(266 days)
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.
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.
The provided text describes a 510(k) summary for the FSC Anti-Static Valved Collapsible Holding Chamber, which is a medical device used to administer aerosolized medication from Metered Dose Inhalers (pMDIs). The summary focuses on demonstrating substantial equivalence to predicate devices, namely the AeroChamber Plus Z-stat (K052332) and the E-Z Spacer (K933090).
However, the document does not outline specific, quantifiable acceptance criteria in the format of a table, nor does it provide a study that explicitly 'proves' the device meets such criteria in a typical clinical trial sense. Instead, it demonstrates equivalence to a predicate device through various non-clinical performance tests.
Therefore, the following information is extracted and presented as closely as possible to the requested format, acknowledging the limitations of the provided text.
Acceptance Criteria and Device Performance (Based on Equivalence Testing)
The document doesn't explicitly state numerical "acceptance criteria" but rather demonstrates performance that is "equivalent" or "better than" the predicate device, specifically the AeroChamber Plus Z-Stat (K052332), for particle characterization. For other tests, it states the device "passed or met its performance specifications."
| Acceptance Criteria Category | Specific Performance Parameter | Predicate Performance (K052332 or general) | Reported Device Performance (FSC Anti-Static Valved Collapsible Holding Chamber) |
|---|---|---|---|
| Particle Characterization | Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (Ventolin HFA) | 37.5-46.8 ug/burst (MDI only for comparison) | 50.6-55.0 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. |
| Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (Atrovent HFA) | 7.5-8.1 ug/burst (MDI only) | 6.3-8.3 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. | |
| Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (QVAR 40) | 12.1-14.8 ug/burst (MDI only) | 10.7-15.4 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. | |
| Material Biocompatibility | Cytotoxicity, Sensitization, Genotoxicity, Exhaustive Leachable/Extractable Testing | (Standard ISO 10993 requirements) | Passed required tests for External Communicating and Surface Contact classifications. |
| Simulated Lifetime | Pre and post-exposure, Cleaning | (Not specified, but predicate performance implied baseline) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Environmental & Mechanical | High and Low temperature, Drop test | (Not specified) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Anti-static Property | Surface resistivity | "Yes" (for K052332) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Differential Pressure | Comparative testing | (Not specified) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size for Particle Characterization:
- @ 28 lpm flow rate: 3 samples of the device, tested with 3 different drugs, 3 times each, for a total of 9 sample points for MDI-Spacer data. "MDI only" data used 3 samples tested with 3 drugs (number of times not specified, but implied to be comparable for a total of 9 tests or fewer for baseline).
- @ 12 lpm flow rate: 3 samples of the device, tested with 3 different drugs, 3 times each, for a total of 9 sample points.
- Data Provenance: Not explicitly stated, but the context of a 510(k) submission implies that these were laboratory-based, non-clinical tests conducted by or for FSC Laboratories, Inc. (the submitter). Therefore, it is prospective in the sense that it was conducted for this submission, and the country of origin would likely be the USA, where the company is based.
- Test Set Sample Size for Particle Characterization:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a non-clinical, in-vitro performance study. There were no human "experts" establishing a "ground truth" for a test set in the sense of medical diagnosis or interpretation. The ground truth was based on objective physical measurements (e.g., particle size, dose delivered) using a cascade impactor and established testing protocols.
-
Adjudication method for the test set:
- Not applicable as this was a non-clinical, in-vitro performance test based on objective measurements rather than subjective assessment requiring adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, along with the effect size:
- No. This was a non-clinical device performance study, not a clinical study involving human readers or cases.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- "Standalone performance" in this context refers to the device's performance without a human in the loop, which is exactly what the non-clinical particle characterization and other mechanical/environmental tests represent. The data provided (Tables 4, 5, 6) are the results of the device performing its intended function in a laboratory setting. So, yes, standalone performance was assessed.
-
The type of ground truth used:
- The "ground truth" for the particle characterization and dose delivery tests was based on direct, objective physical measurements obtained through standard laboratory techniques, such as using an 8-stage cascade impactor and measuring drug quantities. For other tests (like biocompatibility, anti-static properties), the ground truth was defined by meeting specific ISO standards or internal performance specifications.
-
The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set." The tests described are to validate the physical performance of the manufactured device.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set for a physical device.
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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.
{1}------------------------------------------------
Page 2 - Mr. Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Statement 4
We have prepared the Indications for Use statement utilizing Form 3881 which follows.
