The HI-Ox80 is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 |pm. It is a simple device consisting of a central manifold section where the patient mask, oxygen tubing and an oxygen reservoir bag attach. The triple valving in the manifold directs the oxygen to the patient and acts as an anti-asphyxiation valve removing the need for ventilation holes in the mask itself, thus allowing for delivery of high FiO2's.

Oxygen from the supply is either delivered to the patient via a one-way valve (inhalation valve) or stored temporarily in the oxygen reservoir bag. During exhalation, expired gas is directed to the atmosphere via another one-way valve (exhalation valve). In the event the patient's minute ventilation exceeds the oxygen supply flow rate, a third sequential dilution valve allows ambient air to get drawn into the inspired limb of the manifold eliminating the potential for asphyxiation.

The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1,5 cmH,O, typically ~ 1.07 cmH2O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve is specified to be less than 3 cmH2O/U/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.

AI/ML Overview

Here's an analysis of the provided text regarding the Hi-Ox® High FiO2 Mask, focusing on acceptance criteria and the study used to demonstrate compliance.

Hi-Ox® High FiO2 Mask - Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
FiO2 (inspired oxygen concentration)	In excess of 90% and over 80% at all times. The device is intended to deliver "high inspired oxygen concentrations." The documented performance clearly meets this general goal with specific values.
Inhalation one-way valve flow resistance	Less than 1.5 cmH2O at 60 lpm. (Specified design target) Typically ~1.07 cmH2O at 60 lpm. (Actual measurement) 0.025 cmH2O per lpm. (Calculated from typical pressure drop at 60 lpm)
Exhalation one-way valve flow resistance	Less than 1.5 cmH2O at 60 lpm. (Specified design target) Typically ~1.07 cmH2O at 60 lpm. (Actual measurement) 0.025 cmH2O per lpm. (Calculated from typical pressure drop at 60 lpm)
Sequential dilution valve flow resistance	Less than 3 cmH2O/L/sec. (Specified)
Mask fit/seal	Better sealing due to dual straps, lower durometer material, foam, and metal strip at nose bridge. (Subjective description of design improvements)
Anti-asphyxiation capability	Triple valving in the manifold directs oxygen to the patient and acts as an anti-asphyxiation valve, removing the need for ventilation holes in the mask itself. (Design feature) A third sequential dilution valve allows ambient air to get drawn in if patient's minute ventilation exceeds oxygen supply flow rate, eliminating potential for asphyxiation. (Design feature)
Work of breathing	Subjective testing also confirms little or no effort required for breathing through the Hi-Ox® oxygen mask assembly. (Subjective assessment)

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

The document does not explicitly state the sample size for the tests performed. It mentions "experiments conducted using a SensorMedics 229 metabolic measurement system." It does not specify the number of subjects or runs.

The data provenance is not explicitly stated regarding country of origin. The company is SensorMedics Corporation, located in Yorba Linda, CA, USA. This suggests the tests were likely conducted in the USA. The study design appears to be prospective as it describes direct experimentation to measure product performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish a ground truth with regard to the performance metrics (FiO2, flow resistance). The measurements for these criteria seem to be objective, instrument-based readings. For the "work of breathing," subjective testing was performed, but the number or qualifications of individuals providing this feedback are not specified.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the reported performance seems to be based on direct measurements and objective criteria, not on expert consensus or interpretation requiring adjudication.

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

This device is not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This device is a physical medical device (oxygen mask), not an algorithm or software. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

7. The Type of Ground Truth Used

The ground truth for the performance criteria (FiO2, flow resistance) was based on objective, instrument-based measurements. For the "work of breathing," it was based on subjective patient feedback.

8. The Sample Size for the Training Set

This device does not involve machine learning or AI, so there is no training set and therefore no sample size for such a set.

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

As there is no training set, this question is not applicable.

Summary

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JUL 3 0 2002

Koodlus

Appendix 2

Hi-Ox® - Summary of Safety and Effectiveness

Company: Address:

Telephone

SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887 714 283-1830 714 283-8493

Contact:

Fax

Earl Draper

Proprietary Name: Hi-Ox80

Common Name:

High FiO2 Mask

Intended Use:

The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

Description of the Device:

The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1,5 cmH,O, typically ~ 1.07 cmH2O at flow rates of 60 lpm) to minimize the work of breathing. The

SensorMedics

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sequential dilution valve is specified to be less than 3 cmH2O/U/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.

Clinical and Non-Clinical Tests of Equivalency:

Most oxygen masks dilute the inspired oxygen because of two reasons. One is the presence of two entrainment ports on the mask that patients exhaled through and the other is gas leaking due to poor fit of the mask to the face.

On inspiration, these entrainment ports provided a large source of dilution, particularly when the flow path between the inspired reservoir and the mask is of higher resistance than the holes. The Hi-Ox® mask has no holes in the mask thereby eliminating this major source of oxygen dilution.

The Hi-Ox® mask has dual straps (one above and one below the ear) to achieve better sealing between the mask and the face. Additionally, the lower durometer mask material allows the mask to conform better to the face. The use of foam on the inside of the nose bridge portion of the mask and a metal strip further improve the seal across the bridge.

By positioning a sampling port (probe) through a hole on the side of the mask and directly in front of a user's nose, we can monitor the oxygen concentration of the inhaled gas. In experiments conducted using a SensorMedics 229 metabolic measurement system, we have observed FiO, values in excess of 90% and over 80% at all times. These tests are reported in Appendix 7a.

Flow resistance of all the one-way valves employed have been found to be well below the design target of 1.5 cmHzO at flows of 60 lpm, i.e. 0.025 cmH2O per Ipm. Typical pressure drops are in the range of 1.07 cmH2O at 60 lpm. Subjective testing also confirm little or no effort required for breathing through the Hi-Ox® oxygen mask assembly.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2002

Mr. Earl W. Draper Director of RA/OS SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645

Re: K020665

Trade/Device Name: Hi-Ox® High Fi02 Mask Regulation Number: 868.5870 and 868.5570 Regulation Name: Non-Rebreathing Value and Non-Rebreathing Mask Regulatory Class: II and I Product Code: CBP and KGB Dated: July 1, 2002 Received: July 2, 2002

Dear Mr. Draper:

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 such 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.

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.

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Page 2 - Mr. Draper

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timo 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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Appendix 9 Indication for Use

Page 1 1

510(k) Number (if known): K020665

Device Name: Hi-Ox80 High FiO2 Mask

Indications For Use:

The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lott Westerhee

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

SensorMedics

Amendment 1, K020665

Regulation Number and Section

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).