(90 days)
Not Found
No
The device description relies on the Bernoulli Effect and mechanical principles for nebulization, with no mention of AI or ML. The performance studies focus on particle size and residual volume, not algorithmic performance.
Yes
The device is intended to treat medical conditions such as "bronchial spasms, or airway obstruction, associated with diseases such as asthma, chronic bronchitis, and emphysema," which are therapeutic claims. Furthermore, it is designed to deliver "hydrating agents or other prescribed inclusions for inhalation," suggesting the administration of medicinal substances.
No
The device is a nebulizer designed to deliver medication as an aerosol, not to diagnose a medical condition.
No
The device description clearly details a physical nebulizer that uses the Bernoulli Effect to aerosolize liquid medication. This involves hardware components like a capillary tube, gas stream, and baffle, not just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "spraying liquids in aerosol form into gases that are delivered directly to the patient for breathing." It's used to deliver medication or hydrating agents for inhalation to treat respiratory conditions. This is a therapeutic delivery device, not a diagnostic one.
- Device Description: The description focuses on the mechanical process of transforming liquid medication into an aerosol for inhalation. It doesn't mention any analysis of biological samples or diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device's function is to deliver a substance to the patient, not to analyze something from the patient for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
73 CAF
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.
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
pediatric and adult patients.
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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
1
510(K) SUMMARY Side Draft Neb-U-Mist® Nebulizer
Section 20
Device Description 9.0
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.
Intended Use 10.0
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.
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.
2
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.
3
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.
4
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
5
510(k) Number (if Known): K994352 Device Name: Hudson RCI Side Draft Neb-U-Mist Nebulizer
Indications for Use
Indications for Use
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.
(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
OR
Over-the-Counter Use
Por 21 CFR 801.109
(Optional format 1-2-96)