FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER

K140062 · Fsc Laboratories, Inc. · NVP · Oct 3, 2014 · Anesthesiology

Device Facts

• Record ID: K140062
• Device Name: FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
• Applicant: Fsc Laboratories, Inc.
• Product Code: NVP · Anesthesiology
• Decision Date: Oct 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FSC Anti-Static Valved Collapsible Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs). Environment of use - Home, hospitals and clinics. This product is intended for patients who can follow verbal instructions.

Device Story

The FSC Anti-Static Valved Collapsible Holding Chamber is a non-sterile, single-patient, multi-use spacer device used in homes, hospitals, and clinics. It acts as an interface between a pressurized Metered Dose Inhaler (pMDI) and the patient's respiratory system. The device features a collapsible housing, an integral mouthpiece, and a one-way valve that prevents the patient from exhaling into the chamber. To operate, the patient attaches the pMDI to the chamber, actuates the inhaler, and inhales the aerosolized medication through the mouthpiece. The collapsible bag serves as a visual indicator of inhalation progress. By reducing the velocity of the aerosol and providing a holding space, the device facilitates the delivery of corticosteroids, anti-cholinergics, beta-2-sympathomimetics, and non-steroidal chromones to the upper and lower respiratory tracts. The anti-static properties of the chamber help ensure consistent medication delivery by minimizing drug adherence to the device walls. The device is intended for patients who can follow verbal instructions, aiding in effective medication administration and potentially improving therapeutic outcomes.

Clinical Evidence

Bench testing only. Performance was evaluated using an 8-stage cascade impactor at 28 lpm and 12 lpm flow rates with three different MDI drugs (Ventolin HFA, Atrovent HFA, QVAR 40). Metrics included Total Delivered Dose, Total Respirable Dose (0.5-5.0 microns), MMAD, and GSD. Results showed equivalent performance to the predicate. Additional testing included simulated lifetime cycle, cleaning validation, environmental/mechanical stress (high/low temp, drop test), differential pressure, and anti-static surface resistivity. Biocompatibility testing (cytotoxicity, sensitization, genotoxicity, extractables/leachables) was performed per ISO 10993-1.

Technological Characteristics

Collapsible housing with integral mouthpiece; one-way inhalation valve; anti-static material construction. Designed for prolonged (>30 days) mucosal surface contact. Tested per ISO 10993-1 for biocompatibility. Operates via passive inhalation; no external energy source. Dimensions/form factor collapsible for portability.

Indications for Use

Indicated for patients under the care of a licensed healthcare professional capable of following verbal instructions for the administration of aerosolized medication from pressurized Metered Dose Inhalers (pMDIs).

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

• AeroChamber Plus Z-stat (K052332)
• E-Z Spacer (K933090)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2014

FSC Laboratories, Inc. C/O Mr. Paul Dryden Promedic, Inc., President Regulatory Consultant for FSC Laboratories 6000 Fairview Rd., Suite 600 Charlotte, NC 28210

Re: K140062

Trade/Device Name: FSC Anti-Static Valved Collapsible Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: September 4, 2014 Received: September 4, 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement 4

We have prepared the Indications for Use statement utilizing Form 3881 which follows.

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

Device Name

FSC Anti-Static Valved Collapsible Holding Chamber

#### Indications for Use (Describe)

The FSC Anti-Static Valved Collapsible Holding Chamber is intended to be used by patients who are under the care or treatinent of a licensed health care professional. The device is intended to be used by these patients to administer acrosolized medication from nost pressurized Metered Dose Inhalers, (pMDIs).

Environment of use - Home, hospitals and clinics.

This product is intended for patients who can follow verbal instructions.

Type of Use (Select one or both, as applicable) [x] 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 CONLY CONSTITUTION OF

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Page 1 of 2

PSC Publishing Services [phone]

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#### 510(k) Summary Page 1 of 8

| Date Prepared: | 03-Sep-2014 | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--|
| FSC Laboratories, Inc.<br>6000 Fairview Rd., Suite 6000<br>Charlotte, NC 28210 | Tel - 704-941-2500<br>Fax - 866-289-0893 | |
| Official Contact: | Karla Worley Ham<br>Quality and Regulatory Affairs Officer | |
| Proprietary or Trade Name: | FSC Anti-Static Valved Collapsible Holding Chamber | |
| Common/Usual Name: | Spacer / Holding Chamber | |
| Classification Name: | Holding Chambers, Direct Patient Interface<br>Product Classification - NVP<br>21 CFR 868.5630<br>Class II | |
| Predicate Devices: | K052332 - Trudell - AeroChamber Plus Z-stat<br>K933090 - FSC Laboratories - E-Z Spacer | |

#### Device Description:

The FSC Anti-Static Valved Collapsible Holding Chamber is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a collapsible housing and mouth piece and a one-way valve to prevent exhaling into the chamber.

