(133 days)
Not Found
Not Found
No
The device description and performance studies focus on the materials and manufacturing process of a simple mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device description and information provided do not indicate that it is intended to diagnose, treat, cure, or prevent disease. It is described as a mask used with a spacer device, suggesting it is an accessory for drug delivery rather than a standalone therapeutic device.
No
Explanation: The device description indicates it is a mask and it does not mention any diagnostic capabilities or functions. The information provided heavily emphasizes the materials used and its identification, fitting the description of a medical device accessory rather than a diagnostic tool.
No
The device description explicitly states it is an injected molded mask made of physical materials, 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/Indications for Use: This section is "Not Found," which is a key indicator of the device's purpose. IVDs have specific intended uses related to diagnosing diseases or conditions using samples from the human body.
- Device Description: The description details a mask made of specific materials for medical applications. This aligns with a device used externally or for delivering something, not for analyzing biological samples.
- No mention of biological samples: The description does not mention anything about collecting, analyzing, or testing biological samples (like blood, urine, tissue, etc.), which is fundamental to IVDs.
- Predicate Device: The predicate device is an "AeroChamber®," which is a spacer device used with inhalers to help deliver medication to the lungs. This further confirms the device's function is related to drug delivery, not in vitro diagnostics.
Therefore, the E-Z SPACER® Mask (Small) appears to be a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The E-Z SPACER® Mask (Small) uses FDA approved materials: Dynaflex G2706 Kraton thermoplasiic rubber designed for medical applications, and 21 CFR 178.3297 colorant pigments as specified by the Food and Drug Administration (Colorants for polymers). The E-Z SPACER Mask is injected molded with cavity I.D. mask (E-Z SPACER®MASK (Small) for identification.
Dynaflex G2706 elastomers are used in a wide variety of injection molded and extruded parts. Kraton polymers and compounds carry a number of different FDA approvals and have found use in many modical applications. Some characteristics of the polymers that have made them attractive to the medical parts manufacturer include. Iow extractables, cleaniness, dimensional stability, good vapor and gas transmission properties, ease of sterilization, chemical inertness and softness.
In addition, Kraton rubber is used in a currently marketed spacer with mask, the AeroChamber®) manufactured by Monaghan Medical Corporation in Plattsburgh, NY 12901. The AcroChamber with Mask uses Kraton rubber at its end plate where the aerosol medication is inserted and administered.
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
Not Found
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
The E-Z SPACER Mask was attached to the E-Z SPACER device. The E-Z SPACER with Mask was opened and closed 1,460 times based on using the product four times per day. The E-Z SPACER Mask was washed following patient instructions based on cleaning once a week. The Mask was evaluated overy 50 cycles. There were no signs of breakdown.
Particle size studies are submitted showing E-Z SPACER with Mask and without.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
0
Image /page/0/Picture/2 description: The image shows a logo for WE Pharmaceuticals, Inc. The logo features a black diamond shape with the letters "WE" in white inside. The word "PHARMACEUTICALS, INC." is written in smaller letters below the diamond. There are also a series of short, horizontal lines extending from the left side of the diamond.
April 23, 1997
Allergy/Asthma Products
SUMMARY OF SAFETY AND EFFECTIVENESS
The E-Z SPACER® Mask (Small) uses FDA approved materials: Dynaflex G2706 Kraton thermoplasiic rubber designed for medical applications, and 21 CFR 178.3297 colorant pigments as specified by the Food and Drug Administration (Colorants for polymers). The E-Z SPACER Mask is injected molded with cavity I.D. mask (E-Z SPACER®MASK (Small) for identification.
Dynaflex G2706 elastomers are used in a wide variety of injection molded and extruded parts. Kraton polymers and compounds carry a number of different FDA approvals and have found use in many modical applications. Some characteristics of the polymers that have made them attractive to the medical parts manufacturer include. Iow extractables, cleaniness, dimensional stability, good vapor and gas transmission properties, ease of sterilization, chemical inertness and softness.
In addition, Kraton rubber is used in a currently marketed spacer with mask, the AeroChamber®) manufactured by Monaghan Medical Corporation in Plattsburgh, NY 12901. The AcroChamber with Mask uses Kraton rubber at its end plate where the aerosol medication is inserted and administered.
In addition to using FDA approved grade materials for the E-Z SPACER Mask, we conducted faligue testing. The E-Z SPACER Mask was attached to the E-Z SPACER device. The E-Z SPACER with Mask was opened and closed 1,460 times based on using the product four times per day. The E-Z SPACER Mask was washed following patient instructions based on cleaning once a week. The Mask was evaluated overy 50 cycles. There were no signs of breakdown.
The E-Z SPACER Mask has easy to follow patient instructions for cleaning, operating, and safety precautions.
Particle size studies are submitted showing E-Z SPACER with Mask and without.
The manufacturing sites are UNI-TECH of SAN DIEGO, 730 Opper Street, Escondido, CA 92025, and COMPLEX TOOLING & MOLDING, 10948 Willow Court, San Diego, Ca 92127. These sites are in compliance with the GMP regulations (21 CFR Part 820).
After conducting a reasonable search of information known and available about spacer devices, we found no problems associated with safety and effectiveness.
Tom Largerquist
Tom Franklin