FOX MOBILE

K142059 · Vectura GmbH · CAF · Jan 9, 2015 · Anesthesiology

Device Facts

• Record ID: K142059
• Device Name: FOX MOBILE
• Applicant: Vectura GmbH
• Product Code: CAF · Anesthesiology
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

FOX MOBILE is a handheld, single-patient, multi-use vibrating mesh nebulizer system. It delivers aerosolized medication to patients; system includes base unit, disposable reservoir, cap, and mouthpiece. Device features flow limitation valve (LIMIX) and air control. Operation is breathe-activated; device detects patient inhalation via pressure signal to trigger synchronized drug delivery on demand. User receives feedback via LEDs during inhalation. Inhalation times are adjustable via pre-sets. Device is battery-powered. Used in home, nursing home, sub-acute, or hospital environments. Healthcare providers prescribe the medication; patients operate the device. Benefits include synchronized, on-demand delivery of aerosolized medication, potentially improving drug deposition efficiency.

Clinical Evidence

Bench testing only. Comparative particle characterization testing was performed using a Cascade Impactor at adult (15 lpm) and pediatric (12 lpm) flow rates. Metrics included MMAD, GSD, Total Delivered Dose, Total Respirable Dose, and Total Output Rate for three drugs (Sultanol, CromoHEXAL, Atrovent). Results demonstrated performance equivalent to the predicate AKITA2 APIXNEB. Material biocompatibility was verified per ISO 10993-1.

Technological Characteristics

Vibrating mesh nebulizer technology. Materials tested per ISO 10993-1 (cytotoxicity, sensitization, genotoxicity, implantation, systemic/subchronic toxicity). Battery-powered. Features flow limitation valve (LIMIX) and LED user feedback. Synchronized, breathe-activated delivery triggered by pressure signal. Dimensions/form factor: handheld. Connectivity: none specified. Sterilization: not specified.

Indications for Use

Indicated for patients 3 years and older who can coordinate breathing, for whom medication has been prescribed for nebulization in home, nursing home, sub-acute, or hospital settings.

Regulatory Classification

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.

Predicate Devices

• Activaero (Vectura) - AKITA2 APIXNEB (K072019)
• Vortran - AutoNeb (K935693)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

K142059

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 [phone]

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<br>Robert-Koch-Allee 29<br>82131 Gauting, GERMANY | Tel - [phone] Ext 19<br>Fax - [phone] |
| Official Contact: | Raimund Gleixner<br>Director of Regulatory Affairs, Devices |
| Proprietary or Trade Name: | FOX MOBILE |
| Common/Usual Name: | Nebulizer (Direct Patient Interface) |
| Classification Name: | Nebulizer (Direct Patient Interface)<br>Product Classification – CAF<br>21 CFR 868.5630<br>Class II |
| Predicate Devices: | K072019 - Activaero (Vectura) - AKITA2 APIXNEB<br>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.

- K072019 - Activaero - AKITA2 APIXNEB
- K935693 Vortran AutoNeb ●

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<br>nebulizing drugs | X | Jet nebulizer |
| Synchronized delivery of nebulizer drug | X | X |
| Drug delivery on demand | X | X |
| Adjustable inhalation times that are<br>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<br>AKITA2 APIXNEB (K072019) | Proposed<br>FOX MOBILE |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The AKITA2 APIXNEB is a nebulizer<br>system that will be used with patients for<br>whom doctors have prescribed<br>medication (except pentamidine) for<br>nebulization in the home care, nursing<br>home, sub-acute institution, or hospital<br>environment.<br><br>The AKITA2 APIXNEB is intended for<br>patients 3 years and older who can<br>coordinate breathing. | The FOX MOBILE inhalation system<br>is a nebulizer system that will be used<br>with patients for whom doctors have<br>prescribed medication for nebulization<br>in the home care, nursing home, sub-<br>acute institution, or hospital<br>environments.<br><br>It is intended for patients 3 years and<br>older who can coordinate breathing. |
| Single patient, multi-use | Yes | Yes |
| Basic components | Control unit<br>Disposable reservoir with cap<br>Disposable aerosol generator<br>Disposable Mouthpiece | Base unit<br>Disposable reservoir with nebulizer<br>Disposable Cap<br>Disposable Mouthpiece |
| Technology, Features and Specifications | | |
| Nebulizer technology | Vibrating mesh | Vibrating mesh |
| Synchronized delivery of<br>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<br>AKITA2 APIXNEB (K072019) | Proposed<br>FOX MOBILE |
|---------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance testing | Particle characterization<br>Comparison results found to be<br>equivalent | Particle characterization<br>Mechanical<br>Environmental<br>Simulated lifetime cycle (cleaning)<br>Differential Pressure<br>IEC 60601-1 plus deviations<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-11 |

