(51 days)
Not Found
No
The document describes a simple air compressor for nebulizers and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is an air compressor for jet nebulizers, providing compressed air but not directly administering therapy or treating a condition itself.
No
The device, the Trek S nebulizer compressor, is intended to provide compressed air for use with jet nebulizers, which are therapeutic devices for drug delivery. It does not mention any function for diagnosis or detection of disease.
No
The device description explicitly states it is a "portable, DC-powered air compressor," which is a hardware component.
Based on the provided information, the Trek S nebulizer compressor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an air compressor intended to provide compressed air for use with jet nebulizers. This is a device used to deliver medication to a patient's lungs, not to perform tests on samples taken from the body.
- Device Description: The description reinforces its function as an air compressor for nebulizers.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. IVDs are typically used to detect diseases, conditions, or infections, or to monitor treatment.
The Trek S is a medical device, but it falls under the category of a therapeutic device used for drug delivery, not a diagnostic device.
N/A
Intended Use / Indications for Use
The TrekTM S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Trel MS nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients. The dev e is non-sterile, prescription-use only, intended for use in bospital, clinic, or home environments.
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 pediatic patients.
Intended User / Care Setting
for use in bospital, 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 T km S was tested with various nebulizers to compare performance to the predicate devices, includin :
- Tot 1 Output Rate: PARI Trek™ S TOR is comparable to the predicate devices D
- a MN D: PARI Trek™ S MMD is comparable to the predicate devices
- Voi me %
§ 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
5 2006 APR
PARI rek™ S 510(k) submission 510(k) Summary
Submitt r Information PARI Innovative Manufacturers, Inc. Name: 2943 Oak Lake Blvd. Address Midlothian, VA 23112 804-253-7274 x269 Phone N imber: 804-639-7244 Fax Nun ber: Contact lame: Michael Judge December 19, 2005 Date Pre ared:
| Device Name | ||
|---|---|---|
| Common Name: | Nebulizer compressor | |
| Proprietary Name: | PARI Trek™ S | |
| Classification Name: | Nebulizer (Direct Patient Interface), 21 CFR 868.5630, Product Code CAF |
Legally Marketed Predicate Device(s)
| Manufa turer | Device | 510(k) Number |
|---|---|---|
| PARI Ir ovative Manufacturers, Inc. | Walkhaler Portable Compressor | K960675 |
| PARI Ir. ovative Manufacturers, Inc. | Proneb® Ultra | K002862 |
Device | escription
The Trel MS nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients. The dev e is non-sterile, prescription-use only, intended for use in bospital, clinic, or home environments.
Intende Use
The Tre TM S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients.
Technol gical Characteristics Compared to Predicate Device
PARI Ti :k™ S, PARI Proneb® Ultra, and PARI Walkhaler® are all air compressors intended to provide a source o compressed air for use with jet nebulizers. All three devices are piston-driven, oil-free reciproc ting air compressors.
PARI Ti :k™ S employs similar materials compared to the predicate devices, including a polymer cylinder and hou ng, Teflon piston seal and silicon valves. PARI Trek™ S is similar to the Walkhaler® compres or regarding the DC motor, AC-to-DC adapter, and optional battery pack for portable use. Operati 3 pressure and jet flow produced by the PARI Trek™ S is comparable to the predicates.
Non-Cli rical Test Summary
PARI T km S was tested with various nebulizers to compare performance to the predicate devices, includin :
- Tot 1 Output Rate: PARI Trek™ S TOR is comparable to the predicate devices D
- a MN D: PARI Trek™ S MMD is comparable to the predicate devices
- Voi me %