(89 days)
De Vilbiss Atomizer Model 5005
Not Found
No
The device description and intended use describe a mechanical sprayer/atomizer with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
Explanation: The device is intended to apply solutions, not to provide therapy itself. The therapeutic effect comes from the solution being applied (e.g., topical anesthetics), not from the sprayer/atomizer device.
No
The device is described as a sprayer/atomizer for applying solutions to the nose and/or throat, and its intended use focuses on delivery, not on detecting, monitoring, or diagnosing medical conditions.
No
The device description clearly describes a physical, disposable sprayer/atomizer with a reservoir, button, and nozzle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The EZ-Sprayer is intended to apply solutions topically to the nose and/or throat. It is a delivery device for medications or solutions, not a device that analyzes biological samples.
The description clearly indicates its function is to deliver a substance to a specific anatomical site, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
EZ-Sprayer is intended to apply topically by spray or atomizing an oil or water base solution to either the nose and / or throat, for example, topical anesthetics solutions of lidocaine or xylocaine. The device will not be supplied with water or oil base solutions.
Product codes
73 CCQ
Device Description
The disposable, air or gas powered venturi sprayer / atomizer with reservoir and spring loaded flow control button, with an adjustable spray nozzle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nose and / or throat
Indicated Patient Age Range
Child to adults
Intended User / Care Setting
Hospital (Anesthesia, ICU, OR, Cath Lab, Endoscopy, Cardiology, Pulmonolgy, Burn units, General patient wards), physician offices and home care.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
De Vilbiss Atomizer Model 5005 - preamendment
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
0
Intertex Research, Inc.
P.O. Box 90785
Houston, TX 77090
Non-Confidential Summary of Safety and Effectiveness
page 1 of 2 June 24, 1997
Intertex Research, Inc. P.O. Box 90785 Houston, TX 77090
Device Description:
Tel - 281-537-5388
| Official Contact: | John Bullock, Ex. Vice President |
|---|---|
| Proprietary or Trade Name: | EZ Spray |
| Common/Usual Name: | Powered atomizer |
| Classification Name: | Nebulizer, medicinal, non-ventilatory (atomizer) |
| Device: | EZ Spray |
| Predicate Devices: | De Vilbiss Atomizer Model 5005 - preamendment |
The disposable, air or gas powered venturi sprayer / atomizer with reservoir and spring loaded flow control button, with an adjustable spray nozzle.
A disposable, nose or throat atomizer for either oil or water base Indicated Use -solutions. Environment of Use --Hospital, Operating Room (OR), ICU, anesthesia or physician office. Patients requiring a nasal or throat lavage. Patient population --
Comparison to Predicate Devices:
| Attribute | EZ Spray | DeVilbiss Atomizer |
|---|---|---|
| Use | ||
| Intended for lavaging nose and throat | Yes | Yes |
| Atomizing oil and water base solutions | Yes | Yes |
| Environment of use - Hospital, OR, anesthesia, ICU, physician office | Yes | Yes |
| Disposable | Yes | No |
| Attribute | EZ Spray | DeVilbiss Atomizer |
| Design / Theory of Operation | ||
| Venturi design for atomizing solution | Yes | Yes |
| Utilizes air or oxygen to atomizer | ||
| solutions | Yes | Yes |
| Adjustable tip to direct spray up | ||
| or down | Yes | Yes |
| Available to adjust flow / output | Yes | Yes |
| Method of adjusting flow | Spring loaded button | Opening which is manually |
| covered | ||
| Reservoir bottle | Yes | Yes |
| Connection port for air source | Yes | Yes |
| Materials | ||
| Bottle | Polycarbonate | Glass |
| Nozzle assembly | ABS | Metal |
| Performance Standards / Specifications | ||
| Gas or air source is dry, compressed air | ||
| or oxygen | Yes | Yes |
| Plume geometry generally concial | Yes | Yes |
| Operating pressure and flow | ||
| 10 Lpm @ 50 psi | Yes | Yes |
| Delivers a volume of at full flow in | ||
| 60 seconds | 1.9 oz | 2 oz |
1
Non-Confidential Summary of Safety and Effectiveness
(continued)
June 24, 1997
Differences between Other Legally Marketed Predicate Devices
There is no differences between the intended device and the predicate device which would be significant to patient safety or effectiveness. Page 4 of 28
page 2 of 2
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized depiction of a human figure. The figure is composed of three profiles facing right, symbolizing health and human services. The text is arranged in a circular pattern around the figure.
SEP 2 3 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Bullock Intertex Research, Inc. P.O. Box 90785 Houston, Texas 77090
K972397 Re: EZ Sprayer Regulatory Class: I (one) Product Code: 73 CCQ Dated: June 24, 1997 Received: June 26, 1997
. Dear Mr. Bullock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. John Bullock
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Cella
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 3
INDICATIONS FOR USE
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | K972379 |
|---|---|
| Device Name: | EZ Spray |
| Indications for Use: | EZ-Sprayer is intended to apply topically by spray or |
| atomizing an oil or water base solution to either the nose | |
| and / or throat, for example, topical anesthetics solutions of | |
| lidocaine or xylocaine. |
The device will not be supplied with water or oil base
solutions. |
| Contraindications: | Not intended for use for Meter Dose Inhalation agents such
as bronchial dilators and inhaled steroids. |
| Environment of use: | Hospital (Anesthesia, ICU, OR, Cath Lab, Endoscopy,
Cardiology, Pulmonolgy, Burn units, General patient
wards), physician offices and home care. |
| Patient Population: | Child to adults |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ath. A. Ciatt.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
or
Prescription Use
(Per CFR 801.109)
Over-the-counter use Pag: 9 of 28