(474 days)
The Space Chamber Plus and Compact Space Chamber Plus are intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The devices are 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 intended environments for use include home, hospitals and clinics.
The Space Chamber Plus and Compact Space Chamber Plus are devices designed to assist patients with inhaling aerosolized medication dispensed through a Metered Dose Inhaler. The devices consist of a cylindrical chamber with an opening at each end. One opening is for the aerosol medication to be inserted, the other is tapered into a mouthpiece for inhalation. The mouthpiece can be used with or without a mask. The Compact Space Chamber Plus is a smaller version of the Space Chamber Plus that allows for easier storage and handling.
Here's a breakdown of the acceptance criteria and the study details for the Space Chamber Plus and Compact Space Chamber Plus devices, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria for the Space Chamber Plus and Compact Space Chamber Plus devices are based on demonstrating substantial equivalence to the predicate device, AeroChamber Plus aVHC with Flow-Vu IFI (K070674), particularly with respect to particle size distribution and respirable dose. The study performed involved non-clinical testing of particle size distribution.
Table of Acceptance Criteria and Reported Device Performance (Summary of Equivalence)
| Performance Metric | Acceptance Criteria (Demonstrate Equivalence to Predicate) | Space Chamber Plus Reported Performance | Compact Space Chamber Plus Reported Performance |
|---|---|---|---|
| Particle Size, Mean MMAD, μm | Demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 2.5 (0.04) Ipratropium Bromide: 0.93 (0.05) Beclomethasone Dipropionate: 1.3 (0.02) (All values are within a narrow 95% CI and comparable to the predicate's MMAD values: Albuterol 2.4 (0.03), Ipratropium Bromide 0.76 (0.05), Beclomethasone Dipropionate 1.3 (0.03)) | Albuterol: 2.3 (0.05) Ipratropium Bromide: 0.80 (0.02) Beclomethasone Dipropionate: 1.3 (NA^) (All values are within a narrow 95% CI (where applicable) and comparable to the predicate's MMAD values: Albuterol 2.4 (0.03), Ipratropium Bromide 0.76 (0.05), Beclomethasone Dipropionate 1.3 (0.03)) |
| Mean Total Respirable Dose, μg | Demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 286.9 (36.3) Ipratropium Bromide: 85.26 (3.3) Beclomethasone Dipropionate: 328.05 (9.9) (Comparable to predicate's values: Albuterol 292.2 (19.2), Ipratropium Bromide 55.28 (3.0), Beclomethasone Dipropionate 316.25 (17.6)) | Albuterol: 253.4 (38.7) Ipratropium Bromide: 65.19 (2.1) Beclomethasone Dipropionate: 308.29 (12.7) (Comparable to predicate's values: Albuterol 292.2 (19.2), Ipratropium Bromide 55.28 (3.0), Beclomethasone Dipropionate 316.25 (17.6)) |
| Mean Respirable Fraction PF% (0.5-4.7) | Greater than pMDI alone and demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 86.1 (0.9) (Predicate: 87.6 (0.7), pMDI alone: 79.7 (3.3)) Ipratropium Bromide: 65.3 (0.9) (Predicate: 60.0 (1.8), pMDI alone: 54.7 (1.7)) Beclomethasone Dipropionate: 82.7 (0.8) (Predicate: 83.9 (1.1), pMDI alone: 77.3 (2.4)) | Albuterol: 88.0 (0.6) (Predicate: 87.6 (0.7), pMDI alone: 79.7 (3.3)) Ipratropium Bromide: 61.9 (0.7) (Predicate: 60.0 (1.8), pMDI alone: 54.7 (1.7)) Beclomethasone Dipropionate: 83.7 (1.0) (Predicate: 83.9 (1.1), pMDI alone: 77.3 (2.4)) |
^(NA: Not applicable when results for each individual run are the same)
Study Details Proving Acceptance Criteria
The study performed was a non-clinical performance study focused on the particle size distribution of aerosolized medication delivered by the Space Chamber Plus and Compact Space Chamber Plus, in comparison to the predicate device and the pMDI alone.
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific numerical sample size for each test run (e.g., number of inhalations tested, number of devices tested). However, the presence of 95% Confidence Intervals (CI) suggests multiple replicates were performed for each measurement.
- Data Provenance: The study was conducted by Medical Developments International Limited, an Australian company. The testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODF/DCRD/ADDB -1993), implying a controlled laboratory environment. The data is retrospective to the submission date.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a non-clinical performance study involving physical measurements of particle size distribution, not an evaluation requiring expert interpretation of clinical images or patient data. The "ground truth" was established by the physical testing methodology itself, following established guidance.
