K Number
K080926
Device Name
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
Date Cleared
2008-08-12

(132 days)

Product Code
Regulation Number
868.5630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics. The device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.
Device Description
AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device.
More Information

Not Found

Not Found

No
The summary describes a mechanical nebulizer and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Yes
The device is intended to administer aerosolized medication prescribed by a physician or health care professional, indicating a therapeutic purpose.

No
The device is described as administering aerosolized medication, which is a therapeutic function, not a diagnostic one.

No

The device description clearly states it is a "Durable Breath Actuated Nebulizer," which is a physical hardware device used to administer medication. There is no mention of software as the primary or sole component.

Based on the provided information, the AeroEclipse® Durable Breath Actuated Nebulizer 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, or tissue) to provide information for diagnosis, monitoring, or screening.
  • AeroEclipse® Function: The description clearly states the device is used to administer aerosolized medication to a patient. It's a drug delivery device, not a device that analyzes biological samples.

The intended use and device description focus on delivering medication directly to the patient's respiratory system, which is a therapeutic function, not a diagnostic one.

N/A

Intended Use / Indications for Use

The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.

Product codes

CAF

Device Description

A single patient, reusable device, intended to be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Licensed health care provider or physician / home, hospitals and clinics.

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is a common symbol of the United States, and its presence in the logo represents the department's role in protecting the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2008

Mr. Darryl Fischer Associate Director, Quality & Regulatory Affairs Trudell Medical International 725 Third Street London, Ontario, CANADA N5V 5G4

Re: K080926

Trade/Device Name: AeroEclipse® Durable Breath Actuated Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 7, 2008 Received: July 8, 2008

Dear Mr. Fischer:

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.

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Page 2 - Mr. Fischer

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) 276-0120. 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 vours.

Thommels-Leidner Bell

Chiu S. Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K080926

Device Name: AeroEclipse® Durable Breath Actuated Nebulizer

Indications for Use:

The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

or

h. Mch for m. Husband

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080926

Prescription Use: (per 21CFR 801.109) Over the Counter Use: _