(121 days)
Not Found
No
The device description and performance summaries focus on the mechanical and electrical characteristics of a compressor, with no mention of AI or ML technologies.
No.
A therapeutic device is one that treats a disease or condition. This device provides compressed air to nebulizers, which deliver medication; the device itself does not provide therapy.
No
The device is a compressor designed to deliver compressed air to a nebulizer, which is used for medication delivery. It does not perform any diagnostic functions.
No
The device description explicitly states it is a "motor-driven compressor, housed in a plastic case with rubber skids" and operates from 120V/60Hz, indicating it is a hardware device.
Based on the provided information, the Ombra® Table Top Compressor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to deliver compressed air to a jet or pneumatic nebulizer for administering medication to patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of providing compressed air. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Ombra® Table Top Compressor does not perform any such analysis.
The device is clearly described as a medical device used for delivering medication via nebulization, which falls under the category of therapeutic devices.
N/A
Intended Use / Indications for Use
The Ombra* Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.
Product codes (comma separated list FDA assigned to the subject device)
BTI
Device Description
The Ombra* Table Top Compressor provides a source of compressed air for use with jet nebulizers. The device is a motor-driven compressor, housed in a plastic case with rubber skids. It operates from 120V/60Hz. It is supplied with several replaceable air filters. The Ombra* Table Top Compressor is intended for adult, child and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
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
adult, child or pediatric patients.
Intended User / Care Setting
medical device, and should only be used as directed by your healthcare professional. 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: Testing was conducted to characterize the operating parameters of the Ombra* Table Top Compressor to the predicate device. The Ombra* Table Top Compressor has been tested to determine the maximum emission levels emanating from the device, its ensured severity levels and performance criterion. The device is technically compliant with the requirements of EN 60601-1-2:2007 Electromagnetic Compatibility standard. The Ombra* Table Top Compressor has been tested to determine its compliance against IEC EN 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007). The device is technically compliant with the requirements of the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
Premarket Notification 510(k) Ombra* Table Top Compressor 510k Number: K131881
Section 5 – 510(k) Summary
Prepared: 24 October 2013
| 510(k) Owner | Trudell Medical International
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@trudellmed.com | | |
| Device Name | | | OCT 2 4 2013 |
| Proprietary | Ombra* Table Top Compressor | | |
| Common/Classification | Compressor, air, portable | | |
| Product Code | BTI | | |
| Classification Regulation | 868.6250 | | |
| Predicate Device | | | |
| 510(k) Number | Trade/Model Name | Manufacturer | |
| K031413 | Airial MQ5600 | Medquip | |
| K092918 | Pari Vios Compressor | Pari | |
Device Description
The Ombra* Table Top Compressor provides a source of compressed air for use with jet nebulizers. The device is a motor-driven compressor, housed in a plastic case with rubber skids. It operates from 120V/60Hz. It is supplied with several replaceable air filters. The Ombra* Table Top Compressor is intended for adult, child and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
- Trade marks and registered trademarks of Trudell Medical International
1
Section 5 – 510(k) Summary
Intended Use
The Ombra* Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.
| Characteristics | Ombra* Table Top Compressor.
