(189 days)
No
The description details a standard jet nebulizer and compressor system, with no mention of AI or ML capabilities. The device functions by converting liquid medication into an aerosol mist using compressed gas.
Yes
The system is used for the treatment of asthma, bronchitis, and other respiratory diseases by converting liquid medication into an aerosol mist for inhalation, which is a therapeutic function.
No
This device is used for the treatment of respiratory diseases by converting liquid medication into an aerosol mist for inhalation. It is a therapeutic device, not a diagnostic one, as it does not diagnose or identify medical conditions.
No
The device description clearly describes a physical, reusable hand-held jet nebulizer and its use with compressed gas compressors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of respiratory diseases by delivering medication directly to the patient's airway. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a nebulizer that converts liquid medication into an aerosol for inhalation. This is a drug delivery system, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly described as a therapeutic device used in conjunction with a compressor for respiratory therapy.
N/A
Intended Use / Indications for Use
The Sunrise Medical Model 800 Series iet nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway.
The Sunrise Medical Model 800 Series jet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of DeVilbiss such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S.
The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer. The nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The nebulizer & compressor system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway.
The Sunrise Medical Model 800 Series iet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of Sunrise Medical such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S.
Accessories include a triggering system to shut off airflow to the nebulizer to conserve medication between breaths.
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
The target patient population for this device is comprised of both children and adults
Intended User / Care Setting
The intended environment of use is in the home with AC powered compressors or for portable use with DC/battery powered compressors.
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)
Testing performed on the aerosol output and particle size show that the new Sunrise Medical Model 800 Nebulizer is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KG93492
510(k) Summary
| Submitter's Name: | Sunrise Medical HHG, Inc.
100 DeVilbiss Drive
Somerset PA 15501
Frank Clementi
814-443-7474 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Date Prepared: | October 7, 1999 |
| Device Name: | Nebulizer FDA Classification CAF |
| Common or Usual Name: | Jet Nebulizer |
| DeVilbiss Model Number: | Nebulizer Model 800 |
| Trade Proprietary Name: | N/A Model number only. |
| Established Registration
Number: | 2515872 |
| FDA Classification: | Class II |
| Equivalent Legally Marketed Predicate Devices: | |
| Legally Marketed Predicate Device 510(k) Registration # | |
| Sunrise Medical Model 700 | K952249 |
| Pari LC Plus | K894555 |
Pari PariJet
Description of Device:
The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer. The nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The nebulizer & compressor system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway.
1
The Sunrise Medical Model 800 Series iet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of Sunrise Medical such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S.
Accessories include a triggering system to shut off airflow to the nebulizer to conserve medication between breaths.
Statement of Intended Use:
The Sunrise Medical Model 800 Series iet nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway.
The Sunrise Medical Model 800 Series jet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of DeVilbiss such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S.
The target patient population for this device is comprised of both children and adults suffering from asthma, bronchitis, emphysema, and other respiratory disorders. The device is to be used by the patient only on the order of a physician in conjunction with prescribed medication(s).
The intended environment of use is in the home with AC powered compressors or for portable use with DC/battery powered compressors.
Technological Characteristics:
The Sunrise Medical Model 800 Nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize a compressed air source for operation.
Testing performed on the aerosol output and particle size show that the new Sunrise Medical Model 800 Nebulizer is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
APR 2 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Clementi Sunrise Medical HHG Inc. Respiratory Products Division Dba DeVilbiss Health Care 100 DeVilbiss Drive P.O. Box 635 Somerset, PA 15501-0635
K993492 Re: Sunrise Medical Model 800 Nebulizer Regulatory Class: II (two) Product Code: CAF Dated: January 21, 2000 Received: January 24, 2000
Dear Mr. Clementi:
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 requlation (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 regulation 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
3
Page 2 - Mr. Frank Clementi
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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,
Joanna Westerhausen for
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
510(k) Number: (if known):
Sunrise Medical Model 800 Nebulizer Device Name:
Indications For Use:
The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
f. Allertson