The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03 are intended to provide a source of compressed air for medical purposes, to be used in home health care and hospital use. The Walkie-Neb model is intended to be used only in home health care.

These devices are indicated for use with all commercially available small volume pneumatic nebulizers, to produce a fine aerosol mist of medication for respiratory therapy, for both adult and pediatric patients who have been prescribed inhalation therapy or medication.

Device Description

The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb. FJ03, Q03 and Walkie-Neb are a family of nebulizer compressors intended to be used as compressed air generators for pneumatic nebulizers used by patients for aerosol therapy. There are 7 model families with an AC powered motor (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03) and one model with a DC low voltage motor (Walkie-Neb), with a rechargeable battery pack and an external charger/power supplier.

The 7 AC model families have different plastic housings, which define the model name of the product. Inside they have the same compressor but with different electrical motors, to provide different pneumatic performances.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the nebulizer compressors, focusing on acceptance criteria and the study proving device performance:

1. Acceptance Criteria and Reported Device Performance

For this device, the acceptance criteria are not explicitly stated as numerical thresholds (e.g., "sensitivity must be >90%"). Instead, the core acceptance criterion for these nebulizer compressors is substantial equivalence to their predicate devices based on equivalent operating flow rate and pressure. The study demonstrates this equivalence through performance tests.

Acceptance Criterion	Reported Device Performance
Pneumatic Performance (Operating Flow Rate and Pressure): The new devices must demonstrate equivalent operating flow rate and pressure compared to the identified predicate devices.	Achieved Equivalence: - Flaem Nuova compressors (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03 and Walkie-Neb): Have the same performance, safety, and EMC requirements as the predicate devices. - AC Flaem Nuova compressors (series F700): Have the identical operating pressure and flow ranges as the Respironics Mister Neb compressor (K013027). - AC Flaem Nuova compressors (series F1000 and F1500): Have the identical operating pressure and flow ranges as the Healthdyne Inc. NEBULIZER SYSTEM compressor (K922623). - Walkie Neb Model: Has equivalent operating pressure and flow ranges to the Respironics Mister Neb compressor (K013027).
Intended Use: The new devices must have the same or equivalent intended use as the predicate devices.	Achieved Equivalence: - The Flaem Nuova compressors and the predicate devices (explicitly mentioning Salter Labs, Salter Aire Compressor, K992285) are indicated for the same intended use. - The new devices are intended to provide a source of compressed air for medical purposes, for use with pneumatic nebulizers to produce aerosol mist for respiratory therapy in adult and pediatric patients. This aligns with typical nebulizer compressor intended uses.
Technology/Design: The new devices' technological characteristics should be substantially equivalent to the predicate devices.	Achieved Equivalence: - AC and DC power supply: Same as predicate devices. - Internal Compressor (for AC models F700, F1000, F1500) and electrical motors: Identical or very similar to specific predicate devices, leading to identical performance. - Walkie Neb: Mechanical configuration, batteries, charging system, and accessories are substantially equivalent to Invacare Portable Desktop (K042483).

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

The document does not specify a "test set" in the context of clinical trials involving human subjects or a defined set of performance measurements on a specific number of units in a population study. The performance tests are described as in-house laboratory engineering tests performed by Flaem Nuova on their own devices.

Sample Size: Not specified quantitatively. It likely refers to testing individual units of each model family (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03, and Walkie-Neb) rather than a statistically significant sample size of manufactured devices.
Data Provenance: The tests were conducted by Flaem Nuova, the manufacturer, in Italy. The data is thus retrospective in the sense that it's based on tests already completed on their devices. It is not clinical data from patients.

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

This information is not applicable to this type of device and study. The "ground truth" here is the measured physical performance (flow rate and pressure) of the devices, compared against the known specifications or performance of the predicate devices. This does not involve expert interpretation or subjective assessment of clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Since there is no expert interpretation or human assessment of results where discrepancies might occur, no adjudication method (like 2+1, 3+1) is needed. The performance is measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. This type of study would involve human readers (e.g., clinicians) assessing cases both with and without AI assistance, which is not relevant for a nebulizer compressor. The submission explicitly states: "Clinical data were not required."

