The Merits Model N Series Nebulizer Compressors are AC-powered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are used in conjunction with a pneumatic nebulizers to produce fine aerosol mists of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, etc.

Device Description

The Merits Model N Series Nebulizer Compressors consist of AC powered piston-type compressors that generates compressed air. They are small, lightweight and designed for convenience. The piston-type compressor is housed in a plastic cabinet with rubber bumpers. The motor driven piston compressor is connected with a power cord and a switch. The devices contain no microprocessors or other electronic components. They operate from 115VAC/60Hz. Each of them is supplied with tubing, a nebulizer kit and several replaceable filters.

Model N281 and N282 are identical in specifications and components. The only difference is they use different cabinets which are different in size and shape.

When using, the compressor is placed on a flat surface. Air delivery tubing and a nebulizer kit are connected to the outlet hose barb. The air passes the replaceable filter is compressed and delivered to the nebulizer kit through the tubing.

AI/ML Overview

This 510(k) summary describes a Nebulizer Compressor, a device that provides a source of compressed air for pneumatic nebulizers. The context provided is a regulatory submission for a medical device trying to demonstrate "substantial equivalence" to a predicate device. This type of submission generally focuses on comparing the new device's specifications and performance to an already legally marketed device rather than proving novel effectiveness through a new study with strict "acceptance criteria" and "ground truth" as might be found for AI/ML or diagnostic devices.

Given the nature of the device (a nebulizer compressor) and the available document, the questions provided in the prompt are not directly applicable. This document is a 510(k) summary for a relatively simple mechanical device, not a sophisticated diagnostic or AI-driven system. Therefore, concepts like "ground truth," "expert adjudication," "MRMC studies," "training set," and "acceptance criteria" in the way they are typically applied to AI/ML or complex diagnostic devices are not detailed here.

However, I can interpret the document's content to extract what could be considered analogous to acceptance criteria and the "study" that proves it, within the framework of a substantial equivalence submission for this type of device.

Acceptance Criteria and Device Performance for Merits Model N Series Nebulizer Compressor

The "acceptance criteria" for this device are implicitly defined by its performance comparison to a legally marketed predicate device, the SAN UP S.A. Nebulizer Compressor Model: 3050 (K002468). The goal is to demonstrate "substantial equivalence," meaning its characteristics and performance are "basically the same" and "bring forth no new questions of safety and effectiveness."

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Acceptance Criteria Category (Implicit)	Specific Criteria (Implicitly based on Predicate)	Reported Device Performance	Study that Proves it Meets Criteria
AC-Powered Operation	Should operate from 115VAC/60Hz, similar to predicate.	Operates from 115VAC/60Hz.	Comparative Performance Test of Merits N281/N282 Nebulizer Compressor & SanUp Model 3050 Compressor
Filter Material	Use the same or equivalent filter material as predicate.	Contains the same filter material.	Comparative Performance Test
Environmental/Safety/EMC	Meet relevant environmental, safety, and electromagnetic compatibility (EMC) requirements similar to predicate.	Meets Environmental, Safety and EMC requirements.	IEC/UL 60601-1, Medical Electrical Equipment Part1: General Requirements for Safety; IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility
Compressor Operating Pressure Range	Similar compressor operating pressure range as predicate.	Within similar compressor operating pressure range.	Comparative Performance Test
Compressor Flow Range	Similar compressor flow range as predicate.	Within similar compressor flow range.	Comparative Performance Test
Performance Characteristics	Performance characteristics are "basically the same" as the predicate.	Performance characteristics are "basically the same."	Comparative Performance Test
Particle Size Analysis (Nebulization Efficacy)	Produce fine aerosol mists for respiratory therapy, comparable to predicate.	Data from Cascade Impaction Testing for Particle Size Analysis. (Specific values not provided but implied to be acceptable)	Cascade Impaction Testing for Particle Size Analysis
Emission of Harmful Substances	No harmful emissions (VOCs, CO, O3, PM2.5) above acceptable levels.	Emissions (VOCs, CO, O3 & PM2.5) evaluated. (Specific values not provided but implied to be acceptable)	Emission of VOCs, CO, O3 & PM2.5
Intended Use	Aligns with the predicate's intended use for respiratory therapy in home health care.	Intended use matches description for home health care, pneumatic nebulizers, respiratory therapy for children/adults with asthma, allergies, etc.	(Implicit, based on device design and intended use statement)

