The MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, are ACpowered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.

Device Description

These line powered piston compressors are housed in a plastic cabinet (case). The plastic cabinet is the only distinctive component between the three devices, that are identical for all other components, material and characteristics. Dimensions are 4.7 in. x 9.1 x 7.5 in. and weight 3.3 lbs. P3, P4 and P5 units contain no microprocessors or other electronic components. They operate from 115 VAC, 60 Hz. Each unit is supplied with an instruction manual and an accessory kit containing a nebulizer pediatric mask, a mouthpiece.

AI/ML Overview

The provided document describes a 510(k) premarket notification for MED2000 SpA Nebulizer Compressors, Models P3, P4, and P5. This submission focuses on establishing substantial equivalence to a predicate device (Med2000 SpA Nebulizer Compressor, Models P1 and P2). The testing performed is primarily non-clinical, demonstrating safety and effectiveness in accordance with FDA guidance, rather than a study proving specific acceptance criteria related to disease diagnosis or treatment efficacy.

Therefore, many of the requested elements are not applicable to this type of regulatory submission. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (General)	Reported Device Performance (Non-Clinical Testing)
Meet electrical, mechanical, environmental safety and EMC requirements	Testing performed in accordance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND.
Similar compressor operating pressure and flow ranges as predicate	Performance characteristics are basically the same as predicate.
No design characteristics violating Reviewer Guidance requirements or resulting in safety hazards	None of the testing demonstrated any design characteristics that violated requirements or resulted in safety hazards.
Meet relevant requirements of specified testing	Devices met all relevant requirements of the aforementioned testing requirements.

Specific Tests Performed (acting as implicit acceptance criteria for safety and performance):

EPA PM 2.5 Testing
EMC testing
Dielectric Withstand
Current Dispersion Test or Leakage Current Test
Surface Temperature Test
Air Temperature Test
Storage conditions Operating environment extremes
Sinusoidal Vibration Test
Impact Resistance - Drop Test
Fluid Spill Resistance Test

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set for clinical performance, as it primarily relies on non-clinical engineering and performance testing. The "device sample(s) tested" is mentioned, but the exact number isn't quantified. The data provenance is internal testing performed by the manufacturer, MED2000 SpA, or its contracted labs, for regulatory submission purposes, and is inherently "prospective" for the purpose of demonstrating equivalence. The country of origin of the manufacturer is Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a nebulizer compressor, and its performance is evaluated through engineering and safety tests rather than clinical outcomes requiring expert-established ground truth.

4. Adjudication method for the test set
Not applicable. The tests performed are objective engineering and safety measurements, not subjective evaluations requiring adjudication.

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 is a medical device (nebulizer compressor), not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" in the context of its function.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of submission is defined by established engineering standards, regulatory guidance (e.g., FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND), and comparison to the predicate device's known performance for safety and basic operational characteristics. There is no clinical "ground truth" like pathology or outcomes data needed for this 510(k) submission.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable. See point 8.

Summary

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AUG 2 4 2004

EXHIBIT #1

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: Ko41974

Submitter's Identification: 1.

MED2000 SpA Via Dell'Artigianato, 23/25 25080 Padenghe sul Garda - Brescia ltalv Tel: 011 39 030 9907034 Fax:011 39 030 9903786

Date Summary Prepared: July 21, 2004

Contact: Mr. Sandro Rossi, CEO

Name of the Device: 2.

1. MED2000 SpA Nebulizer Compressor, Model P3, with Nebulizer
1. MED2000 SpA Nebulizer Compressor, Model P4, with Nebulizer
1. MED2000 SpA Nebulizer Compressor, Model P5, with Nebulizer

Predicate Device Information: 3.

K# 031908, Med2000 SpA Nebulizer Compressor, Models P1 and P2, with Nebulizer, Med2000 SpA, Italy

Device Description: 4.

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In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. Inlet air to the compressor passes through a replaceable filter.

Intended Use: 5.

The MED2000 SpA Nebulizer Compressors, Models P1, P2 and P3, are ACpowered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.

6. Comparison to Predicate Devices:

The subject devices (P3, P4 and P5) and the predicate devices (P1 and P2) are indicated for the same intended use, meet electrical, mechanical, environmental safety and EMC requirements, and have similar compressor operating pressure and flow ranges. Performance characteristics are basically the same. The differences between the subject devices and predicates are in power consumption and electrical requirements.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the P3, P4 and P5 nebulizer compressors, with Nebulizer Andiflow in the intended environment of use is supported by testing that was conducted in accordance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

Testing included:

EPA PM 2.5 Testing EMC testing Dielectric Withstand Current Dispersion Test or Leakage Current Test Surface Temperature Test Air Temperature Test Storage conditions Operating environment extremes Sinusoidal Vibration Test

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Impact Resistance - Drop Test Fluid Spill Resistance Test

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the MED2000 SpA Nebulizer Compressors P3, P4 and P5, with Nebulizer device sample(s) tested met all relevant requirements of the aforementioned testing requirements.

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

The MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, have the same intended use and similar characteristics as the predicate devices. Moreover, bench testing contained in this submission demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

MED2000 SpA C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard Suite 200 Great Neck, New York 11021

Re: K041974

Trade/Device Name: Med2000 SpA Nebulizer Compressors, Models P3, P4 and P5, With Nebulizer Regulation Number: 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: July 21, 2004 Received: July 26, 2004

Dear Ms. Goldstein-Falk:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Goldstein-Falk

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Chiu Lin, Ph.D.

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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Exhibit #B

Page 1

510(k) Number (if known): KOY 19774

Device Name: Med2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer

Indications For Use:

The Med2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, 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 provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.

Prescription Use V (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFT 807 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:	K041974

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.