Current 510(k) Application | Airial MQ5600
(Predicate) 510(k) K031413 |
|-------------------------------------|------------------------------------------------------------|----------------------------------------------------------|
| Power | AC 120V, 60Hz powered | AC 120V, 60Hz powered |
| Principle of operation | delivers compressed air to a jet or pneumatic nebulizer. | delivers compressed air to a jet or pneumatic nebulizer. |
| Mechanism of action | motor-driven | motor-driven |
| Patient Contact | no patient-contacting components | no patient-contacting components |
| Weight (lbs) | 3.35 | 2.7 |
| Dimensions (LxWxH) (mm) | 180x145x105 | 170x135x88 |
| Sound Level (dB A) | 62.5 | 58.6 |
| Maximum Pressure (psi) | 43.1 | 28.8 |
| Operating Pressure (psi) | 19.6 | 16.4 |
| Free Flow Rate (L/min) | 9.13 | 10.46 |
| Operating Flow (L/min) | 4.52 | 4.09 |
| Voltage (Vac) | 122 | 122 |
| Free Flow Current (A) | 0.88 | 0.77 |
| Operating Current (A) | 0.93 | 0.81 |
| Maximum Current (A) | 0.87 | 0.78 |
| Operating Temperature Range | +15°C to +40°C (59°F to 104°F) | +10°C to +40°C (50°F to 104°F) |
| Operating Humidity Range | 15 to 95% (non-condensing) | 10 to 95% RH |
| Storage/Transport Temperature Range | -20°C to +60°C (-4°F to 140°F) | -20°C to +60°C (-4°F to 140°F) |
| Storage/Transport Humidity Range | 15 to 95% (non-condensing) | 10 to 95% (non-condensing) |
Technological Characteristic Comparison to Predicate Device(s)
- Trade marks and registered trademarks of Trudell Medical International
2
Premarket Notification 510(k) Ombra* Table Top Compressor 510k Number: K131881
Section 5 - 510(k) Summary
| Characteristics | Ombra* Table Top
Compressor
Current 510(k)
Application | Pari Vios Compressor
510(k) K092918 |
|--------------------------|-----------------------------------------------------------------|----------------------------------------|
| Maximum Pressure (psi) | 43.1 | 43.7 |
| Operating Pressure (psi) | 19.6 | 19.6 |
The Ombra* Table Top Compressor maximum and operating pressures are somewhat higher than the Airial MQ5600 (Predicate) 510(k) K031413, but less than or equal to the previously cleared Pari Vios compressor 510(k) K092918. The maximum and operating pressures of the subject device raises no new issues and demonstrates the device is as safe and as effective as other devices in the market.
Relevant differences between the Ombra* Table Top Compressor and the Airial MQ5600 predicate device;
- outer case
- the motor power
Non-Clinical Test Summary
Testing was conducted to characterize the operating parameters of the Ombra* Table Top Compressor · to the predicate device.
The Ombra* Table Top Compressor has been tested to determine the maximum emission levels emanating from the device, its ensured severity levels and performance criterion. The device is technically compliant with the requirements of EN 60601-1-2:2007 Electromagnetic Compatibility standard.
The Ombra* Table Top Compressor has been tested to determine its compliance against IEC EN 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007). The device is technically compliant with the requirements of the standard.
3
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 Ombra* Table Top compressor has been evaluated against the currently marketed (predicates) Airial MQ5600 and Pari Vios for the determination of substantial equivalency. The Ombro* Toble Top compressor and the predicate devices share common indications for use, operating characteristics and usage environments. The devices are both single patient use, non-sterile and are available by prescription. The differences in the devices do not add any new type of safety or effectiveness questions. The Ombro* Table Top compressor has been demonstrated to be as safe and as effective as the predicate devices.
- Trade marks and registered trademarks of Trudell Medical International
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2013
Trudell Medical International Darryl Fischer, CQM Associate Director. Global Regulatory Affairs 725 Third Street LONDON. ONTARIO CANADA, N5V 5G4
Re: K131881
Trade/Device Name: Ombra* Table Top Compressor Regulation Number: 21 CFR 868.6250 Regulation Name: Compressor, air, portable Regulatory Class: Class II Product Code: BTI Dated: July 22, 2013 Received: July 26, 2013
Dear Mr. 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: CDRI 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 may or sables 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 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 cicctronic 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/Resources/orYou/Industry/default.htm. Also, please note the regulation entilled, "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 vours,
Image /page/5/Picture/8 description: The image contains a combination of text and graphic elements. The text includes the name "Tejashri Purohit-Sheth, M.D.", followed by "Clinical Deputy Director" and "DAGRID". There is also a signature on the left side of the image. The text and graphic elements are arranged in a way that suggests they might be part of a formal document or letterhead.
Kwame Ulmer, M.S. Acting Division 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
KIJI 881 510(k) Number:
Device Name:
Indications for Use:
The Ombra® Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.
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)
ned by Anya C. Harry -S
-U.S. Government, our Anya C. Harry: Poople, Ch-Anya C.I =001131559 11 - 11 - 0 9 2 42 152
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· Trade marks and registered trademarks of Trudell Medical International
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