(126 days)
The Oxygen Diverter Valve is an accessory to a CPAP or Bilevel Flow Generator intended to prevent the backflow of oxygen or water when the unit is not operating.
The Oxygen Diverter Valve is an in-line one-way valve that is intended to prevent oxygen or water in the patient circuit from back flowing into a CPAP or Bilevel Flow Generator when the unit is not operating. The Oxygen Diverter Valve incorporates a silicone membrane that seals against the outer housing to vent any backflow to the atmosphere when the pressure drops of the CPAP or Bilevel Flow Generator drops below 2.0cm H20.
The principle of operation is the same as used in the Full Face Mask Anti-asphyxia valve (510(k) number K982530), the difference being in application - in the Full Face Mask, the valve is used to vent CO2 to atmosphere to prevent patient rebreathing.
The ResMed Oxygen Diverter Valve is an accessory designed to prevent the backflow of oxygen or water into a CPAP or Bilevel Flow Generator when the unit is not operating. The device operates by incorporating a silicone membrane that seals against an outer housing, venting any backflow to the atmosphere when the pressure drops below 2.0cm H2O.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a series of performance tests without explicitly stating predefined acceptance criteria with numerical targets. Instead, the "Effectiveness of intended use to prevent oxygen backflow" and "Effectiveness of its intended use to divert water" are considered key criteria, implying successful prevention of backflow. The other tests ensure the device's functional integrity and compatibility with the therapy system.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance |
|---|---|
| Effectiveness of intended use to prevent oxygen backflow | Demonstrated effectiveness |
| Activation and Deactivation Pressure | Tested |
| Deactivation Pressure during Therapy | Tested |
| Pneumatic performance (Impedance added during therapy) | Tested |
| Leak rate and pressure range | Tested |
| Effectiveness of its intended use to divert water | Demonstrated effectiveness |
| Effectiveness of oxygen diversion after wetting | Tested |
| Lifetime testing | Tested |
| Environmental testing | Tested |
| System Compatibility | Tested |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the precise sample size used for each test. It uses the general phrase "Performance testing has been conducted to ensure the safety and effectiveness." There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for the performance tests. Given this is a 510(k) for a medical device accessory, these tests are typically performed in a laboratory setting by the manufacturer, rather than on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to the Remsed Oxygen Diverter Valve. The "ground truth" for this device is based on objective physical measurements and engineering specifications, not expert interpretation of medical images or patient data. The performance tests would be evaluated against established engineering standards and functional requirements.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. For a device like the Oxygen Diverter Valve, the evaluation of performance tests would be based on objective measurements and comparison against predefined technical specifications, typically reviewed and verified by engineering and quality assurance teams, not by an adjudication panel in the medical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of an AI algorithm on human reader performance, particularly in diagnostic imaging or clinical decision-making. The Oxygen Diverter Valve is a passive mechanical accessory, and its function does not involve human interpretation or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of "standalone performance" in the context of an algorithm does not apply here. The device itself is a standalone mechanical accessory. The performance tests conducted evaluated the device's mechanical and pneumatic functionality independently, without human intervention during the measurement phase (though humans operate the testing equipment).
7. The Type of Ground Truth Used:
The "ground truth" for the Oxygen Diverter Valve is based on objective engineering measurements and functional specifications. For example:
- Effectiveness of preventing backflow: Measured by observing if oxygen or water successfully breaches the valve under specific conditions.
- Activation and Deactivation Pressure: Measured using pressure gauges to confirm the valve opens and closes at specified pressure thresholds.
- Leak rate: Measured using flow meters to quantify any gas leakage.
- Impedance: Measured to quantify the resistance the device adds to the airflow during therapy.
These are not based on expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic medical devices.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable to this device. Training sets are used in machine learning or AI development to teach an algorithm patterns. The Oxygen Diverter Valve is a mechanical device, and its design and functionality are based on engineering principles, not on learned data.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this mechanical device, the ground truth establishment for a training set is not applicable.
