EZ SPRAY

K972397 · Intertex Research, Inc. · CCQ · Sep 23, 1997 · Anesthesiology

Device Facts

• Record ID: K972397
• Device Name: EZ SPRAY
• Applicant: Intertex Research, Inc.
• Product Code: CCQ · Anesthesiology
• Decision Date: Sep 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5640
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Disposable, air/gas-powered venturi atomizer; used for topical application of oil or water-based solutions to nose or throat. Components include reservoir bottle, adjustable spray nozzle, and spring-loaded flow control button. Operated by connecting to external dry compressed air or oxygen source (10 Lpm @ 50 psi). Used in hospital settings (OR, ICU, anesthesia, etc.), physician offices, and home care. Healthcare provider directs spray via adjustable tip to deliver solution; aids in topical anesthesia or lavage. Disposable design replaces reusable glass/metal predecessors.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing comparing performance specifications, including plume geometry, operating pressure/flow (10 Lpm @ 50 psi), and delivery volume (1.9 oz vs 2 oz in 60 seconds).

Technological Characteristics

Venturi-based atomizer. Materials: Polycarbonate (bottle), ABS (nozzle assembly). Energy source: External dry compressed air or oxygen. Form factor: Handheld, disposable. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for topical application of oil or water-based solutions (e.g., lidocaine, xylocaine) to the nose or throat in patients ranging from children to adults. Contraindicated for use with Metered Dose Inhalation agents such as bronchial dilators and inhaled steroids.

Regulatory Classification

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.

Predicate Devices

• De Vilbiss Atomizer Model 5005

Submission Summary (Full Text)

{0}------------------------------------------------

K972397

### 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<br>solutions | Yes | Yes |
| Adjustable tip to direct spray up<br>or down | Yes | Yes |
| Available to adjust flow / output | Yes | Yes |
| Method of adjusting flow | Spring loaded button | Opening which is manually<br>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<br>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<br>60 seconds | 1.9 oz | 2 oz |

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## 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

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# 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<br>atomizing an oil or water base solution to either the nose<br>and / or throat, for example, topical anesthetics solutions of<br>lidocaine or xylocaine.<br><br>The device will not be supplied with water or oil base<br>solutions. |
| Contraindications: | Not intended for use for Meter Dose Inhalation agents such<br>as bronchial dilators and inhaled steroids. |
| Environment of use: | Hospital (Anesthesia, ICU, OR, Cath Lab, Endoscopy,<br>Cardiology, Pulmonolgy, Burn units, General patient<br>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