(105 days)
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.
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
The provided text describes the AKITA2 APIXNEB nebulizer system and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study proving device performance in the context of an AI/ML medical device, nor does it detail a study methodology as requested.
The document is a 510(k) premarket notification for a traditional medical device (a nebulizer), not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML evaluations (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or present in this submission.
The document discusses "safety and effectiveness testing" which includes various performance tests (e.g., flow performance, trigger pressure performance, nebulization time performance), but it does not specify acceptance criteria for these tests nor does it provide a report of the device's performance against specific numerical or qualitative targets. Instead, it states that these tests were "done" to demonstrate substantial equivalence and safety/effectiveness.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's an attempt to fill in the table based on the available information, with many fields noted as "Not applicable" or "Not provided."
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Not explicitly stated in text) | Reported Device Performance (Implied by substantial equivalence claim) |
|---|---|---|
| I. Clinical Performance (AI/ML Specific) | ||
| - Sensitivity | Not applicable (Not an AI/ML device) | Not provided |
| - Specificity | Not applicable (Not an AI/ML device) | Not provided |
| - Accuracy | Not applicable (Not an AI/ML device) | Not provided |
| - AUC (Area Under the Curve) | Not applicable (Not an AI/ML device) | Not provided |
| II. Device Performance (General) | ||
| - Flow performance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Trigger Pressure performance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - On/Off performance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Nebulization Time performance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Time lag performance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Timing Parameters | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Life Time test | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Cleaning performance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Smart Card performance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Inhalation / Exhalation resistance | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - VOC and PM25 testing | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
| - Electrical safety, EMC, EMI, Mechanical and environmental testing | Not explicitly stated | Performed to demonstrate substantial equivalence and safety/effectiveness |
Study Details (AI/ML Specific - Not applicable to this device)
- Sample size used for the test set and the data provenance: Not applicable; this is a traditional medical device, not an AI/ML device. No test set for an algorithm is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth for an AI/ML model test set is discussed.
- Adjudication method for the test set: Not applicable; no test set for an AI/ML algorithm is mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable; this is not an AI-driven device.
- The type of ground truth used: For traditional device performance tests, the "ground truth" would be established by validated measurement techniques and adherence to industry standards, but specific methodologies and validation for each test are not detailed in this summary. It's not clinical ground truth (e.g., pathology, outcomes).
- The sample size for the training set: Not applicable; this is a traditional medical device, not an AI/ML device.
- How the ground truth for the training set was established: Not applicable; no training set for an AI/ML model is discussed.
Summary of available information:
The K072019 submission for the AKITA2 APIXNEB nebulizer system focuses on demonstrating substantial equivalence to existing predicate devices (I-neb Insight, ProDose, eFlow™, AutoNeb). The device is a traditional nebulizer, not an AI/ML-driven medical device.
To support substantial equivalence and claims of safety and effectiveness, a series of performance tests were conducted, including:
- Flow performance
- Trigger Pressure performance
- On/Off performance
- Nebulization Time performance
- Time lag performance
- Timing Parameters
- Life Time test
- Cleaning performance
- Smart Card performance
- Inhalation / Exhalation resistance
- VOC and PM25 testing
- Electrical safety, EMC, EMI, Mechanical and environmental testing
The document states that these tests were performed, and the conclusion is that "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices." This implies that the device performed acceptably in these tests, aligning with the performance of the predicate devices. However, specific acceptance criteria (e.g., numerical ranges, pass/fail thresholds) and the detailed results of these tests are not provided in this non-confidential summary. The study design and results are presented as foundational for the "substantial equivalence" claim rather than a detailed report against specific performance criteria.
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Non-Confidential Summary of Safety and Effectiveness
Page 1 of 3 18-Sep-07
| Activaero America, Inc.P.O. Box 351Dublin, OH 43017-9684 | Tel - (614) 761-3555Fax - (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 / RespironicsProDose - K030747 - Profile / RespironicseFlow™ - K033833 - PariAutoNeb -- 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
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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 ●
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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.
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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.
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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
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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
§ 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).