(239 days)
Unknown
The description mentions "Smart Card series for defined patient breathing patterns," which could potentially involve some form of adaptive or learning algorithm, but it's not explicitly stated as AI or ML. Without further detail, it's impossible to confirm.
Yes
The device is a nebulizer system designed to aerosolize liquid medications for patients, indicating its use addresses a medical condition or ailment.
No
The device description clearly states it is a nebulizer system designed to aerosolize liquid medications, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it includes an electrically powered compressor and a nebulizer handset, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AKITA JET is a "nebulizer system that will be used with patients for whom doctors have prescribed medication... for nebulization". This describes a device used to deliver medication to a patient, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanical and electrical aspects of aerosolizing liquid medications and delivering them to the patient's respiratory system. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic, monitoring, or screening information based on sample analysis
The device is a therapeutic device used for drug delivery, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.
Product codes
CAF
Device Description
The AKITA JET nebulizer and the AKITA JET nebulizer handset together constitute a multi-use, electronic nebulizer system designed to aerosolize liquid medications. The system includes and features:
- An electrically powered compressor which provides an air flow to the AKITA JET ● nebulizer handset.
- . A nebulizer handset based upon the PARI LC Sprint, K060399
- Single patient, multi-use in the home setting .
- . Multiple patient, multi-use in the hospital and clinical settings
- .
- . Nebulization only during inhalation phase
- Smart Card series for defined patient breathing patterns .
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
The AKITA JET is intended for patients 3 years and older who can coordinate breathing.
Intended User / Care Setting
home care, nursing home, subacute institution, or hospital
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)
To demonstrate substantial equivalence as well as safety and effectiveness a series of performance tests were done.
The predicate comparison is broken into several categories:
- . General Attributes
- o Indications for Use
- o Patient Population
- o Environments of use
- Nebulizer performance
- ಂ Particle characterization
- PARI LC Sprint Reusable Nebulizer K060399 o
- . Delivery during inhalation
- Delivery based upon breathing patterns . Activaero AKITA2 APIXNEB K072019 o
- . Algorithm to program breathing patterns
- Activaero AKITA2 APIXNEB K072019 ಂ
- . Controlled inhalation flow
- Activaero AKITA2 APIXNEB K072019 O
- Use of programmable Smart Cards for setting inspiration and nebulization time .
- Activaero AKITA2 APIXNEB K072019 o
For safety and effectiveness testing included:
- Performance of the AKITA JET system via Cascade Impactor testing ●
- . VOC, PM2
§ 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
510(k) Summary Page 1 of 2 8-Sep-09
NOV 1 8 2009
| Activaero America, Inc.
P.O. Box 351
Dublin, OH 43017-9684 | Tel - (614) 761-3555
Fax - (614) 761-3505 |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Official Contact: | William Zimlich - CEO |
| Proprietary or Trade Name: | AKITA JET |
| Common/Usual Name: | Nebulizer systems |
| Classification Name: | Nebulizer (Direct Patient Interface)
CAF - 868.5630 |
| Predicate Devices: | AKITA 2 APIXNEB - K072019 - Activaero
LC Sprint nebulizer - K060399 - PARI
AutoNeb - K935693 - Vortran |
Device Description
The AKITA JET nebulizer and the AKITA JET nebulizer handset together constitute a multi-use, electronic nebulizer system designed to aerosolize liquid medications. The system includes and features:
- An electrically powered compressor which provides an air flow to the AKITA JET ● nebulizer handset.
- . A nebulizer handset based upon the PARI LC Sprint, K060399
- Single patient, multi-use in the home setting .
- . Multiple patient, multi-use in the hospital and clinical settings
- .
- . Nebulization only during inhalation phase
- Smart Card series for defined patient breathing patterns .
Indications for Use
The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.
Patient Population
The AKITA JET is intended for patients 3 years and older who can coordinate breathing.
Environment of Use
Home care, nursing home, sub-acute institution, or hospital
Contraindications
None
1
510(k) Summary Page 2 of 2 8-Sep-09
To demonstrate substantial equivalence as well as safety and effectiveness a series of performance tests were done.
The predicate comparison is broken into several categories:
- . General Attributes
- o Indications for Use
- o Patient Population
- o Environments of use
- Nebulizer performance
- ಂ Particle characterization
- PARI LC Sprint Reusable Nebulizer K060399 o
- . Delivery during inhalation
- Delivery based upon breathing patterns . Activaero AKITA2 APIXNEB K072019 o
- . Algorithm to program breathing patterns
- Activaero AKITA2 APIXNEB K072019 ಂ
- . Controlled inhalation flow
- Activaero AKITA2 APIXNEB K072019 O
- Use of programmable Smart Cards for setting inspiration and nebulization time .
- Activaero AKITA2 APIXNEB K072019 o
For safety and effectiveness testing included:
- Performance of the AKITA JET system via Cascade Impactor testing ●
- . VOC, PM2