(108 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on mechanical and aerosol delivery characteristics, not data processing or algorithmic decision-making.
Yes
The device is a nebulizer intended to deliver prescribed aerosolized medication to patients, which is a therapeutic function.
No
Explanation: The device is a nebulizer designed to deliver aerosolized medication to patients, not to diagnose medical conditions.
No
The device description clearly states it is a "single-use (disposable) continuous nebulizer system" and mentions "Biocompatibility testing" and "Mechanical safety testing," indicating it is a physical hardware 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 deliver aerosolized medication to mechanically ventilated patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a nebulizer system for aerosolizing medications. This aligns with a drug delivery device, not a diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device's function is to deliver medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
The Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and subacute care environments.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Solarys* Ventilator Aerosol Delivery System (AS) is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize physician-prescribed medications for inhalation.
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
pediatric and adults patients
Intended User / Care Setting
Not Found
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 Solarys* AS 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).
Aerosol characterization testing for the Solarys* AS and the predicate device has been conducted with 3 commonly prescribed drugs using the cascade impactor method. The total mass of each drug emitted was determined by simulating normal device usage in a ventilator circuit and demonstrates that the performance of the Solarys* AS raises no new issues of safety or effectiveness from the legally marketed predicate device. Constant sampling through an impactor at a fixed flow rate does not provide an accurate indication of the amount of medication potentially available in a clinically relevant situation, so in order to obtain a representative measurement of total emitted mass (TEM), a simulated adult mechanically ventilated patient was used to assess the mass of medication available at the exit of a 7.0 mm I.D. ETT. The aerosolized medication exiting the ETT was collected directly onto a polypropylene microfiber filter, connected to an adult mechanical test lung that was used as the patient model.
Biocompatibility testing was conducted on the Solarys* AS device according to ISO 10993-1.
Mechanical safety testing consisted of the following: Simulated use, Maximum pressure testing, Environmental limit testing (operating limits and environmental storage and transportation testing), Drop testing, Connection leakage, Strain relief fatigue and tensile testing.
The aerosol characterizations below have been defined based on statistical analysis (95% confidence interval) of the observed data collected using cascade impactor methodology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particle Size Characterization (Combivent):
Total Delivered Dose ex ETT (µg): Albuterol 1593, Ipratropium Bromide 390
NGI Data:
Particle Fraction Greater Than 8.64µm (%): 26.3
Particle Fraction Between 0.98 - 8.64 µm (%): 68.2
Particle Fraction Less Than 0.98 µm (%): 5.5
MMAD (µm): 4.6
GSD: 2.7
Particle Size Characterization (Albuterol):
Total Delivered Dose ex ETT (µg): 724
NGI Data:
Particle Fraction Greater Than 8.64µm (%): 24.3
Particle Fraction Between 0.98 - 8.64 µm (%): 70.2
Particle Fraction Less Than 0.98 µm (%): 5.5
MMAD (µm): 4.3
GSD: 2.8
Particle Size Characterization (Ratio-Ipratropium):
Total Delivered Dose ex ETT (µg): 296
NGI Data:
Particle Fraction Greater Than 8.64µm (%): 21.6
Particle Fraction Between 0.98 - 8.64 µm (%): 73.4
Particle Fraction Less Than 0.98 µm (%): 5.0
MMAD (µm): 4.0
GSD: 2.8
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.
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
Trudell Medical International
MAR 1 1 2013
Premarket Notification 510(k) Solarys* Ventilator Aerosol Delivery System
Section 5 – 510(k) Summary
Prepared: 20 November 2012
Trudell Medical International 510(k) Owner 725 Third Street London, Ontario N5V 5G4 CANADA Contact Person Darryl Fischer Associate Director, Global Regulatory Affairs Phone 1-519-455-7060 ext 2140 Fax 1-519-455-6329 e-mail dfischer@trudelimed.com
Device Name
Solarys* Ventilator Aerosol Delivery System Proprietary Common/Classification Nebulizer, Direct Patient Interface
| Product Code | CAF |
|---|---|
| -------------- | ----- |
Classification Regulation 868.5630
Predicate Device 510(k) Number Trade/Model Name(s) Manufacturer K070642 Aeroneb Professional Nebulizer System Aerogen Limited -Aeroneb Solo
Device Description
The Solarys* Ventilator Aerosol Delivery System (AS)
The Solarys* Ventilator Aerosol Delivery System (AS) is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize physician-prescribed medications for inhalation.
Amended 11 March 2013
1
Section 5 -- 510(k) Summary
Intended Use
The Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and subacute care environments.
