(164 days)
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.
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
This document is a 510(k) Summary for a medical device called "FOX MOBILE," a nebulizer system. It does not describe an AI medical device, but rather a traditional medical device for drug nebulization. Therefore, many of the requested criteria related to AI device evaluation (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and performance related to the physical characteristics and drug delivery performance of the nebulizer based on the provided text.
Here's a summary of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparative testing against the predicate device, K072019 - AKITA2 APIXNEB. The study aims to demonstrate equivalent performance to this predicate. While specific numerical "acceptance criteria" are not explicitly stated for each parameter as a pass/fail threshold, the "reported device performance" are the values obtained for FOX MOBILE and the predicate, allowing for a judgment of equivalence based on statistical confidence intervals. The document concludes that the results "demonstrated equivalent performance."
Comparative Particle Characterization (Adult Flow Rate – 15 lpm)
| Particle Characterization | Drug | Acceptance Criteria (Implied: Equivalent to K072019) | FOX MOBILE Reported Performance | AKITA2 APIXNEB (K072019) (Predicate) | Confidence Interval |
|---|---|---|---|---|---|
| MMAD (um) | Sultanol | Equivalent to 4.6 ± 0.1 | 4.0 ± 0.1 | 4.6 ± 0.1 | 95% |
| CromoHEXAL | Equivalent to 4.6 ± 0.1 | 4.0 ± 0.1 | 4.6 ± 0.1 | 95% | |
| Atrovent | Equivalent to 4.3 ± 0.1 | 4.0 ± 0.1 | 4.3 ± 0.1 | 95% | |
| GSD | Sultanol | Equivalent to 1.70 ± 0.06 | 1.65 ± 0.01 | 1.70 ± 0.06 | 95% |
| CromoHEXAL | Equivalent to 1.72 ± 0.15 | 1.69 ± 0.03 | 1.72 ± 0.15 | 95% | |
| Atrovent | Equivalent to 1.63 ± 0.03 | 1.67 ± 0.02 | 1.63 ± 0.03 | 95% | |
| Total Delivered Dose by Device (mg) | Sultanol | Equivalent to 2.23 ± 0.10 | 2.22 ± 0.08 | 2.23 ± 0.10 | 95% |
| CromoHEXAL | Equivalent to 18.4 ± 0.5 | 17.8 ± 0.3 | 18.4 ± 0.5 | 95% | |
| Atrovent | Equivalent to 0.48 ± 0.01 | 0.48 ± 0.01 | 0.48 ± 0.01 | 95% | |
| Total Respirable Dose (< 5 um) (%) | Sultanol | Equivalent to 56.3% ± 3.2 | 67.7% ± 1.1 | 56.3% ± 3.2 | 95% |
| CromoHEXAL | Equivalent to 56.5% ± 9.0 | 66.2% ± 2.0 | 56.5% ± 9.0 | 95% | |
| Atrovent | Equivalent to 64.9% ± 1.7 | 67.8% ± 2.4 | 64.9% ± 1.7 | 95% | |
| Total Respirable Dose (<5 um) (mg) | Sultanol | Equivalent to 1.23 ± 0.07 | 1.49 ± 0.06 | 1.23 ± 0.07 | 95% |
| CromoHEXAL | Equivalent to 10.43 ± 1.87 | 11.77 ± 0.44 | 10.43 ± 1.87 | 95% | |
| Atrovent | Equivalent to 0.30 ± 0.00 | 0.31 ± 0.02 | 0.30 ± 0.00 | 95% | |
| Total Output Rate (TOR) (mg/min) | Sultanol | Equivalent to 0.80 ± 0.14 | 0.66 ± 0.03 | 0.80 ± 0.14 | 95% |
| CromoHEXAL | Equivalent to 7.50 ± 1.38 | 6.01 ± 0.19 | 7.50 ± 1.38 | 95% | |
| Atrovent | Equivalent to 0.16 ± 0.02 | 0.15 ± 0.01 | 0.16 ± 0.02 | 95% | |
| Coarse Particle Dose >4.7 microns - % | Sultanol | Equivalent to 49.1% ± 3.1 | 37.0% ± 1.2 | 49.1% ± 3.1 | 95% |
| CromoHEXAL | Equivalent to 48.7% ± 8.6 | 38.5% ± 2.0 | 48.7% ± 8.6 | 95% | |
| Atrovent | Equivalent to 45.4% ± 2.0 | 37.2% ± 2.5 | 45.4% ± 2.0 | 95% | |
| Fine Particle Dose <4.7 microns (mg) | Sultanol | Equivalent to 1.13 ± 0.04 | 1.40 ± 0.06 | 1.13 ± 0.04 | 95% |