The FSC Anti-Static Valved Holding Chamber is intended to inhale aerosolized drugs of approved MDIs from the following groups of active substances:

- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and ß2-sympathomimetics (bronchodilator medications)
- · Non-steroidal chromones (DNCG)

It is a single patient, multi-use, non-sterile device.

#### Indications for Use:

The FSC Anti-Static Valved Collapsible Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).

Environment of use - Home, hospitals and clinics.

This product is intended for patients who can follow verbal instructions.

#### 510(k) Summary

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#### Page 2 of 8 03-Sep-2014

## Comparison to Predicates

We have chosen two (2) predicates for our substantial equivalence claim. The following is a rationale for this selection.

AeroChamber Plus Z-stat (K052332) and E-Z Spacer (K933090)

Table 1 is a table which highlights the reason for selecting each predicate.

| SE Element | AeroChamber<br>Plus Z-stat (K052332) | E-Z Spacer<br>(K933090) |
|-----------------------------------|--------------------------------------|--------------------------------------|
| Indications for Use | X | X |
| Environment of Use | X | X |
| Patient Population | X | X |
| Technology of collapsible chamber | | X |
| Feature inhalation progress | X | X |
| | Has a whistle | Bag collapses as visual<br>indicator |
| Anti-static feature | X | |
| Design and usability | | X |

## Table 2 - Comparison to Predicate - AeroChamber Plus Z-Stat (K052332)

| Attribute | AeroChamber Plus Z-stat<br>K052332 | Proposed<br>FSC Chamber |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use with MDIs | For use with MDIs |
| Indications for Use | Intended to be used by patients who<br>are under the care or treatment of a<br>licensed health care provider or<br>physician. The device is intended to<br>be used by these patients to<br>administer aerosolized medication<br>from most pressurized Metered<br>Dose Inhalers, prescribed by a<br>physician or health care<br>professional. | The FSC Anti-Static Valved<br>Collapsible Holding Chamber is<br>intended to be used by patients who are<br>under the care or treatment of a<br>licensed health care professional. The<br>device is intended to be used by these<br>patients to administer aerosolized<br>medication from most pressurized<br>Metered Dose Inhalers, (pMDIs).<br>Environment of use - Home, hospitals<br>and clinics.<br>This product is intended for patients<br>who can follow verbal instructions. |
| Environments of use | Home, hospitals and clinics. | Home, hospitals and clinics |
| Prescriptive | Yes | Yes |
| Patient population | All - not specified | Intended for patients who can follow<br>verbal instructions |

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# 510(k) Summary Page 3 of 8
03-Sep-2014

| Attribute | AeroChamber Plus Z-stat<br>K052332 | Proposed<br>FSC Chamber |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single patient, multi-use | Yes | Yes |
| Patient interface | Mouthpiece<br>Face Mask | Integral Mouthpiece |
| Basic components | Housing<br>One-way valve to prevent<br>exhalation into chamber<br>End caps - removable | Housing<br>One-way valve to prevent<br>exhalation into chamber<br>End caps - removable |
| Anti-static properties | Yes | Yes |
| Housing | Rigid | Collapsible |
| Indicator of inhalation | Whistle to alert user | Visual collapse of the bag |
| Single patient, multi-use | Yes | Yes |
| Materials Patient<br>Contact | Materials in the gas pathway<br>External Communicating<br>Tissue<br>Prolonged<br><br>Materials in direct patient contact<br>Surface Contact<br>Mucosal<br>Prolonged | Materials in the gas pathway<br>External Communicating<br>Tissue<br>Prolonged Duration of Use<br><br>Materials in direct patient contact<br>Surface Contact<br>Mucosal<br>Prolonged Duration of Use |
| Performance testing | Particle characterization<br>Comparison results found to be<br>equivalent | Particle characterization<br>Mechanical<br>Environmental<br>Simulated lifetime cycle (cleaning)<br>Differential Pressure<br>ISO 10993 testing |
| Attribute | E-Z Spacer<br>K933090 | Proposed<br>FSC Chamber |
| Intended Use | For use with MDIs | For use with MDIs |
| Indications for Use | Intended to be used by patients who<br>are under the care or treatment of a<br>licensed health care provider or<br>physician. The device is intended to<br>be used by these patients to<br>administer aerosolized medication<br>from most pressurized Metered<br>Dose Inhalers, prescribed by a<br>physician or health care<br>professional. (Not specified in FDA<br>database) | The FSC Anti-Static Valved<br>Collapsible Holding Chamber is<br>intended to be used by patients who are<br>under the care or treatment of a<br>licensed health care professional. The<br>device is intended to be used by these<br>patients to administer aerosolized<br>medication from most pressurized<br>Metered Dose Inhalers, (pMDIs).<br>Environment of use - Home, hospitals<br>and clinics.<br>This product is intended for patients<br>who can follow verbal instructions. |
| Environments of use | Home, hospitals and clinics. | Home, hospitals and clinics |
| Prescriptive | Yes | Yes |
| Patient population | All - not specified | This product is intended for patients<br>who can follow verbal instructions |
| Single patient, multi-<br>use | Yes | Yes |
| Patient interface | Integral Mouthpiece | Integral Mouthpiece |
| Basic components | Housing<br>End caps - removable | Housing<br>One-way valve to prevent exhalation<br>into chamber<br>End caps - removable |
| Anti-static properties | No | Yes |
| Housing | Collapsible | Collapsible |
| Indicator of inhalation | Visual collapse of the bag | Visual collapse of the bag |
| Single patient, multi-<br>use | Yes | Yes |
| Materials Patient<br>Contact | Materials in the gas pathway<br>External Communicating<br>Tissue<br>Prolonged<br>Materials in direct patient contact<br>Surface Contact<br>Mucosal | Materials in the gas pathway<br>External Communicating<br>Tissue<br>Prolonged<br>Materials in direct patient contact<br>Surface Contact<br>Mucosal |
| | Prolonged | Prolonged |

