(105 days)
No
The document mentions "Smart Card series for defined patient breathing patterns" and "Algorithm to program breathing patterns," which suggests programmable logic or pre-defined settings based on breathing patterns, but not adaptive learning or AI/ML. There is no mention of AI, ML, DNN, or image processing.
Yes
The device is a nebulizer system intended to aerosolize liquid medications for patients for whom doctors have prescribed such medication. This falls under the definition of a therapeutic device as it is used to deliver a medical treatment.
No
The device is described as a nebulizer system intended for the delivery of prescribed medication, not for diagnosing a condition.
No
The device description explicitly states it includes an electrically powered compressor and a nebulizer handset based on piezoelectric vibration, 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 device is a nebulizer system used to administer prescribed medication to patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details how the device aerosolizes liquid medications for inhalation. This process is for delivering treatment, not for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on the device's ability to effectively nebulize and deliver medication based on breathing patterns and other operational parameters. They do not involve evaluating the device's accuracy in detecting or measuring substances in biological samples.
In summary, the AKITA2 APIXNEB is a medical device used for drug delivery, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AKITA2 APIXNEB 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, sub-acute institution, or hospital environment.
The AKITA2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.
Product codes
CAF
Device Description
The AKITA? APIXNEB nebulizer and the handset together constitute a single patient, 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 AKITA2 . APIXNEB nebulizer handset.
- . A nebulizer handset based upon the PARI e-Flow™, K033833, which uses piezoelectric vibration of a perforated stainless steel membrane (head) for the aerosol generation.
- . Single patient use, reusable
- 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 AKITA2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.
Intended User / Care Setting
will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, subacute institution, or hospital environment.
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 as series of performance tests were done.
For safety and effectiveness testing included:
- Performance of the AKITA2 APIXNEB system .
- Flow performance o
- o Trigger Pressure performance
- o On/Off performance
- Nebulization Time performance 0
- Time lag performance o
- Timing Parameters o
- Life Time test O
- Cleaning performance 0
- o Smart Card performance
- Inhalation / Exhalation resistance
- . VOC and PM25 testing
- Electrical safety, EMC, EMI, Mechanical and environmental testing ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052941, K030747, K033833, K935693
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 3 18-Sep-07
| 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: | AKITA² APIXNEB | NOV - 5 200 |
| Common/Usual Name: | Nebulizer systems | |
| Classification Name: | Nebulizer (Direct Patient Interface)
CAF - 868.5630 | |
| Predicate Devices: | I-neb Insight -- K052941 -- Profile / Respironics
ProDose - K030747 - Profile / Respironics
eFlow™ - K033833 - Pari
AutoNeb -- K935693 - Vortran | |
Device Description
The AKITA? APIXNEB nebulizer and the handset together constitute a single patient, 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 AKITA2 . APIXNEB nebulizer handset.
- . A nebulizer handset based upon the PARI e-Flow™, K033833, which uses piezoelectric vibration of a perforated stainless steel membrane (head) for the aerosol generation.
- . Single patient use, reusable
- Nebulization only during inhalation phase .
- . Smart Card series for defined patient breathing patterns
Indications for Use
The AKITA2 APIXNEB 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, sub-acute institution, or hospital environment.
Patient Population
The AKITA2 APIXNEB 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
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 3 18-Sep-07
To demonstrate substantial equivalence as well as safety and effectiveness as series of performance tests were done.
For substantial equivalence the predicate comparisons included:
- . General Attributes
- . Nebulizer performance
.
.
- Particle characterization ্ত
- Pari eFlow™ K033833 o
- Nebulization during inhalation
- Delivery based upon breathing patterns .
- 1-neb K052941and Prodose AAD System K030747 0
- . Algorithm to program breathing patterns
- . Use of programmable disc (Smart cards) for setting nebulization and delivery parameters
For safety and effectiveness testing included:
- Performance of the AKITA2 APIXNEB system .
- Flow performance o
- o Trigger Pressure performance
- o On/Off performance
- Nebulization Time performance 0
- Time lag performance o
- Timing Parameters o
- Life Time test O
- Cleaning performance 0
- o Smart Card performance
- Inhalation / Exhalation resistance
- . VOC and PM25 testing
- Electrical safety, EMC, EMI, Mechanical and environmental testing ●
2
Non-Confidential Summary of Safety and Effectiveness
Page 3 of 3 18-Sep-07
Differences Between Other Legally Marketed Predicate Devices
The AKITA2 APIXNEB system is viewed as substantially equivalent to the predicates.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
3
Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Activaero America, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creck Court, # 102 Bonita Springs, Florida 34134
NOV - 5 2007
Rc: K072019
Trade/Device Name: AKITA2 APIXNEB Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 18, 2007 Received: September 20, 2007
Dear Mr. Dryden:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. Dryden
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation cntitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Neil R. Ogden
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Page 1 of 1
510(k) Number: K072019 (To be assigned)
AKITA2 APIXNEB Device Name:
Indications for Use:
The AKITA2 APIXNEB is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, subacute institution, or hospital environment.
The AKITA2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC)72016