EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 by PIPER MEDICAL PRODUCTS

The provided document is a 510(k) premarket notification letter from the FDA to Piper Medical Products regarding their EZflow Continuous Nebulizer™ Model 1005. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this type of FDA correspondence for a 510(k) clearance does not contain acceptance criteria or study data for the device's performance. A 510(k) submission typically relies on demonstrating substantial equivalence to a predicate device, which might involve comparing technical characteristics and, in some cases, performance data. However, the FDA letter itself does not detail these studies or their results.

Therefore,Based on the provided document, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: This document does not contain performance criteria or study results.
Sample size used for the test set and the data provenance: This document does not describe any specific test set or its provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This document does not mention the use of experts or ground truth establishment for a test set.
Adjudication method for the test set: This document does not describe any adjudication method.
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 document is related to a nebulizer, which is a medical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As mentioned above, this device is not an algorithm, so standalone performance is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed in relation to performance studies.
The sample size for the training set: There is no mention of a training set as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

This document serves as a regulatory clearance, indicating that the device is deemed substantially equivalent to a pre-existing device, allowing it to be marketed. Information about specific performance studies and their results would typically be contained within the 510(k) submission itself, not in the FDA's clearance letter.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 1999

Mr. Samuel David Piper Piper Medical Products 4007 Seaport Blvd. West Sacramento, CA 95691

Re: K990384 EZflow Continuous Nebulizer™ Model 1005 Regulatory Class: II (two) Product Code: 73 CAF February 5, 1999 Dated: Received: February 8, 1999

Dear Mr. Piper:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Samuel David Piper

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

1990394 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

EZflow Continuous Nebulizer™ Device Name:

Indication for Use:

To be used under proper medical supervision to deliver medicinal aerosol and diagnostic formulation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use : (Per 21 CFR 810.109)

Over-the-Counter Use

Arth A. Garkowski.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 10344 k T 510(k) Number .

(Optional Format 1-2-96)

INTNDUSE.DOC

Regulation Number and Section

§ 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).