HI-OX

K020665 · Sensor Medics Corp. · CBP · Jul 30, 2002 · Anesthesiology

Device Facts

• Record ID: K020665
• Device Name: HI-OX
• Applicant: Sensor Medics Corp.
• Product Code: CBP · Anesthesiology
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Hi-Ox80 is a high FiO2 oxygen mask designed to deliver high oxygen concentrations at moderate flow rates (8-10 lpm). Device consists of a central manifold, patient mask, oxygen tubing, and reservoir bag. Triple valving system manages gas flow: inhalation valve directs oxygen to patient; exhalation valve directs expired gas to atmosphere; sequential dilution valve acts as anti-asphyxiation mechanism if patient minute ventilation exceeds supply flow. Mask features soft material, dual straps, foam nose bridge, and metal strip to ensure tight facial seal, minimizing dilution from ambient air. Used in clinical settings; operated by healthcare providers. By eliminating mask ventilation holes and improving facial seal, device achieves FiO2 values >80-90%. Low-resistance valves minimize work of breathing. Output is high-concentration oxygen delivery to patient; clinical benefit is effective oxygen therapy for patients requiring elevated inspired oxygen.

Clinical Evidence

Bench testing only. Experiments conducted using a SensorMedics 229 metabolic measurement system demonstrated FiO2 values in excess of 90% and over 80% at all times. Flow resistance of one-way valves measured at ~1.07 cmH2O at 60 lpm, below the 1.5 cmH2O design target.

Technological Characteristics

Oxygen mask with central manifold, reservoir bag, and triple-valve system (inhalation, exhalation, sequential dilution). Materials: soft mask material, foam nose bridge, metal strip. Sensing/Actuation: passive mechanical valves. Flow resistance: <1.5 cmH2O at 60 lpm. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for patients requiring elevated inspired oxygen concentrations.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Submission Summary (Full Text)

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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 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

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 [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" (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 [phone] or [phone] 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.

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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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

SensorMedics

Amendment 1, K020665

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