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# 510(k) Summary Page 4 of 8
03-Sep-2014

## Table 3 - Comparison to Predicate - E-Z Spacer (K933090)

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510(k) Summary Page 5 of 8 03-Sep-2014

#### Substantial Equivalence Discussion

Tables 2 to 3 above compare the key features of the proposed FSC Anti-static Valved Collapsible Holding Chamber 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:

#### Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate -K052332 - AeroChamber Plus Z-Stat. The predicate K933090 - E-Z spacer does not have published indications but is known to be similar.

Discussion - Each device is indicated for use with MDIs of the same category of medications.

#### Technology and construction -

The design, fabrication, shape, size, etc. are equivalent to the predicate - K933090 - E-Z Spacer which is a collapsible chamber with integral mouthpiece.

Discussion - This design incorporates a collapsible housing, end caps, one way valve for inhalation, and patient interface of a mouthpiece which are the same as the predicate.

We are offering Anti-static properties for the whole device, which is identical to the predicate K052332 - AeroChamber Plus Z-Stat.

Discussion - We have performed testing to support the anti-static claim.

#### Environment of Use -

The environments of use are identical to both predicates - K052332 - AeroChamber Plus Z-Stat and K933090 - E-Z spacer.

Discussion - The environments of use are identical to both predicates - K052332 - AeroChamber Plus Z-Stat and K933090 - E-Z spacer.

#### Patient Population -

The patient population are those who are able to follow verbal instructions. This is similar to the predicates which do not specify the patient population, however they offer face mask for pediatric patients.

Discussion - The patient populations are equivalent to both predicates - K052332 -AeroChamber Plus Z-Stat and K933090 - E-Z spacer.

#### Non-clinical Testing Summary -

#### Particle Characterization -

We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated equivalent performance concluding that the proposed device is equivalent to the predicate K052332 - AeroChamber Plus Z-Stat.

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#### 510(k) Summary Page 6 of 8 03-Sep-2014

In addition, we performed testing related to simulated life testing, cleaning validation, environmental and mechanical, differential pressure, and anti-static property testing. The results demonstrated that the proposed device either passed or met its performance specifications after each test and where appropriate was equivalent or better than the predicate, K052332 -AeroChamber Plus Z-Stat.

#### Materials -

We have performed ISO 10993-1 testing on the component materials of the FSC Anti-Static Valved Collapsible Holding Chamber which is considered as having two(2) patient contact classifications, External Communicating and Surface Contact. Per ISO 10993-1 and G95-1 the required tests for the duration of use are the same. The following are details.

- External Communication (Indirect contact) for all materials not in direct contact .
- Tissue communicating .
- · Permanent duration (>30 days)

For those materials in direct contact, the mouthpiece, it is considered

- · Surface Contact
- · Mucosal membrane
- · Permanent duration (> 30 days)

We performed: cytotoxicity, sensitization, genotoxicity, and exhaustive leachable and extractable testing and included a risk assessment.

Discussion - We have tested the materials which are common to chambers.

