(225 days)
Not Found
No
The description details a purely mechanical nebulizer and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes.
It is intended to aerosolize physician-prescribed inhalation solutions, which are used for therapeutic purposes (administering medication to patients).
No
The device is a nebulizer designed to deliver aerosolized medication for inhalation, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical, hardware-based nebulizer that aerosolizes liquid medication using an air source and tubing. There is no mention of software as the primary or sole component.
Based on the provided information, the Care2 Medical Nebulizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to aerosolize physician-prescribed inhalation solutions for direct administration to patients (infant, pediatric, and adult) for therapeutic purposes. This is a treatment delivery device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details how the device physically transforms liquid medication into an aerosol for inhalation. It does not describe any process of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The Care2 Medical Nebulizer is a medical device used for drug delivery, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes inhalation solutions to a patient using a small volume nebulizer. The device is single patient use.
Product codes
CAF
Device Description
The Care2 Medical Small Volume Nebulizer is a single patient use device. The device is filled with a liquid medication and connected to an air source via flexible tubing. Once the gas comes in contact with the liquid medication, the gas shatters the liquid into small particles. These particles then hit a baffle which further reduces the size of the particles. The smaller particles are administrated to the patient as the patient breathes. The larger particles settle inside the device returning the mist to a liquid to repeat the process until a majority of the medication is nebulized.
The Care2 Medical Nebulizer is unique in that it has a side port which allows the user to add medication to the nebulizer without removing the top.
The Small Volume Nebulizer is packaged non-sterile in a polyethylene bag.
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
infant, pediatric and adult patients
Intended User / Care Setting
physician or healthcare professional
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
Particle size distribution testing showed that the performance of the Care2 Medical Nebulizer was substantially equivalent to that of the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
KC09179 Y
JAN 2 8 2010
510(k) Summary (As required by 21 CFR 807.92(a))
- Submitter Information A.
Care2 Medical Products, Inc. 1599 Superior Ave, Ste B5 Costa Mesa, CA 92627
Phone Number: Fax Number: Contact:
949-481-5713 949-481-5745 Jim Barley Director RA/QA
Care2 Medical Nebulizer
Care2 Medical Nebulizer
Nebulizer
Nebulizer
868.5630
New Device
CAF
II
Trade Name:
B. Device Information
Trade/Proprietary Name:
Common name of device:
Classification Name:
Product Code:
Regulatory Class:
Classification Number:
Predicate 510(k) #:
Reason for 510(k):
Predicate Device:
C. Predicate Device: Hudson Hand Held (T "Up-Draft) Nebulizer
Predicate product code; CCQ
Circulaire Nebulizer
Predicate 510(k) #: K926055
Predicate product code: CAF
1
Predicate Device:
1 Airlife Misty Max 10 Nebulizer Predicate 510(k) #: K023602 Predicate product code: CAF
- Device Description D.
The Care2 Medical Small Volume Nebulizer is a single patient use device. The device is filled with a liquid medication and connected to an air source via flexible tubing. Once the gas comes in contact with the liquid medication, the gas shatters the liquid into small particles. These particles then hit a baffle which further reduces the size of the particles. The smaller particles are administrated to the patient as the patient breathes. The larger particles settle inside the device returning the mist to a liquid to repeat the process until a majority of the medication is nebulized.
The Care2 Medical Nebulizer is unique in that it has a side port which allows the user to add medication to the nebulizer without removing the top.
The Small Volume Nebulizer is packaged non-sterile in a polyethylene bag.
Statement of Indications for Use E.
The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes inhalation solutions to a patient using a small volume nebulizer. The device is single patient use.
F. Comparison of Required Technological Characteristics:
The Care2 Medical Nebulizer has the same design, function and intended use as the Hudson Hand Held (T "Up-Daft") Nebulizer, Airlife Misty Max 10 Nebulizer and the Circulaire Nebulizer.
The Care2 Medical Nebulizer Bottle is approximately the same size and shape as the Hudson Hand Held (T "Up-Daft") Nebulizer, Airlife Misty Max 10 Nebulizer and the Circulaire Nebulizer. Each nebulizer consists of a Nebulizer Bottle, Supply Tubing, Tee Connector and Mouthpiece. The Nebulizer Bottle has a top, bottom and funnel. The top of each Nebulizer can be removed to add medication.
2
The Care2 Medical Nebulizer, Hudson Hand Held (T "Up-Daft") Nebulizer, Airlife Misty Max 10 Nebulizer and Circulaire Nebulizer tubing assemblies are almost identical. In addition, the TEE Connector, Mouthpiece and Corrugated Tubing are almost identical. Each component is the same size, shape and color.
The Care2 Medical Nebulizer, Hudson Hand Held (T "Up-Daft") Nebulizer, Airlife Misty Max 10 Nebulizer and Circulaire Nebulizer are packaged in a polyethylene bag and are sold as Non-Sterile devices.
The only significant difference between the Care2 Medical Nebulizer, Hudson Hand Held (T "Up-Daft") Nebulizer, Airlife Misty Max 10 Nebulizer and the Circulaire Nebulizer is the side port on the Care2 Medical Nebulizer. The side port on the Care2 Medical Nebulizer allows the health care professional to add medication to the Nebulizer Bottle by inserting the medication pillow through the side port and squeezing the medication into the Nebulizer Bottle.
The Circulaire Nebulizer has a 750 mL bag to store aerosol during exhalation, a one-way valve to prevent exhaled gas from entering the reservoir bag and a variable inspiratory/expiratory resister.
All other differences between the the Care2 Medical Nebulizer, Hudson Hand Held (T "Up-Daft") Nebulizer, Airlife Misty Max 10 Nebulizer and the Circulaire Nebulizer are cosmetic.
Summary and Conclusion of Nonclinical and Clinical Tests: G.
The product/performance requirements for the Care2 Medical Nebulizer were as follows:
All components of the Care2 Medical Nebulizer met the dimensional, visual and functional requirements listed on the part/assembly drawing.
All materials used in the fabrication of the Care2 Medical Nebulizer met the requirements of ISO 10993 Part-1, "Biological Evaluation of Medical Devices".
Particle size distribution testing showed that the performance of the Care2 Medical Nebulizer was substantially equivalent to that of the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an emblem that features three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 8 2010
Steve Islava C/O Mr. Jim Barley President DBA Care2 Medical Nebulizer 1599 Superior Avenue #B5 Costa Mesa, California 92627
Re: K091794
Trade/Device Name: Care2 Medical Nebulizer Model 101/ 202 Regulation Number: 21CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 20, 2010 Received: January 25, 2010
Dear Mr. Barley:
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2- Mr. Barley
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows a scattering of small, dark, irregular shapes against a white background. The shapes vary in size and density, with some appearing as isolated dots and others clustered together. The overall impression is that of a random distribution of particles or imperfections on a surface.
Indications For Use
510(k) Number (if known): K091794
Device Name:
Indications For Use:
The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes inhalation solutions to a patient using a small volume nebulizer. The device is single patient use.
Image /page/5/Figure/4 description: The image shows a form with two options: "Prescription Use" and "Over-The-Counter Use", with "AND/OR" in between. The "Prescription Use" option is marked with an "X", and the corresponding CFR section is listed as "(Part 21 CFR 801 Subpart D)". The CFR section for "Over-The-Counter Use" is listed as "(21 CFR 807 Subpart C)".
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. For Tony Watson
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: