(78 days)
Not Found
No
The description focuses on the mechanical operation of a jet nebulizer using compressed gas and the venturi principle. There is no mention of AI, ML, or any computational processing of data for diagnosis, treatment planning, or device control.
Yes
The device is used to administer aerosol treatments with FDA-approved drugs for patients, indicating its role in medical therapy.
No
Explanation: The device is a nebulizer used to administer medication, not to diagnose a medical condition. Its function is therapeutic rather than diagnostic.
No
The device description clearly describes a physical nebulizer that operates on a compressed gas source and includes a refillable jar. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer aerosol treatments to patients. This is a therapeutic use, not a diagnostic one.
- Device Description: The device description focuses on how the nebulizer works to aerosolize and deliver medication. It does not describe any function related to testing samples from the human body for diagnostic purposes.
- Performance Studies: The performance studies described are related to the physical characteristics of the aerosol produced (particle size, delivery time), which are relevant to drug delivery, not diagnosis.
- Key Metrics: The key metrics listed (MMAD, GSD, Respirable Fraction, etc.) are all related to the performance of the nebulizer in delivering medication, not to diagnostic accuracy.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Hsiner Jet Nebulizer does not perform this function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and 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.
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
Adult and pediatric patients.
Intended User / Care Setting
Homecare and hospital settings.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mass Mean Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), Respirable Fraction, Respirable Mass, Treatment Time, Operating pressures.
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
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.
1
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.
2
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.
3
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
4
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".
Page 1 of 1
510(k) Submission for the Usiner Jet Nebulizer Revised 12-09-2005
Page 8