← Product Code MJV · K073401 # EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (K073401) _Micromedics, Inc. · MJV · Mar 14, 2008 · EN · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K073401 ## Device Facts - **Applicant:** Micromedics, Inc. - **Product Code:** MJV - **Decision Date:** Mar 14, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** EN - **Attributes:** Therapeutic ## 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 Story EarPopper is a non-surgical, battery-powered device for home use by patients or under adult supervision. It treats negative middle ear pressure by delivering controlled air pressure to the nasal cavity. The device consists of a plastic nosepiece, air pump, batteries, and a printed circuit board. The user holds the nosepiece against the nostril and activates the pump to deliver continuous air pressure (3 PSI or 6 PSI settings) into the nose and Eustachian tube. This momentary pressure increase ventilates the middle ear, equalizing pressure to prevent fluid accumulation and associated hearing loss. It serves as an alternative to manual methods like the Politzer bag or balloon-based devices. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to predicate devices. ## Technological Characteristics Battery-powered, non-sterile device. Components: ABS/Polycarbonate/Polystyrene nosepiece, air pump, PCB. Dimensions/form factor: handheld. Energy source: battery. Pressure output: controlled 3 PSI (0.6 L/min) or 6 PSI (1.3 L/min). ## Predicate Devices - Earclear ([K951596](/device/K951596.md)) - Otovent ([K920840](/device/K920840.md)) ## Reference Devices - Politzer Bag ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: 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. #### SUBSTANTIALLY EQUIVALENT TO: Earclear (K951596) Arisil Medical Otovent (K920840) ABIGO Medical Co. Politzer Bag {1}------------------------------------------------ ## 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 | {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ # K07340 ### STATEMENT OF INDICATIONS FOR USE 510(k) Number (if known): Device Name: EarPopper Indications for 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. Prescription Use: X (Per 21 CFT 801.109) OR 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 --- **Source:** [https://fda.innolitics.com/device/K073401](https://fda.innolitics.com/device/K073401) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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