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 Description

The InnoSpire Go nebulizer is a small, handheld, internally powered nebulizer which utilizes vibrating mesh technology to generate aerosol.

AI/ML Overview

The provided document describes the InnoSpire Go nebulizer's acceptance criteria and the study that proves it meets those criteria, primarily through comparison to a predicate device, the Aerogen AeroNeb Go.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds but are implied through the comparison to the predicate device's performance, aiming for "substantially equivalent" results. The study demonstrates that where differences exist, the InnoSpire Go either performs comparably or better, particularly in delivering a higher total respirable dose or having smaller particle sizes.

Parameter (Metric)	Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	InnoSpire Go Performance (Mean ± 95% CI)	Predicate (Aeroneb Go) Performance (Mean ± 95% CI)	Notes on Equivalence/Difference
Adult Flow Rate - 30 Ipm
Delivered dose (µg) - Salbutamol	Equivalent or better	2370 ± 113	2206 ± 216	Higher
Delivered dose (µg) - Ipratropium bromide	Equivalent or better	234 ± 6	229 ± 12	Higher
Delivered dose (µg) - Sodium cromoglicate	Equivalent or better	10146 ± 507	9210 ± 500	Higher
MMAD (µm) - Salbutamol	Equivalent or better (smaller is better)	3.90 ± 1.04	4.06 ± 0.47	Smaller particle size
MMAD (µm) - Ipratropium bromide	Equivalent or better (smaller is better)	3.87 ± 0.9	3.79 ± 0.20	Comparable
MMAD (µm) - Sodium cromoglicate	Equivalent or better (smaller is better)	4.02 ± 0.91	4.15 ± 0.32	Smaller particle size
GSD - Salbutamol	Equivalent or better (smaller is better)	2.02 ± 0.11	2.00 ± 0.05	Comparable
GSD - Ipratropium bromide	Equivalent or better (smaller is better)	2.02 ± 0.18	2.06 ± 0.07	Smaller particle size
GSD - Sodium cromoglicate	Equivalent or better (smaller is better)	2.00 ± 0.18	2.02 ± 0.04	Smaller particle size
Fine particle fraction <5 µm (%) - Salbutamol	Equivalent or better (higher is better)	61.1 ± 14.4	58.9 ± 7.4	Higher
Fine particle fraction <5 µm (%) - Ipratropium bromide	Equivalent or better (higher is better)	61.9 ± 11.4	62.4 ± 2.6	Comparable
Fine particle fraction <5 µm (%) - Sodium cromoglicate	Equivalent or better (higher is better)	59.6 ± 11.6	56.9 ± 4.5	Higher
Fine particle dose <5 µm (µg) - Salbutamol	Equivalent or better (higher is better)	1450 ± 389	1300 ± 198	Higher
Fine particle dose <5 µm (µg) - Ipratropium bromide	Equivalent or better (higher is better)	145 ± 30	143 ± 13	Higher
Fine particle dose <5 µm (µg) - Sodium cromoglicate	Equivalent or better (higher is better)	6047 ± 1407	5240 ± 358	Higher
Coarse particle fraction >5 µm (%) - Salbutamol	Equivalent or better (lower is better)	38.9 ± 14.4	41.1 ± 7.4	Lower
