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.

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 lpm.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Med2000 SpA Nebulizer, AndyFlow Model A1/C with accessories. This is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way clinical trials or performance evaluations typically do for AI/ML devices. Therefore, a direct answer to your request in the format provided is not fully applicable.

However, I can extract information related to the "acceptance criteria" and "study" as presented within the context of a 510(k) for this specific type of medical device (a nebulizer). For medical devices like nebulizers, "acceptance criteria" are typically related to performance specifications that ensure the device delivers medication effectively, and "studies" are often bench tests demonstrating these performance characteristics.

Here's the information broken down based on your request, with an explanation of why some sections are "Not Applicable" for this type of submission:

Acceptance Criteria and Device Performance for Med2000 SpA Nebulizer, AndyFlow Model A1/C

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance/Findings
Performance (Bench Test)	Nebulizer Particle Characterization Studies at 4 lpm	Revealed no other parameters were affected by changes from predicate. (Implies satisfactory performance).
Performance (Bench Test)	Nebulizer Particle Characterization Studies at 8 lpm	Revealed no other parameters were affected by changes from predicate. (Implies satisfactory performance).
Safety	EPA PM 2.5 Testing	Testing remained unchanged (from predicate), implying satisfactory.
Biocompatibility	ISO 10993 Biocompatibility Testing	Testing remained unchanged (from predicate), implying satisfactory.
Equivalence	Intended Use	Same as predicate: "nebulizes specific inhalable drugs for inhalation by a patient. Can be used with adult or pediatric patients."
Equivalence	Technological Characteristics	Similar to predicate. Differences (labeling change for flow range 4-8 lpm, pressure value deleted) do not raise new safety/effectiveness questions.
Operation Range	Compatible air compressor/air source	May be used with compatible compressors or an air source providing between 4 and 8 lpm.

Explanation: In a 510(k) process for a device like a nebulizer, the "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device. This means showing that the new device performs as intended and is as safe and effective as the predicate. The "reported device performance" demonstrates that these criteria are met, primarily through bench testing in this case.

Detailed Information as Requested:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified for the bench tests. For device performance tests like particle characterization, sample sizes typically refer to the number of devices tested or the number of particle measurements taken, but this level of detail is not provided.
Data Provenance: Not explicitly stated, but the manufacturer is Med2000 SpA, located in Padenghe Sul Garda, Italy. The testing would likely have been conducted by or for the manufacturer. The data is prospective in the sense that the tests were performed specifically for this submission.

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

Not Applicable. For a nebulizer's particle characterization and safety testing (bench tests), "ground truth" is established by validated measurement techniques and adherence to international standards (e.g., ISO 10993). It does not involve expert consensus on subjective observations like in image interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for subjective evaluations typically found in clinical trials or studies involving human interpretation. Bench testing for device performance relies on objective measurements and established protocols.

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 nebulizer, not an AI/ML diagnostic or image analysis tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

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

Not Applicable. This device is a mechanical nebulizer; it does not contain an "algorithm" or operate in a "standalone" computational capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth Type: For the performance tests (Nebulizer Particle Characterization), the "ground truth" is based on objective physical measurements and adherence to recognized standards (e.g., for particle size distribution or nebulization rate). For biocompatibility, it's compliance with ISO 10993 standards. For safety, it's compliance with EPA PM 2.5 standards (though the context here indicates it's related to the device itself and not environmental monitoring).

8. The sample size for the training set

Not Applicable. This device relies on mechanical and physical principles, not a machine learning model. Therefore, there is no "training set."

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

Not Applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary of the "Study" (Non-Clinical Tests):

The "study" performed to demonstrate substantial equivalence consisted of non-clinical bench testing:

Nebulizer Particle Characterization Studies: Conducted at both 4 lpm and 8 lpm flow rates. The purpose was to verify that the nebulizer effectively produces aerosols with appropriate particle characteristics for drug delivery, especially given the new broadened flow range (4-8 lpm). The submission states these tests "revealed that no other parameters were affected," indicating satisfactory performance and equivalence.
EPA PM 2.5 Testing: This test was previously performed for the predicate device and remained unchanged, implying its continued relevance and compliance.
ISO 10993 Biocompatibility Testing: Similar to PM 2.5 testing, this was previously done for the predicate and remained unchanged, demonstrating the materials used in the device are biocompatible.

The overall "study" conducted for this 510(k) was focused on demonstrating that the slight labeling change (flow range) did not negatively impact the performance, safety, or effectiveness of the device compared to its predicate. No clinical studies were deemed necessary ("Not Applicable" for clinical tests).

Summary

{0}------------------------------------------------

JUL 2 0 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:_长64|327

1. Submitter's Identification:

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

Contact: Mr. Sandro Rossi, CEO

Date Summary Prepared: May 17, 2004

2. Name of the Device:

MED2000 SpA Nebulizer, AndyFlow Model A1/C with accessories

3. Predicate Device Information:

K#031908, AndyFlow Nebulizer Model A1/C with accessories, MED2000 SpA, ltalv

4. Device Description:

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

{1}------------------------------------------------

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.

5. Intended Use:

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air source providing between 4 and 8 lpm.

Comparison to Predicate Devices: 6.

The Med200 SpA Nebulizer, and Accessories, Model A1/C (AndyFlow), is substantially equivalent to the K#031908, AndyFlow Nebulizer Model A1/C with accessories, MED2000 SpA, Italy. The difference between the two devices is the labeling change made to the subject device: a flow range between 4 and 8 lpm has been added instead of one value and the pressure value has been deleted.

7.

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

In accordance with the risk analysis testing, the following performance testing was performed:

Nebulizer Particle Characterization Studies at 4 and 8 lpm ranges .
Because the PCS testing revealed that no other parameters were affected, previously performed testing remained unchanged such as:

EPA PM 2.5 Testing ISO 10993 Biocompatibility Testing

8. Discussion of Clinical Tests Performed:

Not Applicable

{2}------------------------------------------------

9. Conclusions:

The Med2000 SpA Nebulizer AndyFlow Model A1/C with Accessories has the same intended use and similar characteristics as the predicate. Moreover, bench testing intoniated in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Med2000 SpA Nebulizer, AndyFlow, Model A1/C with Accessories is substantially equivalent to the predicate device.

{3}------------------------------------------------

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2004

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

Re: K041327

Trade/Device Name: Med2000 SpA Nebulizer Model A1/C (AndyFlow) with Accessories Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 2, 2004 Received: July 6, 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.

{4}------------------------------------------------

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

Sincerely yours.

Shirin Liu, Ph.D.

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

{5}------------------------------------------------

Exhibit B

Page 1

510(k) Number (if known): _ K0Y | 327

Device Name: The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories

Indications For Use:

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 lpm.

Prescription Use X (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:	K041327

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).