The study that proves the device meets the acceptance criteria is detailed in Section 9.10, "Performance Data." This section lists various tests performed to demonstrate the device's safety and performance characteristics are substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for the Test Set: Not explicitly stated. For a mechanical device like a nebulizer compressor, "sample size" usually refers to the number of units tested. It's common in such submissions to test a limited number of production units (e.g., 3-5 units) to confirm specifications. The document refers to "Merits N281/N282 Nebulizer Compressor," implying at least one of each model was tested, but does not specify the number of individual units.
Data Provenance (Country of origin, retrospective/prospective): Not specified. The submitter is Merits Health Products Co., LTD. in Taichung, Taiwan R.O.C. It is highly probable that the tests were conducted at their facilities or by a contracted lab, likely in Taiwan or a region that adheres to international testing standards (e.g., IEC/UL). These would be prospective tests performed on the new device designs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This concept is not applicable here. For a nebulizer compressor, "ground truth" is established by direct measurement of physical properties (e.g., pressure, flow, electrical safety, particle size) against established engineering standards and the predicate device's performance, not by expert consensus on interpretations of data (like medical images).
The IEC/UL 60601-1 and IEC 60601-1-2 standards are objective engineering and safety standards. Cascade Impaction Testing and Emission Testing also rely on objective laboratory measurements.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the evaluation relies on objective measurements against engineering standards and comparison to the predicate device's physical specifications and performance, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. MRMC studies are typically performed for diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) and their performance is compared with and without AI assistance. This device is a mechanical air compressor, not a diagnostic tool or an AI-driven system.

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

Not applicable. This device does not have an "algorithm" in the sense of a standalone AI/ML component that performs a function subject to such evaluation. It is a mechanical device.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is objective physical and performance measurements obtained through standardized engineering and safety tests (e.g., IEC/UL standards, comparative performance tests for pressure/flow, cascade impaction for particle size, emission testing). The "truth" is that the device's measured parameters meet safety standards and are "basically the same" as those of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This device does not use an "algorithm" based on AI/ML that requires a training set. Its design and operation are based on established mechanical engineering principles.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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092859 page 1 of 2

9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

9.1 Submitter:

"510(k) SUMMARY"

JUL -- 2 2010

Steve Chao Merits Health Products Co., LTD. 9. Road 36. Taichung Industrial Park Taichung, Taiwan R.O.C. Tel: 886-4-2359-4985 ext. 240 Fax: 886-4-2359-4992 E-mail: stevechao@merits.com.tw

9.2	Date of Preparation:	April 13, 2010
9.3	Trade/Proprietary Name:	Merits Model N Series Nebulizer Compressor
9.4	Common/Usual Name:	Nebulizer Compressor

Classification Name: Portable Air Compressor તે. ક

Comparison to Currently Marketed Devices તે છે. કિ

Both the Merits Model N Series Nebulizer Compressors and the predicate devices are AC-powered, contain the same filter material, meet Environmental, Safety and EMC requirements, and are in the similar compressor operating pressure and flow range. Performance characteristics are basically the same. That is, the Merits Model N Series Nebulizer Compressors are substantially equivalent to the currently marketed SAN UP S.A. Nebulizer Compressor Model: 3050 (K002468).

9.7 Device Description

Model N281 and N282 are identical in specifications and components. The only difference is they use different cabinets which are different in size and shape.

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9.8 intended Use

The Merits Model N Series Nebulizer Compressors are AC-powered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are used in conjunction with pneumatic nebulizers to produce fine aerosol mists of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, etc.

ರಿ ರಿ Technological Characteristics

The Merits Model N Series Nebulizer Compressors operates by using AC-powered motor-driven piston compressor to drive liquid medication via Nebulizer. Compressor type nebulizer has been in use on portable model for many years. Technologies utilized by the Model N Series Nebulizer Compressors bring forth no new questions of safety and effectiveness. These technologies are well established and have been used in other legally marketed products. There are no major technologies differences.

9.10 Performance Data

The Performance & Safety tests performed are summarized in the following.

a. Comparative Performance Test of Merits N281/N282 Nebulizer Compressor & SanUp Model 3050 Compressor
b. IEC/UL 60601-1, Medical Electrical Equipment Part1: General Requirements for Safety,
c. IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility,
d. Emission of VOCs, CO, 03 & PM2.5
e. Cascade Impaction Testing for Particle Size Analysis

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

9.11 Conclusion

Based on the design, performance specifications and intended use, the Merits Model N Series Nebulizer Compressors are substantially equivalent to the currently marketed device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL - 2 2010

Mr. Steve Chao Manager Merits Health Products Company, Limited 9, Road 36, Taichung Industrial Park Taichung China TAIWAN 407

Re: K092859

Trade/Device Name: Merits Model N Series Nebulizer Compressor Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 28, 2010 Received: July 2, 2010

Dear Mr. Chao:

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.

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Page 2- Mr. Chao

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 (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 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/CDRH/CDRHOffices/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,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) File Number:

Device Name:

Merits Model N Series Nebulizer Compressor

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092859

Regulation Number and Section

§ 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).