(267 days)
No
The summary describes a standard compressor nebulizer and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device converts liquid medication into an aerosol for inhalation to treat respiratory disorders, indicating a therapeutic purpose.
No
The device is described as an AC powered air compressor that provides compressed air for a jet nebulizer to convert liquid medication into an aerosol form for inhalation. Its purpose is for treatment of respiratory disorders, not for diagnosis.
No
The device description clearly indicates it is an AC powered air compressor and works to convert liquid medication into an aerosol form, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Quality Life Technologies Compressor Nebulizer is a medical device that delivers medication to the patient's respiratory tract. It works by converting liquid medication into an aerosol for inhalation.
- Intended Use: The intended use is for the treatment of respiratory disorders by delivering medication directly to the patient's lungs. It does not involve testing or analyzing samples from the body.
The device is a therapeutic device used for drug delivery, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patient's respiratory tract for the treatment of respiratory disorders.
The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional applications for aerosolized medication are constantly under investigation and this device may be deemed suitable for such applications as prescribed.
The intended environment for use of the product is in the patient's home on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
Our Quality Life Technologies Compressor Nebulizer works to convert the medication to a high-quality mist of fine particles and spray liquid medications in aerosol form into gases that are directly delivered to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory tract
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Home health care user; in the patient's home on the order of a physician.
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)
The performance requirements for Quality Life Technologies Compressor Nebulizer were met:
The patient contact components of the Quality Life Technologies Compressor Nebulizer met the requirements of ISO 10993 Part-1, "Biological Evaluation of Medical Devices".
Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1 and IEC 60601-1-2.
The performance of the Quality Life Technologies Compressor Nebulizer was tested by third party lab and demonstrated substantially equivalent to that of the predicate device.
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 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
510(k) Summary k / 12824
JUN 2 1 2012
Summary Prepared Date: 04/12/2012
Submission Sponsor:
Quality Life Technologies Co., Ltd
No.5 Lao Fu Wu Road, Huang Wu Industrial District, Dong Keng Town, Dongguan, Guangdong, P.R.China 523447
Submission Correspondent:
Mr. Leon Lu Director of Quality and Requlatory Affairs
MEDevice Services, LLC
3500 South Dupont Highway Dover, Delaware 19901 USA Phone: 1-877-202-1588 Fax: 1-888-202-8884 Email: info@medeviceservices.com Website: www.medeviceservices.com
Trade/Device Name:
Quality Life Technologies Compressor Nebulizer, Models NBA02-XXX Common or Usual Name: Nebulizer (direct patient interface) Device Class: II Classification Name: Nebulizer (direct patient interface) Regulation Number: 21 CFR 868.5630 Product Code: CAF Review Panel: Anesthesiology
Predicate Device:
- K931015, DEVILBISS HEALTH CARE, INC. THUNGER TIGER CORP. . � DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
- K870027, SALTER LABS . HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
1
- K052438, EMG Technology Co., Ltd . EMG Handle Nebulizer NB02 Series
Device Description:
Our Quality Life Technologies Compressor Nebulizer works to convert the medication to a high-quality mist of fine particles and spray liquid medications in aerosol form into gases that are directly delivered to the patient.
Intended Use:
The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patient's respiratory tract for the treatment of respiratory disorders.
The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional applications for aerosolized medication are constantly under, investigation and this device may be deemed suitable for such applications as prescribed.
The intended environment for use of the product is in the patient's home on the order of a physician.
| Descriptive
| Information | Proposed Device | Predicate Device |
|---|---|---|
| 510(k) Number | NONE | K931015 |
| Manufacturer | Quality Life Technologies Co., Ltd | DEVILBISS HEALTH CARE, INC |
| Proprietary or | ||
| Model Name | Quality Life Technologies | |
| Compressor Nebulizer, Models | ||
| NBA02-XXX | DEVILBISS MODEL 4650 | |
| COMPRESSOR NEUBULIZER | ||
| Indication for Use | The Quality Life Technologies | |
| Compressor Nebulizer is an AC | ||
| powered air compressor that | ||
| provides a source of compressed | ||
| air for home health care use. The | ||
| product is used in conjunction with | ||
| a jet (pneumatic) nebulizer to | ||
| convert liquid medication into an | ||
| aerosol form with particles smaller | ||
| than 5 microns diameter for | The DeVilbiss compressor/nebulizer is an | |
| AC powered air compressor that provides | ||
| a source of compressed air for home | ||
| health care use. The product is used in | ||
| conjunction with a jet (pneumatic) | ||
| nebulizer to convert liquid medication into | ||
| an aerosol form with particles smaller | ||
| than 5 microns diameter for inhalation into | ||
| the patient's respiratory tract for the | ||
| treatment of respiratory disorders. |
Comparison to Predicate Devices:
2
| inhalation into the patient's
respiratory tract for the treatment of
respiratory disorders. | The target population for this device
consists of adult patients suffering from,
but not limited to asthma, cystic fibrosis, |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The target population for this device
consists of adult patients suffering
from, but not limited to asthma,
cystic fibrosis, and chronic
obstructive pulmonary disease.
Further, additional applications for
aerosolized medication are
constantly under investigation and
this device may be deemed suitable
for such applications as prescribed. | and chronic obstructive pulmonary
disease. Further, additional applications
for aerosolized medication are constantly
under investigation and this device may
be deemed suitable for such applications
as prescribed.
The intended environment for use of the
product is in the patient's home on the
order of a physician. |
| The intended environment for use
of the product is in the patient's
home on the order of a physician. | |
.
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| Descriptive
| Information | Proposed Device | Predicate Device |
|---|---|---|
| 510(k) Number | NONE | K870027 |
| Manufacturer | Quality Life Technologies Co., Ltd | SALTER LABS |
| Proprietary or | ||
| Model Name | Quality Life Technologies Compressor | |
| Nebulizer, Models NBA02-XXX | HAND HELD PHEUMATIC | |
| POWERED (DISPOSABLE) | ||
| NEBULIZER | ||
| Indication for Use | The Quality Life Technologies | |
| Compressor Nebulizer is an AC | ||
| powered air compressor that provides | ||
| a source of compressed air for home | ||
| health care use. The product is used in | ||
| conjunction with a jet (pneumatic) | ||
| nebulizer to convert liquid medication | ||
| into an aerosol form with particles | ||
| smaller than 5 microns diameter for | ||
| inhalation into the patient's respiratory | ||
| tract for the treatment of respiratory | ||
| disorders. | Hand Held Pheumatic Powered | |
| (Disposable) Nebulizer is to convert | ||
| liquid medication into an aerosol form | ||
| with particles smaller than 5 microns | ||
| diameter for inhalation into the | ||
| patient's respiratory tract for the | ||
| treatment of respiratory disorders | ||
| The target population for this device | ||
| consists of adult patients suffering | ||
| from, but not limited to asthma, cystic | ||
| fibrosis, and chronic obstructive | ||
| pulmonary disease. Further, additional | ||
| applications for aerosolized medication | ||
| are constantly under investigation and | ||
| this device may be deemed suitable for | ||
| such applications as prescribed. | ||
| The intended environment for use of | ||
| the product is in the patient's home on | ||
| the order of a physician. | ||
| Principle | Aerosolizes liquid into aerosol form by | |
| compressing air. | Aerosolizes liquid into aerosol form by | |
| compressing air | ||
| MMAD |