Technological Characteristic Comparison to Predicate Device(s)
Common characteristics to both the Solarys* AS and the predicate device ;
-
operate primarily by atomizing bulk liquid containing medication into an aerosol form that can be inhaled
-
both have a reservoir that is part of the medication delivery system for extended treatments
-
both devices allow for refilling during extended treatments, without having to break the patient circuit
Relevant differences in operating principles of the Solarys* AS and the predicate device; - the Solarys* AS is a pneumatically driven nebulizer, whereas the Aerogen Solo system is a vibrating mesh nebulizer that is electrically driven.
- No cleaning of the Solarys* AS system is required to maintain nebulizer performance (remains in the patient circuit for the duration of circuit life). The predicate device requires cleaning to prevent clogging of the vibrating mesh to maintain its performance with many formulations.
Non-Clinical Test Summary
Evaluation of the Solarys* AS 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).
- . Aerosol characterization testing for the Solarys* AS and the predicate device has been conducted with 3 commonly prescribed drugs using the cascade impactor method. The total mass of each drug emitted was determined by simulating normal device usage in a ventilator circuit and demonstrates that the performance of the Solarys* AS raises no new issues of safety or effectiveness from the legally marketed predicate device. Constant sampling through an
Amended 11 March 2013
2
Premarket Notification 510(k) Solarys* Ventilator Aerosol Delivery System
Section 5 – 510(k) Summary
impactor at a fixed flow rate does not provide an accurate indication of the amount of medication potentially available in a clinically relevant situation, so in order to obtain a representative measurement of total emitted mass (TEM), a simulated adult mechanically ventilated patient was used to assess the mass of medication available at the exit of a 7.0 mm I.D. ETT. The aerosolized medication exiting the ETT was collected directly onto a polypropylene microfiber filter, connected to an adult mechanical test lung that was used as the patient model.
- . Biocompatibility testing was conducted on the Solarys* AS device according to ISO 10993-1
- Mechanical safety testing consisted of the following; .
- 0 Simulated use
- 0 Maximum pressure testing
- Environmental limit testing (operating limits and environmental storage and o transportation testing)
- Drop testing O
- o Connection leakage
- Strain relief fatigue and tensile testing o
The aerosol characterizations below have been defined based on statistical analysis (95% confidence interval) of the observed data collected using cascade impactor methodology.
| Particle Size Characterization | |||||
|---|---|---|---|---|---|
| Combivent | |||||
| Albuterol | Ratio- | ||||
| Ipratropium | Albuterol | Ipratropium Bromide | |||
| Filter / Breathing Simulator Data | |||||
| Total Delivered Dose ex ETT (µg) | 724 | 296 | 1593 | 390 | |
| NGI Data | |||||
| Particle Fraction Greater Than | |||||
| 8.64µm (%) | 24.3 | 21.6 | 26.3 | 26.5 | |
| Particle Fraction Between 0.98 - | |||||
| 8.64 µm (%) | 70.2 | 73.4 | 68.2 | 68.0 | |
| Particle Fraction Less Than 0.98 | |||||
| µm (%) | 5.5 | 5.0 | 5.5 | 5.5 | |
| MMAD (µm) | 4.3 | 4.0 | 4.6 | 4.7 | |
| GSD | 2.8 | 2.8 | 2.7 | 2.8 |
3
Premarket Notification 510(k) Solarys * Ventilator Aerosol Delivery System
Trudell Medical International
Section 5 - 510(k) Summary
Clinical Performance Summary
Not applicable, the determination of substantial equivalence is not based on Clinical Performance Data.
Conclusions from Testing
The Solarys* AS has been evaluated against a currently marketed (predicate) device for the determination of substantial equivalency. The Solarys* AS and the predicate device share common indications for use and usage environments. The devices are both single patient use, non-sterile, disposable and are available by prescription.
Performance data, gathered in accordance with "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODE/DCRD/ADDB -1993), demonstrate that the Solarys* AS raises no new issues of safety or effectiveness from the legally marketed predicate device.
Amended 11 March 2013
4
Image /page/4/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 lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2013
Mr. Darryl Fischer, COM Associate Director, Global Regulatory Affairs Trudell Medical International 725 Third Street London Canada N5V 5G4
Re: K123614
Trade/Device Name: Solarys * Ventilator Aberosol Delivery System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 21, 2012 Received: December 26, 2012
Dear Fischer:
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.
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
5
Page 2 - Mr. Fischer
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Kwame O. Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number:
Device Name: Solarys* Ventilator Aerosol Delivery System
Indications for Use:
Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and sub-acute care environments.
Prescription Use: (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE) Albert E. Moyal: 5 Jan 1992 - 1992 - 1994 - 1994 - 1994 - 1994 - 1994 - 1994 - 1 for LS
'Division Sign-Off) rision of Anestheslology, General Hospital ection Control, Dental Devices
10(k) Number:
.
Page 1 of 1
- Trade marks and registered trademarks of Trudell Medical International 11:00:00 14
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