InnoSpire Go
Device Facts
| Record ID | K170853 |
|---|---|
| Device Name | InnoSpire Go |
| Applicant | Respironics Respiratory Drug Delivery (Uk) , Ltd. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Nov 2, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The InnoSpire Go is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (2 years and older), defined by the prescribed medication, and adults patients in the home environment or in a hospital/clinic setting.
Device Story
InnoSpire Go is a handheld, battery-powered vibrating mesh nebulizer; aerosolizes liquid medications for inhalation. Operates by vibrating a palladium-nickel mesh at 137 kHz to generate aerosol; continuous delivery during inhalation and exhalation. Used in home or clinical settings by patients or caregivers. Device features an 8 mL reservoir; rechargeable battery; mouthpiece or mask interface. Healthcare providers prescribe the medication; device output (aerosolized drug) allows patient to inhale medication for respiratory treatment. Benefits include portable, efficient drug delivery.
Clinical Evidence
Bench testing only. Comparative aerosol performance testing (MMAD, GSD, delivered dose, fine/respirable particle fractions) conducted at 15 lpm and 30 lpm using Salbutamol, Ipratropium bromide, and Sodium cromoglicate. Results showed comparable or improved performance metrics versus predicate. Biocompatibility testing per ISO 10993-1 and electrical safety/EMC testing per IEC 60601 series performed.
Technological Characteristics
Vibrating mesh technology (palladium-nickel mesh, 137 kHz). Handheld form factor; 8 mL reservoir. Rechargeable battery power. Materials tested per ISO 10993-1. Standards met: AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62133.
Indications for Use
Indicated for pediatric (2 years+) and adult patients requiring aerosolized liquid medications. No contraindications.
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
- Aerogen AeroNeb nebulizer (K081650)
Reference Devices
- Optichamber Diamond Valved Holding Chamber (K110293)
Submission Summary (Full Text)
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November 2, 2017
Respironics Respiratory Drug Delivery (UK) Ltd. % Paul Dryden ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K170853
Trade/Device Name: InnoSpire Go Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: September 29, 2017 Received: October 2, 2017
Dear Paul 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.
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 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);
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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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/SafetyReportaProblem/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 (DICE) 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.
# Tara A. Ryan -S
for
Tina Kiang, Ph.D. Acting 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)
K170853
Device Name
# InnoSpire Go
Indications for Use (Describe)
The InnoSpire Go is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (2 years and older), defined by the prescribed medication, and adults patients in the home environment or in a hospital/clinic setting.
Type of Use (Select one or both, as applicable)
| <b>XX</b> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary Page 1 of 8 2-Nov-17
| Company: | Respironics Respiratory Drug Delivery (UK) Ltd.<br>Chichester Business Park<br>City Fields Way, Tangmere<br>Chichester PO20 2FT UK<br>Tel: +011 [44] 870 423 1558 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Filippo Quadrelli - Project Manager |
| Proprietary or Trade Name: | InnoSpire Go |
| Common/Usual Name: | Nebulizer (Direct Patient Interface) |
| Classification Name: | CAF |
| Regulation number: | 21 CFR 868.5630 |
| Class | II |
| Predicate Device: | K081650 – Aerogen AeroNeb nebulizer |
# Device Description:
The InnoSpire Go nebulizer is a small, handheld, internally powered nebulizer which utilizes vibrating mesh technology to generate aerosol.
### Indications for Use:
The InnoSpire Go is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (2 years and older), defined by the prescribed medication and adult patients in the home environment or in a hospital/clinic setting.
# Patient Population:
Pediatric (2 years or older), defined by the prescribed medication, and adult patients
# Environment of Use:
The InnoSpire Go is intended to be used in home environment or in a hospital/clinic setting.
### Contraindications:
None.
# Predicate Device Comparison
As indicated the subject device utilizes the vibrating mesh technology of the predicate. K081650 – Aerogen Aeroneb® Go.
The primary differences between the devices is the design related to form factor, otherwise they are very similar. We will present a comparison of the proposed device and a predicate in Tables 1 to 4 and then discuss the table and any differences.
