The Hi-Ox® High FiO2 Mask with the Aerosol Adapter is intended as an accessory for compatible nebulizers. The mask with adaptor is intended to enable the delivery of nebulized drugs to patients who also require elevated inspired oxygen concentrations.

Device Description

The Aerosol Adapter for the Hi-Ox® is an adapter that enables standard small-volume nebulizers (use only cup type, gas driven nebulizers without tee-fittings or air entrainment ports) with either 18 mm OD or 22 mm ID outlet ports to be adapted to the Hi-Ox®. This will enable patients to be treated with nebulized products while receiving high concentrations of oxygen at moderate flow rates of 8 -10 lpm. The valves in the Hi-Ox® have been tested and found to function normally after nebulization of some commonly nebulized drugs in aqueous formulations. However, the valves could malfunction if the prescribed drug creates a sticky residue on the valves. The practitioner should observe the patient's respiration and the function of the Hi-Ox valves during and after nebulization of drugs via the Hi-Ox80. The Aerosol Adapter is a simple right angle fitting made of Santoprene, a medical grade thermoplastic elastomer material. The adapter can be snapped into a normally plugged port on the Hi-Ox® just below the mask and between the inhalation-exhalation valves. This location for the adapter places nothing between the nebulizer and the patient's airway so as to not impact any of the particles produced by the nebulizer. The qas driving the nebulizer can supplement the normal oxygen supply for the Hi-Ox®, and any flow in excess of what is required by the patient can exit the mask via the normal exhalation pathway. There is no risk of pressure buildup beyond that of the cracking pressure and flow resistance of the exhalation valve (~ 1 cmH2O/L/sec). This enables the patient to receive their nebulizer treatments while maintaining an elevated FiO2.

AI/ML Overview

This document describes the Hi-Ox® High FiO2 Oxygen Mask with the Aerosol Adapter, a Class II medical device. The information provided focuses on its safety and effectiveness, leading to its clearance by the FDA. As such, the "study" referenced in the prompt may not be a traditional clinical trial but rather a series of non-clinical tests and a comparison to predicate devices, which is common for 510(k) clearances.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with corresponding device performance metrics. Instead, it describes a "design target" for flow resistance and the results of nebulization tests.

Acceptance Criteria (Design Target)	Reported Device Performance
Flow resistance < 1.5 cmH2O at 60 lpm	Typical pressure drops are in the range of 1.07 cmH2O at 60 lpm.
Valves function normally after nebulization of commonly nebulized aqueous drugs	Testing of up to 2.5 hours of continuous nebulization indicates that nebulization of specific drugs (Albuterol Sulfate, Ipratropium Bromide, Cromolyn Sodium) has no material impact on valve performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of human subjects or a clinical study. The tests described are non-clinical, focusing on device mechanics and material compatibility.

The data provenance is from non-clinical tests conducted by SensorMedics Corporation. There is no mention of country of origin for any human data, as no human data is presented for performance testing. All data is retrospective to the submission date of December 9, 2003.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the document describes non-clinical engineering and material compatibility tests, not evaluations by medical experts to establish ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human-based test set or ground truth requiring adjudication described. The tests are laboratory-based measurements and observations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The device is an accessory to an oxygen mask and nebulizer, and the evaluation focuses on its mechanical performance and compatibility rather than its impact on diagnostic interpretation or a human reader's performance.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device is a physical medical accessory, not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this device.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on the physical characteristics and performance of the device itself as measured in a laboratory setting. This includes:

Measured flow resistance of the one-way valves.
Observed functionality of the valves after exposure to nebulized pharmaceutical solutions.

8. Sample Size for the Training Set

This information is not applicable as no "training set" for an algorithm or a clinical study is described. The device is a physical product, not an AI or machine learning system.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8. No training set or associated ground truth establishment process for a training set is mentioned.

Summary

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SMDA Summary: ର)

Hi-Ox® High FiO2 Oxygen Mask with the Aerosol Adapter - Summary of Safety and Effectivenesss

Company:	SensorMedics Corporation
Address:	22705 Savi Ranch Parkway
	Yorba Linda, CA 92887
Telephone:	714 283-2228
Fax:	714 283-8426

Contact:

Yvette Lloyd

Proprietary Name:

Hi-Ox® High FiO2 Oxygen Mask with the Aerosol Adapter

Common Name:

Oxygen Mask with Nebulizer Adapter

Intended Use:

The Hi-Ox® High FiO2 Mask with the Aerosol Adapter is intended as an accessory for compatible nebulizers. The mask with adaptor is -intended to enable the delivery of nebulized drugs to patients who also require elevated inspired oxygen concentrations.

Description of the Device:

The Aerosol Adapter is a simple right angle fitting made of Santoprene, a medical grade thermoplastic elastomer material. The adapter can be snapped into a normally plugged port on the Hi-Ox® just below the mask and between the inhalation-exhalation valves. This location for

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the adapter places nothing between the nebulizer and the patient's airway so as to not impact any of the particles produced by the nebulizer.

The qas driving the nebulizer can supplement the normal oxygen supply for the Hi-Ox®, and any flow in excess of what is required by the patient can exit the mask via the normal exhalation pathway. There is no risk of pressure buildup beyond that of the cracking pressure and flow resistance of the exhalation valve (~ 1 cmH2O/L/sec). This enables the patient to receive their nebulizer treatments while maintaining an elevated FiO2.

Clinical and Non-Clinical Tests of Equivalency:

Most aerosol adapters, which are considered as Class I devices, connect a nebulizer either directly to a disposable aerosol mask or via a right-angle adapter to a mouthpiece. The Aerosol Adapter for the Hi-Ox 0 is equivalent to a right-angle adapter that connects a nebulizer to a mask. The Aerosol Adapter for the Hi-Ox80 would have the same effects on nebulizer performance as any other tee-fitting for nebulizer connections.

Flow resistance of all the one-way valves in the Hi-Ox® employed have been found to be well below the design target of <1.5 cmH2O at flows of 60 lpm, (i.e. 0.025 cmH2O per lpm): "Typical pressure drops are in the range of 1.07 cmH2O at 60 lpm. Testing of up to 2.5 hours of continuous nebulization of commonly nebulized aqueous solutions (i.e., Albuterol Sulfate, Ipratropium Bromide and Cromolyn Sodium) indicates that nebulization of these drugs have no material impact on the performance of the valves within the Hi-Ox® and therefore imposes no increase in risk to the patient.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or waves, arranged in a cascading manner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 2004

Mr. Paul Kittinger Manager, Regulatory Affairs SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645

Re: K032516

Trade/Device Name: Hi-OX 80 Aerosol Adapter Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 9, 2003 Received: December 11, 2003

Dear Mr. Kittinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mayor 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 Interside commerce proces that have been reclassified in accordance with the provisions of Amendments, of to are , 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 approvisions of the Act. The general controls provisions of the Act include controls provided by 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 such additional controls. Existing major regulations affecting (1 Mr), it may of badyers in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device A may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kittinger

Please be advised that F.DA'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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

hiu Lin, Ph

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

Ko32516 510{k) Number (if known):

Hi-Ox® High FiO2 Mask with the Aerosol Adapter Device Name:

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

CAWh

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

Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________

510(k) Number: K032516

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).