(164 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description or performance studies.
No
The device, a nebulizer system, delivers medication but does not inherently treat a condition. Its function is to facilitate the delivery of medication prescribed by a doctor, which then performs the therapeutic action.
No
The device is described as a nebulizer system for delivering medication, not for diagnosing conditions. Its intended use is for medication delivery, and the performance studies focus on particle characterization and material testing, not diagnostic accuracy.
No
The device description explicitly lists hardware components such as a vibrating mesh nebulizer, LEDs, a flow limitation valve, and air control, indicating it is a physical medical device, not software-only.
Based on the provided information, the FOX MOBILE inhalation system 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 deliver prescribed medication for inhalation. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details components related to aerosolizing and delivering medication (vibrating mesh nebulizer, flow limitation valve, air control). There are no components or functions described that would be used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information
The device is a medical device used for drug delivery, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The FOX MOBILE inhalation system is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, sub-acute institution, or hospital environments. It is intended for patients 3 years and older who can coordinate breathing.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The FOX MOBILE is a single patient, multi-use, handheld inhalation system to deliver medications which are to be aerosolized. The system includes:
- A vibrating mesh nebulizer
- LEDs for user feedback
- . Flow limitation valve (LIMIX)
- Air control
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
patients 3 years and older
Intended User / Care Setting
home care, nursing home, sub-acute institution, or hospital 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 Testing Summary –
Particle Characterization -
We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated equivalent performance to the predicate K072019 - AKITA2 APIXNEB.
Materials -
We have tested the materials per ISO 10993-1 and the results supported the material satisfying the requirements. Testing included, Cytotoxicity, Sensitization, Genotoxicity, Implantation, Systemic Toxicity, Subchronic toxicity, Leachable and Extractable at 50°C for 72 hours, VOC and PM2.5 with a complete Risk Based Assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MMAD (um), GSD, Total Delivered Dose by Device (mg), Total Respirable Dose (4.7 microns - %, Fine Particle Dose
§ 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
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that they appear to be interconnected. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2015
Vectura GmbH c/o Paul Dryden Consultant Robert-Koch-Allee 29 Gauting, Germany 82131
Re: K142059
Trade/Device Name: FOX MOBILE Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: December 11, 2014 Received: December 12, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
FOX MOBILE
Indications for Use (Describe)
The FOX MOBILE inhalation system is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, sub-acute institution, or hospital environments. It is intended for patients 3 years and older who can coordinate breathing.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
EF PSC Publishing Services (301) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
3
Attachment # 26
510(k) Summary
4
510(k) Summary
Page 1 of 6
| Date Prepared: | 11-Dec-14 |
|---|---|
| Vectura GmbH | |
| Robert-Koch-Allee 29 | |
| 82131 Gauting, GERMANY | Tel - +49 89 89 79 69 Ext 19 |
| Fax - +49 89 89 79 69 22 | |
| Official Contact: | Raimund Gleixner |
| Director of Regulatory Affairs, Devices | |
| Proprietary or Trade Name: | FOX MOBILE |
| Common/Usual Name: | Nebulizer (Direct Patient Interface) |
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Product Classification – CAF | |
| 21 CFR 868.5630 | |
| Class II | |
| Predicate Devices: | K072019 - Activaero (Vectura) - AKITA2 APIXNEB |
| K935693 - Vortran - AutoNeb |
Device Description:
The FOX MOBILE is a single patient, multi-use, handheld inhalation system to deliver medications which are to be aerosolized. The system includes:
- A vibrating mesh nebulizer
- LEDs for user feedback
- . Flow limitation valve (LIMIX)
- Air control
Indications for Use:
The FOX MOBILE inhalation system 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 environments. It is intended for patients 3 years and older who can coordinate breathing.
Comparison to Predicates
We have chosen two (2) predicates for our substantial equivalence claim. The following is a rationale for this selection.
Table 1 is a table which highlights the reason for selecting each predicate.
