(233 days)
The Aesomist LT nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for health care use. This device must be used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
AC-powered air compressor intended to provide a source of compressed air for medical purposes for health care use. This device must be used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy.
1. Acceptance Criteria and Reported Device Performance
This document describes the FDA clearance for the Medline Aeromist LT Nebulizer Compressor (K031686) as "substantially equivalent" to legally marketed predicate devices. It does not contain specific acceptance criteria or performance metrics for the device itself. The FDA letter states that the device is subject to "general controls provisions of the Act," which include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text, as these specific details are not present. The clearance is based on substantial equivalence, implying the device performs similarly to predicate devices already on the market and meets existing safety and effectiveness standards.
Regarding other information requested:
Since the provided document is an FDA 510(k) clearance letter based on substantial equivalence, and not a study report detailing clinical performance or algorithm evaluation, the following information is not present and cannot be extracted:
- 2. Sample size used for the test set and the data provenance: Not applicable.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
This document is a regulatory approval, not a scientific study report. It indicates that the device has met the regulatory requirements for market entry based on its similarity to existing, approved devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486
Re: K031686
Trade/Device Name: Medline Aeromist LT Nebulizer Compressor Regulation Number: 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: October 17, 2003 Received: October 27, 2003
Dear Ms. Haferkamp:
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, thereforc, 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 – Ms. Andrea Haferkamp
Please be advised that FDA' s issuance of a substantial equivalence determination does not mean that FDA has made a dctermination that your device complies with other requirements mean that I Dring 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Chiu 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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Indications for Use
510(k) Number (if known): KO31686
Device Name:
Aeromist LT Nebulizer Compressor
Indications For Use:
The Aesomist LT nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for health care use. This device must be used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page: 1 of
Division of Anesthesiology, General Hospital,
Infection Control, Devices
510(k) Number: K031686
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.