The NebSonic N550 Nebulizer delivers nebulized medication for patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic is indicated for adult, pediatric, and neonatal patients.

Device Description

The NebSonic N550 Nebulizer is an ultrasonic nebulizer designed to deliver nebulized medication to patients being mechanically ventilated without affecting ventilator performance or patient data. It is powered by external AC (100-240 volts), allowing its use with patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic N550 Nebulizer contains piezoelectric crystal that generates ultrasonic vibrations that travel through distilled water in a vial to liquid medication in a medication cup. The vibrations convert the medication into an aerosol mist. The nebulized medication is carried to the patient by the gas traveling through the ventilator breathing circuit.

AI/ML Overview

The provided text describes a 510(k) submission for the Newport NebSonic N550 Ultrasonic Nebulizer, a traditional 510(k) submission (K041082). The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's efficacy through a clinical study with acceptance criteria in the typical sense.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific "acceptance criteria" in terms of clinical or performance benchmarks (e.g., a specific percentage improvement in a clinical outcome, or a defined accuracy threshold for a diagnostic device). Instead, it states that:

"Testing was conducted to characterize particle size and drug mass generated by the NebSonic N550 Nebulizer in comparison to a predicate device. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use."

This implies that the "acceptance criteria" were met if the device's particle size and drug mass characteristics were comparable or within an acceptable range relative to the predicate device. However, the specific numerical criteria for "comparable" are not provided.

Acceptance Criteria (Implied)	Reported Device Performance
Particle size generation comparable to predicate device.	"Characterized... in comparison to a predicate device." (Specific values not provided)
Drug mass generation comparable to predicate device.	"Characterized... in comparison to a predicate device." (Specific values not provided)
Meets specifications.	"Provides assurance that the device meets its specifications." (Specific specifications not provided)
Safe and effective for intended use.	"Provides assurance that the device... is safe and effective for its intended use." (Conclusion based on testing)

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

The document mentions "thoroughly evaluated at the unit and system level" and "comprehensive testing," but it does not specify the sample size for any test set. The data provenance is also not explicitly stated as retrospective or prospective, or country of origin. Given the nature of a medical device submission for a nebulizer, it's highly likely that this testing involved in vitro laboratory experiments on a sample of manufactured devices, rather than human subjects or a clinical study.

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

This information is not applicable and not provided in the document. The "ground truth" for a nebulizer's performance typically comes from direct measurements using specialized equipment (e.g., laser diffraction for particle size, gravimetric analysis for drug mass), not expert consensus in the way a diagnostic imaging study would require.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication is relevant for subjective assessments, typically in clinical trials or diagnostic studies. For objective performance metrics like particle size and drug mass, direct measurement is performed.

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

This information is not applicable. The NebSonic N550 is an ultrasonic nebulizer, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this device.

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

This information is not applicable. The device is an ultrasonic nebulizer, a physical medical device for drug delivery, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance (particle size and drug mass) would have been established through direct experimental measurements in a laboratory setting, using standardized methodologies for nebulizer characterization. This is an objective measurement, not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product directly performing its function, not a machine learning model that requires a training set.

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

This information is not applicable. As it's not an AI/ML device, there is no training set or ground truth for such a set.

Summary of the Study:

The study described for the NebSonic N550 Nebulizer was a device performance characterization study primarily focused on demonstrating substantial equivalence to existing predicate devices. It involved:

In vitro testing of the nebulizer's performance.
Measured parameters: particle size and drug mass generation.
Comparison to predicate devices (Siemens Servo Ultra Nebulizer, Models 145 and 345; Puritan-Bennett EasyNeb Nebulizer).
Compliance with various industry recognized standards (IEC 60601-1-2:1993, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011:1998 &A1:1999) for electrical safety and electromagnetic compatibility.

The 510(k) clearance (K041082) indicates that the FDA found this testing and comparison sufficient to determine that the NebSonic N550 Nebulizer is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use. The documentation provided focuses on the regulatory submission process for a traditional medical device, not a diagnostic or AI-powered system, which would necessitate different evaluation methodologies.

Summary

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Traditional 510(k)

K041082

SECTION 11. 510(k) SUMMARY SEP - 7 2004

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name, Address, Phone and Fax Number of the Applicant A.

Newport Medical Instruments, Inc. 760 West 16th Street, Building N Costa Mesa, California 92627 Telephone: (949) 642-3910 Fax: (949) 645-5026

B. Contact Person

Richard Waters Vice President, Regulatory Affairs / Quality Assurance 760 West 16th Street, Building N Costa Mesa, California 92627 Telephone: (949) 642-3910 Fax: (949) 645-5026

C. Date Prepared

April 23, 2004

Device Name D.

Newport NebSonic N550 Ultrasonic Nebulizer

Device Description E.

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mist. The nebulized medication is carried to the patient by the gas traveling through the ventilator breathing circuit.

Device Intended Use F.

Traditional 510(k)

Substantial Equivalence Summary G.

The NebSonic N550 Nebulizer is substantially equivalent to the Siemens Servo Ultra Nebulizer, Models 145 and 345, cleared under K960854, and the Puritan-Bennett EasyNeb Nebulizer, cleared as an accessory to the Puritan-Bennett 700 Series Ventilator under K990897.

H. Device Testing

The NebSonic N550 Nebulizer has been thoroughly evaluated at the unit and system level. Comprehensive testing has been conducted on the NebSonic N550 Nebulizer in accordance with various industry recognized standards, including: IEC 60601-1-2:1993. CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011:1998 &A1:1999. Testing was conducted to characterize particle size and drug mass generated by the NebSonic N550 Nebulizer in comparison to a predicate device. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes on its wing, symbolizing service, knowledge, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2004

Mr. Richard Waters Vice President, Regulatory Affairs/Quality Assurance Newport Medical Instruments, Incorporated 760 West 16th Street, Building N Costa Mesa, California 92627

Re: K041082

Trade/Device Name: NebSonic N550 Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 31, 2004 Received: August 31, 2004

Dear Mr. Waters:

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 - Mr. Waters

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,

Clive Lin, 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

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Indications for Use

510(k) Number (if known): __ K041082

Device Name: NebSonic N550 Nebulizer________________________________________________________________________________________________________________________________________

Indications for Use:

The NebSonic N550 Nebulizer delivers nebulized medication for patients on mechanical The NebSonic NSS o Noodized dearrers tee teentilator. The NebSonic is indicated for adult, pediatric, and neonatal patients

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)

Anne Taylor

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:

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(Posted November 13, 2003)

CONFIDENTIAL

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).