5
510(k) Summary Page 2 of 6
11-Dec-14
| Substantial Equivalent Elements | K072019 | K935693 |
|---|---|---|
| Activaero - AKITA2 | Vortran - AutoNeb | |
| APIXNEB | ||
| Indications for Use | X | X |
| Environment of Use | X | X |
| Patient Population | X | X |
| Technology of vibrating mesh for | ||
| nebulizing drugs | X | Jet nebulizer |
| Synchronized delivery of nebulizer drug | X | X |
| Drug delivery on demand | X | X |
| Adjustable inhalation times that are | ||
| breathe activated | X | X |
| Pre-set Smart Cards | Manual | |
| Patient can adjust inhalation times | X |
Table 2 Compares the FOX MOBILE to Activaero - AKITA2 APIXNEB (K072019)
| Attribute | Activaero
AKITA2 APIXNEB (K072019) | Proposed
FOX MOBILE |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The FOX MOBILE inhalation system
is a nebulizer system that will be used
with patients for whom doctors have
prescribed medication for nebulization
in the home care, nursing home, sub-
acute institution, or hospital
environments.
It is intended for patients 3 years and
older who can coordinate breathing. |
| Single patient, multi-use | Yes | Yes |
| Basic components | Control unit
Disposable reservoir with cap
Disposable aerosol generator
Disposable Mouthpiece | Base unit
Disposable reservoir with nebulizer
Disposable Cap
Disposable Mouthpiece |
| Technology, Features and Specifications | | |
| Nebulizer technology | Vibrating mesh | Vibrating mesh |
| Synchronized delivery of
nebulized drug | Yes | Yes |
| Drug delivery on demand | Yes | Yes |
| Inhalation Volume (times) | 2 – 8 seconds | 1.5 to 8 seconds |
| Gas source | Compressor | Self-generated by user |
| Flow rate | 15 lpm | 15 lpm |
| Power source | Mains | Battery AC |
6
510(k) Summary Page 3 of 6
| Attribute | Activaero
AKITA2 APIXNEB (K072019) | Proposed
FOX MOBILE |
|---------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance testing | Particle characterization
Comparison results found to be
equivalent | Particle characterization
Mechanical
Environmental
Simulated lifetime cycle (cleaning)
Differential Pressure
IEC 60601-1 plus deviations
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11 |
Table 3 - Compares FOX MOBILE to Predicate - Vortran - AutoNeb (K935693)
| Attribute | Predicate
Vortran AutoNeb
K935693 | Proposed
FOX MOBILE |
|--------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Not listed but a general purpose
nebulizer | The FOX MOBILE inhalation system is a
nebulizer system that will be used with
patients for whom doctors have prescribed
medication for nebulization in the home care,
nursing home, sub-acute institution, or
hospital environments.
It is intended for patients 3 years and older
who can coordinate breathing. |
| Environments of use | Not specified but includes home care
setting | home care, nursing home, sub-acute
institution, or hospital environment |
| Patient population | All - not specified | patients 3 years and older who can coordinate
breathing |
| Technology | Jet nebulizer | Vibrating mesh |
| Operational Flow Rate | 1.5-16 LPM | 15 LPM |
| Synchronized delivery of
nebulized drug | Yes | Yes |
| Mode of Operation | Breathe activated | Breathe activated |
| Drug delivery triggered by | Patient Inhalation
Pressure signal | Patient Inhalation
Pressure signal |
| Adjustable Inhalation
times | 0.5 - 9.9 sec - patient adjustable | 1.5 - 8 sec - patient adjustable |
Substantial Equivalence Discussion
Tables 2 to 3 above compare the key features of the proposed FOX MOBILE with the identified predicates and demonstrates that the device can be found to be substantially equivalent. In summary one can conclude that substantial equivalence is met based upon the following:
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510(k) Summary Page 4 of 6 11-Dec-14
Indications for Use -
The indications for use are identical for the proposed device when compared to the predicate -K072019 - AKITA2 APIXNEB. The predicate K935693 - AutoNeb does not have published indications but is known to be similar as a general purpose nebulizer. Discussion - Each device is indicated for use as a general purpose nebulizer.