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# 510(k) Summary Page 2 of 8 Table 1 – Substantial Equivalence Comparative Table - Nebulizer
| Features | Predicate | Proposed |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aerogen AeroNeb® Go | InnoSpire Go Nebulizer |
| | K081650 | |
| Indications for use | The Aeroneb® Go nebulizer, for use by pediatric and | The InnoSpire Go is a vibrating mesh nebulizer system |
| | adult patients, is intended to aerosolize physician- | designed to aerosolize liquid medications for inhalation by |
| | prescribed solutions for inhalation that are approved for | the patient. The device may be used with pediatric (2 years |
| | use with a general purpose nebulizer. | and older), defined by the prescribed medication and adult |
| Patient Population | Pediatric and adult patients | patients in the home environment or in a hospital/clinic |
| Environment of Use | None specified, but known to be used in the home, | setting. |
| | hospital, and sub-acute care settings | |
| Contraindications | None | None |
| Principle of Operation and rate | Vibrating mesh - Palladium nickel 128 kHz | Vibrating mesh - Palladium nickel 137 KHz |
| Aerosolization | Continuous during inhalation and exhalation | Continuous during inhalation and exhalation |
| Compressed gas source | None needed | None needed |
| Reservoir volume | 6 ml | 8 ml |
| Nebulization rate | >0.3 ml/min | >0.45 ml/min |
| Duration of Use | Home setting | Home and clinical setting |
| | Single patient, multi-use | Single patient, multi-use |
| Nebulizer components cleanable | Yes | Yes |
| Software driven | Yes | Yes |
| Patient interface | Mouthpiece and multiple size mask | Mouthpiece and 2 mask sizes |
| | | Internal volume |
| | | Large - 99 ml |
| | | Medium (2 yo – 5 yo) – 34 ml |
| Power source | "AA" battery | Rechargeable battery |
| | AC Adapter 100-240 V | AC Adapter 100-240 V |
| Power consumption | < 2 W | < 5 W when charging |
| Weight | Nebulizer - 65g | <130g (including battery) |
| | Control module – 260g (excluding battery) | |
| Dimensions (mm) | Nebulizer - 40 x 105 x 95mm | 46 x 130 x 70mm (approx.) |
| | Control module - 70 x 110 x 32mm | |
| 2-Nov-17 | | |
| Features | Predicate<br>Aerogen AeroNeb® Go<br>K081650 | Proposed<br>InnoSpire Go Nebulizer |
| Operating Conditions | 5 to 45°C / up to 95%% RH | +5°C to +40°C<br>15% to 93% RH, non-condensing<br>Atmospheric pressure 70 kPa to 106 kPa |
| Storage Conditions | -20 to + 60°C / up to 95% RH | -25°C to +70°C,<br>10% to 93% RH, non-condensing<br>Atmospheric pressure 50 kPa to 106 kPa |
| User interface | On/Off switch<br>LED indicators | On/Off switch<br>LED indicators |
| Standards met | ES 60601-1<br>IEC 60601-1-2 | AAMI ANSI ES 60601-1: 2005 +A1: 2012<br>IEC 60601-1-2:2014<br>IEC 60601-1-6:2013<br>IEC 60601-1-1:2015 |
| Performance | | |
| Materials per<br>ISO 10993-1 | External Communicating<br>(Indirect gas pathway)<br>Tissue / Bone / Dentin communicating<br>Duration of Use – permanent (> 30 days)<br>And<br>Surface Contact<br>Mucosal membrane<br>Duration of Use – permanent (> 30 days) | External Communicating<br>(Indirect gas pathway)<br>Tissue / Bone / Dentin communicating<br>Duration of Use – permanent (> 30 days)<br>And<br>Surface Contact<br>Mucosal membrane<br>Duration of Use – permanent (> 30 days) |
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# 510(k) Summary
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# 510(k) Summary Page 4 of 8 2-Nov-17 Table 2 – Substantial Equivalence Comparative Table - Face Mask
| Face mask | Reference Device | Proposed InnoSpire Go Nebulizer |
|-----------------|-----------------------------------------------|-------------------------------------------------------------------|
| | K110293 | |
| | Optichamber Diamond Valved Holding Chamber | |
| | Respironics New Jersey (Philips) | |
| Sizes | 2 | 2<br>It is intended that patient 2 to 5 years old use a face mask |
| Internal volume | Large - 99 ml<br>Medium (2 yo – 5 yo) – 34 ml | Large - 99 ml<br>Medium (2 yo – 5 yo) – 34 ml |
Note the intended face masks are the identical mask cleared under a sister company.