Coarse particle fraction >5 µm (%) - Ipratropium bromide	Equivalent or better (lower is better)	38.1 ± 11.4	37.6 ± 2.6	Comparable
Coarse particle fraction >5 µm (%) - Sodium cromoglicate	Equivalent or better (lower is better)	40.4 ± 11.6	43.1 ± 4.5	Lower
Coarse particle dose >5 µm (µg) - Salbutamol	Equivalent or better (lower is better)	920 ± 315	906 ± 188	Comparable
Coarse particle dose >5 µm (µg) - Ipratropium bromide	Equivalent or better (lower is better)	89 ± 25	86 ± 4	Comparable
Coarse particle dose >5 µm (µg) - Sodium cromoglicate	Equivalent or better (lower is better)	4098 ± 1054	3970 ± 556	Comparable
Respirable fraction 1 - 5 µm (%) - Salbutamol	Equivalent or better (higher is better)	56.0 ± 11.9	53.8 ± 6.6	Higher
Respirable fraction 1 - 5 µm (%) - Ipratropium bromide	Equivalent or better (higher is better)	56.6 ± 9	56.4 ± 1.6	Comparable
Respirable fraction 1 - 5 µm (%) - Sodium cromoglicate	Equivalent or better (higher is better)	47.9 ± 6.4	43.7 ± 1.7	Higher
Respirable dose 1 - 5 µm (µg) - Salbutamol	Equivalent or better (higher is better)	1328 ± 328	1187 ± 185	Higher
Respirable dose 1 - 5 µm (µg) - Ipratropium bromide	Equivalent or better (higher is better)	132 ± 24	129 ± 10	Higher
Respirable dose 1 - 5 µm (µg) - Sodium cromoglicate	Equivalent or better (higher is better)	4859 ± 790	4023 ± 83	Higher
Ultra-fine particle fraction <1 µm (%) - Salbutamol	Equivalent or better	5.2 ± 2.6	5.1 ± 0.9	Comparable
Ultra-fine particle fraction <1 µm (%) - Ipratropium bromide	Equivalent or better	5.4 ± 3.2	6.0 ± 1.0	Comparable
Ultra-fine particle fraction <1 µm (%) - Sodium cromoglicate	Equivalent or better	11.7 ± 5.8	13.2 ± 3.4	Comparable
Ultra-fine particle dose <1 µm (µg) - Salbutamol	Equivalent or better	123 ± 65	112 ± 16	Higher
Ultra-fine particle dose <1 µm (µg) - Ipratropium bromide	Equivalent or better	12.6 ± 8	13.7 ± 3	Comparable
Ultra-fine particle dose <1 µm (µg) - Sodium cromoglicate	Equivalent or better	1189 ± 643	1217 ± 304	Comparable
Pediatric Flow Rate - 15 Ipm
Delivered dose (µg) - Salbutamol	Equivalent or better	2370 ± 113	2206 ± 216	Higher
Delivered dose (µg) - Ipratropium bromide	Equivalent or better	234 ± 6	229 ± 12	Higher
Delivered dose (µg) - Sodium cromoglicate	Equivalent or better	10146 ± 507	9210 ± 500	Higher
MMAD (µm) - Salbutamol	Equivalent or better (smaller is better)	3.99 ± 0.73	4.85 ± 0.77	Smaller particle size
MMAD (µm) - Ipratropium bromide	Equivalent or better (smaller is better)	3.93 ± 0.74	5.08 ± 0.48	Smaller particle size
MMAD (µm) - Sodium cromoglicate	Equivalent or better (smaller is better)	4.27 ± 0.76	4.87 ± 0.54	Smaller particle size
GSD - Salbutamol	Equivalent or better (smaller is better)	1.82 ± 0.02	2.10 ± 0.09	Smaller particle size
GSD - Ipratropium bromide	Equivalent or better (smaller is better)	1.82 ± 0.03	2.09 ± 0.11	Smaller particle size
