The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.

Device Description

The DDI Ultrasonic Nebulizer System is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen nebulizers. The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies and provide fine particles to the patient's lungs. The DDI Ultrasonic Nebulizer System is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries.

AI/ML Overview

Here's an analysis based on the provided text, outlining the acceptance criteria and the study details for the DDI Ultrasonic Nebulizer System:

The provided document (K090307) is a 510(k) summary for a Medical Device. For 510(k) submissions, the primary "study" is often a comparison of technical characteristics and performance to a legally marketed predicate device, rather than a traditional clinical trial with acceptance criteria for new device performance metrics. The goal of a 510(k) is to demonstrate substantial equivalence, not necessarily to prove absolute efficacy or safety with new, independent studies.

Therefore, the "acceptance criteria" for this device are implicitly the performance specifications and safety standards met by its predicate devices, and the "study" is the comparison against those predicates to establish substantial equivalence.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in the document. Instead, the DDI Ultrasonic Nebulizer System is deemed acceptable because its performance parameters are "statistically identical" to the predicate devices. The table below presents the key performance characteristics reported for the new device and its predicates, implying that matching or being substantially similar to these predicate values constitutes acceptance.

Parameter	Acceptance Criteria (Implied by Predicate A)	Reported Device Performance (DDI Ultrasonic Nebulizer System)
Intended Use	Aerosolize medications for inhalation	Aerosolize medications for inhalation
Target Population	Pediatric and adult	Pediatric and adult
Environment of Use	Home, hospital, sub-acute care	Home, hospital, sub-acute care
Anatomical Site	Mouth	Mouth
Mode of Operation	Ultrasonic	Ultrasonic
Energy Type	Electricity	Electricity
Energy Source	115 VAC or 2 AA Alkaline batteries	115 VAC or 2 AA Alkaline batteries
Battery Life	4 Hours	4 Hours
Aerosolization Element	Metal Mesh	Metal Mesh
Nebulizing Method	Vibrating mesh	Vibrating mesh
Nebulization Rate	0.2 ml/min (Predicate A) / 0.25 ml/min (Predicate B)	0.2 ml/min
Particle Size (MMAD)	Approx 5 microns	Approx 5 microns
Patient Connector	Mouthpiece, Optional Mask	Mouthpiece, Optional Mask
Patient Interface	Hand-held	Hand-held
Use	Single patient	Single patient
Dimensions (in)	4.3" x 2.2" x 1.7" (Predicate A)	4.3" x 2.2" x 1.7"
Weight	98 grams (Excluding batteries) (Predicate A)	98 grams (Excluding batteries)
Portable	Yes	Yes
Reservoir (mL)	8 ml maximum (Predicate A)	8 ml maximum
Ultrasonic Nebulizer	Yes	Yes
Nebulizer components cleanable	Yes	Yes
Materials of Construction	Plastic and metal	Plastic and metal
Electrical Safety	Meets IEC 60601:1988 + A1:1991 + A2:1996, EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, EN 60 601-1-2:2001	Meets the same standards

Study Details Proving Acceptance

The "study" for this 510(k) submission is primarily a nonclinical comparison of technical characteristics and performance against two legally marketed predicate devices:

Omron Micro-Air Vibrating Mesh Nebulizer (K062263)
Health & Life Co. Ultrasonic Nebulizer System Model HL 100 (K081738)

The conclusion states that "All of the performance parameters of the devices are statistically identical, and do not raise any new safety or efficacy." This forms the basis of the substantial equivalence determination.

Sample size used for the test set and data provenance:
- The document does not describe a clinical "test set" in the traditional sense of patient data. The evaluation appears to be based on bench testing of the device's technical specifications and electrical safety.
- Data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing as part of their regulatory submission. The data is retrospective in the sense that it's comparing a new device against established predicate device specifications, and the testing of the new device likely occurred prior to the submission date.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there was no "test set" requiring expert ground truth in the context of diagnostic interpretation. Ground truth for device performance parameters (e.g., nebulization rate, particle size) would have been established through standardized engineering and laboratory testing protocols.
Adjudication method for the test set:
- Not applicable, as there was no "test set" requiring human adjudication in the context of interpretation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a MRMC comparative effectiveness study was not done. This submission is for a medical device (nebulizer) that delivers medication, not a diagnostic imaging or screening tool that would involve human readers interpreting cases.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is a physical medical device (nebulizer), not an algorithm or AI system. Its performance is inherent to its design and mechanical/electrical operation.
The type of ground truth used:
- The "ground truth" for the device's performance characteristics (e.g., nebulization rate, particle size, battery life, dimensions) would have been established through laboratory measurements and engineering specifications. For electrical safety, the ground truth is defined by compliance with the referenced international standards (IEC 60601, EN 60601-1, EN 60 601-1-2).
The sample size for the training set:
- Not applicable. This device is not an AI or machine learning system, so there is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not applicable as there is no training set.

Summary

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K090307

510(k) Summary 807.92(c)

JUN 18 2009

SPONSOR

807.92(a)(1)

Company Name:

Company Address

Diagnostic Devices Inc.