{3}------------------------------------------------
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 (301) 443-6740
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510(k) Summary Page 1 of 8
| Date Prepared: | 03-Sep-2014 | |
|---|---|---|
| FSC Laboratories, Inc.6000 Fairview Rd., Suite 6000Charlotte, NC 28210 | Tel - 704-941-2500Fax - 866-289-0893 | |
| Official Contact: | Karla Worley HamQuality 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 InterfaceProduct Classification - NVP21 CFR 868.5630Class II | |
| Predicate Devices: | K052332 - Trudell - AeroChamber Plus Z-statK933090 - 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 | AeroChamberPlus Z-stat (K052332) | E-Z Spacer(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 visualindicator | |
| Anti-static feature | X | |
| Design and usability | X |
Table 2 - Comparison to Predicate - AeroChamber Plus Z-Stat (K052332)
| Attribute | AeroChamber Plus Z-statK052332 | ProposedFSC Chamber |
|---|---|---|
| Intended Use | For use with MDIs | For use with MDIs |
| Indications for Use | Intended to be used by patients whoare under the care or treatment of alicensed health care provider orphysician. The device is intended tobe used by these patients toadminister aerosolized medicationfrom most pressurized MeteredDose Inhalers, prescribed by aphysician or health careprofessional. | The FSC Anti-Static ValvedCollapsible Holding Chamber isintended to be used by patients who areunder the care or treatment of alicensed health care professional. Thedevice is intended to be used by thesepatients to administer aerosolizedmedication from most pressurizedMetered Dose Inhalers, (pMDIs).Environment of use - Home, hospitalsand clinics.This product is intended for patientswho 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 followverbal instructions |
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510(k) Summary Page 3 of 8
03-Sep-2014
| Attribute | AeroChamber Plus Z-statK052332 | ProposedFSC Chamber |
|---|---|---|
| Single patient, multi-use | Yes | Yes |
| Patient interface | MouthpieceFace Mask | Integral Mouthpiece |
| Basic components | HousingOne-way valve to preventexhalation into chamberEnd caps - removable | HousingOne-way valve to preventexhalation into chamberEnd 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 PatientContact | Materials in the gas pathwayExternal CommunicatingTissueProlongedMaterials in direct patient contactSurface ContactMucosalProlonged | Materials in the gas pathwayExternal CommunicatingTissueProlonged Duration of UseMaterials in direct patient contactSurface ContactMucosalProlonged Duration of Use |
| Performance testing | Particle characterizationComparison results found to beequivalent | Particle characterizationMechanicalEnvironmentalSimulated lifetime cycle (cleaning)Differential PressureISO 10993 testing |
| Attribute | E-Z SpacerK933090 | ProposedFSC Chamber |
| Intended Use | For use with MDIs | For use with MDIs |
| Indications for Use | Intended to be used by patients whoare under the care or treatment of alicensed health care provider orphysician. The device is intended tobe used by these patients toadminister aerosolized medicationfrom most pressurized MeteredDose Inhalers, prescribed by aphysician or health careprofessional. (Not specified in FDAdatabase) | The FSC Anti-Static ValvedCollapsible Holding Chamber isintended to be used by patients who areunder the care or treatment of alicensed health care professional. Thedevice is intended to be used by thesepatients to administer aerosolizedmedication from most pressurizedMetered Dose Inhalers, (pMDIs).Environment of use - Home, hospitalsand clinics.This product is intended for patientswho 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 patientswho can follow verbal instructions |
| Single patient, multi-use | Yes | Yes |
| Patient interface | Integral Mouthpiece | Integral Mouthpiece |
| Basic components | HousingEnd caps - removable | HousingOne-way valve to prevent exhalationinto chamberEnd 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-use | Yes | Yes |
| Materials PatientContact | Materials in the gas pathwayExternal CommunicatingTissueProlongedMaterials in direct patient contactSurface ContactMucosal | Materials in the gas pathwayExternal CommunicatingTissueProlongedMaterials in direct patient contactSurface ContactMucosal |
| 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
| VentolinHFA | Atrovent HFA | Qvar 40 | |
|---|---|---|---|
| Particle Size (MMAD)(um) | 1.68-1.8 | 0.76-0.92 | 0.4-0.49 |
| Geometric StandardDeviation (GSD) | 1.87-2.15 | 3.03-3.51 | 2.84-3.33 |
| Total Delivered Dose byDevice - ug / burst | 61.3-66.1 | 13.2-15.4 | 26.4-34.1 |
| Total Respirable Dose(0.5 - 5 um) - ug/burst | 50.6-55.0 | 6.3-8.3 | 10.7-15.4 |
| Coarse Particle Dose>4.7 microns - ug/burst | 9.0-10.1 | 3.1-4 | 1.8-2.3 |
| Fine Particle Dose<4.7 microns - ug/burst | 51.6-56.7 | 9.5-12.0 | 24.4-32.0 |
| Ultra-Fine Particle Dose<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 StandardDeviation (GSD) | 1.85-2.02 | 2.71-3.0 | 2.14-3.0 |
| Total Delivered Dose byDevice - ug / burst | 56.0-68.9 | 12.7-13.8 | 21.7-28.5 |
| Total Respirable Dose(0.5 - 5 um) - ug/burst | 49.0-57.2 | 6.5-7.4 | 13.1-17.2 |
| Coarse Particle Dose>4.7 microns - ug/burst | 8.2-13.2 | 3.3-3.5 | 0.8-1.9 |
| Fine Particle Dose<4.7 microns - ug/burst | 47.8-55.7 | 9.4-10.3 | 20.9-26.5 |
| Ultra-Fine Particle Dose <1.0microns - 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.
§ 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).