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 Description

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 solutions.

AI/ML Overview

The provided text describes the "EZ Spray" powered atomizer and its substantial equivalence to a predicate device, the DeVilbiss Atomizer Model 5005. It does not contain information about a study proving the device meets acceptance criteria in the manner typically associated with AI/ML device evaluations (i.e., performance metrics, sample sizes, ground truth establishment, or expert reviews).

The document is a 510(k) submission summary for a medical device (EZ Spray) and focuses on demonstrating substantial equivalence to a pre-amendment predicate device, the DeVilbiss Atomizer Model 5005. The "acceptance criteria" here refer to design and performance specifications intended to show that the EZ Spray functions similarly to the predicate, and these are compared directly against the predicate device's characteristics rather than against a predefined set of independent performance benchmarks with associated statistical studies for standalone or human-assisted AI.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of medical device submission.

Here's the relevant information that can be extracted, framed within the requested structure where possible, and noting where information is not applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device. The "reported device performance" is the EZ Spray's characteristics, which are claimed to be equivalent.

Attribute/Acceptance Criteria (based on Predicate)	Reported Device Performance (EZ Spray)
Use
Intended for lavaging nose and throat	Yes
Atomizing oil and water base solutions	Yes
Environment of use - Hospital, OR, anesthesia, ICU, physician office	Yes
Disposable	Yes
Design / Theory of Operation
Venturi design for atomizing solution	Yes
Utilizes air or oxygen to atomize solutions	Yes
Adjustable tip to direct spray up or down	Yes
Available to adjust flow / output	Yes
Method of adjusting flow (Spring loaded button)	Yes
Reservoir bottle	Yes
Connection port for air source	Yes
Materials
Bottle (Polycarbonate)	Polycarbonate
Nozzle assembly (ABS)	ABS
Performance Standards / Specifications
Gas or air source is dry, compressed air or oxygen	Yes
Plume geometry generally concial	Yes
Operating pressure and flow (10 Lpm @ 50 psi)	Yes
Delivers a volume of liquid at full flow in 60 seconds (approx. 2 oz)	1.9 oz

2. Sample sized used for the test set and the data provenance

Sample Size: Not applicable. This is not an AI/ML device. The "test set" in this context refers to the device itself being compared against a predicate, not a dataset for performance evaluation.
Data Provenance: Not applicable. The comparison is based on the functional and material characteristics of the EZ Spray and the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the comparison is the established characteristics and performance of the predicate device.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There was no need for adjudication as the comparison was made against the known properties of the predicate device.

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

MRMC Study: No. This is not an AI-assisted device. Therefore, no MRMC study or effect size calculation for human readers with/without AI assistance was performed.

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

Standalone Performance Study: Not applicable. This device is a mechanical atomizer, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: The "ground truth" used for this submission is the established characteristics, materials, and performance specifications of the predicate device (DeVilbiss Atomizer Model 5005), which was pre-amendment and legally marketed. The submission asserts that the EZ Spray is substantially equivalent to this predicate based on these established attributes.

8. The sample size for the training set

Training Set Size: Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not applicable. There is no training set for this type of device.

Summary

{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 atomizersolutions	Yes	Yes
Adjustable tip to direct spray upor down	Yes	Yes
Available to adjust flow / output	Yes	Yes
Method of adjusting flow	Spring loaded button	Opening which is manuallycovered
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 airor 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 in60 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 oratomizing an oil or water base solution to either the noseand / or throat, for example, topical anesthetics solutions oflidocaine or xylocaine.The device will not be supplied with water or oil basesolutions.
Contraindications:	Not intended for use for Meter Dose Inhalation agents suchas bronchial dilators and inhaled steroids.
Environment of use:	Hospital (Anesthesia, ICU, OR, Cath Lab, Endoscopy,Cardiology, Pulmonolgy, Burn units, General patientwards), 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 _

Prescription Use
(Per CFR 801.109)

Over-the-counter use Pag: 9 of 28

Regulation Number and Section

§ 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.