The Side Draft Neb-U-Mist Nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device is for single patient use and is not intended for reprocessing.

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer is a non-sterile, single patient use. Disposable Small Volume Nebulizer device designed to be used for intermittent aerosol therapy to deliver hydrating agents or other prescribed inclutions for inhalation. The Hudson RCI Side Draft Neb-U-Mist® Nebulizers intended to treat bronchial spasms, or airway obstruction, associated with diseases such as asthma, chronic bronchitis, and emphysema.

Device Description

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer employs the Bernoulli Effect in order to transform the solution of liquid medication into tiny particles that can in order to transform the belation on the Bernoulli Effect - the phenomenon be carried in a gad mixture to with increased stream velocity in a fluid – causes the lowering of lateral pressure around the stream of gas to draw liquid up a the lowering of lateral peaches the top of the capillary tube it comes into contact with the stream of gas, it is then shattered into small particles (approximately 3 to 5 microns). These particles are then forced against a baffle (approximately o to o microne) of the particles that will be delivered to the patient that rouses the larger particles. The larger particles settle inside the Nebulizer by removing the largor particles, returning mist to liquid to repeat nebulization process. The smaller particles are then administered as the patient inhales.

AI/ML Overview

The document provided describes a 510(k) submission for the "Side Draft Neb-U-Mist Nebulizer" and its substantial equivalence to a predicate device. This type of submission focuses on comparing a new device to an already legally marketed device (predicate device) and demonstrating that it is as safe and effective. It does not typically involve a clinical study in the same way a pre-market approval (PMA) application would for a novel device.

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Acceptance Criteria and Reported Device Performance

The core acceptance criterion for substantial equivalence in this context is that the new device performs similarly to the predicate device, particularly in critical functions. For a nebulizer, this primarily concerns particle size generation and residual volume.

Acceptance Criteria (Implied)	Reported Device Performance
Generate particle sizes in the desired range of 0.5µm - 5.0µm.	"Test results indicate that the Hudson RCI Side Draft Neb-U-Mist® Nebulizer and the predicate device both generate particle sizes in the desired range of 0.5um - 5.0μm."
Demonstrate comparable residual medication volume to the predicate device.	"Residual testing for both the predicate and proposed devices demonstrated that the devices are substantially equivalent."
Be suitable for intermittent aerosol therapy.	"The Hudson RCI Side Draft Neb-U-Mist® Nebulizer is a non-sterile, single patient use. Disposable Small Volume Nebulizer device designed to be used for intermittent aerosol therapy to deliver hydrating agents or other prescribed inclutions for inhalation." (Matches predicate's implied function.)

Study Details

Given this is a 510(k) submission based on substantial equivalence to a predicate device, the "study" is primarily a bench-top comparative test, not a clinical trial with human subjects.

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of nebulizers tested for particle size and residual volume. It broadly states "Particle Size testing... was performed on both devices" and "Residual testing for both the predicate and proposed devices demonstrated...". Typically, such tests involve multiple units of each device for statistical robustness, but the specific number isn't mentioned.
- Data Provenance: The tests were conducted internally by Hudson Respiratory Care, Inc. The data is retrospective in the sense that it's a comparison to an existing device, but the tests themselves were likely performed prospectively for the purpose of this 510(k) submission. No country of origin for data is stated, but the company is based in California, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For technological characteristics like particle size and residual volume, the "ground truth" is established through objective measurement methods using laboratory equipment (e.g., laser diffraction for particle size, gravimetric analysis for residual volume). It does not involve expert consensus in the same way clinical image interpretation or diagnosis would.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used for subjective interpretations (e.g., evaluating medical images) where human experts might disagree. Bench-top performance tests are objective and quantitative; data is analyzed statistically, not adjudicated by experts.
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:
- No, an MRMC study was not done. This is a mechanical device (nebulizer) and the submission focuses on its physical performance characteristics, not on diagnostic accuracy involving human readers or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no "algorithm" in this context. This is a medical device, not a software or AI product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Measurement Data. The "ground truth" for the performance characteristics (particle size, residual volume) is derived from direct, quantitative measurements obtained in a laboratory setting using standardized testing protocols.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML model for this device. The development and testing are based on engineering design and bench-top performance evaluation.
How the ground truth for the training set was established:
- Not applicable. As there is no training set or AI/ML component, this question does not apply.

