(281 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of the nebulizer (vibrating mesh technology, particle size, delivery rates) and do not mention any software or algorithms that would suggest AI/ML is used. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
Yes
This device is a therapeutic device because its intended use is to deliver prescribed medications to the respiratory system, which is a therapeutic action. The performance studies also mention "therapeutic effects."
No
The device is a nebulizer intended to aerosolize prescribed solutions for inhalation, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components like a vibrating mesh technology, a medical-grade stainless steel disk, and a rechargeable lithium-ion battery, indicating it is a physical device, not software-only.
Based on the provided information, the Airworks™ Nebulizer pe1200m is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Airworks™ Nebulizer Function: The Airworks™ Nebulizer pe1200m is a medical device designed to aerosolize liquid medications for inhalation. It delivers medication directly to the patient's lungs.
- Intended Use: The intended use clearly states it's for "aerosolize healthcare provider-prescribed solutions for inhalation." This is a method of drug delivery, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the mechanism of aerosolization (vibrating mesh technology) and the physical characteristics of the device. It does not mention any analysis of biological samples.
- Performance Studies and Metrics: The performance studies and key metrics relate to the efficiency and characteristics of the aerosolized particles and drug delivery, which are relevant to the device's function as a nebulizer, not as a diagnostic tool.
In summary, the Airworks™ Nebulizer pe1200m is a therapeutic device used for delivering medication, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Airworks™ Nebulizer pel 200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.
Product codes
CAF
Device Description
The Airworks™ Nebulizer pe1200m uses a vibrating mesh technology, which is comprised of a medicalgrade stainless steel disk containing 1,000 precision-formed holes. When energy is applied, the disk vibrates approximately 110,000 times per second. This rapid vibration causes a difference in pressure on either side of each aperture, drawing liquid through the holes to form consistently sized droplets.
The Airworks™ Nebulizer pe1200m is lightweight, compact and virtually silent. A rechargeable lithiumion battery powers the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Adolescent to adult
Intended User / Care Setting
Home or a medical facility, such as a hospital or doctor's office.
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
Non-Clinical Testing Summary:
Particle characterization - Comparative particle test results via Cascade Impactor were shown for Albuterol Sulfate, Ipratropium Bromide, and Cromolyn.
The Airworks™ Nebulizer pel 200m was found to be substantially equivalent in all performance areas having therapeutic effects except differences in GSD and Respirable Particle Fraction are explained by the subject device's relative outperformance of the predicate. Differences in MMAD within the desired range do not raise new questions of safety and effectiveness. Respirable Drug Delivery Rate (ipratropium only) was slower than the predicate device; however, this slower rate did not result in a statistically significant difference in either Respirable Particle Fraction, Total Respirable Dose, or Total Delivered Dose, therefore the difference does not raise new questions of safety and effectiveness. Differences in Total Coarse Particle Dose (for albuterol only) are explained by the subject device's relative outperformance in Total Respirable Dose. Differences in Total Extra-Fine Particle Dose do not raise new questions of safety and effectiveness.
Materials Testing - Materials in patient contact or in the gas pathway were tested in accordance with ISO 10993-1 (2009, Revised 2013). Testing included Ozone, Carbon Monoxide and Carbon Dioxide, VOC, PM25, Cytotoxicity, Sensitization, Ames Assay, Chromosomal Aberration, Mouse Lymphoma, Implantation, and Leachability and Extractability at 50°C for 72 hours with a complete Risk Assessment.
Non-Clinical Testing (Aerosol Performance) - Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, Cleaning and Disinfection Validation, Office of Device Evaluation, Division of Cardiovascular and Respiratory Devices, October 1, 1993.
Cleaning and Disinfection Validation - AAMI / ANSI / ISO 11737-1:2006(R)2011, ISO / TS 15883-5:2005, AAMI TIR 12:2010, AAMI TIR 30:2011, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, March 17, 2015.
Electromagnetic Compatibility, Electrical Safety and Battery Testing - The proposed device was tested to comply with IEC 62133 (2012), IEC 60601-1 (2012), IEC 60601-1-11 (2010), and IEC 60601-1-2 tests evaluated to the requirements in ed4.0 (2014-02). All acceptance criteria were met with no safety or efficacy issues discovered.