#### Performance Testing including Comparative Testing:

We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated equivalent performance between the proposed device and the predicate. This testing included:

- Particle Characterization testing via Cascade Impactor .
- 0 Adult 28 lpm
- o Pediatric 12 lpm
- o Intra- and Inter-sample variance
- Simulated lifetime testing .
- Pre and post- exposure o
- Cleaning o
- Environmental and mechanical testing (part of Simulated Life Cycle testing) ●
- o High and Low temperature
- o Drop test
- Anti-static surface resistivity ●
- Differential Pressure comparative ●

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#### 510(k) Summary Page 7 of 8 03-Sep-2014

A series of aerosol performance tests were performed using an 8 stage cascade impactor at sampling flow rates of 28 lpm and 12 lpm, equipped with a USP <601> induction port throat. Aerosol was sampled directly from the outlet. A summary of the results is listed below with 95% confidence intervals.

@ 28 lpm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.

@ 12 1pm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.

MDI only - 3 samples were tested with 3 drugs.

. '

Ventolin HFA Atrovent HFA QVAR 40

#### Table 4 -- Total Respirable Dose Delivered @ 28 lpm flow rate MDI vs. MDI-Spacer - 95% Confidence Intervals

| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst | | | |
|------------------------------------------------------------|--------------|--------------|-----------|
| | Ventolin HFA | Atrovent HFA | QVAR 40 |
| MDI only | 37.5-46.8 | 7.5-8.1 | 12.1-14.8 |
| MDI - Spacer | 50.6-55.0 | 6.3-8.3 | 10.7-15.4 |

### Table 5 - Total Dose Delivered @ 28 lpm flow rate MDI vs. MDI-Spacer - 95% Confidence Intervals

| Total Dose Delivered - ug/burst | | | |
|---------------------------------|---------------|--------------|-----------|
| | Ventolin HFA | Atrovent HFA | QVAR 40 |
| MDI only | 102.7 - 104.8 | 19.0-21.0 | 33.6-38.4 |
| MDI - Spacer | 61.3 - 66.1 | 13.2-15.4 | 26.4-34.1 |

#### Table 6 - MDI - Spacer with 3 Drugs @ 28 lpm

| | Ventolin<br>HFA | Atrovent HFA | Qvar 40 |
|-----------------------------------------------------|-----------------|--------------|-----------|
| Particle Size (MMAD)<br>(um) | 1.68-1.8 | 0.76-0.92 | 0.4-0.49 |
| Geometric Standard<br>Deviation (GSD) | 1.87-2.15 | 3.03-3.51 | 2.84-3.33 |
| Total Delivered Dose by<br>Device - ug / burst | 61.3-66.1 | 13.2-15.4 | 26.4-34.1 |
| Total Respirable Dose<br>(0.5 - 5 um) - ug/burst | 50.6-55.0 | 6.3-8.3 | 10.7-15.4 |
| Coarse Particle Dose<br>>4.7 microns - ug/burst | 9.0-10.1 | 3.1-4 | 1.8-2.3 |
| Fine Particle Dose<br><4.7 microns - ug/burst | 51.6-56.7 | 9.5-12.0 | 24.4-32.0 |
| Ultra-Fine Particle Dose<br><1.0 microns - ug/burst | 10.3-14.7 | 5.4-6.8 | 19.2-25.1 |

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### 510(k) Summary Page 8 of 8 03-Sep-2014

| | Ventolin HFA | Atrovent HFA | Qvar 40 |
|-----------------------------------------------------|--------------|--------------|-----------|
| Particle Size (MMAD) (um) | 1.97-2.1 | 0.99-1.21 | 0.6-0.73 |
| Geometric Standard<br>Deviation (GSD) | 1.85-2.02 | 2.71-3.0 | 2.14-3.0 |
| Total Delivered Dose by<br>Device - ug / burst | 56.0-68.9 | 12.7-13.8 | 21.7-28.5 |
| Total Respirable Dose<br>(0.5 - 5 um) - ug/burst | 49.0-57.2 | 6.5-7.4 | 13.1-17.2 |
| Coarse Particle Dose<br>>4.7 microns - ug/burst | 8.2-13.2 | 3.3-3.5 | 0.8-1.9 |
| Fine Particle Dose<br><4.7 microns - ug/burst | 47.8-55.7 | 9.4-10.3 | 20.9-26.5 |
| Ultra-Fine Particle Dose <1.0<br>microns - ug/burst | 6.3-8.3 | 4.7-5.6 | 13.9-17.8 |

## Table 5.7 – MDI – Spacer with 3 Drugs @ 12 lpm

## 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.