(90 days)
Not Found
No
The description focuses on the mechanical function of a valved holding chamber and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is intended to assist in the administration of aerosolized medication but does not itself provide therapy or treat a disease. It's an accessory to a therapeutic process.
No
The description explicitly states that the device is for administering aerosolized medication, not for diagnosing any condition. It's a delivery device to help patients inhale medication more effectively.
No
The device description clearly indicates it is a physical valved holding chamber used for administering medication, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RespiChamber Valved Holding Chamber is a device used to facilitate the delivery of aerosolized medication from a metered dose inhaler to a patient's lungs. It is a drug delivery device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for administering medication, not for diagnosing any condition.
- Device Description: The description focuses on how the device helps the patient inhale medication effectively.
- Performance Studies: The performance studies evaluate the device's ability to deliver medication particles of a specific size, which is relevant to drug delivery, not diagnostic accuracy.
Therefore, the RespiChamber Valved Holding Chamber falls under the category of a drug delivery device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The RespiChamber* Valved Holding Chamber 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 the home, hospitals and clinics.
Product codes
NVP
Device Description
The RespiChamber* Valved Holding Chamber (VHC) is a device used for the administration of metered dose inhaler medication to a spontaneously breathing patient. By means of a one-way valve, medication particles are held in the chamber for several seconds after actuation has occurred enabling inhalation by the patient. The device is designed to minimize delivery of the larger particles of aerosolized medication, which may otherwise lodge in the mouth, throat and upper airway, while allowing the smaller therapeutic particles to be inspired.
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. The intended environments for use include the 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 Test Summary: Evaluation of the RespiChamber* VHC 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/ODE/DCRD/ADDB -1993). Particle size distribution testing has been conducted with three drug classification types. The determination of the mass of each drug emitted in the therapeutic range (Fine Particle Mass, μg
§ 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
Section 5 – 510(k) Summary
APR 1 8 2011
Prepared: 11 January 2011
| 510(k) Owner | Trudell Medical International |
|---|---|
| 725 Third Street | |
| London, Ontario N5V 5G4 | |
| CANADA | |
| Official Contact | Darryl Fischer |
| Associate Director, Quality & Regulatory Affairs | |
| Phone | 1-519-455-7060 ext 2140 |
| Fax | 1-519-455-6329 |
| dfischer@trudellmed.com |
Device Name
| Proprietary | RespiChamber* Valved Holding Chamber |
|---|---|
| Common | Holding Chamber, Direct Patient Interface |
Product Code NVP
Classification Regulation 868.5630
Predicate Device
| 510(k) # | Trade/Model Name | Manufacturer |
|---|---|---|
| K962822 | OptiChamber Advantage Valved Holding Chamber | Respironics New Jersey, Inc. |
Device Description
The RespiChamber* Valved Holding Chamber (VHC) is a device used for the administration of metered dose inhaler medication to a spontaneously breathing patient. By means of a one-way valve, medication particles are held in the chamber for several seconds after actuation has occurred enabling inhalation by the patient. The device is designed to minimize delivery of the larger particles of aerosolized medication, which may otherwise lodge in the mouth, throat and upper airway, while allowing the smaller therapeutic particles to be inspired.
Intended Use
The RespiChamber* Valved Holding Chamber 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
1
Section 5 -- 510(k) Summary
by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
Technological Characteristic Comparison to Predicate Device
Both the RespiChamber* VHC and the predicate device utilize a reservoir and one-way valve system through which metered dose inhaler medication passes to the patient. While the operating principle is similar, the design of each of the systems is unique. Non-clinical testing of the RespiChamber* VHC and the predicate device demonstrate the differences in product design lead to no new issues of safety or effectiveness.
Non-Clinical Test Summary
Evaluation of the RespiChamber* VHC 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/ODE/DCRD/ADDB -1993).
Particle size distribution testing has been conducted with three drug classification types. The determination of the mass of each drug emitted in the therapeutic range (Fine Particle Mass, μg