Key Metrics
MMAD (µm)
GSD (µm)
Respirable Particle Fraction (%)
Total Respirable Dose (0.4 - 4.7 µm) (µg)
Total Delivered Dose (µg)
Total Coarse Particle Dose (>4.7 µm) (µg)
Total Fine Particle Dose (
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2017
Convexity Scientific LLC % Susan Goldstein-Falk Official Correspondent mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K162041
Trade/Device Name: Airworks™ Nebulizer pe1200m Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: March 29, 2017 Received: March 30, 2017
Dear Ms. Goldstein-Falk:
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.
1
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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162041
Device Name
Airworks™ Nebulizer pe1200m
Indications for Use (Describe)
The Airworks™ Nebulizer pel 200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K162041
| Convexity Scientific LLC
36 Church Lane
| Westport, CT 06880 | Tel: (203) 557-6254 |
|---|---|
| Date: | May 1, 2017 |
| Official Contact: | Paul Reiferson—President |
| Proprietary or Trade Name: | Airworks™ Nebulizer pe1200m |
| Common/Usual Name: | Nebulizer |
| Classification Name/Code: | CAF, Class 2, Nebulizer |
| CFR 868.5630 | |
| Predicate Device: | Aerogen, Inc.—Aeroneb® Go Nebulizer—K032849 |
Device Description
The Airworks™ Nebulizer pe1200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
The Airworks™ Nebulizer pe1200m uses a vibrating mesh technology, which is comprised of a medicalgrade stainless steel disk containing 1,000 precision-formed holes. When energy is applied, the disk vibrates approximately 110,000 times per second. This rapid vibration causes a difference in pressure on either side of each aperture, drawing liquid through the holes to form consistently sized droplets.
The Airworks™ Nebulizer pe1200m is lightweight, compact and virtually silent. A rechargeable lithiumion battery powers the device.
Indications for Use
The Airworks™ Nebulizer pe1200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.
4
510(k) Summary
Comparison and Equivalence of Proposed Device and Predicate Device
| Features | Proposed Device | Predicate Device (K032849) | Substantially
Equivalent
(SE) or
Different |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Device Name | Airworks™ Nebulizer pe1200m | Aeroneb® Go nebulizer | |
| 510(k) Number | K162041 | K032849 | |
| Indications for use | The Airworks™ Nebulizer
pe1200m, for use by adolescent
and adult patients, is intended to
aerosolize clinician-prescribed
solutions for inhalation that are
approved for use with a general-
purpose nebulizer. Airworks™
Nebulizer pe1200m is intended for
use at home or a medical facility,
such as a hospital or doctor's
office. | The Aeroneb® Go nebulizer, for
use by pediatric and adult patients,
is intended to aerosolize physician-
prescribed solutions for inhalation
that are approved for use with a
general-purpose nebulizer. | SE |
| Target Population | Adolescent to adult | Pediatric to adult | Different |
| Mode of Operation | | | |
| Energy Source | Lithium-ion battery (rechargeable)
3.7 VDC, 500mA | Battery—3 "AA" disposable or
rechargeable batteries, 4.5 VDC,
350 mA | Different |
| Anatomical Site | Mouth | Mouth | SE |
| Mode of Operation | Piezoelectric/Ultrasonic | Piezoelectric/Ultrasonic | SE |
| Energy Type | Electricity | Electricity | SE |
| Nebulizing method | Vibrating mesh | Vibrating mesh | SE |
| Aerosolization Element | Aperture disk | Aperture disk | SE |
| Software-driven | No | No | SE |
| User Interface | | | |
| Patient Connector | Mouthpiece | Mouthpiece or optional mask | SE |
| Patient Interface | Hand-Held | Hand-Held | SE |
| Use | Single Patient | Single Patient | SE |
| Physical Description | | | |
| Components Cleanable | Yes | Yes | SE |
| Operating Conditions | 5°C to 40°C to 95% RH | 5°C to 45°C to 95% RH | SE |
| Storage Conditions | -10°C to 45°C to 93% RH | -20°C to 60°C to 95% RH | Different |
| Dimensions (Main Unit) | 27 x 119 x 54 mm | 40 x 105 x 95 mm | Different |
| Weight | 103 g | 325 g | Different |
| Portable | Yes | Yes | SE |
| Reservoir (mL) | 5 mL | 6 mL | Different |
5
510(k) Summary Page 3 of 5 May 1, 2017
Differences Between Proposed Device and Predicate Device
The differences between the proposed device and the predicate device are:
- Energy source: the proposed device uses a rechargeable lithium-ion battery; the predicate device uses 3 "AA" disposable or rechargeable batteries.