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# 510(k) Summary Page 5 of 8 2-Nov-17
# Table 3 - Comparative Aerosol Performance - Adult Flow Rate - 30 Ipm (Values shown are mean and 95% confidence interval)
| Parameter | Drug | InnoSpire Go | Aeroneb Go |
|----------------------------------------------------|-------------------------------------|--------------|-------------|
| Delivered dose (µg) * | Salbutamol (5 mg/ 2.5 mL) | 2370 ± 113 | 2206 ± 216 |
| | Ipratropium bromide (500 µg / 2 mL) | 234 ± 6 | 229 ± 12 |
| | Sodium cromoglicate (20 mg/2mL) | 10146 ± 507 | 9210 ± 500 |
| Mass median<br>aerodynamic diameter<br>/ MMAD (µm) | Salbutamol (5 mg / 2.5 mL) | 3.90 ± 1.04 | 4.06 ± 0.47 |
| | Ipratropium bromide (500 µg / 2 mL) | 3.87 ± 0.9 | 3.79 ± 0.20 |
| | Sodium cromoglicate (20mg/2mL) | 4.02 ± 0.91 | 4.15 ± 0.32 |
| Geometric standard<br>deviation/ GSD | Salbutamol (5 mg/ 2.5 mL) | 2.02 ± 0.11 | 2.00 ± 0.05 |
| | Ipratropium bromide (500 µg / 2 mL) | 2.02 ± 0.18 | 2.06 ± 0.07 |
| | Sodium cromoglicate (20 mg/2mL) | 2.00 ± 0.18 | 2.02 ± 0.04 |
| Fine particle fraction <5<br>μm (%) | Salbutamol (5 mg/2.5 mL) | 61.1 ± 14.4 | 58.9 ± 7.4 |
| | Ipratropium bromide (500 µg / 2 mL) | 61.9 ± 11.4 | 62.4 ± 2.6 |
| | Sodium cromoglicate (20mg/2mL) | 59.6 ± 11.6 | 56.9 ± 4.5 |
| Fine particle dose <5<br>μm (µg) | Salbutamol (5 mg/ 2.5 mL) | 1450 ± 389 | 1300 ± 198 |
| | Ipratropium bromide (500 µg / 2 mL) | 145 ± 30 | 143 ± 13 |
| | Sodium cromoglicate (20mg/2mL) | 6047 ± 1407 | 5240 ± 358 |
| Coarse particle fraction<br>>5 µm (%) | Salbutamol (5 mg / 2.5 mL) | 38.9 ± 14.4 | 41.1 ± 7.4 |
| | Ipratropium bromide (500 µg / 2 mL) | 38.1 ± 11.4 | 37.6 ± 2.6 |
| | Sodium cromoglicate (20 mg/2mL) | 40.4 ± 11.6 | 43.1 ± 4.5 |
| Coarse particle dose >5<br>μm (µg) | Salbutamol (5 mg/ 2.5 mL) | 920 ± 315 | 906 ± 188 |
| | Ipratropium bromide (500 µg / 2 mL) | 89 ± 25 | 86 ± 4 |
| | Sodium cromoglicate (20 mg/2mL) | 4098 ± 1054 | 3970 ± 556 |
| Respirable fraction 1 - 5<br>μm (%) | Salbutamol (5 mg/ 2.5 mL) | 56.0 ± 11.9 | 53.8 ± 6.6 |
| | Ipratropium bromide (500 µg / 2 mL) | 56.6 ± 9 | 56.4 ± 1.6 |
| | Sodium cromoglicate (20 mg/2mL) | 47.9 ± 6.4 | 43.7 ± 1.7 |
| Respirable dose 1 - 5<br>μm (µg) | Salbutamol (5 mg/2.5 mL) | 1328 ± 328 | 1187 ± 185 |
| | Ipratropium bromide (500 µg / 2 mL) | 132 ± 24 | 129 ± 10 |
| | Sodium cromoglicate (20 mg / 2 mL) | 4859 ± 790 | 4023 ± 83 |
| Ultra-fine particle<br>fraction <1 µm (%) | Salbutamol (5 mg / 2.5 mL) | 5.2 ± 2.6 | 5.1 ± 0.9 |
| | Ipratropium bromide (500 µg / 2 mL) | 5.4 ± 3.2 | 6.0 ± 1.0 |
| | Sodium cromoglicate (20mg/2mL) | 11.7 ± 5.8 | 13.2 ± 3.4 |
| Ultra-fine particle dose<br><1 µm (µg) | Salbutamol (5 mg / 2.5 mL) | 123 ± 65 | 112 ± 16 |
| | Ipratropium bromide (500 µg / 2 mL) | 12.6 ± 8 | 13.7 ± 3 |
| | Sodium cromoglicate (20 mg/2mL) | 1189 ± 643 | 1217 ± 304 |
* determined using a simulated breathing pattern (tidal volume = 500 mL, I:E ratio = 1:1, breaths per minute = 15)
# Discussion:
The statistical analysis of comparison showed that there are some statistically significant differences in performance at 95% confidence, but in those cases the InnoSpire Go provided either higher Total Dose; smaller particle size (MMAD and GSD); larger Total Respirable Dose.
