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 accumulation of fluid and prevent hearing loss.

Device Description

The EarPopper is a non-surgical, non-drug related treatment for middle ear pressure problems such as:

. Middle ear fluid (Otitis Media with Effusion)
Eustachian Tube Dysfunction
. Temporary hearing loss
Ear pain and pressure caused by air travel .
. Ear fullness caused by colds, allergies, sinusitis

AI/ML Overview

The provided 510(k) summary for the EarPopper device (K073401) is a premarket notification for substantial equivalence, not a clinical study proving performance against acceptance criteria in the typical sense of a diagnostic device.

Instead of an acceptance criteria table and device performance, the document provides a comparison of characteristics between the EarPopper and its predicate devices (Earclear, Politzer Bag, Otovent) to demonstrate substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence rather than a study validating specific performance metrics against pre-defined acceptance criteria, the document does not contain a "table of acceptance criteria and reported device performance" in the traditional sense for a diagnostic device.

Instead, the submission demonstrates equivalence by comparing the EarPopper's characteristics to those of its predicate devices. The "SUMMARY of EQUIVALENCE" table serves this purpose by showing that the EarPopper's intended use, patient use, principle of operation, mode of operation, major components, and air pressure output are sufficiently similar to the legally marketed predicate devices.

Characteristic	EarPopper Performance/Description	Predicate Performance/Description (from K951596,K920840)
Intended use	Treatment of negative middle ear pressure, preventing fluid accumulation and hearing loss by ventilating the middle ear; momentarily increasing air pressure in the nose and eustachian tube.	Earclear (K951596): Treatment of negative middle ear pressure, preventing fluid accumulation and hearing loss by forcing air pressure through the nose and Eustachian tube into the middle ear. Politzer Bag: Treatment of negative middle ear pressure. Otovent (K920840): Treatment of negative middle ear pressure.
Patient Use	Performed at home by patient on his own, or under adult supervision.	Earclear (K951596): Performed at home by patient on his own, or under adult supervision. Politzer Bag: Performed at home by patient on his own, or under adult supervision, but typically requires a second person to deliver the air pressure. Otovent (K920840): Performed at home by patient on his own, or under adult supervision.
Principle of Operation	Ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube.	Earclear (K951596): Ventilation of the middle ear by forcing air under pressure through the nose and the eustachian tube into the middle ear. Politzer Bag: Ventilation of the middle ear by forcing air under pressure through the nose and the eustachian tube into the middle ear. Otovent (K920840): Ventilation of the middle ear by forcing air under pressure through the nose and the eustachian tube into the middle ear.
Mode of Operation	Non-sterile, battery powered device held against the nostril, delivering continuous air pressure via an air pump.	Earclear (K951596): Non-sterile, battery powered device held against the nostril, delivering continuous air pressure via an air pump. Politzer Bag: Non-sterile, manual device held against the nostril, delivering varying amount of air pressure via the compression of a bulb (bag). Otovent (K920840): Non-sterile, manual device held against the nostril, delivering varying amount of air pressure via the deflation of the patient-inflated balloon.
Major Components	Plastic (ABS / Polycarbonate / Polystyrene) nosepiece mounted to a plastic case, housing an air pump, batteries and a printed circuit board.	Earclear (K951596): Plastic (PVC/ABS/PEI) nosepiece mounted to a plastic case, housing an air pump, batteries and a printed circuit board. Politzer Bag: Plastic or glass nosepiece mounted to a rubber tube which is connected to a rubber bulb (bag). Otovent (K920840): Plastic (PVC) nosepiece mounted to a latex balloon.
Air Pressure	Continuous, controlled to 3 PSI with air flow of 0.6 L/minute on low setting and 6 PSI with air flow of 1.3 L/minute on high setting.	Earclear (K951596): Continuous, controlled to 1.5 PSI on low setting and 3 PSI on high setting. Politzer Bag: Varying, uncontrolled range: 1.5 to 5.9 PSI reported by Politzer, 5.2 PSI reported by Schwartz, 10 to 30 PSI. Otovent (K920840):* Varying, uncontrolled, value not specified in the product literature.

Outcome: The FDA determined that the EarPopper is substantially equivalent to the predicate devices, indicating that its performance and safety are comparable.

2. Sample Size Used for the Test Set and the Data Provenance

The provided 510(k) summary does not describe a clinical study with a test set as it pertains to diagnostic accuracy or clinical effectiveness. The submission focuses on demonstrating substantial equivalence based on technological characteristics and intended use. Therefore, no information on sample size or data provenance (country, retrospective/prospective) is provided in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Since a clinical effectiveness study with a test set and ground truth establishment is not detailed in this 510(k) summary, no information is available regarding the number or qualifications of experts for establishing ground truth.

4. Adjudication Method for the Test Set

As no clinical study with a test set is described, there is no adjudication method 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

This device (EarPopper) is a non-surgical, non-drug treatment device for middle ear pressure problems, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable and not mentioned in the document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Similarly, since the EarPopper is a physical, non-AI treatment device, a standalone algorithm performance study is not applicable and not described.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

As this is a 510(k) submission for substantial equivalence based on technological characteristics and intended use, and not a performance study that requires a "ground truth" to validate diagnostic accuracy, no type of ground truth is mentioned or used in this document.

8. The Sample Size for the Training Set

No training set is referenced as no machine learning algorithm development or validation is being described.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set or ground truth establishment for an algorithm is described.