93030 Harris Corner Parkway Suite 450 Charlotte, NC 28269

Telephone: Fax:

704-285-6400 704-285-6475

Rick Admani Contact Person:

Summary Preparation Date: February 5, 2008

DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

DDI Ultrasonic Nebulizer System Nebulizer Nebulizer (Direct Patient Interface) CFR21 868,5360 CAF Class II

PREDICATE DEVICE

807.92(a)(3)

807.92(a)(4)

Legally Marketed Equivalent Device 510(k) # Product Company Micro Air Vibrating Mesh Nebulizer K062263 Omron Healthcare Inc. Ultrasonic Nebulizer System Model HL 100 K081738 Health & Life Co., Ltd.

DEVICE DESCRIPTION

DEVICE INTENDED USE

807.92(a)(5)

Indicated Use: The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.

807.92(a)(2)

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Patient Population: The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.

Environment of Use: Home, hospital, and sub-acute care

Contraindications: None

COMPARISON OF TECHNICAL CHARACTERISTICS 807,92(a)(6)

Parameters	New Device	Predicate Device	Predicate Device
Device Name	DDI Ultrasonic Nebulizer System	Health & Life Co.Ultrasonic Nebulizer SystemModel HL 100	Omron Micro-AirVibrating Mesh Nebulizer
510(k) Number	N/A	K081738	K062263
Indented UseStatement	The DDI UltrasonicNebulizer System is anultrasonic (vibrating mesh)nebulizer system designedto aerosolize medicationsfor inhalation by the patient.	The Ultrasonic NebulizerSystem is an ultrasonic(vibrating mesh) nebulizersystem designed to aerosolizemedications for inhalation bythe patient.	The Ultrasonic NebulizerSystem is an ultrasonic(vibrating mesh) nebulizersystem designed toaerosolize medications forinhalation by the patient
TargetPopulation	Pediatric and adult	Pediatric and adult	Pediatric and adult
Environment ofuse	Home, hospital, sub-acutecare	Home, hospital, sub-acute care	Home, hospital, sub-acutecare
Mode of Operation
Anatomical Site	Mouth	Mouth	Mouth
Mode ofOperation	Ultrasonic	Ultrasonic	Ultrasonic
Energy Type	Electricity	Electricity	Electricity
Energy Source	115 VAC or 2 AAAlkaline batteries	115 VAC or 2 AA Alkalinebatteries	115 VAC or 2 AA Alkalinebatteries
Battery Life	4 Hours	4 Hours	4 Hours
AerosolizationElement	Metal Mesh	Metal mesh	Metal Mesh
Nebulizingmethod	Vibrating mesh	Vibrating mesh	Vibrating mesh
Nebulizationrate	0.2 ml/min	0.2 ml/min	0.25 ml/min
Particle Size(MMAD)	Approx 5 microns	Approx 5 microns	Approx 5 microns
User Interface
PatientConnector	MouthpieceOptional Mask	MouthpieceOptional Mask	MouthpieceOptional Mask
Patient Interface	Hand-held	Hand-held	Hand-held
Use	Single patient	Single patient	Single patient
Physical Description
Dimensions (in	4.3" x 2.2" x 1.7"	4.3" x 2.2" x 1.7"	4.1" x 2.1" x 1.5"
Weight	98 grams (Excludingbatteries)	98 grams (Excluding batteries)	97
Portable	Yes	Yes	Yes
Reservoir (mL)	8 ml maximum	8 ml maximum	7 ml maximum
Ultrasonic	Yes	Yes	Yes
Nebulizer
Nebulizercomponentscleanable	Yes	Yes	Yes
Materials of Construction
Materials	Plastic and metal	Plastic and metal	Plastic and metal

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NONCLINICAL AND CLINICAL TEST 807.92(b)

Electrical Safety

The electrical performance of the DDI Ultrasonic Nebulizer System meets the requirements of the following standards:

IEC 60601: 1988 + A1: 1991 + A2: 1996 EN 60601-1:1990 +A1: 1993 + A2: 1995 +A13: 1996 EN 60 601-1-2:2001

CONCLUSION

807.92(b)(3)

The DDI Ultrasonic Nebulizer System and the predicate devices use a micro pore mesh vibrating at ultrasonic frequencies to produce aerosol. All of the performance parameters of the devices are statistically identical, and do not raise any new safety or efficacy. All devices are similar in:

Intended Use .
Materials ●
Design ●
Technological Characteristics .

The DDI Ultrasonic Nebulizer System introduces no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

JUN 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diagnostic Devices Incorporated C/O Mr. E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K090307

Trade/Device Name: DDI Ultrasonic Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 5, 2009 Received: March 20, 2009

Dear Mr. Smith:

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 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. Smith

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Curre

Susan Runner, D.D.S., M.A. Acting Division 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: DDI Ultrasonic Nebulizer System

Indications for Use:

The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.

The device may be used with pediatric and adult patients in the home, hospital, and subacute care settings.

Prescription Use ﺳﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Schultz

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

-04307

Page _ of _

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).