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This question is not applicable as the device is a physical medical device (nebulizer compressor), not an AI algorithm. Its performance is inherent to its mechanical and electrical design, not dependent on an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering performance specifications and comparative measurements. Specifically:

The "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993, which outlines the expected performance parameters for such devices.
The known operating flow rate and pressure of the identified predicate devices. The new devices' measurements were compared directly against these established values to demonstrate equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of machine learning for this physical device. The device's design and manufacturing are based on engineering principles, not an iterative learning process from a dataset.

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

This information is not applicable as there is no training set for a physical nebulizer compressor.

Summary

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K062014

MAR 2 2 2007

510(k) Summary for the nebulizer compressors Master Neb, Primo Neb, SC03 , Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-Neb

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:

Contact Person:

FLAEM NUOVA Via Colli Storici 221, 223, 225 S. Martino della Battaglia Brescia 25010 Italy

Maureen O'Connell O'Connell Regulatory Consultants. Inc. 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-207-1246

Summary Preparation Date:

January 30, 2007

Names

Device Name:

The families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and the Walkie-Neb.

Classification Name:

Portable air compressor Regulation number: 868.6250 Product Code: CAF

3. Predicate Devices

The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03 and Walkie-Neb are substantially equivalent to a combination of the following devices:

Respironics, nebulizer compressor MISTER NEB - K013027,
V Healthdyne Inc NEBULIZER SYSTEM K922623,
Invacare PRO, COMPACT e PORTABLE DESKTOP Nebulizer -K042483, and
V Salter Labs SALTER AIRE COMPRESSOR - K992285.

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4. Device Description

5. Indications for Use

These devices are indicated to be used with all commercially available small volume pneumatic nebulizers, to produce a fine aerosol mist of medication for respiratory therapy, for both adult and pediatric patients who have been prescribed inhalation therapy or medication.

6. Performance Data

The performance tests performed by Flaem Nuova, as requested in "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993, demonstrate that Flaem Nuova nebulizer compressors have the same effectiveness as their predicate devices because they have equivalent operating flow rate and pressure. Clinical data were not required.

7. Comparison to Predicate Devices

The Flaem Nuova compressors (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03 and Walkie-Neb) and the predicate devices are indicated for the same intended use (Salter Labs, Salter Aire Compressor, K992285). They have the same AC and DC power supply and meet the same performance, safety and EMC requirements. The AC Flaem Nuova compressors, series F700, have the same compressor, electrical motor and thus the identical operating pressure and flow ranges as the Respironics Mister Neb compressor (K013027). The AC Flaem Nuova compressors series F1000 and F1500 have the same compressor, electrical motor and thus the identical operating pressure and flow ranges as the Healthdyne Inc. NEBULIZER SYSTEM compressor (K922623). The Walkie Neb Model has

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mechanical configuration, batteries, charging system and accessories which are substantially equivalent to the configuration of the Invacare Portable Desktop (K042483). Concerning the operating pressure and flow ranges, the Walkie Neb has the equivalent performance to the Respironics Mister Neb compressor (K013027).

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Image /page/3/Picture/1 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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Flaem Nuova S.P.A. C/O Ms. Maureen O' Connell Regulatory Consultant O' Connell Regulatory Consultants, Incorporated 5 Timber Lane North Reading, Massachusetts 01864

MAR 2 2 2007

Re: K062014

Trade/Device Name: Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03 and WalkieNeb Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 5, 2007 Received: March 7, 2007

Dear Ms. O' Connell:

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. O' Connell

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely 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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Indications for Use

510(k) Number (if known):

Device Name: Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03 and Walkie-Neb

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 and of simmel Hossellist, Comici, Land Streetses

510(K) FILE

Page viii

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).