(132 days)
Not Found
No
The summary describes a standard ultrasonic nebulizer and explicitly states that mentions of AI, DNN, or ML were "Not Found".
Yes
The device is designed to aerosolize medications for inhalation, directly providing a therapeutic effect to the patient's lungs.
No
Explanation: The device is described as an ultrasonic nebulizer system designed to aerosolize medications for inhalation, which is a therapeutic function, not a diagnostic one. It does not mention analyzing patient data to diagnose a condition.
No
The device description clearly outlines hardware components such as a mesh screen, power cable, AC adapter, and battery power, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize medications for inhalation by the patient." This describes a device used to deliver medication directly to a patient's respiratory system.
- Device Description: The description details how the device creates an aerosol from liquid medication for inhalation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a medical device used for drug delivery, specifically a nebulizer.
N/A
Intended Use / 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.
Product codes
CAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Pediatric and adult patients
Intended User / Care Setting
Home, hospital, and sub-acute care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
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)
1
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 System | |||
| Model HL 100 | Omron Micro-Air | ||
| Vibrating Mesh Nebulizer | |||
| 510(k) Number | N/A | K081738 | K062263 |
| Indented Use | |||
| Statement | The DDI Ultrasonic | ||
| Nebulizer System is an | |||
| ultrasonic (vibrating mesh) | |||
| nebulizer system designed | |||
| to aerosolize medications | |||
| for inhalation by the patient. | The Ultrasonic Nebulizer | ||
| System is an ultrasonic | |||
| (vibrating mesh) nebulizer | |||
| system designed to aerosolize | |||
| medications for inhalation by | |||
| the patient. | The Ultrasonic Nebulizer | ||
| System is an ultrasonic | |||
| (vibrating mesh) nebulizer | |||
| system designed to | |||
| aerosolize medications for | |||
| inhalation by the patient | |||
| Target | |||
| Population | Pediatric and adult | Pediatric and adult | Pediatric and adult |
| Environment of | |||
| use | Home, hospital, sub-acute | ||
| care | Home, hospital, sub-acute care | Home, hospital, sub-acute | |
| care | |||
| Mode of Operation | |||
| Anatomical Site | Mouth | Mouth | Mouth |
| Mode of | |||
| Operation | Ultrasonic | Ultrasonic | Ultrasonic |
| Energy Type | Electricity | Electricity | Electricity |
| Energy Source | 115 VAC or 2 AA | ||
| Alkaline batteries | 115 VAC or 2 AA Alkaline | ||
| batteries | 115 VAC or 2 AA Alkaline | ||
| batteries | |||
| Battery Life | 4 Hours | 4 Hours | 4 Hours |
| Aerosolization | |||
| Element | Metal Mesh | Metal mesh | Metal Mesh |
| Nebulizing | |||
| method | Vibrating mesh | Vibrating mesh | Vibrating mesh |
| Nebulization | |||
| rate | 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 | |||
| Patient | |||
| Connector | Mouthpiece | ||
| Optional Mask | Mouthpiece | ||
| Optional Mask | Mouthpiece | ||
| Optional 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 (Excluding | ||
| batteries) | 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 | |||
| Nebulizer | |||
| components | |||
| cleanable | Yes | Yes | Yes |
| Materials of Construction | |||
| Materials | Plastic and metal | Plastic and metal | Plastic and metal |
20
2
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.
3
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.
4
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
5
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
le
510(k) Number:
-04307
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