(474 days)
Not Found
No
The device description and performance studies focus on the physical design and aerosol delivery characteristics, with no mention of AI or ML.
No
The device is designed to assist patients in inhaling aerosolized medication, acting as an accessory for drug delivery rather than providing a therapeutic effect itself.
No
The device is described as assisting patients with inhaling aerosolized medication, which is a therapeutic function, not a diagnostic one. Its performance evaluation focuses on drug delivery metrics like particle size distribution and respirable fraction, rather than disease detection or patient assessment.
No
The device description clearly states it is a physical device consisting of a cylindrical chamber with openings, designed to assist with inhaling medication. It 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 clearly states the device is for administering aerosolized medication to patients. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a physical device designed to facilitate the inhalation of medication. It does not describe any components or processes related to testing biological samples.
- Performance Studies: The performance studies focus on the delivery of medication (particle size distribution, respirable fraction) and the physical properties of the device (materials, cleaning). These are relevant to a drug delivery device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NVP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care provider or physician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particle size, Mean MMAD, microm (95% CI)
Mean total respirable dose, microgram (95% CI)
Mean respirable fraction PF% 0.5-4.7 (95% CI)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AeroChamber Plus aVHC with Flow-Vu IFI (K070674)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
ﺎ
Image /page/0/Picture/1 description: The image shows the logo for Medical Developments International. The logo consists of a stylized plus sign on the left, followed by the text "Medical Developments International" on the right. The text is stacked in three lines, with "Medical" on the top line, "Developments" on the second line, and "International" on the bottom line.
Space Chamber Plus Traditional 510(k)
510(k) Summary
| Date Prepared:
510(k) Owner: | 4 November 2013
Medical Developments International Limited
7/56 Smith Road
Springvale VIC 3171
Australia | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter/ Official
Contact: | Maggie Oh - Director, Scientific Affairs
7/56 Smith Road
Springvale, Victoria 3171
Australia | NOV 1 3 2013 |
| | Phone: +61 3 9547 1888
Fax: +61 3 9547 0262 | |
| Device Trade Name: | Space Chamber Plus
Compact 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 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. | |
| Intended Use: | 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. | |
1
Image /page/1/Picture/0 description: The image shows the logo for Medical Developments International. The logo consists of a black cross symbol on the left, followed by the company name in a sans-serif font. The text is stacked vertically, with "Medical" on top, "Developments" in the middle, and "International" at the bottom.
Comparison of
Technological Characteristics: Space Chamber Plus Traditional 510(k)
| Technology | Space Chamber
Plus and Compact
Space Chamber
Plus* | AeroChamber
Plus Flow-Vu
Anti-static valved
holding chamber | Comparison |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Valve | Cross Slit Valve
Technology:
Confirms a secure
seal if the valve
opens as the
patient inhales
and closes as the
patient exhales
(as observed
through the clear
transparent body
of the spacers)
indicating proper
inhalation
technique. | Flow-Vu indicator:
Confirms a secure
seal if the
indicator moves
indicating proper
inhalation
technique. | Both technologies
provide an
indication of
proper inhalation
technique. |
| Inhaler base | The orifice in the
overmould
component is
compatible with
all standard types
of metered dose
inhalers. | Orifice in the
backpiece or
inhaler base
allows insertion
of metered dose
Inhalers. Flow
Signal whistle
sound when
inhaling too
quickly | Patients inhale
the amount of
drug within the
holding chamber.
Particle size
testing confirms
the proposed
device delivers an
equivalent
amount of
respirable
fraction
compared to the
predicate (see
report 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.
2
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 total
respirable dose,
μg
(95% CI) | Mean respirable
fraction
PF% 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 Space
Chamber Plus | 2.3 (0.05) | 253.4 (38.7) | 88.0 (0.6) |
| Aerochamber Plus
Flow Vu Anti-static | 2.4 (0.03) | 292.2 (19.2) | 87.6 (0.7) |
| Ipratropium Bromide | | | |
| Ipratropium
Bromide 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 Space
Chamber Plus | 0.80 (0.02) | 65.19 (2.1) | 61.9 (0.7) |
| Aerochamber Plus
Flow Vu Anti-static | 0.76 (0.05) | 55.28 (3.0) | 60.0 (1.8) |
| Beclomethasone Dipropionate | | | |
| Beclomethasone
Dipropionate pMDI | 1.4 (0.07) | 218.12 (16.3) | 77.3 (2.4) |
3
| Space Chamber Plus | 1.3 (0.02) | 328.05 (9.9) | 82.7 (0.8) |
|---|---|---|---|
| Compact Space | |||
| Chamber Plus | 1.3 (NA^) | 308.29 (12.7) | 83.7 (1.0) |
| Aerochamber Plus | |||
| Flow 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. .
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, with three smaller curved lines below representing the tail feathers.
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.
5
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
6
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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