(132 days)
Not Found
No
The device description and performance studies focus on the mechanical and aerosol delivery properties of a valved holding chamber, with no mention of AI or ML capabilities.
Yes
The device is intended to assist in administering aerosolized medication from Metered Dose Inhalers, which is a therapeutic function.
No
Explanation: The device is described as a "Valved Holding Chamber (VHC)" intended to administer aerosolized medication. Its purpose is to facilitate medication delivery, not to diagnose a condition or disease. The performance studies focus on mechanical testing, biocompatibility, and aerosol characterization for medication delivery, not diagnostic accuracy.
No
The device description and performance studies clearly indicate this is a physical valved holding chamber (VHC) for use with metered dose inhalers, not a software-only device.
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 a Metered Dose Inhaler to a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The description reinforces its use as a holding chamber for medication delivery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the device's ability to deliver medication effectively (aerosol characterization) and its mechanical and biocompatibility properties, not on diagnostic accuracy.
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
This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.
Product codes
NVP
Device Description
The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.
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
5+ years
Intended User / Care Setting
Physician or licensed healthcare professional / home use
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)
Aerosol Characterization Testing: Testing involved comparison of AeroChamber2goAnti-Static Valved Holding Chamber (test) with Take Apart AeroChamber Plus aVHCs with Flow-Vu* IFI (predicate) and pMDI alone for three formulations. Key results: The performance of the AeroChamber2go* Anti-Static Valved Holding Chamber (test) was substantially equivalent to the predicate VHC tested. The aerodynamic particle size distributions and fine particle fractions were very closely matched, and although the fine particle dose metric for the test VHC was a little lower than the predicate in some cases, it remained similar or higher to the metered dose inhaler when used alone, therefore would not be clinically significant.
Mechanical Testing: Mechanical tests performed include Temperature Storage and Washing Test, Drop Test, Transportation Test, High Pressure Exhalation, Dishwasher Test. Key results: Results demonstrate that the AeroChamber2go* Anti-Static Valved Holding Chamber meets the requirements outlined in the Product Design Specification. No new issues of safety and efficacy were identified based on the testing performed.
Biocompatibility Testing: In vitro and in vivo studies performed by an independent source included Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), Systemic Toxicity (Pyrogen Study) (ISO 10993-11), and Chemical Characterization (ISO 10993-18). Key results: The AeroChamber2go* Anti-Static Valved Holding Chamber meets the requirements of ISO 10993-1:2018 and can be considered safe for use, as intended.
Dry Gas Pathway Testing: Worst-case assessment of volatile organic compounds (VOCs) and fine particles (particulate matter) was conducted, including Risk Assessment (ISO 18562-1), Tests for emissions of particulate matter (ISO 18562-2), and Tests for emissions of VOCs and aldehydes (ISO 18562-3). Key results: Test results and risk assessment demonstrated that exposure during use of the device is unlikely to result in toxicological effects.
Clinical Testing: Not applicable. The determination of substantial equivalence is not based on clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
January 15, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
Trudell Medical International Marianne Tanton Vice President, Quality and Regulatory Affairs 725 Baransway Drive London, ON N5V 5G4 Canada
Re: K242667
Trade/Device Name: AeroChamber2go Anti-Static Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: NVP Dated: August 30, 2024 Received: September 5, 2024
Dear Marianne Tanton:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242667
Device Name
AeroChamber2go Anti-Static Valved Holding Chamber
Indications for Use (Describe)
This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image is the logo for Trudell Medical International. The logo consists of a shield with the word "TRUDELL" written vertically, and a maple leaf in the upper right quadrant. To the right of the shield, the words "TRUDELL MEDICAL INTERNATIONAL" are written in a simple, sans-serif font.
Traditional 510(k) Submission: 510(k) Summary AeroChamber2go* Anti-Static Valved Holding Chamber (VHC)
510(k) Summary
Prepared: 14 January 2025
1. Contact Details - 21 CFR 807.92(a)(1)
Applicant Name: Trudell Medical International Applicant Address: 725 Baransway Drive, London, ON N5V 5G4, Canada Applicant's Contact Telephone: +1 519-515-2557 Applicant Contact: Ms. Marianne Tanton Applicant Contact Email: mtanton@trudellmed.com
2. Device Name - 21 CFR 807.92(a)(2)
Device Trade Name: AeroChamber2qo* Anti-Static Valved Holding Chamber Common Name: Nebulizer Classification Name: Holding Chambers, Direct Patient Interface Medical Specialty: Anesthesiology Requlation Number: 868.5630 Product Code(s): NVP
3. Legally Marketed Predicate Devices - 21 CFR 807.92(a)(3)
Predicate Number: K181649 Predicate Trade Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber Common Name: Nebulizer Classification Name: Holding Chambers, Direct Patient Interface Medical Specialty: Anesthesiology Requlation Number: 868.5630 Product Code(s): NVP Predicate Owner: Trudell Medical International
4. Device Description Summary - 21 CFR 807.92(a)(4)
The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.
5
5. Intended Use/Indications for Use - 21 CFR 807.92(a)(5)
This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.
6. Intended Use/Indications for Use and Technological Comparison - 21 CFR 807.92(a)(5) and 21 CFR 807.92(a)(6)
The proposed AeroChamber2go* Anti-Static Valved Holding Chamber and AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (predicate) are similar in purpose, function, scientific technology and method of operation. Only minor differences exist between the subject AeroChamber2go* Anti-Static Valved Holding Chamber and the predicate, which do not affect the safety or effectiveness of the subject device.
