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.

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.

AI/ML Overview

The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
All components meet dimensional, visual, and functional requirements on part/assembly drawing.	"All components of the Care2 Medical Nebulizer met the dimensional, visual and functional requirements listed on the part/assembly drawing."
All materials meet ISO 10993 Part-1, "Biological Evaluation of Medical Devices" requirements.	"All materials used in the fabrication of the Care2 Medical Nebulizer met the requirements of ISO 10993 Part-1, 'Biological Evaluation of Medical Devices'."
Performance (specifically particle size distribution) is substantially equivalent to predicate devices.	"Particle size distribution testing showed that the performance of the Care2 Medical Nebulizer was substantially equivalent to that of the predicate devices." (Predicate devices: Hudson Hand Held (T "Up-Draft) Nebulizer K760489, Airlife Misty Max 10 Nebulizer K023602, and Circulaire Nebulizer K926055). This implies that the particle size distribution of the Care2 Medical Nebulizer is within an acceptable range compared to these established devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set used for the "dimensional, visual and functional requirements" or the "biological evaluation." For the particle size distribution testing, the document does not specify the exact sample size. However, the nature of such testing typically involves a statistically significant number of devices to ensure representative data.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) submission for a medical device in the US, it is highly likely the testing was conducted in a controlled environment as part of the device development and validation process, which would be considered prospective for the purpose of this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of "experts" in the context of establishing ground truth for the test set as would be typical for image-based diagnostics. The assessment of dimensional, visual, and functional requirements is typically done by quality control personnel following established specifications. Biological evaluation (ISO 10993) involves standardized laboratory testing, not human expert consensus for ground truth. Particle size distribution is measured using scientific instruments.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or applicable given the nature of the tests (quality control checks, biological evaluation, and instrument-based particle size measurement). These are objective tests with predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The Care2 Medical Nebulizer is a drug delivery device, not a diagnostic one.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The performance evaluation for the Care2 Medical Nebulizer, particularly for particle size distribution, is a standalone performance evaluation of the device itself (the "algorithm" in this context being the device's design and function). There is no "human-in-the-loop" for its primary function of aerosolizing medication, as the device's efficacy is based on the physical properties of the aerosol it produces.

7. The Type of Ground Truth Used:

Dimensional, Visual, and Functional Requirements: The ground truth is established by the specified requirements and tolerances outlined in the part/assembly drawings.
Biological Evaluation: The ground truth is compliance with the requirements of ISO 10993 Part-1.
Particle Size Distribution Testing: The ground truth is the performance (particle size distribution) of the legally marketed predicate devices. The new device's performance is compared against these established benchmarks for substantial equivalence.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here as the Care2 Medical Nebulizer is a physical medical device, not an AI/machine learning algorithm that requires a training data set. The device's design is engineered, manufactured, and tested against specifications.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a physical device.

Summary

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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

Nebulizer

868.5630

New Device

CAF

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

K760489

Predicate product code; CCQ

Circulaire Nebulizer

Predicate 510(k) #: K926055

Predicate product code: CAF

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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.

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.

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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.

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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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Indications For Use

510(k) Number (if known): K091794

Device Name:

Indications For 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:

Regulation Number and Section

§ 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).