K Number

Device Name

EARPOPPER, MODEL EP-2000, EP-2100, EP-3000

Manufacturer

MICROMEDICS, INC.

Date Cleared

2008-03-14

(101 days)

Product Code

MJV

Regulation Number

N/A

Intended Use

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K951596, K920840

Reference Devices

Politzer Bag

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for ventilating the middle ear and does not mention any AI or ML components or capabilities.

Therapeutic

Yes
The device is indicated for the treatment of various middle ear pressure problems, including fluid accumulation, temporary hearing loss, and ear pain, directly addressing health conditions.

Diagnostic

No
Explanation: The device description and intended use clearly state that the EarPopper is a treatment for negative middle ear pressure, not a diagnostic tool. It provides a method of ventilating the middle ear to equalize pressure and manage symptoms, rather than identifying or diagnosing a condition.

SaMD (Software as a Medical Device)

The device description clearly indicates a physical device ("The EarPopper is a non-surgical, non-drug related treatment...") that provides a method of increasing air pressure, which requires hardware components. The summary does not mention any software-only aspects.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
EarPopper Function: The EarPopper is a device that physically interacts with the body (nose, eustachian tube, middle ear) to equalize pressure. It does not analyze any biological specimens.
Intended Use: The intended use is for the treatment of negative middle ear pressure, not for analyzing samples to diagnose a condition.

The EarPopper is a therapeutic device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

MJV

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

middle ear, nose, eustachian tube

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Performed at home by patient on his own, or under adult supervision

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

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.

K951596, K920840

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.

Politzer Bag

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

Regulation Number and Section

N/A

Summary

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

SUMMARY of EQUIVALENCE:

Characteristic	EarPopper	Earclear K951596	Politzer Bag	Otovent K920840
Intended use	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.	The Earclear 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 Earclear provides a
method of ventilating the
middle ear by forcing air
pressure through the nose
and the Eustachian tube
into the middle ear.
Equalizing the pressure
can prevent the
accumulation of fluid and
prevent hearing loss.	Treatment of negative
middle ear pressure	Treatment of negative
middle ear pressure
Patient Use	Performed at home by
patient on his own, or
under adult supervision	Performed at home by
patient on his own, or
under adult supervision	Performed at home by
patient on his own, or
under adult supervision,
but typically requires a
second person to
deliver the air pressure	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	Ventilation of the middle
ear by forcing air under
pressure through the nose
and the eustachian tube
into the middle ear	Ventilation of the
middle ear by forcing
air under pressure
through the nose and
the eustachian tube into
the middle ear	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 is held
against the nostril,
delivering continuous air
pressure via an air pump	Non-sterile, battery
powered device is held
against the nostril,
delivering continuous air
pressure via an air pump	Non-sterile, manual
device is held against
the nostril, delivering
varying amount of air
pressure via the
compression of a bulb
(bag)	Non-sterile, manual
device is 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	Plastic (PVC/ABS/PEI)
nosepiece mounted to a
plastic case, housing an air
pump, batteries and a
printed circuit board	Plastic or glass
nosepiece mounted to a
rubber tube which is
connected to a rubber
bulb (bag)	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	Continuous, controlled to
1.5 PSI on low setting and
3 PSI on high setting	Varying, uncontrolled
range: 1.5 to 5.9 PSI
reported by Politzer, 5.2
PSI reported by
Schwartz, 10 to 30 PSI	Varying,
uncontrolled, value
not specified in the
product literature

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.

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

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

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