OMBRA TABLE TOP COMPRESSOR

K131881 · Trudell Medical Intl. · BTI · Oct 24, 2013 · Anesthesiology

Device Facts

• Record ID: K131881
• Device Name: OMBRA TABLE TOP COMPRESSOR
• Applicant: Trudell Medical Intl.
• Product Code: BTI · Anesthesiology
• Decision Date: Oct 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Ombra Table Top Compressor is a motor-driven device providing compressed air to jet or pneumatic nebulizers. Device operates on 120V/60Hz AC power; housed in plastic case with rubber skids. Used in home, hospital, or clinic settings; operated by patients or healthcare providers. Device output is a continuous stream of compressed air; used to power nebulization of medication for respiratory therapy. Benefits include facilitating delivery of aerosolized medication to patients. No patient-contacting components.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing, including electromagnetic compatibility (EN 60601-1-2:2007) and electrical safety (IEC EN 60601-1:2005).

Technological Characteristics

Motor-driven air compressor; 120V/60Hz AC power. Dimensions: 180x145x105 mm; Weight: 3.35 lbs. Max pressure: 43.1 psi; Operating pressure: 19.6 psi. Operating temperature: +15°C to +40°C. Non-sterile. No patient-contacting components. Compliant with IEC EN 60601-1 and EN 60601-1-2.

Indications for Use

Indicated for adult, child, and pediatric patients requiring compressed air for jet or pneumatic nebulizers. Intended for use in home, hospital, and clinic environments under the direction of a healthcare professional.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Airial MQ5600 (K031413)
• Pari Vios Compressor (K092918)

Submission Summary (Full Text)

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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<br>725 Third Street<br>London, Ontario N5V 5G4<br>CANADA | | |
|---------------------------|----------------------------------------------------------------------------------------|--------------|--------------|
| Contact Person | Darryl Fischer<br>Associate Director, Global Regulatory Affairs | | |
| Phone | 1-519-455-7060 ext 2140 | | |
| Fax | 1-519-455-6329 | | |
| e-mail | [e-mail] | | |
| 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

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## 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.<br>Current 510(k) Application | Airial MQ5600<br>(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

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Premarket Notification 510(k) Ombra* Table Top Compressor 510k Number: K131881

## Section 5 - 510(k) Summary

| Characteristics | Ombra* Table Top<br>Compressor<br>Current 510(k)<br>Application | Pari Vios Compressor<br>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.

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# 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### 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)

K131881

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· Trade marks and registered trademarks of Trudell Medical International

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