Summary

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K073401

MAR 14 2 :: 3

510(k) SUMMARY

Company Name and Address: Micromedics Inc. 1270 Eagan Industrial Road St. Paul, MN. 55121-1385

Image /page/0/Picture/4 description: The image shows the logo for Micromedics. The logo consists of a graphic of three curved lines emanating from a solid circle, resembling sound waves or a stylized ear. Below the graphic is the word "Micromedics" in a bold, sans-serif font. Underneath "Micromedics" are the words "Innovative Surgical Products" in a smaller, less bold font.

toll free US: 1-8 1270 Eagan Industrial Road . St. Paul, MN 55121

Contact Person Tom Lopac Manager of Quality & Regulatory Affairs, Micromedics Inc. Telephone: 651-452-1977 Fax: 651-452-1787

DATE PREPARED: 11-30-07

TRADE NAME: COMMON NAME: PRO CODE:

EarPopper Device, inflation, middle ear MJV

DESCRIPTION of the DEVICE:

The EarPopper is a non-surgical, non-drug related treatment for middle ear pressure problems such as:

. Middle ear fluid (Otitis Media with Effusion)
Eustachian Tube Dysfunction
. Temporary hearing loss
Ear pain and pressure caused by air travel .
. Ear fullness caused by colds, allergies, sinusitis

INDICATIONS FOR USE:

SUBSTANTIALLY EQUIVALENT TO:

Earclear (K951596) Arisil Medical Otovent (K920840) ABIGO Medical Co. Politzer Bag

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SUMMARY of EQUIVALENCE:

Characteristic	EarPopper	Earclear K951596	Politzer Bag	Otovent K920840
Intended use	The EarPopper isindicated for thetreatment of negativemiddle ear pressure.Negative middle earpressure can lead to fluidaccumulation in themiddle ear, impairedhearing and hearing loss.The EarPopper provides amethod of ventilating themiddle ear bymomentarily increasingthe air pressure in thenose and the eustachiantube. Equalizing thepressure can prevent theaccumulation of fluid andprevent hearing loss.	The Earclear is indicatedfor the treatment ofnegative middle earpressure. Negative middleear pressure can lead tofluid accumulation in themiddle ear, impairedhearing and hearing loss.The Earclear provides amethod of ventilating themiddle ear by forcing airpressure through the noseand the Eustachian tubeinto the middle ear.Equalizing the pressurecan prevent theaccumulation of fluid andprevent hearing loss.	Treatment of negativemiddle ear pressure	Treatment of negativemiddle ear pressure
Patient Use	Performed at home bypatient on his own, orunder adult supervision	Performed at home bypatient on his own, orunder adult supervision	Performed at home bypatient on his own, orunder adult supervision,but typically requires asecond person todeliver the air pressure	Performed at home bypatient on his own, orunder adultsupervision
Principle ofOperation	Ventilating the middle earby momentarilyincreasing the air pressurein the nose and theeustachian tube	Ventilation of the middleear by forcing air underpressure through the noseand the eustachian tubeinto the middle ear	Ventilation of themiddle ear by forcingair under pressurethrough the nose andthe eustachian tube intothe middle ear	Ventilation of themiddle ear by forcingair under pressurethrough the nose andthe eustachian tubeinto the middle ear
Mode ofOperation	Non-sterile, batterypowered device is heldagainst the nostril,delivering continuous airpressure via an air pump	Non-sterile, batterypowered device is heldagainst the nostril,delivering continuous airpressure via an air pump	Non-sterile, manualdevice is held againstthe nostril, deliveringvarying amount of airpressure via thecompression of a bulb(bag)	Non-sterile, manualdevice is held againstthe nostril, deliveringvarying amount of airpressure via thedeflation of thepatient-inflatedballoon.
MajorComponents	Plastic (ABS /Polycarbonate /Polystyrene) nosepiecemounted to a plastic case,housing an air pump,batteries and a printedcircuit board	Plastic (PVC/ABS/PEI)nosepiece mounted to aplastic case, housing an airpump, batteries and aprinted circuit board	Plastic or glassnosepiece mounted to arubber tube which isconnected to a rubberbulb (bag)	Plastic (PVC)nosepiece mounted toa latex balloon
Air Pressure	Continuous, controlled to3 PSI with air flow of 0.6L/minute on low settingand 6 PSI with air flow of1.3 L/minute on highsetting	Continuous, controlled to1.5 PSI on low setting and3 PSI on high setting	Varying, uncontrolledrange: 1.5 to 5.9 PSIreported by Politzer, 5.2PSI reported bySchwartz, 10 to 30 PSI	Varying,uncontrolled, valuenot specified in theproduct literature

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micromedics, Inc. c/o Tom Lopac Quality Manager 1270 Eagan Industrial Road Suite 120 St. Paul. MN 55121-1385

MAR 1 4 2008

Re: K073401

Trade/Device Name: EarPopper Regulation Number: Unclassified Product Code: MJV Dated: February 11, 2008 Received: February 15, 2008

Dear Mr. Lopac:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Maling B. Eeplata, ud

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K07340

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: EarPopper

Indications for Use:

Prescription Use: X (Per 21 CFT 801.109)

Over-The-Counter

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laura Bohm

Division Sian-Off vision of Ophthalmic f Nose and Throat Devis

510(k) Number K073401

Page 4-1

Regulation Number and Section

N/A