(145 days)
Not Found
No
The device description and intended use describe a standard air compressor for nebulization, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device's intended use is to provide compressed air to a pneumatic nebulizer for generating aerosolized medications for inhalation by a patient, which directly contributes to a medical therapy.
No
The device is described as an air compressor for nebulizers, used to convert liquid medications into an aerosol for inhalation. It delivers therapy, rather than diagnosing a condition.
No
The device description explicitly states it is an AC powered air compressor with a motor, filter, and plastic body, 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 to provide compressed air to a nebulizer for delivering aerosolized medications for inhalation by a patient. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an air compressor. It does not interact with biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples to diagnose a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
C300 Series Air Nebulizer Compressor is intended to provide a source of compressed air to a pneumatic nebulizer for the generation of aerosolized medications for inhalation by a patient, based on a physicians' prescription.
C300 Series Air Nebulizer Compressor is an AC powered air compressor that provides a source of compressed air for home health care use. The compressor should be used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The C300 Series Air Nebulizer Compressor is AC line powered (120V) device. Only the compressor unit is supplied by the sponsor. Other accessories which are directly contacted the patients are not included in this application. These accessories include Air Tubing, Nebulizer, Adaptor, Flexi Tubing, and Mouthpiece. Suggest selecting those accessories which have already obtained 510(K) clearance and are available on the market.
The compressor is driven with a motor inside, and is AC line powered (120V) with an Inside of the compressor also have an inlet filter and a filter cover. on/off switch. Outside is a plastic body (including a top cover, a left cover, and a right cover).
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
This device can be used by adult or pediatric 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)
The Compressor is compliance to applicable voluntary standards includes IEC 60601-1, IEC 60601-1-2. VOC and PM 2.5 testing also shows the compressor is compliance to relevant EPA standards.
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
510(K) SUMMARY
FEB 2 1 2007
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, and the relevant 510(K) submission guidance.
The assigned 510(K) number is: K062952
1. Submitter's Identifications:
Mr. Mok Chi Wing Choice Smart Health Care Company Limited. RM 1901, CC WU BUILDING 302 HENNESSY ROAD, WANCHAI Hong Kong Phone (852) 28934110 Fax: (852)28934318
Date of Preparation: April 14, 2006
Name of the device: 2.
C300 Series Air Nebulizer Compressor
Common Name: Nebulizer Compressor
Classification Name: Compressor, Air, Portable
3. Predicate Device Information and Substantial Equivalence:
Model IRC 1001 Aerosol Compressor, Invacare Corp., K992643 3655 Series DeVilbiss Pulmo-Aide Compact Compressor, Sunrise Medical HHG, Inc., K020932
4. Device Description:
The C300 Series Air Nebulizer Compressor is AC line powered (120V) device. Only the compressor unit is supplied by the sponsor. Other accessories which are directly contacted the patients are not included in this application. These accessories include Air Tubing, Nebulizer, Adaptor, Flexi Tubing, and Mouthpiece. Suggest selecting those accessories which have already obtained 510(K) clearance and are available on the
1
market.
The compressor is driven with a motor inside, and is AC line powered (120V) with an Inside of the compressor also have an inlet filter and a filter cover. on/off switch. Outside is a plastic body (including a top cover, a left cover, and a right cover).
5. Intended Use:
C300 Series Air Nebulizer Compressor is intended to provide a source of compressed air to a pneumatic nebulizer for the generation of aerosolized medications for inhalation by a patient, based on a physicians' prescription.
6. Comparison to the 510(k) Cleared Device (Predicate Device):
The C300 Series Air Nebulizer Compressor has the same intended use and technological characteristics as the cleared device of Model IRC 1001 Aerosol Compressor (K992643) and DeVilbiss Pulmo-Aide Compact Compressor (K020932). Although there are slight differences between the new device and the legally marketed one, these differences do not affect the safety, performance of the subject device. So the new device is substantial equivalent to the selected predicate device.
7. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
The Compressor is compliance to applicable voluntary standards includes IEC 60601-1, IEC 60601-1-2. VOC and PM 2.5 testing also shows the compressor is compliance to relevant EPA standards.
8. Conclusions:
The C300 Series Air Nebulizer Compressor is substantial equivalent to predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. 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 abstract image of an eagle.
Public Health Service
FEB 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Choice Smart Health Care Company, Limited C/O Ms. Michelle S. Lee Reviewer Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K062952
Trade/Device Name: C300 Series Air Nebulizer Compressor Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 9, 2007 Received: February 13, 2007
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the greneral 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Lee
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 requirements 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) 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), please contact the Office of Compliance at (240) 276-0115. 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 Division 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.
Clu
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
Enclosure
4
Indication for Use Statement
510(k) Number (if known):
Device name: C300 Series Air Nebulizer Compressor
Indications for Use:
C300 Series Air Nebulizer Compressor is an AC powered air compressor that provides a source of compressed air for home health care use. The compressor should be used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a This device can be used by adult or pediatric patients. patient.
Prescription Use V (Per 21CFR 801.109) OR
Over-The-Counter Use
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)