-
Adjudication method for the test set:
- Not Applicable. As this was a non-clinical, objective measurement study, there was no need for expert adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was a non-clinical performance study of a medical device (spacer/valved holding chamber) focused on drug delivery characteristics, not an AI-based diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance was involved.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This study assessed the physical performance of a mechanical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" was established through objective physical measurements using scientific instruments (e.g., cascade impactors for particle size distribution) following the methodology outlined in the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" and generating quantitative data for MMAD, respirable dose, and respirable fraction.
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The sample size for the training set:
- Not Applicable. This was a non-clinical performance validation against a predicate device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
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Space Chamber Plus Traditional 510(k)
510(k) Summary
| Date Prepared:510(k) Owner: | 4 November 2013Medical Developments International Limited7/56 Smith RoadSpringvale VIC 3171Australia | |
|---|---|---|
| Submitter/ OfficialContact: | Maggie Oh - Director, Scientific Affairs7/56 Smith RoadSpringvale, Victoria 3171Australia | NOV 1 3 2013 |
| Phone: +61 3 9547 1888Fax: +61 3 9547 0262 | ||
| Device Trade Name: | Space Chamber PlusCompact Space Chamber Plus | |
| Device Common /Classification Name: | Spacer / Valved Holding Chamber;Nebulizer (Direct Patient Interface) | |
| Device Classification: | 21 CFR868.5630, Class II | |
| Product Code: | NVP | |
| Predicate: | AeroChamber Plus aVHC with Flow-Vu IFI (K070674) | |
| Description: | The Space Chamber Plus and Compact Space Chamber Plus are devicesdesigned to assist patients with inhaling aerosolized medication dispensedthrough a Metered Dose Inhaler.The devices consist of a cylindrical chamber with an opening at each end.One opening is for the aerosol medication to be inserted, the other istapered into a mouthpiece for inhalation. The mouthpiece can be used withor without a mask. | |
| The Compact Space Chamber Plus is a smaller version of the SpaceChamber Plus that allows for easier storage and handling. | ||
| Intended Use: | The Space Chamber Plus and Compact Space Chamber Plus are intendedto be used by patients who are under the care or treatment of a licensedhealth care provider or physician. The devices are intended to be used bythese patients to administer aerosolized medication from most pressurizedMetered Dose Inhalers, prescribed by a physician or health careprofessional. The intended environments for use include home, hospitalsand clinics. |
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Comparison of
Technological Characteristics: Space Chamber Plus Traditional 510(k)
| Technology | Space ChamberPlus and CompactSpace ChamberPlus* | AeroChamberPlus Flow-VuAnti-static valvedholding chamber | Comparison |
|---|---|---|---|
| Valve | Cross Slit ValveTechnology:Confirms a secureseal if the valveopens as thepatient inhalesand closes as thepatient exhales(as observedthrough the cleartransparent bodyof the spacers)indicating properinhalationtechnique. | Flow-Vu indicator:Confirms a secureseal if theindicator movesindicating properinhalationtechnique. | Both technologiesprovide anindication ofproper inhalationtechnique. |
| Inhaler base | The orifice in theovermouldcomponent iscompatible withall standard typesof metered doseinhalers. | Orifice in thebackpiece orinhaler baseallows insertionof metered doseInhalers. FlowSignal whistlesound wheninhaling tooquickly | Patients inhalethe amount ofdrug within theholding chamber.Particle sizetesting confirmsthe proposeddevice delivers anequivalentamount ofrespirablefractioncompared to thepredicate (seereport in) |
The technological characteristics of the new devices are similar to the legally marketed predicate as summarised below:
The Space Chamber Plus, Compact Space Chamber Plus and the predicate all use a holding chamber and one-way valve system through which metered dose inhaler medication passes to the patient.
Particle size distribution testing confirms the substantial equivalence of respirable dose delivered to the patient between the proposed devices and the predicate.
Clinical Data:
The use of Valved Holding Chambers to assist with the administration of aerosolized medication is proven technology and is well accepted by the medical community. Non-clinical data is sufficient to demonstrate the safety and efficacy of the Space Chamber Plus and Compact Space Chamber Plus devices.
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Space Chamber Plus Traditional 510(k)
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Non-clinical Performance Data:
Evaluation of the new device and the predicate device was performed in accordance with the relevant sections of the CDRH Guidance Document "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODF/DCRD/ADDB -1993).