- Dimensions and weight: the proposed device is smaller than the predicate device. The smaller size of the proposed device's Main Unit is largely attributable to its internalized mouthpiece, which can be engaged into position when needed. The predicate device also includes a separate control module that uses 3 "AA" batteries, which adds 260 g to its weight.
- . Storage conditions: the proposed device uses an IEC 62133-certified, rechargeable lithium-ion battery whose specifications indicate storage conditions of -10℃ to +45℃. The only component affected by storage temperature is the battery. Conditions for storage and transport were taken into consideration for the selection of materials used in the subject device's construction: namely, a battery that complies with applicable consensus standards.
- Reservoir: the proposed device has a 5mL capacity reservoir; the predicate device has a 6mL capacity reservoir. The proposed device's smaller reservoir mitigates the hazard a patient could inhale two medication ampules in one sitting.
These are not significant differences that affect the safety or effectiveness of the intended device compared to the predicate device.
Substantial Equivalence
The Airworks™ Nebulizer pe1200m is viewed as substantially equivalent to the predicate device because:
Indications for Use-
The indications for use are as a general-purpose nebulizer intended to aerosolize clinician-prescribed solutions for inhalation by adolescent and adult patients.
Discussion-The indications for use statements are nearly identical except for patient population. The subject device's patient population is more restrictive than the predicate device's. Since non-physician clinicians may prescribe nebulizers, we have substituted the word "clinician" above. Both devices are indicated for use as a general-purpose nebulizer.
Technology-
Both the proposed and the predicate device use piezoelectric energy to vibrate an element with precisely drilled holes ("vibrating mesh") to create an aerosol. The proposed device uses a different battery technology than the predicate.
Discussion-The particle characterization performance demonstrates that the two devices perform substantially equivalently. The proposed device's battery decreases its weight and, relative to disposable batteries, its long-term cost of use. The battery is IEC 62133-compliant and does not raise new safety issues.
6
510(k) Summary
Page 4 of 5 May 1, 2017
Non-Clinical Testing Summary
Particle characterization -
Comparative particle test results via Cascade Impactor are shown below:
(All data shown at a 95% confidence level)
| Characteristic | Airworks™ Nebulizer pe1200m (K162041) | Predicate Device – Aeroneb Go (K032849) | ||||
|---|---|---|---|---|---|---|
| Albuterol | Ipratropium | Cromolyn | Albuterol | Ipratropium | Cromolyn | |
| Sulfate | Bromide | Sulfate | Bromide | |||
| 2.5mg/3ml | 0.5mg/2ml | 4.0mg/2ml | 2.5mg/3ml | 0.5mg/2ml | 4.0mg/2ml | |
| MMAD (µm) | 2.21 - 2.41 | 2.12 - 2.22 | 2.15 - 2.37 | 1.96 - 2.26 | 1.92 - 2.12 | 1.65 - 2.17 |
| GSD (µm) | 1.53 - 1.67 | 1.45 - 1.51 | 1.48 - 1.60 | 2.04 - 2.50 | 1.83 - 2.29 | 1.96 - 2.20 |
| Respirable Particle Fraction (%) | 84.2 - 91.4 | 87.4 - 93.2 | 83.5 - 92.7 | 78.8 - 83.2 | 84.0 - 91.2 | 76.7 - 86.3 |
| Total Respirable Dose (0.4 - 4.7 µm) (µg) | 851.3 - 991.9 | 194.5 - 224.3 | 773.3 - 942.1 | 818.2 - 1031.4 | 197.3 - 235.3 | 608.5 - 981.9 |
| Total Delivered Dose (µg) | 984.3 - 1093.5 | 211.6 - 250.1 | 897.0 - 1019.9 | 1012.7- 1257.0 | 221.8 - 270.5 | 758.7 - 1186.60 |
| Total Coarse Particle Dose (>4.7 µm) (µg) | 33.1 - 105.3 | 3.6 - 11.2 | 48.5 - 122.9 | 110.6 - 177.4 | 17.0- 35.6 | 66.4 - 171.8 |
| Total Fine Particle Dose ( |