(225 days)
K081650 – Aerogen AeroNeb nebulizer
No
The summary describes a vibrating mesh nebulizer and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is designed to aerosolize liquid medications for inhalation by the patient, indicating its use in treating medical conditions.
No
The device is described as a nebulizer system designed to aerosolize liquid medications for inhalation, which indicates it is a therapeutic device, not a diagnostic one. Its intended use is medication delivery, not diagnosis or detection of a condition.
No
The device description explicitly states it is a "small, handheld, internally powered nebulizer which utilizes vibrating mesh technology to generate aerosol," indicating it is a hardware device. The performance studies also focus on physical characteristics and performance of the hardware.
Based on the provided information, the InnoSpire Go is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "aerosolize liquid medications for inhalation by the patient." This describes a device used to deliver medication directly to the patient's respiratory system.
- Device Description: The description confirms it's a "vibrating mesh nebulizer system" that "generates aerosol." This aligns with a drug delivery device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical/physical in converting liquid medication into an inhalable form.
Therefore, the InnoSpire Go is a medical device for drug delivery, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The InnoSpire Go nebulizer is a small, handheld, internally powered nebulizer which utilizes vibrating mesh technology to generate aerosol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric (2 years and older) and adults
Intended User / Care Setting
home environment or in a hospital/clinic setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- 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
Performance results: 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. Overall the results are comparable to the predicate and would support a determination of substantial equivalence.
Performance differences With and Without a Mask: 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.
Biocompatibility / Materials:
- Cytotoxicity - ISO 10993-5:2009
- Sensitization - ISO 10993-10:2010
- Irritation (for surface contact materials) ISO 10993-10:2010
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Delivered dose (µg), Mass median aerodynamic diameter (MMAD) (µm), Geometric standard deviation (GSD), Fine particle fraction 5 µm (%), Coarse particle dose >5 µm (µg), Respirable fraction 1 - 5 μm (%), Respirable dose 1 - 5 μm (µg), Ultra-fine particle fraction
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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);
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
| XX Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Page 1 of 1
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510(k) Summary Page 1 of 8 2-Nov-17
| Company: | Respironics Respiratory Drug Delivery (UK) Ltd.
Chichester Business Park
City Fields Way, Tangmere
Chichester PO20 2FT UK
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.
4
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 | 30 days) | |
| And | ||
| Surface Contact | ||
| Mucosal membrane | ||
| Duration of Use – permanent (> 30 days) | 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) |
5
510(k) Summary
6
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 |
| It is intended that patient 2 to 5 years old use a face mask | ||
| Internal volume | Large - 99 ml | |
| Medium (2 yo – 5 yo) – 34 ml | Large - 99 ml | |
| 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 | |||
| aerodynamic 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 standard | |||
| 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 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 | |||
| 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 | |||
| 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 | |||
| 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 | |||
| 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 >5 | |||
| 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 | |||
| 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 | |||
| 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 | |||
| fraction 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 .
10
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.