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 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.

AI/ML Overview

The Ombra* Table Top Compressor is a medical device designed to provide compressed air for use with jet nebulizers. The provided text details the device's characteristics and its comparison to predicate devices, but it does not describe a study involving acceptance criteria in the traditional sense of clinical performance or algorithm evaluation.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and comparison of technological characteristics. This is a common pathway for medical devices seeking 510(k) clearance, where direct clinical trials or extensive performance studies with acceptance criteria based on patient outcomes are often not required if the new device is sufficiently similar to a predicate.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in this context.

Here's the information that can be extracted from the provided text, framed within the substantial equivalence approach:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are typically defined by demonstrating that the new device's parameters are comparable to or within acceptable limits relative to the predicate devices, and that it complies with relevant safety and performance standards.

Characteristic	Acceptance Criteria (based on predicate ranges/standards)	Ombra* Table Top Compressor Reported Performance
Power	AC 120V, 60Hz powered (matching predicates)	AC 120V, 60Hz powered
Principle of operation	Delivers compressed air to a jet/pneumatic nebulizer (matching predicates)	Delivers compressed air to a jet or pneumatic nebulizer.
Mechanism of action	Motor-driven (matching predicates)	Motor-driven
Patient Contact	No patient-contacting components (matching predicates)	No patient-contacting components
Maximum Pressure (psi)	Comparable to or less than Pari Vios Compressor (43.7 psi) and greater than or comparable to Airial MQ5600 (28.8 psi). "Raises no new issues."	43.1
Operating Pressure (psi)	Comparable to or less than Pari Vios Compressor (19.6 psi) and greater than or comparable to Airial MQ5600 (16.4 psi). "Raises no new issues."	19.6
Free Flow Rate (L/min)	Comparable to predicate devices (Airial MQ5600: 10.46 L/min)	9.13
Operating Flow (L/min)	Comparable to predicate devices (Airial MQ5600: 4.09 L/min)	4.52
Sound Level (dB A)	Acceptable sound level for intended use environment (predicate Airial MQ5600: 58.6 dB A)	62.5
Dimensions (LxWxH)(mm)	Size suitable for intended use (predicate Airial MQ5600: 170x135x88 mm)	180x145x105
Weight (lbs)	Weight suitable for intended use (predicate Airial MQ5600: 2.7 lbs)	3.35
Compliance: Electromagnetic Compatibility	Technical compliance with EN 60601-1-2:2007	Technically compliant
Compliance: Electrical Safety	Technical compliance with IEC EN 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007)	Technically compliant

The "study" that proves the device meets these criteria is the "Non-Clinical Test Summary."

2. Sample size used for the test set and the data provenance:

Sample size: Not specified as a "sample size" in the context of patient data. The testing involved one unit of the Ombra* Table Top Compressor to characterize its operating parameters.
Data provenance: Not applicable in the context of clinical data. The tests were conducted internally to characterize the device's physical and electrical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in this context refers to objective measurements of the device's physical and electrical performance, not expert clinical interpretation.

4. Adjudication method for the test set:

Not applicable. There was no human interpretation or adjudication involved in the objective measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a compressor, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a standalone hardware component. Its performance is measured directly, not via an algorithm.

7. The type of ground truth used:

Objective physical and electrical measurements of the device's operating parameters (e.g., pressure, flow rate, current, sound level, temperature ranges) and compliance with recognized safety and EMC standards. Comparisons were made against the specifications of predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, this question is irrelevant.

In summary, the Ombra Table Top Compressor gained clearance through a 510(k) submission based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing and adherence to recognized electrical and electromagnetic compatibility standards.* The "acceptance criteria" were met by showing that its technical specifications were comparable to predicates and that it complied with relevant safety standards, raising no new safety or effectiveness concerns. No clinical performance studies or AI-related evaluations were conducted or required for this type of device.

Summary

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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 International725 Third StreetLondon, Ontario N5V 5G4CANADA
Contact Person	Darryl FischerAssociate 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

* 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.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

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

Section 5 - 510(k) Summary

Characteristics	Ombra* Table TopCompressorCurrent 510(k)Application	Pari Vios Compressor510(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 (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

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Indications for Use

KIJI 881 510(k) Number:

Device Name:

Indications for Use:

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

Regulation Number and Section

§ 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.