(266 days)
K052332 - AeroChamber Plus Z-Stat
No
The device description and performance studies focus on the mechanical and physical properties of a holding chamber for MDI administration, with no mention of AI or ML capabilities.
No
The device is a holding chamber for administering aerosolized medication, facilitating drug delivery rather than directly providing therapy.
No.
Explanation: The device is an anti-static valved collapsible holding chamber designed to administer aerosolized medication from Metered Dose Inhalers, not to diagnose a condition. Its function is to facilitate the delivery of medication to the respiratory system.
No
The device description clearly outlines a physical, collapsible holding chamber with a mouthpiece and valve, intended for use with Metered Dose Inhalers. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer aerosolized medication from Metered Dose Inhalers to patients for inhalation into the respiratory system. This is a therapeutic delivery device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical device for holding and delivering medication, not a test or assay system.
- Performance Studies and Metrics: The performance studies focus on the physical characteristics of the device and its ability to deliver medication effectively (particle size, delivered dose), not on the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly intended for drug delivery to the respiratory system, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
NVP
Device Description
The FSC Anti-Static Valued 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 mouthpiece and a one-way valve to prevent exhaling into the chamber.
The FSC Anti-Static Valued 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower respiratory system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care professional / Home, hospitals and clinics.
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
The sponsor performed comparative particle characterization testing via Cascade Impactor.
Particle Characterization testing via Cascade Impactor was performed with:
- Adult 28 lpm
- Pediatric 12 lpm
- Intra- and Inter-sample variance
Simulated lifetime testing was performed with:
- Pre and post- exposure
- Cleaning
Environmental and mechanical testing (part of Simulated Life Cycle testing) was performed with:
- High and Low temperature
- Drop test
Other tests: Anti-static surface resistivity and Differential Pressure comparative.
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 induction port throat. Aerosol was sampled directly from the outlet.
@ 28 lpm - 3 samples of the device were tested with 3 drugs (Ventolin HFA, Atrovent HFA, QVAR 40), 3 times for a total of 9 sample points.
@ 12 lpm - 3 samples of the device were tested with 3 drugs (Ventolin HFA, Atrovent HFA, QVAR 40), 3 times for a total of 9 sample points.
MDI only - 3 samples were tested with 3 drugs.
Results demonstrated equivalent performance or that the proposed device passed or met its performance specifications after each test and where appropriate was equivalent or better than the predicate, K052332 - AeroChamber Plus Z-Stat.
Key Metrics
95% Confidence Intervals are provided for:
- Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst @ 28 lpm flow rate for MDI only and MDI - Spacer with Ventolin HFA, Atrovent HFA, and QVAR 40.
- Total Dose Delivered - ug/burst @ 28 lpm flow rate for MDI only and MDI - Spacer with Ventolin HFA, Atrovent HFA, and QVAR 40.
- MDI - Spacer with 3 Drugs @ 28 lpm: Particle Size (MMAD) (um), Geometric Standard Deviation (GSD), Total Delivered Dose by Device - ug / burst, Total Respirable Dose (0.5 - 5 um) - ug/burst, Coarse Particle Dose >4.7 microns - ug/burst, Fine Particle Dose 4.7 microns - ug/burst, Fine Particle Dose
§ 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/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
4
510(k) Summary Page 1 of 8
| Date Prepared: | 03-Sep-2014 | |
|---|---|---|
| FSC Laboratories, Inc. | ||
| 6000 Fairview Rd., Suite 6000 | ||
| Charlotte, NC 28210 | Tel - 704-941-2500 | |
| Fax - 866-289-0893 | ||
| Official Contact: | Karla Worley Ham | |
| 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 | |
| Product Classification - NVP | ||
| 21 CFR 868.5630 | ||
| Class II | ||
| Predicate Devices: | K052332 - Trudell - AeroChamber Plus Z-stat | |
| 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
5
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
Plus 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 visual
indicator |
| Anti-static feature | X | |
| Design and usability | | X |
Table 2 - Comparison to Predicate - AeroChamber Plus Z-Stat (K052332)
| Attribute | AeroChamber Plus Z-stat
K052332 | Proposed
FSC Chamber |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use with MDIs | For use with MDIs |
| Indications for Use | Intended to be used by patients who
are under the care or treatment of a
licensed health care provider or
physician. The device is intended to
be used by these patients to
administer aerosolized medication
from most pressurized Metered
Dose Inhalers, prescribed by a
physician or health care
professional. | 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. |
| 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
verbal instructions |
6
510(k) Summary Page 3 of 8
03-Sep-2014
| Attribute | AeroChamber Plus Z-stat
K052332 | Proposed
FSC Chamber |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single patient, multi-use | Yes | Yes |
| Patient interface | Mouthpiece
Face Mask | Integral Mouthpiece |
| Basic components | Housing
One-way valve to prevent
exhalation into chamber
End caps - removable | Housing
One-way valve to prevent
exhalation into chamber
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
Contact | Materials in the gas pathway
External Communicating
Tissue
Prolonged
Materials in direct patient contact
Surface Contact
Mucosal
Prolonged | Materials in the gas pathway
External Communicating
Tissue
Prolonged Duration of Use
Materials in direct patient contact
Surface Contact
Mucosal
Prolonged Duration of Use |
| Performance testing | Particle characterization
Comparison results found to be
equivalent | Particle characterization
Mechanical
Environmental
Simulated lifetime cycle (cleaning)
Differential Pressure
ISO 10993 testing |
| Attribute | E-Z Spacer
K933090 | Proposed
FSC Chamber |
| Intended Use | For use with MDIs | For use with MDIs |
| Indications for Use | Intended to be used by patients who
are under the care or treatment of a
licensed health care provider or
physician. The device is intended to
be used by these patients to
administer aerosolized medication
from most pressurized Metered
Dose Inhalers, prescribed by a
physician or health care
professional. (Not specified in FDA
database) | 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. |
| 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
who can follow verbal instructions |
| Single patient, multi-
use | Yes | Yes |
| Patient interface | Integral Mouthpiece | Integral Mouthpiece |
| Basic components | Housing
End caps - removable | Housing
One-way valve to prevent exhalation
into chamber
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-
use | Yes | Yes |
| Materials Patient
Contact | Materials in the gas pathway
External Communicating
Tissue
Prolonged
Materials in direct patient contact
Surface Contact
Mucosal | Materials in the gas pathway
External Communicating
Tissue
Prolonged
Materials in direct patient contact
Surface Contact
Mucosal |
| | Prolonged | Prolonged |
7
510(k) Summary Page 4 of 8
03-Sep-2014
Table 3 - Comparison to Predicate - E-Z Spacer (K933090)
8
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.
9
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 ●
10
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 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
HFA | Atrovent HFA | Qvar 40 |
|-----------------------------------------------------|-----------------|--------------|-----------|
| Particle Size (MMAD)
(um) | 1.68-1.8 | 0.76-0.92 | 0.4-0.49 |
| Geometric Standard
Deviation (GSD) | 1.87-2.15 | 3.03-3.51 | 2.84-3.33 |
| Total Delivered Dose by
Device - 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 | 8.2-13.2 | 3.3-3.5 | 0.8-1.9 |
| Fine Particle Dose