The Med2000 SpA Nebulizer Compressors, Models P1 and P2, are AC-powered air compressors, with adapter, 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.

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients.

Device Description

Med2000 SpA Nebulizer Compressors, Models P1 and P2: The two models (P1 and P2) differ only in minor cosmetic aspects of their shape that have no effect on performance or safety. These piston compressors are housed in a compact, irregularly-shaped white-plastic housing. Dimensions are: 60" x 4.7" x 2.4" for both compressors, and weigh 1.1 lbs. Neither models contain microprocessors. A "power cube" transformer (Med2000 Class 2 power unit) plugs into a wall outlet (2-blade plug) and provides 16 VAC to the motor via a thin 2-conductor cord that plugs into the compressor. The compressors are supplied with compatible patient tubing (2 meters), and will be marketed with a compatible medication nebulizer and respective instruction manuals.

Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories: The Nebulizer, Model A1/C (AndyFlow), is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device operates on the Venturi principle and is refillable. It is manufactured using polypropylene plastics, injection molded and is intended for single patient use. The Nebulizer, Model A1/C (AndyFlow), has several attachments that are used with the nebulizer during the nebulization process. The attachments include a mouthpiece, a 2 meter connecting tube (which connects to the lower part of the nebulizer opposite the mouthpiece), a pediatric breathing mask and an adult breathing mask. These are standard accessories for nebulizer devices. The Nebulizer, Model A1/C (AndyFlow), is a hand-held pneumatically powered nebulizer that consists of a nebulizer top that is screwed into a nebulizer cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. The device consists of a nebulizer portion (which forms and conveys an aerosol) and a reservoir portion (which contains non-aerosolized drug).

AI/ML Overview

The provided text describes a 510(k) summary for Med2000 SpA Nebulizer Compressors and Nebulizer, aiming to demonstrate substantial equivalence to predicate devices, rather than establishing new acceptance criteria or conducting a study to prove performance against specific acceptance criteria.

The document discusses comparisons to predicate devices based on "similarities and differences" in characteristics and lists "performance testing" conducted. However, it does not define explicit acceptance criteria or report performance against such criteria in the way a study proving device meeting acceptance would. Furthermore, it explicitly states "Discussion of Clinical Tests Performed: Not Applicable".

Therefore, I cannot extract the requested information in the format of a table of acceptance criteria and reported device performance or details about study design elements like sample sizes, expert qualifications, or adjudication methods, as this information is not present in the provided text.

Based on the provided text, here's what can be stated about the device and its testing:

Device: Med2000 SpA Nebulizer Compressors, Models P1 and P2, with Nebulizer, and Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories.

Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria or prove performance against a new set of acceptance criteria.

"Acceptance Criteria" (Implicit from Substantial Equivalence and Performance Testing):
While not formally presented as "acceptance criteria," the submission implies that the device's performance should be comparable to or not raise new questions of safety or effectiveness relative to the predicate devices. The non-clinical tests performed serve to demonstrate this comparability.

"Reported Device Performance" (Implicit from Non-Clinical Tests and Comparison):
The document lists "performance testing" conducted, but it doesn't provide specific quantitative results for the Med2000 device or a direct comparison to acceptance criteria. Instead, it states that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

Unable to Provide Due to Lack of Information in the Text:

A table of acceptance criteria and the reported device performance: This document is a 510(k) summary for substantial equivalence, not a detailed performance study with explicit acceptance criteria. Performance data against specific criteria is not presented.
Sample size used for the test set and the data provenance: Not applicable, as this was a non-clinical bench testing submission, not a study involving human subjects or data sets in the way a clinical study would.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 not an AI device or a comparative effectiveness study involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this was non-clinical bench testing against established engineering and safety standards, and comparison to predicate device characteristics.
The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Text:

Non-Clinical Tests Performed (as a proxy for demonstrating equivalence/ "meeting implicit criteria"):
- EPA PM 10 Testing
- Nebulizer Particle Characterization Studies
- ISO 10993 Biocompatibility Testing
- Maximum pressure and flow under various conditions (temperatures, line voltage, storage)
- Fluid Spill Resistance
- Maximum Surface and Air Temperatures
- Sinusoidal Vibration
- Impact (drop) Resistance
- Leakage Current and Dielectric Withstand (Electrical Safety)
- EMC Testing
Clinical Tests Performed: Not Applicable (explicitly stated)
Conclusion: The bench testing demonstrated that any technological differences do not raise new questions of safety or effectiveness, leading to a finding of substantial equivalence to the predicate devices.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string is oriented diagonally, running from the lower-left to the upper-right corner of the image. The characters are written in a simple, somewhat childlike style, with thick, uneven lines. The string appears to read "K031908".

JAN 1 4 2004

Attachment #2

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 510(k) number is:________________________________________________________________________________________________________________________________________________

Submitter's Identification: 1.

Med2000 SpA Via dell'Artigianato, 23/25 25080 Padenghe Sul Garda, (BS) ITALY

Contact:

Mr. Sandro Rossi CEO

Date Summary Prepared:

January 9, 2004

2. Name of the Device:

1. Med2000 Nebulizer Compressor, Model P1, with Nebulizer
1. Med2000 Nebulizer Compressor, Model P2, with Nebulizer
1. Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories

Predicate Device Information: 3.

1. K#013027, Mister Neb ™ Nebulizer Compressor, with Nebulizer, Model HS123, Respironics Healthscan, Inc., Cedar Grove, NJ
1. K#961476, Salter Labs Ultramist Nebulizer, 8960 Series, Salter Labs, Arvin, CA
1. K#014056, Salter Labs Modified Ultramist Nebulizer, Salter Labs, Arvin, CA
1. K#021742, Galemed Neb-Easy Nebulizer, Galemed Corp., Temecula, CA

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4. Device Description:

Med2000 SpA Nebulizer Compressors, Models P1 and P2: .

The two models (P1 and P2) differ only in minor cosmetic aspects of their shape that have no effect on performance or safety. These piston compressors are housed in a compact, irregularly-shaped white-plastic housing. Dimensions are: 60" x 4.7" x 2.4" for both compressors, and weigh 1.1 lbs. Neither models contain microprocessors. A "power cube" transformer (Med2000 Class 2 power unit) plugs into a wall outlet (2-blade plug) and provides 16 VAC to the motor via a thin 2-conductor cord that plugs into the compressor. The compressors are supplied with compatible patient tubing (2 meters), and will be marketed with a compatible medication nebulizer and respective instruction manuals.

Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories: .

The Nebulizer, Model A1/C (AndyFlow), is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing.

This device operates on the Venturi principle and is refillable. It is manufactured using polypropylene plastics, injection molded and is intended for single patient use.

The Nebulizer, Model A1/C (AndyFlow), has several attachments that are used with the nebulizer during the nebulization process. The attachments include a mouthpiece, a 2 meter connecting tube (which connects to the lower part of the nebulizer opposite the mouthpiece), a pediatric breathing mask and an adult breathing mask. These are standard accessories for nebulizer devices.

The Nebulizer, Model A1/C (AndyFlow), is a hand-held pneumatically powered nebulizer that consists of a nebulizer top that is screwed into a nebulizer cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. The device consists of a nebulizer portion (which forms and conveys an aerosol) and a reservoir portion (which contains non-aerosolized drug).

5. Intended Use:

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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.

Comparison to Predicate Devices: 6.

Nebulizer Compressors:

The Med2000 SpA Nebulizer Compressors, Models P1 and P2 (difference between models is body shape only) is substantially equivalent to the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123, K#013027, Respironics Healthscan, Inc., Cedar Grove, NJ. This predicate device was cleared with the same indications for use as our device.

