(27 days)
Not Found
Not Found
No
The device description focuses on mechanical components (valves, mask material, straps) and their physical properties (flow resistance, seal). There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies describe physical measurements and subjective testing, not algorithmic performance.
Yes
The device is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen, indicating a therapeutic purpose.
No
Explanation: The device is an oxygen mask designed to deliver high concentrations of oxygen for therapeutic purposes, not to diagnose a condition or disease.
No
The device description clearly outlines a physical oxygen mask with a manifold, reservoir bag, and valves, indicating it is a hardware device.
Based on the provided information, the Hi-Ox® High FiO2 Mask is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen." This describes a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details a mechanical device for delivering oxygen and managing airflow. It does not involve the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in these samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed to directly interact with the patient's respiratory system to provide oxygen, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.
Product codes (comma separated list FDA assigned to the subject device)
CBP, KGB
Device Description
The Hi-Ox® is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 lpm. 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 cmH,O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve's resistance is specified to be less than 3 cmH2O/I/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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, the oxygen concentration of the inhaled gas can be monitored. In experiments conducted using a SensorMedics 229 metabolic measurement system, we observed FiO2 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 cmH,O at flows of 60 lpm, i.e. 0.025 cmHJO per lpm. Typical pressure drops are in the range of 1.07 cmHJ,O at 60 lpm. Subjective testing also confirm little or no effort required for breathing through the Hi-Ox® oxygen mask assembly.
The valve flow resistance performance after exposure to extreme storage temperatures has been found to be unchanged from room temperature. This validation was completed with the help of a nationally recognized test laboratory (NRTL) and following the established ASTM F920 test protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
- SMDA Summary:
Hi-Ox® - Summary of Safety and Effectiveness
| Company: | SensorMedics Corporation |
|---|---|
| Address: | 22705 Savi Ranch Parkway |
| Yorba Linda, CA 92887 | |
| Telephone | 714 283-1830 |
| Fax | 714 283-8493 |
Contact:
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-Ox® is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 lpm. 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 cmH,O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution
SensorMedics
Special 510(k) Submission Addition of Pediatric Mask to HiOX80
1
valve's resistance is specified to be less than 3 cmH2O/I/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, the oxygen concentration of the inhaled gas can be monitored. In experiments conducted using a SensorMedics 229 metabolic measurement system, we observed FiO2 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 cmH,O at flows of 60 lpm, i.e. 0.025 cmHJO per lpm. Typical pressure drops are in the range of 1.07 cmHJ,O at 60 lpm. Subjective testing also confirm little or no effort required for breathing through the Hi-Ox® oxygen mask assembly.
The valve flow resistance performance after exposure to extreme storage temperatures has been found to be unchanged from room temperature. This validation was completed with the help of a nationally recognized test laboratory (NRTL) and following the established ASTM F920 test protocols.
SensorMedics
2
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2003
Mr. Earl W. Draper Director of Quality Systems & Regulatory Affairs SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887
Re: K030943
Trade/Device Name: Hi-Ox® High FiO2 Mask Regulation Number: 868.5870 Regulation Name: Non-Rebreathing Valve Regulatory Class: II Product Code: CBP and KGB Dated: March 24, 2003 Received: March 26, 2003
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.
3
Page 2 - Mr. Draper
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. 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.
Supr Ruass
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications For Use Enclosure:
Indication for Use
Page of 1
510(k) Number (if known): Ko30943
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)
SAWutroh
on of Anesthesiology. General Hospital. Infection Control, Dental D
510(k) Number:
SensorMedics
Special 510(k) Submission Addition of Pediatric Mask to HiOX®º