| CromoHEXAL | Equivalent to 9.45 ± 1.78 | 10.92 ± 0.43 | 9.45 ± 1.78 | 95% | |
| Atrovent | Equivalent to 0.26 ± 0.01 | 0.30 ± 0.02 | 0.26 ± 0.01 | 95% | |
| Ultra-Fine Particle Dose <1.0 microns – (mg) | Sultanol | Equivalent to <LoD | <LoD | <LoD | N/A |
| CromoHEXAL | Equivalent to <LoD | N/A | Limit of Detection | N/A | |
| Atrovent | Equivalent to <LoD | N/A | N/A | N/A |
Comparative Particle Characterization (Pediatric Flow Rate – 12 lpm)
| Particle Characterization | Drug | Acceptance Criteria (Implied: Equivalent to K072019) | FOX MOBILE Reported Performance | AKITA2 APIXNEB (K072019) (Predicate) | Confidence Interval |
|---|---|---|---|---|---|
| MMAD (um) | Sultanol | Equivalent to 4.35 + 0.28 | 3.77 + 0.09 | 4.35 + 0.28 | 95% |
| CromoHEXAL | Equivalent to 4.09 + 0.07 | 3.77 + 0.1 | 4.09 + 0.07 | 95% | |
| Atrovent | Equivalent to 4.31 + 0.24 | 3.68 + 0.09 | 4.31 + 0.24 | 95% | |
| GSD | Sultanol | Equivalent to 1.80 + 0.08 | 1.73 + 0.04 | 1.80 + 0.08 | 95% |
| CromoHEXAL | Equivalent to 1.74 + 0.06 | 1.58 + 0.39 | 1.74 + 0.06 | 95% | |
| Atrovent | Equivalent to 1.73 + 0.10 | 1.75 + 0.02 | 1.73 + 0.10 | 95% | |
| Emitted Dose (Total Delivered Dose) (mg) | Sultanol | Equivalent to 2.19 + 0.06 | 2.19 + 0.03 | 2.19 + 0.06 | 95% |
| CromoHEXAL | Equivalent to 18.51 + 1.12 | 18.15 ± 0.32 | 18.51 + 1.12 | 95% | |
| Atrovent | Equivalent to 0.48 + 0.01 | 0.47 + 0.01 | 0.48 + 0.01 | 95% | |
| Total Respirable Dose (< 5 um) (%) | Sultanol | Equivalent to 59.6% + 6.0 | 70.5% ± 1.5 | 59.6% + 6.0 | 95% |
| CromoHEXAL | Equivalent to 65.8% + 0.00 | 69.1% ± 1.5 | 65.8% + 0.00 | 95% | |
| Atrovent | Equivalent to 56.6% ± 0.00 | 71.1% + 1.7 | 56.6% ± 0.00 | 95% | |
| Total Respirable Dose (0.5 - 5 um) (mg) | Sultanol | Equivalent to 1.30 + 0.11 | 1.53 + 0.06 | 1.30 + 0.11 | 95% |
| CromoHEXAL | Equivalent to 12.13 + 1.20 | 12.53 + 0.40 | 12.13 + 1.20 | 95% | |
| Atrovent | Equivalent to 0.30 ± 0.00 | 0.32 ± 0.03 | 0.30 ± 0.00 | 95% | |
| Total Output Rate (TOR) (mg/min) | Sultanol | Equivalent to 0.78 + 0.18 | 0.62 + 0.02 | 0.78 + 0.18 | 95% |
| CromoHEXAL | Equivalent to 6.77 + 0.23 | 5.75 + 0.32 | 6.77 + 0.23 | 95% | |
| Atrovent | Equivalent to 0.17 + 0.03 | 0.14 + 0.01 | 0.17 + 0.03 | 95% | |
| Coarse Particle Dose >4.7 microns - % | Sultanol | Equivalent to 45.0% + 5.8 | 33.8% ± 1.6 | 45.0% + 5.8 | 95% |
| CromoHEXAL | Equivalent to 39.5% + 2.5 | 35.0% + 1.7 | 39.5% + 2.5 | 95% | |
| Atrovent | Equivalent to 44.8% + 4.5 | 33.0% + 1.8 | 44.8% + 4.5 | 95% | |
| Fine Particle Dose <4.7 microns (mg) | Sultanol | Equivalent to 1.20 + 0.10 | 1.45 + 0.05 | 1.20 + 0.10 | 95% |
| CromoHEXAL | Equivalent to 11.21 + 1.13 | 11.80 + 0.42 | 11.21 + 1.13 | 95% | |
| Atrovent | Equivalent to 0.26 + 0.02 | 0.32 ± 0.01 | 0.26 + 0.02 | 95% | |
| Ultra-Fine Particle Dose <1.0 microns – (mg) | Sultanol | Equivalent to <LoD | <LoD | <LoD | N/A |
| CromoHEXAL | Equivalent to <LoD | N/A | Limit of Detection | N/A | |
| Atrovent | Equivalent to <LoD | N/A | N/A | N/A |
Other Non-Clinical Testing:
- Materials: Tested per ISO 10993-1. Results supported material requirements, including 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. (No specific acceptance criteria or quantitative results given in the summary, just statement that requirements were satisfied).