Table 1 provides a comparison of the subject and predicate device on all applicable parameters. The following parameters which do not apply to the device are not: "Disposable", "Conformance", "Shelf Life", "Contraindications", "Regulation Conformance", and "Average Treatment Time".
| Element of
Comparison | AeroChamber2go*
Anti-Static VHC
(Subject Device) | AeroChamber Plus* Flow-Vu*
Anti-Static VHC
(Predicate Device - K181649) | Comparison |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device
Classification
Name | Holding Chamber, direct patient interface | | Similar |
| Medical
Specialty | Anesthesiology | | Similar |
| Classification | Class II | | Similar |
| Regulation
Number | 21 CFR 868.5630 | | Similar |
| Product Code | NVP | | Similar |
| Intended
Use/Indications
for Use | This product is intended to
be used by patients (5+
years) who are under the
care or treatment of a
physician or licensed
healthcare professional.
The device is intended to
be used by these patients
to administer aerosolized
medication from most
pressurized Metered Dose
Inhalers. It is a single
patient, multiple use
device intended for home
use. | This product is intended to be
used by adult and pediatric
patients who are under the care
or treatment of a physician or
licensed healthcare
professional. The device is
intended to be used by these
patients to administer
aerosolized medication from
most pressurized Metered Dose
Inhalers and Soft Mist Inhalers.
The intended environments for
use include the home, hospitals
and clinics. It is a single patient,
multiple use device. | Similar |
Table 1: Comparison to Predicate Device
6
| Element of Comparison | AeroChamber2go*
Anti-Static VHC
(Subject Device) | AeroChamber Plus* Flow-Vu*
Anti-Static VHC
(Predicate Device - K181649) | Comparison |
|--------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Patient Interface | VHC with Mouthpiece | VHC with Small Mask
VHC with Medium Mask
VHC with Adult Small Mask
VHC with Adult Large Mask
VHC with Mouthpiece
Device configurations are
differentiated by color | Similar |
| Principle of Operation | Valved Holding Chamber | | Similar |
| Environment of Use | Home | Hospital, Clinic or Home | Similar |
| Patient Population | Patients 5+ years | Adult and pediatric patients | Similar |
| Type of Device | Prescription only, single patient use, non-sterile | | Similar |
| Useful Life | Recommended replacement after 12 months of use | | Similar |
| Material of Construction | Thermoplastic Polymer, Thermoplastic Elastomer and
Silicone components | | Similar |
| Manufacturing process | Plastic molding and mechanical assembly | | Similar |
| Chamber Size | Width - 3.6 cm, Length -
6.2 cm, Height - 12.7 cm | 5.86" Length x 1.75' Diameter | Similar |
| Chamber Volume | 140 cc | 149 cc | Similar |
7. Non-Clinical and/or Clinical Tests Summary & Conclusions - 21 CFR 807.92(b)
Aerosol Characterization Testing:
Aerosol characterization testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). Testing involved comparison of AeroChamber2goAnti-Static Valved Holding Chamber (test) with Take Apart AeroChamber Plus aVHCs with Flow-Vu* IFI (predicate) and pMDI alone for three formulations.
By comparing the range of aerosol metrics reported in the summary of performance data, it can be concluded that the performance of the AeroChamber2go* Anti-Static Valved Holding Chamber (test) was substantially equivalent to the predicate VHC tested. The aerodynamic particle size distributions and fine particle fractions were very closely matched, and although the fine particle dose metric for the test VHC was a little lower than the predicate in some cases, it remained similar or higher to the metered dose inhaler when used alone, therefore would not be clinically significant.
7
Mechanical Testing:
Evaluation of AeroChamber2go* Anti-Static Valved Holding Chamber was performed to characterise the device's mechanical performance. The following mechanical tests were performed on the subject device:
- Temperature Storage and Washing Test ●
- Drop Test
- Transportation Test ●
- High Pressure Exhalation ●
- . Dishwasher Test
Results demonstrate that the AeroChamber2go* Anti-Static Valved Holding Chamber meets the requirements outlined in the Product Design Specification. No new issues of safety and efficacy were identified based on the testing performed.
Biocompatibility Testing:
Biological endpoints applicable to an externally communicating device with tissue contact, long term duration (permanent) is listed below. All in vitro and in vivo studies were performed by an independent source and included the following battery of tests: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (Pyrogen Study), and Chemical Characterization. The AeroChamber2go* Anti-Static Valved Holding Chamber meets the requirements of ISO 10993-1:2018 and can be considered safe for use, as intended.
| ISO Standard | Test/Assessment |
|---|---|
| 10993-5 | Tests for in vitro cytotoxicity |
| 10993-10 | Tests for skin sensitization |
| 10993-23 | Tests for irritation (Intracutaneous) |
| 10993-11 | Tests for systemic toxicity (Pyrogen Study) |
| 10993-18 | Chemical characterization of medical device materials within a risk |
| management process |
Summary of Biocompatibility/Chemical Characterization Testing Conducted
8
Dry Gas Pathway Testing:
To support the safe use of the device in dry gas conditions, a worst-case assessment of volatile organic compounds (VOCs) and fine particles (particulate matter) was conducted. Test results and risk assessment demonstrated that exposure during use of the device is unlikely to result in toxicological effects.
| ISO Standard | Test/Assessment |
|---|---|
| 18562-1 | Risk Assessment |
| 18562-2 | Tests for emissions of particulate matter |
| 18562-3 | Tests for emissions of VOCs and aldehydes |
Clinical Testing:
Not applicable.
The determination of substantial equivalence is not based on clinical performance data.
Conclusion:
The non-clinical test data demonstrate that the AeroChamber2go* Anti-Static Valved Holding Chamber is substantially equivalent to the predicate (AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber). Use of the subject device does not raise any new questions of safety and/or effectiveness.