GSD - Sodium cromoglicate	Equivalent or better (smaller is better)	1.83 ± 0.05	2.00 ± 0.08	Smaller particle size
Fine particle fraction <5 µm (%) - Salbutamol	Equivalent or better (higher is better)	64.4 ± 12.2	51.1 ± 9.5	Higher
Fine particle fraction <5 µm (%) - Ipratropium bromide	Equivalent or better (higher is better)	65.3 ± 12.3	48.4 ± 5.1	Higher
Fine particle fraction <5 µm (%) - Sodium cromoglicate	Equivalent or better (higher is better)	59.8 ± 11.6	51.0 ± 6.7	Higher
Fine particle dose <5 µm (µg) - Salbutamol	Equivalent or better (higher is better)	1526 ± 285	1129 ± 324	Higher
Fine particle dose <5 µm (µg) - Ipratropium bromide	Equivalent or better (higher is better)	153 ± 29	111 ± 6	Higher
Fine particle dose <5 µm (µg) - Sodium cromoglicate	Equivalent or better (higher is better)	6070 ± 1460	4689 ± 375	Higher
Coarse particle fraction >5 µm (%) - Salbutamol	Equivalent or better (lower is better)	35.6 ± 12.2	48.9 ± 9.5	Lower
Coarse particle fraction >5 µm (%) - Ipratropium bromide	Equivalent or better (lower is better)	34.7 ± 12.3	51.6 ± 5.1	Lower
Coarse particle fraction >5 µm (%) - Sodium cromoglicate	Equivalent or better (lower is better)	40.2 ± 11.6	49.1 ± 6.7	Lower
Coarse particle dose >5 µm (µg) - Salbutamol	Equivalent or better (lower is better)	844 ± 305	1076 ± 109	Lower
Coarse particle dose >5 µm (µg) - Ipratropium bromide	Equivalent or better (lower is better)	81 ± 29	118 ± 18.1	Lower
Coarse particle dose >5 µm (µg) - Sodium cromoglicate	Equivalent or better (lower is better)	4076 ± 1000	4521 ± 852	Lower
Respirable fraction 1 - 5 µm (%) - Salbutamol	Equivalent or better (higher is better)	62.7 ± 11.6	47.2 ± 0.2	Higher
Respirable fraction 1 - 5 µm (%) - Ipratropium bromide	Equivalent or better (higher is better)	63.6 ± 11.8	64.3 ± 0.2	Comparable
Respirable fraction 1 - 5 µm (%) - Sodium cromoglicate	Equivalent or better (higher is better)	58.3 ± 11.2	59.3 ± 11.2	Comparable
Respirable dose 1 - 5 µm (µg) - Salbutamol	Equivalent or better (higher is better)	1485 ± 270	1042 ± 100	Higher
Respirable dose 1 - 5 µm (µg) - Ipratropium bromide	Equivalent or better (higher is better)	149 ± 28	147 ± 8.3	Higher
Respirable dose 1 - 5 µm (µg) - Sodium cromoglicate	Equivalent or better (higher is better)	5922 ± 1403	5458 ± 750	Higher
Ultra-fine particle fraction <1 µm (%) - Salbutamol	Equivalent or better	1.7 ± 0.6	1.0 ± 0.2	Higher
Ultra-fine particle fraction <1 µm (%) - Ipratropium bromide	Equivalent or better	1.8 ± 0.6	1.0 ± 0.2	Higher
Ultra-fine particle fraction <1 µm (%) - Sodium cromoglicate	Equivalent or better	1.5 ± 0.5	0.4 ± 0.4	Higher
Ultra-fine particle dose <1 µm (µg) - Salbutamol	Equivalent or better	41 ± 15	23 ± 5	Higher
Ultra-fine particle dose <1 µm (µg) - Ipratropium bromide	Equivalent or better	4.1 ± 1.4	2.2 ± 0.4	Higher
Ultra-fine particle dose <1 µm (µg) - Sodium cromoglicate	Equivalent or better	148 ± 58.2	40 ± 36.1	Higher