- 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 (List of tests performed, but no specific acceptance criteria or results are detailed in this summary).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the particle characterization tests, only "Confidence interval of 95%." For material testing, it just says "We have tested the materials."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing was presented by Vectura GmbH (Germany), so it potentially took place there or was commissioned by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device performance study, not an AI study requiring expert ground truth for interpretation (e.g., image analysis). The ground truth here is the measured physical characteristics of the aerosol.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is a physical device performance study, not an AI study involving human interpretation and adjudication.
5. 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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For particle characterization: The ground truth is the measured aerosol characteristics (e.g., MMAD, GSD, emitted dose) as determined by standard laboratory methods (Cascade Impactor).
- For material testing: Industry standards and regulations (e.g., ISO 10993-1).
8. The sample size for the training set:
- Not Applicable. This is not an AI device that requires a training set. The device is a physical nebulizer.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for a physical nebulizer.
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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.
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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 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
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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.
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Attachment # 26
510(k) Summary
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510(k) Summary
Page 1 of 6
| Date Prepared: | 11-Dec-14 |
|---|---|
| Vectura GmbHRobert-Koch-Allee 2982131 Gauting, GERMANY | Tel - +49 89 89 79 69 Ext 19Fax - +49 89 89 79 69 22 |
| Official Contact: | Raimund GleixnerDirector 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 – CAF21 CFR 868.5630Class II |
| Predicate Devices: | K072019 - Activaero (Vectura) - AKITA2 APIXNEBK935693 - 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.
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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 fornebulizing drugs | X | Jet nebulizer |
| Synchronized delivery of nebulizer drug | X | X |
| Drug delivery on demand | X | X |
| Adjustable inhalation times that arebreathe 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 | ActivaeroAKITA2 APIXNEB (K072019) | ProposedFOX MOBILE |
|---|---|---|
| Indications for Use | The AKITA2 APIXNEB is a nebulizersystem that will be used with patients forwhom doctors have prescribedmedication (except pentamidine) fornebulization in the home care, nursinghome, sub-acute institution, or hospitalenvironment.The AKITA2 APIXNEB is intended forpatients 3 years and older who cancoordinate breathing. | The FOX MOBILE inhalation systemis a nebulizer system that will be usedwith patients for whom doctors haveprescribed medication for nebulizationin the home care, nursing home, sub-acute institution, or hospitalenvironments.It is intended for patients 3 years andolder who can coordinate breathing. |
| Single patient, multi-use | Yes | Yes |
| Basic components | Control unitDisposable reservoir with capDisposable aerosol generatorDisposable Mouthpiece | Base unitDisposable reservoir with nebulizerDisposable CapDisposable Mouthpiece |
| Technology, Features and Specifications | ||
| Nebulizer technology | Vibrating mesh | Vibrating mesh |
| Synchronized delivery ofnebulized 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 |
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510(k) Summary Page 3 of 6
| Attribute | ActivaeroAKITA2 APIXNEB (K072019) | ProposedFOX MOBILE |
|---|---|---|
| Performance testing | Particle characterizationComparison results found to beequivalent | Particle characterizationMechanicalEnvironmentalSimulated lifetime cycle (cleaning)Differential PressureIEC 60601-1 plus deviationsIEC 60601-1-2IEC 60601-1-6IEC 60601-1-11 |
Table 3 - Compares FOX MOBILE to Predicate - Vortran - AutoNeb (K935693)
| Attribute | PredicateVortran AutoNebK935693 | ProposedFOX MOBILE |
|---|---|---|
| Indications for Use | Not listed but a general purposenebulizer | The FOX MOBILE inhalation system is anebulizer system that will be used withpatients for whom doctors have prescribedmedication for nebulization in the home care,nursing home, sub-acute institution, orhospital environments.It is intended for patients 3 years and olderwho can coordinate breathing. |
| Environments of use | Not specified but includes home caresetting | home care, nursing home, sub-acuteinstitution, or hospital environment |
| Patient population | All - not specified | patients 3 years and older who can coordinatebreathing |
| Technology | Jet nebulizer | Vibrating mesh |
| Operational Flow Rate | 1.5-16 LPM | 15 LPM |
| Synchronized delivery ofnebulized drug | Yes | Yes |
| Mode of Operation | Breathe activated | Breathe activated |
| Drug delivery triggered by | Patient InhalationPressure signal | Patient InhalationPressure signal |
| Adjustable Inhalationtimes | 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 byDevice (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(< 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(<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)(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>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 (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<1.0 microns – (mg) | Sultanol | <LoD | <LoD |
| CromoHEXAL | Limit of Detection | ||
| Atrovent |
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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=""><lod< td=""></lod<></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.
§ 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).