Table 1, below, outlines similarities and differences between our nebulizer compressor and the predicate device, as follows:

CHARACTERISTICS	MED 2000 SpANEBULIZERCOMPRESSORS WITHNEBULIZER	MISTER NEB™NEBULIZERCOMPRESSOR WITHNEBULIZER
Model	P1 and P2	HS123
Dimensions	6.0" x 4.7" x 2.4" *	7.48" x 7.08" x 4.3"
Weight	2.3 lbs.	3.2.lbs
Electrical Requirements	115 VAC/16 VAC (withAC/AC adapter) 60 Hz	115 VAC/ 60 Hz
Power Consumption	23 watts	81 watts
Maximum CompressorPressure	29 psig	29 psig
Maximum Flow	15 Ipm	Not Available
Typical Performance withNebulizer (AverageCompressor Flow Rate)	9.0 lpm @ 6 psig	8.0 lpm @ 10 psig
Power Indicator	NO	NO
Intensity Control	NO	NO
Intensity Indicator	NO	NO

TABLE 1: NEBULIZER COMPRESSOR COMPARISON CHART

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On/Off Switch	YES	YES
Without AC/AC Adapter

Nebulizer:

The Med200 SpA Nebulizer, and Accessories, Model A1/C (AndyFlow), is substantially equivalent to the Salter Labs Ultramist Nebulilzer, Model 9860 Series, K#961476 and K#014056, Salter Labs, Aruin, Ca, and, the Galemed Neh-Easy Nebulizer, K#021742, Galemed Corp, Temecula, CA. These predicate devices were cleared with the same indications for use as our device.

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

The following performance testing was conducted:

EPA PM 10 Testing .
Nebulizer Particle Characterization Studies .
ISO 10993 Biocompatibility Testing .
Maximum pressure and flow under all combinations of the following: .
- Temperatures of +5º C and +20º C, and 40º C with 90% RH
  - Line voltage of 95, 115 and 132 V
  - Storage at -20º C and at +60º C
  - Fluid Spill Resistance C.
  - Maximum Surface and Air Temperatures ರ.
  - Sinusoidal Vibration e.
  - Impact (drop) Resistance ت
  - Leakage Current and Dielectric Withstand (Electrical Safety) ದಿ.
EMC Testing .

Discussion of Clinical Tests Performed: 8.

Not Applicable

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9. Conclusions:

The Med2000 SpA Nebulizer Compressors, Models P1 and P2, with Nebulizer, and, a separate Nebulizer, to be known as the Med2000 SpA Nebulizer, Model A1/C soparate NoballED), to sories have the same intended use and similar characteristics as the predicate. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of any allettiveness. Thus, the Med2000 SpA Nebulizer Compressors, Models P1 and P2, with Nebulizer, and, a separate Nebulizer, to be known as the Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories is substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or flowing lines. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2004

Mcd2000 SpA c/o Ms. Susan D. Goldstein-Falk mdi Consultants 55 Northern Blvd Suite 200 Great Neck. New York 11021

K031908 Re:

Trade Name: Med2000 Nebulizer Compressor, Model P1, with Nebulizer Med2000 Nebulizer Compressor, Model P2, with Nebulizer Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories Regulation Number: 21 CFR 868.5630 Regulation Namc: Nebulizer (Direct Patient Interface) Regulatory Class: II Product Code: CAF, BTI Dated: October 22, 2003 Received: October 23, 2003

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 micrate commerce prior to was as 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 നിം Federal I vou, Drug, und Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (1 MA), it may be subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be roundsh further announcements concerning your device in the Ecderal Register.

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Page 2 - Ms. Susan D. 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 mean that 227 mas made statutes and regulations administered by other Federal agencies. or the Act of any 1 each a the Act' s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ibuing (= = = = = 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), rt you deems specifical 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

Sincerely vours,

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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Attachment #1

Page __ 1 __ of __ 1

510(k) Number (if known): _(03(409)

Device Name: Med2000 SpA Nebulizer Compressors, Models P1 and P2, with Nebulizer, and, Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories

Indications For Use:

Prescription Use Use (Per 21 CFR 801 Subpart D) Over-The Counter

OR (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-On)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number.__

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).