The Hsiner Jet Nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Device Description

The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs. The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.

AI/ML Overview

This submission describes the Hsiner Jet Nebulizer, a device used to administer aerosol treatments. The primary evidence provided is a substantial equivalence claim based on performance testing comparing it to legally marketed predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence by demonstrating that the Hsiner Jet Nebulizer's performance characteristics are not significantly different from predicate devices. The specific acceptance criteria are implicitly that the performance metrics of the Hsiner Jet Nebulizer should be not significantly different from those of the predicate devices.

Performance Characteristic	Acceptance Criterion (Implicit)	Reported Device Performance
Mass Mean Aerodynamic Diameter (MMAD)	Not significantly different from predicate devices	Not found to be significantly different from the predicate device for any of the drugs tested.
Geometric Standard Deviation (GSD)	Not significantly different from predicate devices	Not found to be significantly different from the predicate device for any of the drugs tested.
Respirable Fraction (% mass btw 0.5-5 µm)	Not significantly different from predicate devices	Not found to be significantly different from the predicate device for any of the drugs tested. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Respirable Mass	Not significantly different from predicate devices	Not found to be significantly different from the predicate device for any of the drugs tested. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Treatment Time	Not significantly different from predicate devices	Not found to be significantly different from the predicate device for any of the drugs tested. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Operating Pressures	Not significantly different from predicate devices	Data not explicitly stated as "not significantly different" but listed as a characteristic determined. The general conclusion is that it's not significantly different across all parameters. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a number of devices or experimental replicates. The testing was conducted "in-vitro" and involved "any of the drugs tested," implying multiple drug types were used with the device and predicate devices.
Data Provenance: In-vitro testing. No specific country of origin for the data is mentioned, but the submitter is from Taiwan, ROC, and the preparer of submission is from the US. The testing was conducted according to the FDA's "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)," which indicates a standard, controlled laboratory environment for the testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device submission relies on objective, in-vitro physical performance measurements rather than expert human interpretation or clinical data. The "ground truth" is established by direct measurement against physical standards derived from the performance of predicate devices and industry guidance.

4. Adjudication method for the test set

Not applicable. As noted above, this submission relies on objective physical measurements, not human interpretation requiring adjudication.

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. This is a medical device for drug delivery, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical nebulizer, not a software algorithm. The "standalone performance" is the in-vitro performance of the device itself.

7. The type of ground truth used

The ground truth is derived from objective in-vitro performance measurements of the device and predicate devices, as specified by the "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)." This involves physical properties like particle size distribution (MMAD, GSD, Respirable Fraction), drug delivery capability (Respirable Mass), and operational parameters (Treatment Time, Operating pressures). The acceptance criteria are based on demonstrating that these parameters are not significantly different from those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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K052811

DEC 2 1 2005

510(k) Summary 8.

In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.

Submitter Information 8.1.

Hsiner Company, LTD No. 13, Tyan Shin St., Taya Hsiang Taichung Hsien, Taiwan, ROC

+886-4-25664306 Phone:

3003862188 Registration No .: Owner/Operator No .: 9053474

Preparer of Submission and Contact for Information 8.2.

MDVentures Tom Shanks* - Principal 29201 Via Norte Temecula, CA 92591

(951) 506-2674 Phone: FAX: (951) 506-3040 tom(@mdventures E-mail:

Submission contact for correspondence and additional information

Name of Device 8.3.

Proprietary Name:	Jet Nebulizer
Common Name:	Nebulizer
Classification Name:	Nebulizer (direct patient interface)
Product Code:	CAF
Regulation Number:	868.5630
Device Class	2

Substantially equivalent to: 8.4.

트 Allegiance Misty-Neb (K883964).
Salter Labs Nebulizer (K884947) .
Hudson RCI Micro Mist (K930525) .

8.5. Description of the device

The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and This device is intended to only be use with FDA-approved drugs upon the hospital settings.

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specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs.

The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to The nebuilizer sprays respirately sibe derosentes on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.

Intended Use of the Device 8.6.

The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Comparison to Predicate Devices 8.7.

The Hsiner Jet Nebulizer is equivalent in design, materials and performance to the Predicate I he i suices All the predicate devices utilize the same principles of operation and have the same intended use

Performance testing was conducted invitro using a Cadcade Impactor method according to the "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)." The following characteristics were determined for each Nebulizer:

Mass Mean Aerodynamic Diameter (MMAD) .
Geometric Standard Deviation (GSD) .
Respirable Fraction �
Respirable Mass .
Treatment Time ●
Operating pressures .

The mean Mass Median Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), respirable fraction (% mass between 0.5 and 5 microns), total mass of medication delivered, respirable mass (mass of drug between 0.5 and 5 microns), and treatment time for the Hsiner Jet Nebulizer was not found to not be significantly different than the predicate device for any of the drugs tested.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Hsiner Company Limited Mr. Tom Shanks Principal Mdventures 29201 Via Norte Temecula, California 92591

Re: K052811

Trade/Device Name: Hsiner Jet Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 29, 2005 Received: October 4, 2005

Dear Mr. Shanks:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviews your ea your end the device is substantially equivalent (for the received to ruse 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 ntersule comments, or to devices that have been reclassified in accordance with the provisions of Amendinomono, or to active act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 Wr), it may of buyers in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Shanks

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 mount that I Dr. Federal statutes and regulations administered by other Federal agencies. or the For of all , I vath 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 and libuing (s 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) I mis reter 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), n Jose contact the Office of Compliance at (240) 276-0120. 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 maj overn 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/industry/support/index.html.

Sincerely yours,

Snette y. Mckien Oms

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

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Indications for Use

510(k) Number (K052811):

Hsiner Jet Nebulizer Device Name:

Indications for Use:

The Hsiner Jet Nebulizer is used to administer various aerosol treatments to adult and I he Hsiner Jet Nebulizer is ascu to administer val settings. This device is intended for pediatric patients in bon the nomecale and nospecific direction by a physician. Its use is
use only with FDA-approved drugs upon the specific direction by a precribes use only With FDA-approved drugs upon the are professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/11 description: The image shows a signature at the top and a number at the bottom. The signature appears to be cursive and difficult to read. The number at the bottom is "K052811".

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510(k) Submission for the Usiner Jet Nebulizer Revised 12-09-2005

Page 8

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).