### Table 3 - Compares FOX MOBILE to Predicate - Vortran - AutoNeb (K935693)

| Attribute | Predicate<br>Vortran AutoNeb<br>K935693 | Proposed<br>FOX MOBILE |
|--------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Not listed but a general purpose<br>nebulizer | The FOX MOBILE inhalation system is a<br>nebulizer system that will be used with<br>patients for whom doctors have prescribed<br>medication for nebulization in the home care,<br>nursing home, sub-acute institution, or<br>hospital environments.<br><br>It is intended for patients 3 years and older<br>who can coordinate breathing. |
| Environments of use | Not specified but includes home care<br>setting | home care, nursing home, sub-acute<br>institution, or hospital environment |
| Patient population | All - not specified | patients 3 years and older who can coordinate<br>breathing |
| Technology | Jet nebulizer | Vibrating mesh |
| Operational Flow Rate | 1.5-16 LPM | 15 LPM |
| Synchronized delivery of<br>nebulized drug | Yes | Yes |
| Mode of Operation | Breathe activated | Breathe activated |
| Drug delivery triggered by | Patient Inhalation<br>Pressure signal | Patient Inhalation<br>Pressure signal |
| Adjustable Inhalation<br>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:

{7}------------------------------------------------

#### 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.

{8}------------------------------------------------

#### 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<br>(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<br>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<br>(< 5 um) (%) | Sultanol | 67.7% ± 1.1 | 56.3% ± 3.2 |
| | CromoHEXAL | 66.2% ± 2.0 | 56.5% ± 9.0 |
| | Atrovent | 67.8% ± 2.4 | 64.9% ± 1.7 |
| Total Respirable Dose<br>(<5 um) (mg) | Sultanol | 1.49 ± 0.06 | 1.23 ± 0.07 |
| | CromoHEXAL | 11.77 ± 0.44 | 10.43 ± 1.87 |
| | Atrovent | 0.31 ± 0.02 | 0.30 ± 0.00 |
| Total Output Rate (TOR)<br>(mg/min) | Sultanol | 0.66 ± 0.03 | 0.80 ± 0.14 |
| | CromoHEXAL | 6.01 ± 0.19 | 7.50 ± 1.38 |
| | Atrovent | 0.15 ± 0.01 | 0.16 ± 0.02 |
| Coarse Particle Dose<br>>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<br><4.7 microns (mg) | Sultanol | 1.40 ± 0.06 | 1.13 ± 0.04 |
| | CromoHEXAL | 10.92 ± 0.43 | 9.45 ± 1.78 |
| | Atrovent | 0.30 ± 0.02 | 0.26 ± 0.01 |
| Ultra-Fine Particle Dose<br><1.0 microns – (mg) | Sultanol | <LoD | <LoD |
| | CromoHEXAL | | Limit of Detection |
| | Atrovent | | |

{9}------------------------------------------------

### 510(k) Summary Page 6 of 6 11-Dec-14

#### Table 5 - Summary of Comparative Particle Characterization for FOX MOBILE vs. AKITA2 APIXNEB (K072019) - Pediatric flow rate - 12 lpm (Confidence interval of 95%)

| Particle characterization | Drug | FOX MOBILE | AKITA2 APIXNEB |
|---------------------------|------------|-------------------------------------------------|---------------------|
| | | | (K072019) |
| MMAD (um) | Sultanol | 3.77 + 0.09 | 4.35 + 0.28 |
| | CromoHEXAL | 3.77 + 0.1 | 4.09 + 0.07 |
| | Atrovent | 3.68 + 0.09 | 4.31 + 0.24 |
| GSD | Sultanol | 1.73+0.04 | 1.80+0.08 |
| | CromoHEXAL | 1.58+0.39 | 1.74+0.06 |
| | Atrovent | 1.75+0.02 | 1.73+0.10 |
| Emitted Dose (Total | Sultanol | 2.19 + 0.03 | 2.19 + 0.06 |
| Delivered Dose) (mg) | CromoHEXAL | 18.15 ± 0.32 | 18.51 + 1.12 |
| | Atrovent | 0.47 + 0.01 | 0.48 + 0.01 |
| Total Respirable Dose | Sultanol | 70.5% ± 1.5 | 59.6% +6.0 |
| (< 5 um) (%) | CromoHEXAL | 69.1% ± 1.5 | 65.8% + 0.00 |
| | Atrovent | 71.1% + 1.7 | 56.6% ± 0.00 |
| Total Respirable Dose | Sultanol | 1.53 + 0.06 | 1.30 + 0.11 |
| (0.5 - 5 um) (mg) | CromoHEXAL | 12.53 + 0.40 | 12.13 + 1.20 |
| | Atrovent | 0.32 ± 0.03 | 0.30 ± 0.00 |
| Total Output Rate (TOR) | Sultanol | 0.62 + 0.02 | 0.78 + 0.18 |
| (mg/min) | CromoHEXAL | 5.75 + 0.32 | 6.77 + 0.23 |
| | Atrovent | 0.14 + 0.01 | 0.17 + 0.03 |
| Coarse Particle Dose | Sultanol | 33.8 % ±1.6 | 45.0 % +5.8 |
| >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 |
| <4.7 microns (mg) | CromoHEXAL | 11.80 + 0.42 | 11.21 + 1.13 |
| | Atrovent | 0.32 ± 0.01 | 0.26 + 0.02 |
| Ultra-Fine Particle Dose | Sultanol | <lod< td=""><td><lod< td=""></lod<></td></lod<> | <lod< td=""></lod<> |
| <1.0 microns - (mg) | CromoHEXAL | | Limit of Detection |
| | Atrovent | | |

### Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.