or 3+1 is not mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers (e.g., radiologists) with and without AI assistance is evaluated across multiple cases. The Eustachi is a non-AI mechanical device for therapeutic use.

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

No, a standalone algorithm performance study was not done. The Eustachi device is a mechanical device and does not involve an algorithm.

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

The "ground truth" for the Eustachi device's performance studies is based on:

Engineering Specifications: For bench tests (pressure, flow rate, dimensions).
Recognized Standards: For biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), cleaning validation (AAMI TIR30), and usability (IEC 62366-1, IEC 60601-1-6).
User Comprehension and Performance: For usability testing, where users' ability to follow instructions and correctly operate the device indicates effective design and labeling.

8. The sample size for the training set

This question is not applicable. The Eustachi device is not an AI/machine learning device; therefore, there is no "training set."

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

This question is not applicable as there is no training set for this mechanical device.

Summary

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February 19, 2021

Exercore, LLC % Lisa Pritchard Regulatory, Quality & Compliance Consultant DuVal & Associates. P.A. 825 Nicollet Mall, Suite 1840 Minneapolis, Minnesota 55402

Re: K203754

Trade/Device Name: Eustachi Ear Pressure Relief Device Regulatory Class: Unclassified Product Code: MJV Dated: December 22, 2020 Received: December 23, 2020

Dear Lisa Pritchard:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Shu-Chen Peng Assistant 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) K203754

Device Name Eustachi Ear Pressure Relief Device

Indications for Use (Describe)

The Eustachi is indicated for the treatment of negative middle ear pressure.

Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, loss. The Eustachi provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.

Type of Use (Select one or both, as applicable)	One-Time Contribution (26 CFR 301.6114-2)Recurring Use (26 CFR 301.6114-2)		One-Time Contribution (26 CFR 301.6114-2)		Recurring Use (26 CFR 301.6114-2)
	One-Time Contribution (26 CFR 301.6114-2)
	Recurring Use (26 CFR 301.6114-2)

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K203754

I. SUBMITTER

Exercore, LLC 8170 Old Carriage Court North, Suite 200 Minneapolis, MN 55379

Phone: 888-406-0668

Contact Person: Kevin Connelly Date Prepared: February 16, 2021

II. DEVICE
Name of Device: Eustachi® Ear Pressure Relief Device Common or Usual Name: Eustachi Classification Name: Middle Ear Inflation Device Regulatory Class: Unclassified Product Code: MJV

III. PREDICATE DEVICE

EarPopper, K073401 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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Eustachi is provided non-sterile, and is designed for reuse with a single patient.

V. INDICATIONS FOR USE

The Eustachi is indicated for the treatment of negative middle ear pressure.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the subject and predicate devices are designed for user by patients to relieve negative middle ear pressure. Both devices create a flow of air into the nose to eustachian tube, delivered at a specified pressure and volume. Both require the patient to swallow during use to facilitate movement of air into the eustachian tube. At a high level, the subject and predicate devices are based on equivalent technological characteristics as shown in Table 1. Validation from non-clinical testing and usability evaluation demonstrated that minor differences in technological characteristics do not raise any new questions of safety or effectiveness.

Item	Subject DeviceEustachi	Primary Predicate DeviceK073401EarPopper
Intended Use	Treatment of negative middle ear pressure	Treatment of negative middle ear pressure
Indications for Use	The Eustachi is indicated for the treatment of negative middle ear pressure.Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Eustachi provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can	The EarPopper is indicated for the treatment of negative middle ear pressure.Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The EarPopper provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the

Table 1: Comparison of Technological Characteristics

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Item	Subject DeviceEustachi	Primary Predicate DeviceK073401EarPopper
	prevent the accumulation of fluidand prevent hearing loss.	accumulation of fluid andprevent hearing loss.
Type of Use	Over-the-Counter	Prescription Use
Patient Use	Performed at home by patient ontheir own or under adultsupervision	Performed at home by patient ontheir own or under adultsupervision
IntendedUseEnvironment	Home Use	Home Use
Components	Handheld unit	Handheld unit
Mechanismof Action	Provides flow of air to openeustachian tube	Provides flow of air to openeustachian tube
PatientContact Type	Surface-contact device in contactwith mucosal tissue for limitedduration	Surface-contact device in contactwith mucosal tissue for limitedduration
UserInterface	Single button press on handheldunit	Single button press on handheldunit
Air Pressure	31 – 41 kPa (4.5 to 6 PSI)	3 – 6 PSI
Air FlowRate	1.7 – 2.1 LPM	0.6 – 1.3 LPM
PowerSupply	Alkaline Battery-powered (2 AA)	Alkaline Battery-powered (9V)
Sterility	Non-sterile	Non-sterile

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility Testing

The biocompatibility evaluation of the Eustachi device was conducted in accordance with ISO 10993-1: 2018 (FDA recognition # 2-258) and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," issued June 16, 2018. The battery of testing included the following tests:

Cytotoxicity
Sensitization ●
Irritation / Intracutaneous reactivity .

The Eustachi nosepiece (ABS plastic) is considered to be a surface-contact device in contact with mucosal tissue for limited cumulative duration (less than 24 hours).

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Cleaning Validation

Cleaning validation was conducted in accordance with AAMI TIR30:2011/(R)2016 to validate effectiveness of the Eustachi cleaning instructions.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the Eustachi device. The device complies with applicable sections of IEC 60601-1: 2012 and IEC 60601-1-11: 2015 standards for electrical safety, and IEC 60601-1-2 edition 4 for EMC.

Bench Testing

Bench testing was conducted to validate intended performance of the Eustachi device including dimensional verification, pressure value verification, flow rate verification, and drop test verification.

Usability Testing

A study was conducted in accordance with IEC 62366-1: 2016 and IEC 60601-1-6: 2013 to verify the ability of potential users to complete the following tasks when no training is provided to simulate over-the-counter home use:

Identify whether the device would be appropriate for them to use;
Understand and complete the tasks required for use of the device; ●
Understand when a healthcare professional should be consulted ●

Software Verification and Validation

The Eustachi does not contain software; no software verification or validation was required.

Animal Performance Study

No animal performance studies were required for the Eustachi device.

Clinical Study

No clinical studies were required for the Eustachi device.

CONCLUSIONS VIII.

The biocompatibility, electrical safety, EMC, and bench testing conducted provide evidence that the Eustachi performs comparable to the predicate device. The Eustachi has the same intended use as the predicate device. The usability testing conducted provides evidence that the Eustachi labeling is sufficient to support over-the-counter (OTC) use by ensuring the device performs safely when used by lay users with no previous training. The data

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provided supports substantial equivalence of the Eustachi to the predicate device.

Regulation Number and Section

N/A