For the differences in particle size distributions, their differences reflect the results of the Total Respirable Dose, which was an overall higher dose, thus the Coarse, Fine and Ultra- fine particle data would mirror these results as well.
Overall the results are comparable to the predicate and would support a determination of substantial equivalence.
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## 510(k) Summary Page 6 of 8 2-Nov-17
# Table 4 - Comparative Aerosol Performance - Pediatric Flow Rate - 15 Ipm (Values shown are mean and 95% confidence interval)
| Parameter | Drug | InnoSpire Go | Aeroneb Go |
|----------------------------------------------------|-------------------------------------|--------------|-------------|
| Delivered dose (µg) * | Salbutamol (5 mg / 2.5 mL) | 2370 ± 113 | 2206 ± 216 |
| | Ipratropium bromide (500 µg / 2 mL) | 234 ± 6 | 229 ± 12 |
| | Sodium cromoglicate (20 mg / 2 mL) | 10146 ± 507 | 9210 ± 500 |
| Mass median<br>aerodynamic diameter<br>/ MMAD (µm) | Salbutamol (5 mg / 2.5 mL) | 3.99 ± 0.73 | 4.85 ± 0.77 |
| | Ipratropium bromide (500 µg / 2 mL) | 3.93 ± 0.74 | 5.08 ± 0.48 |
| | Sodium cromoglicate (20 mg / 2 mL) | 4.27 ± 0.76 | 4.87 ± 0.54 |
| Geometric standard<br>deviation / GSD | Salbutamol (5 mg / 2.5 mL) | 1.82 ± 0.02 | 2.10 ± 0.09 |
| | Ipratropium bromide (500 µg / 2 mL) | 1.82 ± 0.03 | 2.09 ± 0.11 |
| | Sodium cromoglicate (20 mg / 2 mL) | 1.83 ± 0.05 | 2.00 ± 0.08 |
| Fine particle fraction <5<br>µm (%) | Salbutamol (5 mg / 2.5 mL) | 64.4 ± 12.2 | 51.1 ± 9.5 |
| | Ipratropium bromide (500 µg / 2 mL) | 65.3 ± 12.3 | 48.4 ± 5.1 |
| | Sodium cromoglicate (20 mg / 2 mL) | 59.8 ± 11.6 | 51.0 ± 6.7 |
| Fine particle dose <5<br>µm (µg) | Salbutamol (5 mg / 2.5 mL) | 1526 ± 285 | 1129 ± 324 |
| | Ipratropium bromide (500 µg / 2 mL) | 153 ± 29 | 111 ± 6 |
| | Sodium cromoglicate (20 mg / 2 mL) | 6070 ± 1460 | 4689 ± 375 |
| Coarse particle fraction<br>>5 µm (%) | Salbutamol (5 mg / 2.5 mL) | 35.6 ± 12.2 | 48.9 ± 9.5 |
| | Ipratropium bromide (500 µg / 2 mL) | 34.7 ± 12.3 | 51.6 ± 5.1 |
| | Sodium cromoglicate (20 mg / 2 mL) | 40.2 ± 11.6 | 49.1 ± 6.7 |
| Coarse particle dose >5<br>µm (µg) | Salbutamol (5 mg / 2.5 mL) | 844 ± 305 | 1076 ± 109 |
| | Ipratropium bromide (500 µg / 2 mL) | 81 ± 29 | 118 ± 18.1 |
| | Sodium cromoglicate (20 mg / 2 mL) | 4076 ± 1000 | 4521 ± 852 |
| Respirable fraction 1 - 5<br>µm (%) | Salbutamol (5 mg / 2.5 mL) | 62.7 ± 11.6 | 47.2 ± 0.2 |
| | Ipratropium bromide (500 µg / 2 mL) | 63.6 ± 11.8 | 64.3 ± 0.2 |
| | Sodium cromoglicate (20 mg / 2 mL) | 58.3 ± 11.2 | 59.3 ± 11.2 |
| Respirable dose 1 - 5<br>µm (µg) | Salbutamol (5 mg / 2.5 mL) | 1485 ± 270 | 1042 ± 100 |
| | Ipratropium bromide (500 µg / 2 mL) | 149 ± 28 | 147 ± 8.3 |
| | Sodium cromoglicate (20 mg / 2 mL) | 5922 ± 1403 | 5458 ± 750 |
| Ultra-fine particle<br>fraction <1 µm (%) | Salbutamol (5 mg / 2.5 mL) | 1.7 ± 0.6 | 1.0 ± 0.2 |
| | Ipratropium bromide (500 µg / 2 mL) | 1.8 ± 0.6 | 1.0 ± 0.2 |
| | Sodium cromoglicate (20 mg / 2 mL) | 1.5 ± 0.5 | 0.4 ± 0.4 |
| Ultra-fine particle dose<br><1 µm (µg) | Salbutamol (5 mg / 2.5 mL) | 41 ± 15 | 23 ± 5 |
| | Ipratropium bromide (500 µg / 2 mL) | 4.1 ± 1.4 | 2.2 ± 0.4 |
| | Sodium cromoglicate (20 mg / 2 mL) | 148 ± 58.2 | 40 ± 36.1 |
* determined using a simulated breathing pattern (tidal volume = 500 mL, 1:1, breaths per minute = 15)
### Discussion:
The statistical analysis of comparison showed that there are some statistically significant differences in performance at 95% confidence, but in those cases the InnoSpire Go provided either higher Total Dose; smaller particle size (MMAD and GSD); larger Total Respirable Dose.
