(135 days)
Not Found
No
The summary describes a standard air compressor for nebulizers and does not mention any AI or ML components or functionalities.
No.
The device is an air compressor for jet nebulizers, not a nebulizer that delivers medication, and therefore not directly therapeutic itself.
No
The device is described as an air compressor for jet nebulizers, providing compressed air for treatment, not for diagnosing conditions.
No
The device description explicitly states it is an "AC-powered air compressor" and a "small, lightweight AC-powered air compressor," indicating it is a hardware device.
Based on the provided information, the PARI Vios is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers." This describes a device used to deliver medication to a patient, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces its function as an air compressor for nebulizers.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD.
Therefore, the PARI Vios is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.
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
adult and pediatric patients
Intended User / Care Setting
hospital, clinic, or home environments.
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)
Non-Clinical Test Summary: PARI Vios was tested with various nebulizers to compare performance to the predicate devices, including: Total Output Rate: PARI Vios TOR is comparable to the predicate devices. MMD: PARI Vios MMD is comparable to the predicate devices. Volume %
§ 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
FEB - 4 2010
PARI Vios 510(k) Submission 510(k) Summary
Submitter Information
| Name: | PARI Respiratory Equipment, Inc. |
|---|---|
| Address: | 2943 Oak Lake Blvd. |
| Midlothian, VA 23112 | |
| Phone Number: | 804-253-7274 x269 |
| Fax Number: | 804-639-7244 |
| Contact Name: | Michael Judge |
| Date Prepared; | September 18, 2009 |
Device Name
| Common Name: | Nebulizer Compressor |
|---|---|
| Trade Name: | PARI Vios |
| Classification Name: | Nebulizer (Direct Patient Interface), §868.5630, Product Code CAF |
Legally Marketed Predicate Device(s)
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| PARI Respiratory Equipment, Inc. | Trek S Nebulizer Compressor | K061381 |
| PARI Respiratory Equipment, Inc. | Proneb Ultra | K002862 |
Device Description
The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.
Indications For Use
The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.
Technological Characteristics Compared to Predicate Devices
The PARI Vios, PARI Proneb Ultra, and PARI Trek.S are all air compressors intended to provide a source of compressed air for use with jet nebulizers. All three devices are piston-driven, oil-free, reciprocating air compressors.
PARI Vios employs similar materials compared to the predicate devices, including a polymenc cylinder and housing, Teflon piston seal, and silicone valves. PARI Vios is similar to the Proneb Ultra compressor regarding the fan-cooled shaded pole AC motor, integrated carry handle, and front-panel air outlet and filter access. Operating pressure and jet flow produced by the PARI Vios is comparable to the predicates.
Non-Clinical Test Summary
PARI Vios was tested with various nebulizers to compare performance to the predicate devices, including:
- Total Output Rate: PARI Vios TOR is comparable to the predicate devices. #
- MMD: PARI Vios MMD is comparable to the predicate devices .
- Volume %