The general acceptance criterion is "substantially equivalent" to the predicate device (Aerogen AeroNeb Go), meaning that any differences do not raise new questions of safety or effectiveness. The discussion sections confirm that where statistically significant differences were found, the InnoSpire Go either provided a higher Total Dose, smaller particle size (MMAD and GSD), or larger Total Respirable Dose, all of which are considered beneficial or at least not detrimental, thus supporting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the number of samples (e.g., number of nebulizers tested for performance) for each test. However, the performance tables provide "mean and 95% confidence interval," which implies that multiple measurements were taken for each drug and parameter. The nature of these tests (aerosol performance) suggests they are conducted in a controlled lab environment.

Sample Size: Not explicitly stated as a single number of devices. The "mean and 95% confidence interval" for each parameter suggests statistical analysis from multiple runs/samples.
Data Provenance: The tests are "Bench Testing" (Non-clinical performance testing). The document does not specify country of origin for the performance test data itself, but the company is "Respironics Respiratory Drug Delivery (UK) Ltd." The tests are prospective in the sense that they are specifically conducted to compare the new device to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The study is a bench performance test comparing aerosol characteristics of device-generated output to a predicate device, not an evaluation requiring human expert interpretation or a "ground truth" derived from clinical experts (like radiologists for image analysis). The "ground truth" here is the physical measurement of aerosol particles and drug delivery.

4. Adjudication Method for the Test Set

This section is not applicable. There is no human adjudication process described, as the test involves objective physical measurements of aerosol properties by instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) premarket notification for a nebulizer, which involves laboratory performance testing and comparison to a predicate device, not a clinical trial involving human readers or cases. Therefore, no effect size of human readers improving with or without AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is also not applicable. The device is not an AI/algorithm-driven system. It is a physical medical device (nebulizer). The "standalone" performance here refers to the device's technical specifications and aerosol output in a laboratory setting, which is precisely what the performance tables (Tables 3 & 4) describe.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests (Tables 3 & 4) is objective physical and chemical measurements of aerosol characteristics and drug concentration. This includes:

Delivered dose of drug (µg)
Mass median aerodynamic diameter (MMAD in µm)
Geometric standard deviation (GSD)
Particle size fractions (e.g., fine particle fraction <5 µm, coarse particle fraction >5 µm, respirable fraction 1-5 µm, ultra-fine particle fraction <1 µm)
Corresponding doses for these particle fractions.

These are quantitative measurements, not subjective evaluations or clinical outcomes.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device submission based on predicate device comparison and bench testing, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set mentioned or required for this type of device submission.

Summary

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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)

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)

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510(k) Summary Page 1 of 8 2-Nov-17

Company:	Respironics Respiratory Drug Delivery (UK) Ltd.Chichester Business ParkCity Fields Way, TangmereChichester PO20 2FT UKTel: +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	PredicateAerogen AeroNeb® GoK081650	ProposedInnoSpire Go Nebulizer
Operating Conditions	5 to 45°C / up to 95%% RH	+5°C to +40°C15% to 93% RH, non-condensingAtmospheric pressure 70 kPa to 106 kPa
Storage Conditions	-20 to + 60°C / up to 95% RH	-25°C to +70°C,10% to 93% RH, non-condensingAtmospheric pressure 50 kPa to 106 kPa
User interface	On/Off switchLED indicators	On/Off switchLED indicators
Standards met	ES 60601-1IEC 60601-1-2	AAMI ANSI ES 60601-1: 2005 +A1: 2012IEC 60601-1-2:2014IEC 60601-1-6:2013IEC 60601-1-1:2015
Performance
Materials perISO 10993-1	External Communicating(Indirect gas pathway)Tissue / Bone / Dentin communicatingDuration of Use – permanent (> 30 days)AndSurface ContactMucosal membraneDuration of Use – permanent (> 30 days)	External Communicating(Indirect gas pathway)Tissue / Bone / Dentin communicatingDuration of Use – permanent (> 30 days)AndSurface ContactMucosal membraneDuration 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	2It is intended that patient 2 to 5 years old use a face mask
Internal volume	Large - 99 mlMedium (2 yo – 5 yo) – 34 ml	Large - 99 mlMedium (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 medianaerodynamic diameter/ 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 standarddeviation/ 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 <5μm (%)	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 <5μm (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>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 >5μm (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 - 5μm (%)	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 - 5μm (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 particlefraction <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<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 medianaerodynamic diameter/ 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 standarddeviation / 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 <5µm (%)	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 <5µm (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>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 >5µm (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 - 5µm (%)	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 - 5µm (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 particlefraction <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<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:

Overall the results are comparable to the predicate and would support a determination of substantial equivalence.

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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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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.

Regulation Number and Section

§ 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).