Technology and construction -
The nebulizer technology is identical to the predicate – K072019 - AKITA2 APIXNEB. The basic design, fabrication, etc. are equivalent to the predicates as a handheld nebulizer. Discussion - The design, vibrating mesh nebulizer technology, controlled inhalation flow and adjustable inhalation times are all similar to the predicate K072019 - AKITA A APIXNEB. There is a difference in the power source between the 2 devices. The FOX MOBILE is operated by a rechargeable battery while the predicate K072019 - AKITA2 APIXNEB is powered by standard AC power. The use of battery power to operate a device is common and this difference does not raise any new safety concerns.
Patient Control Features -
The ability of the user to change or adjust inhalation times is substantially equivalent to the predicate K935693 - AutoNeb.
In addition the design of drug delivery on demand, synchronized with inhalation, controlled inhalation flow, user feedback as to how they are performing during inhalation are very similar to the predicate K072019 - AKITA2 APIXNEB while some features are equivalent to the predicate K935693 – AutoNeb.
Discussion - This difference of adjusting the inhalation times between the FOX MOBILE and the predicate K935693 - AutoNeb is that the FOX MOBILE has pre-sets that the user selects, while the predicate AutoNeb, the user makes manual adjustments between the high and low inhalation time range. This difference in how the patient adjusts the inhalation time does not raise new safety issues.
Environment of Use -
The environments of use are identical to both predicates - K072019 - AKITA2 APIXNEB and K935693 - AutoNeb.
Discussion - Both devices are used in the home care, nursing home, sub-acute institution, or hospital environments settings.
Patient Population -
The patient population is identical to the predicate - K072019 - AKITA2 APIXNEB. Discussion - The patient populations are equivalent to K072019 - AKITA2 APIXNEB. The patient populations are believed to be equivalent to the predicate K935693 – AutoNeb but there is little available information.
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510(k) Summary Page 5 of 6 11-Dec-14
Non-clinical Testing Summary –
Particle Characterization -
We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated equivalent performance to the predicate K072019 - AKITA2 APIXNEB.
Materials -
We have tested the materials per ISO 10993-1 and the results supported the material satisfying the requirements. Testing included, Cytotoxicity, Sensitization, Genotoxicity, Implantation, Systemic Toxicity, Subchronic toxicity, Leachable and Extractable at 50°C for 72 hours, VOC and PM2.5 with a complete Risk Based Assessment.
Discussion - We have tested the materials which are commonly used in nebulizers.
| Table 4 – Summary of Comparative Particle Characterization for FOX MOBILE vs. |
|---|
| AKITA² APIXNEB (K072019) – Adult flow rate – 15 lpm (Confidence interval of 95%) |
| Particle characterization | Drug | FOX MOBILE | AKITA2 APIXNEB
(K072019) |
|-------------------------------------------------|------------|--------------|-----------------------------|
| MMAD (um) | Sultanol | 4.0 ± 0.1 | 4.6 ± 0.1 |
| | CromoHEXAL | 4.0 ± 0.1 | 4.6 ± 0.1 |
| | Atrovent | 4.0 ± 0.1 | 4.3 ± 0.1 |
| GSD | Sultanol | 1.65±0.01 | 1.70+0.06 |
| | CromoHEXAL | 1.69±0.03 | 1.72±0.15 |
| | Atrovent | 1.67+0.02 | 1.63+0.03 |
| Total Delivered Dose by
Device (mg) | Sultanol | 2.22 ± 0.08 | 2.23 ± 0.10 |
| | CromoHEXAL | 17.8 ± 0.3 | 18.4 ± 0.5 |
| | Atrovent | 0.48 ± 0.01 | 0.48 ± 0.01 |
| Total Respirable Dose
(4.7 microns - % | Sultanol | 37.0 % ±1.2 | 49.1 % ±3.1 |
| | CromoHEXAL | 38.5 % ±2.0 | 48.7 % ±8.6 |
| | Atrovent | 37.2 % ±2.5 | 45.4 % ±2.0 |
| Fine Particle Dose
4.7 microns - % | CromoHEXAL | 35.0 % +1.7 | 39.5 % +2.5 |
| | Atrovent | 33.0 % +1.8 | 44.8 % +4.5 |
| Fine Particle Dose | Sultanol | 1.45 + 0.05 | 1.20 + 0.10 |
| | |
|