(239 days)
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.
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 .
The provided document is a 510(k) summary for the AKITA JET nebulizer system, demonstrating substantial equivalence to predicate devices. It outlines the device description, indications for use, and a high-level overview of performance tests conducted. However, it does not contain detailed information about specific acceptance criteria or the study data that would allow for a comprehensive answer to your request regarding detailed performance metrics, sample sizes, ground truth establishment, or multi-reader studies.
The document focuses on comparing the AKITA JET to predicate devices across several categories to prove substantial equivalence rather than presenting a de novo performance study against pre-defined acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, based solely on the information given in the provided text.
Here's what can be extracted and what is missing:
Acceptance Criteria and Study Information for AKITA JET Nebulizer System
The provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo acceptance criteria with specific quantitative thresholds that are then met by a new study. The performance tests mentioned are generally for comparison with existing similar devices or to ensure basic safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by comparison to predicates) | Reported Device Performance (Implied from comparison) |
|---|---|
| General Attributes | |
| - Indications for Use (Similar to predicates) | Meets (Substantially equivalent) |
| - Patient Population (Similar to predicates) | Meets (Substantially equivalent) |
| - Environments of Use (Similar to predicates) | Meets (Substantially equivalent) |
| Nebulizer Performance | |
| - Particle Characterization (Compared to PARI LC Sprint K060399) | "performance tests were done" (Implied: comparable) |
| - Delivery during inhalation (Compared to AKITA2 K072019, AutoNeb K935693) | "performance tests were done" (Implied: comparable) |
| - Delivery based on breathing patterns (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Algorithm to program breathing patterns (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Controlled inhalation flow (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Use of programmable Smart Cards (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| Safety and Effectiveness Testing | |
| - Cascade Impactor testing | "Included" (Implied: Met safety/effectiveness benchmarks) |
| - VOC, PM2< and Ozone testing | "Included" (Implied: Met safety/effectiveness benchmarks) |
| - Electrical safety, EMC, EMI, Mechanical, environmental testing | "Included" (Implied: Met safety/effectiveness benchmarks) |
Important Note: The document states, "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices." This is the primary "acceptance criterion" in a 510(k) pathway, implying that the device performs equivalently to the listed predicate devices in the noted categories. Specific quantitative thresholds for these categories are not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. Standard performance testing for medical devices is typically conducted in a laboratory setting, but the geographical origin or whether it's retrospective/prospective is not mentioned.
3. Number of Experts Used and Qualifications
- Number of Experts: Not applicable. This type of performance testing for a nebulizer typically involves technical measurements and comparisons, not expert clinical evaluation of images or data in the way, for example, a diagnostic AI device would.
- Qualifications: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests described (e.g., cascade impactor, electrical safety) involve objective measurements against standards or predicate devices, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images), often with and without AI assistance, to assess diagnostic performance. The AKITA JET is a drug delivery device (nebulizer system), not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Yes, in a sense. The described performance tests (e.g., particle characterization, delivery, electrical safety) are conducted on the device itself without human-in-the-loop clinical interpretation. The "algorithm" in this context refers to the device's operational programming (e.g., for breathing patterns, controlled inhalation flow), and its performance would be assessed as part of the overall device functionality. However, it's not a "standalone algorithm" performance in the way a diagnostic AI would be evaluated.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the performance tests would be established by:
- Objective Measurements: Against established physical and engineering standards (e.g., for particle size distribution, electrical safety, VOC emissions).
- Predicate Device Performance: The measured performance parameters of the AKITA JET were compared directly to those of the predicate devices (PARI LC Sprint, AKITA 2 APIXNEB, Vortran AutoNeb) to establish substantial equivalence.
8. Sample Size for the Training Set
- Sample Size: Not specified. Nebulizers are hardware devices with embedded software; they don't typically undergo machine learning "training" in the same way an AI diagnostic algorithm would. The development process involves engineering, design, and internal testing, which could be considered an iterative development ("training") process, but a specific "training set sample size" as relevant to AI/ML is not applicable or provided here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable as defined for AI/ML models. The functionality and performance of the nebulizer system were established through engineering design principles, manufacturing specifications, and testing against those specifications and relevant regulatory standards.
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510(k) Summary Page 1 of 2 8-Sep-09
NOV 1 8 2009
| 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: | AKITA JET |
| Common/Usual Name: | Nebulizer systems |
| Classification Name: | Nebulizer (Direct Patient Interface)CAF - 868.5630 |
| Predicate Devices: | AKITA 2 APIXNEB - K072019 - ActivaeroLC Sprint nebulizer - K060399 - PARIAutoNeb - 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
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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 < and Ozone testing
- Electrical safety, EMC, EMI, Mechanical and environmental testing .
Differences Between Other Legally Marketed Predicate Devices
The AKITA JET 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol of an eagle or bird-like figure, with stylized wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Activaero America, Incorporated C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
NOV 1 8 2009
Re: K090730 Trade/Device Name: Akita Jet Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 6, 2009
Received: November 9, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Division 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:
K090730 (To be assigned)
Device Name: AKITA JET
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.
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)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
. 510(k) Number: K090730
§ 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).