Particle size distribution testing was performed using 3 drug classes ipratropium bromide (anti-cholinergic bronchodilator), albuterol (beta-agonist bronchodilator) and beclomethasone dipropionate (anti-inflammatory) comparing the Space Chamber Plus and Compact Space Chamber Plus with the predicate. The respirable fraction delivered by the spacers is greater than that delivered by the pMDI alone. The respirable fractions delivered by the Space Chamber Plus and Compact Space Chamber Plus are equivalent to those delivered by the predicate, Aerochamber Plus Flow Vu Anti-static. Likewise, the MMAD values obtained with Space Chamber Plus and Compact Space Chamber Plus are comparable to those obtained with Aerochamber Plus Flow Vu Antistatic. The 95% Cl is narrow for both the respirable fraction and MMAD results, indicating that medication doses can be consistently delivered by the spacers. Particle size distribution testing confirms the proposed devices to be substantially equivalent to the predicate device.
| Device | Particle size,Mean MMAD,μm(95% CI) | Mean totalrespirable dose,μg(95% CI) | Mean respirablefractionPF% 0.5-4.7(95% CI) |
|---|---|---|---|
| Albuterol | |||
| Albuterol pMDI | 2.6 (0.11) | 347.1 (43.3) | 79.7 (3.3) |
| Space Chamber Plus | 2.5 (0.04) | 286.9 (36.3) | 86.1 (0.9) |
| Compact SpaceChamber Plus | 2.3 (0.05) | 253.4 (38.7) | 88.0 (0.6) |
| Aerochamber PlusFlow Vu Anti-static | 2.4 (0.03) | 292.2 (19.2) | 87.6 (0.7) |
| Ipratropium Bromide | |||
| IpratropiumBromide pMDI | 0.72 (0.06) | 51.14 (2.8) | 54.7 (1.7) |
| Space Chamber Plus | 0.93 (0.05) | 85.26 (3.3) | 65.3 (0.9) |
| Compact SpaceChamber Plus | 0.80 (0.02) | 65.19 (2.1) | 61.9 (0.7) |
| Aerochamber PlusFlow Vu Anti-static | 0.76 (0.05) | 55.28 (3.0) | 60.0 (1.8) |
| Beclomethasone Dipropionate | |||
| BeclomethasoneDipropionate pMDI | 1.4 (0.07) | 218.12 (16.3) | 77.3 (2.4) |
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| Space Chamber Plus | 1.3 (0.02) | 328.05 (9.9) | 82.7 (0.8) |
|---|---|---|---|
| Compact SpaceChamber Plus | 1.3 (NA^) | 308.29 (12.7) | 83.7 (1.0) |
| Aerochamber PlusFlow Vu Anti-static | 1.3 (0.03) | 316.25 (17.6) | 83.9 (1.1) |
^ Not applicable (NA) when results for each individual run is the same
Particle size distribution testing was repeated post-cleaning. Performance testing demonstrates that the post-washed Space Chamber Plus and Compact Space Chamber Plus remain equivalent to the pre-washed devices and to the predicate device.
Other performance testing includes materials characterization, particulate analysis, drop test and cleaning validation.
ISO 10993 testing has been performed on the Space Chamber Plus components, including Cytotoxicity, Sensitization, Irritation, Genotoxicity and Implantation tests. The Space Chamber Plus and Compact Space Chamber Plus devices are made of identical materials; the Compact Space Chamber Plus is a smaller version of the Space Chamber Plus that allows for easier storage and handling.
Non-clinical and performance testing demonstrates that the Space Chamber Plus and Compact Space Chamber Plus devices raise no new issues of safety or effectiveness compared to the legally marketed predicate device.
Substantial Equivalence Conclusion:
The new devices, the Space Chamber Plus and Compact Space Chamber Plus, are considered to be substantially equivalent to the predicate device based on the following:
- . they have the same intended use and are indicated for the same user population:
- they have equivalent technological characteristics to the predicate: ●
- they do not raise any new questions of safety or effectiveness; .
- they are at least as safe and effective as the predicate. .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2013
Medical Developments International Limited Maggie Oh Director, Scientific Affairs 7/56 Smith Road Springvale Victoria 3171 Australia
Re: K122252
Trade/Device Name: Space Chamber Plus Compact Space Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: NVP Dated: November 8, 2013 Received: November 12, 2013
Dear Ms. Oh:
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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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
MarySTBmer -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Evaluation Center for Device and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KIZZZZZ
Device Name: Space Chamber Plus
Indications for Use:
The Space Chamber Plus is 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 intended environments for use include home, hospitals and clinics.
Device Name: Compact Space Chamber Plus
Indications for Use:
The Compact Space Chamber Plus is 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 intended environments for use include home, hospitals and clinics.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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).