Summary

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K 994352

510(K) SUMMARY

Side Draft Neb-U-Mist® Nebulizer Section 20

1.0 Date

December 21, 1999

2.0 Submitter

Hudson Respiratory Care, Inc. 27711 Diaz Road Temecula, California 92590

Contact Person 3.0

Jeannie Denning Regulatory Affairs Manager

Telephone 4.0

(909) 676-5611, ext. 1232

5.0 Proprietary Device Name

Side Draft Neb-U-Mist® Nebulizer

6.0 Classification Name

Nebulizer

7.0 Common Name

Nebulizer

8.0 Predicate Device

Hudson RCI 6350 Home Care Nebulizer, 510(k) number K930525

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510(K) SUMMARY Side Draft Neb-U-Mist® Nebulizer

Section 20

Device Description 9.0

Intended Use 10.0

11.0 Patient Population

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer is intended for use with pediatric and adult patients.

12.0 Comparison of Technological Characteristics

Hudson RCI Side Draft Neb-U-Mist® Nebulizer is substantially equivalent to the predicate device in design and function, (Hudson RCI Cat. No. 6350 Nebulizer.) Particle Size testing of the mist generated during the nebulization process was performed on both devices utilizing commonly used medications. (Albuterol Sulfate, Metaproternol Sulfate and Tobramicyn.) Test results indicate that the Hudson RCI Side Draft Neb-U-Mist® Nebulizer and the predicate device both generate particle sizes in the desired range of 0.5um - 5.0μm. Residual testing for both the predicate and proposed devices demonstrated that the devices are substantially equivalent.

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12.1 Materials

The Hudson RCI Side Draft Neb-U-Mist® Nebulizer and the predicate device are made of similar materials of construction which are common to those used in industry for Nebulizer products. The proposed Hudson RCI Side Draft Neb-U-Mist® Nebulizer device is comprised entirely of Polypropylene, while the predicate device utilizes K-Resin for the Jar, Polystyrene for the jar lid, impingement dome and capillary tube.

Device Design 12.2

The Hudson RCI predicate and the proposed device have similar designs. Each product consists of small volume jar, lid, capillary tube and dome on which particles are shattered. Both products function at flows of 6-8 LPM of gas, and both devices are designed with flat exterior bottoms to facilitate steady filling of the jar. Both devices have etched markings to reflect the maximum fill level, although the proposed device indicates the level of fluid in incremental markings and the predicate device reflects Maximum fill. Both devices connect to an oxygen source however, the predicate device is designed with an oxygen connection port at the bottom of the jar, while the proposed device has an oxygen connection port on the side of the lid. The gas enters the predicate device through the bottom of the jar where it hits a dome which shatters the particles into therapeutic size. In the case of the proposed device, the Oxygen enters the device through the cap where it meets with medication that has been drawn up the capillary tube. The medication is forced against a baffle on the lid, where the particles are shattered into therapeutic size.

13.0 Conclusion

Based on the information contained in this 510(k) submission, Hudson RCI has determined that the proposed Hudson RCI Side Draft Neb-U-Mist Nebulizer and the predicate Hudson RCI Cat. no. 6350 Home Care Nebulizer are substanially equivalent.

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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The bird-like symbol in the center is composed of three curved lines that resemble wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2000

Ms. Jeannie Denning Hudson Respiratory Care, Inc. 27711 Diaz Road P.O. Box 9020 Temecula, CA 92589-9020

Re: K994352 Side Draft Neb-U-Mist Nebulizer Requlatory Class: II (two) Product Code: 73 CAF Dated: December 21, 1999 December 23, 1999 Received:

Dear Ms. Denning:

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 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). 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 regulations 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 assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. 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 - Ms. Jeannie Denning

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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,

Jean A. Watson, Jr.

James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if Known): K994352 Device Name: Hudson RCI Side Draft Neb-U-Mist Nebulizer

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

vascular, Respiratory, 510(k) Number

Prescription Use
Rev. 21 CFR 801.109

Over-the-Counter Use

Por 21 CFR 801.109

(Optional format 1-2-96)

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).