For the differences in particle size distributions, their differences reflect the results of the Total Respirable Dose, which was an overall higher dose, thus the Coarse, Fine and Ultra- fine particle data would mirror these results as well.
Overall the results are comparable to the predicate and would support a determination of substantial equivalence.
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## 510(k) Summary Page 7 of 8 2-Nov-17
## Performance differences With and Without a Mask
Comparative performance testing was performed as to the reduction in delivered dose, Fine Particle ad Respirable Dose with and without a mask as compared to the predicate. Discussion:
The results show a decrease in delivered dose and respirable dose as compared to performance with a mouthpiece, however the reduced performance is substantially equivalent to the predicate with a face mask.
# Substantial Equivalence Discussion and Differences Between Predicate Devices
The InnoSpire Go nebulizer is viewed as substantially equivalent to the predicate device because:
Indications for Use – The proposed indications for use are to aerosolize commonly prescribed medications.
Discussion - The indications for use are similar for the proposed device and the predicate -K081650 – Aerogen Aeroneb® Go nebulizer.
Patient Population – The patient population of adult and pediatric (defined by the prescribed medication) patients that is consistent with the indications for the aerosol medication. This is similar to the predicate - K081650 - Aerogen Aeroneb® Go nebulizer.
Discussion - The patient population is similar for the proposed device and the predicate -K081650 – Aerogen Aeroneb® Go nebulizer.
Environment of Use – The proposed environments of use are common and usual for handheld nebulizers, namely home and hospital/clinic settings.
Discussion - The environment of use is identical for the proposed device and the predicate -K081650 – Aerogen Aeroneb® Go nebulizer.
Technology - The design is a vibrating mesh nebulizer which is the same principle of operation. Discussion - The technology is similar for the proposed device as compared to the predicate -K081650 – Aerogen Aeroneb® Go nebulizer.
## Non-clinical performance testing
### Biocompatibility / Materials -
The materials in patient / drug contact have been tested they are characterized as:
- External Communicating (Indirect gas pathway), Tissue / Bone / Dentin communicating. Duration of Use - permanent (> 30 days)
And
- Surface Contact, Mucosal membrane, Duration of Use permanent (> 30 days) ●
### Discussion -
We performed the following tests with guidance from ISO 10993-1 and the results were acceptable.
- . Cytotoxicity - ISO 10993-5:2009
- Sensitization - ISO 10993-10:2010
- Irritation (for surface contact materials) ISO 10993-10:2010 .
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# 510(k) Summary Page 8 of 8 2-Nov-17
- Leachable and Extractables - polar and non-polar - ISO 10993-12:2012 and ISO 10993-18:2005
- Gas emission VOC ASTM D 5466-01:2015 ●
- PM25 ●
- Risk based assessment ISO 10993-17:2002(R)2012 .
# Bench Testing
We have performed a number of tests which are discussed in detail in the respective sections of this submission. These include:
- Durability Testing ●
- . Simulated Life Cycle testing
- Cleaning validation
- Storage and Transportation ISTA 2A ●
- Electrical Safety, EMC, Battery safety IEC 60601-1:2005 (Third Edition)+ CORR. . 1:2006 + CORR. 2:2007+ A1:2012; IEC 60601-1-2:2014; IEC 60601-1-11:2015; IEC 62133:2012
- Particle Characterization Comparative at 15 lpm and 30 lpm ●
- Intra- and Inter- Sample Variability .
# Substantial Equivalence Conclusion
As discussed: the indications for use, patient population, environment of use, technology or principle of operation, and performance are substantially equivalent to the predicate.
Based upon the comparative performance testing we can conclude that the proposed device can be determined as substantially equivalent to the stated predicate.