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APR 2 2 2004
Sponsor:
ResMed Ltd
Oxygen Diverter Valve
Traditional 510(k) Premarket Notification
510(k) SUMMARY—Oxygen Diverter Valve
| Submitter Name: | ResMed Corporation |
|---|---|
| Submitter Address: | 14040 Danielson StreetPoway, CA 92064-6857 |
| Contact Person: | David D'CruzVice President, Regulatory and Clinical Affairs for theAmericas |
| Phone Number: | (858) 746-2238 |
| Fax Number: | (858) 746-2900 |
| Date Prepared: | December 16, 2003 |
| Device Trade Name: | Oxygen Diverter Valve |
| Device Common Name: | Oxygen Diverter Valve |
| Classification Name: | Accessory for Ventilator,Passive exhaust port |
| Predicate Devices: | 1: K963250 Pressure Valve2: K982530 Mirage Full Face Mask |
| Device Description: | The Oxygen Diverter Valve is an in-line one-way valvethat is intended to prevent oxygen or water in the patientcircuit from back flowing into a CPAP or Bilevel Flow |
| Sponsor: | Oxygen Diverter Valve |
| ResMed Ltd | Traditional 510(k) Premarket Notification |
| Generator when the unit is not operating. The OxygenDiverter Valve incorporates a silicone membrane thatseals against the outer housing to vent any backflow tothe atmosphere when the pressure drops of the CPAPor Bilevel Flow Generator drops below 2.0cm H20. | |
| The principle of operation is the same as used in the FullFace Mask Anti-asphyxia valve (510(k) numberK982530), the difference being in application - in theFull Face Mask, the valve is used to vent CO2 toatmosphere to prevent patient rebreathing. | |
| Intended Use: | The Oxygen Diverter Valve is an accessory to a CPAPor Bilevel Flow Generator intended to prevent thebackflow of oxygen or water when the unit is notoperating |
| Device Technological | The device function is the same as the Pressure Valve(K963250), which is to prevent the backflow of oxygenor water when the unit is not operating. The Oxygen |
| Characteristics and | |
| Comparison to | Diverter Valve (ODV) is a simple modification of the |
| Predicate Device(s): | Anti-Asphyxia Valve (AAV) that was FDA cleared as partof the Mirage Full Face Mask 510(k) submission(K982530). The modification is to reverse the genders ofpatient side and flow-generator side connectors to allowthe Oxygen Diverter Valve to be connected, insertedbetween the flow generator and the air tube. This valveis not a medical device in and of itself, but an accessoryto the flow generator system. The Oxygen DiverterValve will be used in combination with an existing T-piece for introduction of supplemental oxygen. |
| Performance Data: | Performance testing has been conducted to ensure thesafety and effectiveness of the Oxygen Diverter Valve.Tests performed include: |
| • Effectiveness of intended use to prevent oxygenbackflow | |
| • Activation and Deactivation Pressure | |
| • Deactivation Pressure during Therapy | |
| • Pneumatic performance characteristics: Impedanceadded during therapy | |
| • Leak rate and pressure range | |
| Sponsor: | Oxygen Diverter Valve |
| ResMed Ltd | Traditional 510(k) Premarket Notification |
| • Effectiveness of its intended use to divert water | |
| • Effectiveness of oxygen diversion after wetting | |
| • Lifetime testing | |
| • Environmental testing, and | |
| • System Compatibility | |
| Conclusion: | Based upon the discussions above, performancestudies, documentation in the appendices, and theproposed device labeling, the Oxygen Diverter Valve issubstantially equivalent to the identified predicatedevices in terms of intended use, safety, andeffectiveness |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2004
Mr. David D'Cruz Resmed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K033914
Trade/Device Name: Oxygen diverter valve, CPAP accessory Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, non-continuous Regulatory Class: II Product Code: BZD Dated: March 12, 2004 Received: March 15, 2004
Dear Mr. D'Cruz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we mare reveal 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to active 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 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 (1 Mr.), it may of backed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device carroe rounder 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 Incan that I Dr nas made statutes and regulations administered by other Federal agencies. of the Act of any I ederal statues and Agenements, including, but not limited to: registration I ou must compry with an all rieves ing (21 CFR Part 801); good manufacturing practice
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Page 2 – Mr. David D'Cruz
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); applicable, the electionic product factation vou to begin marketing your device as described 21 CFR 1000-1030. This letter will affication. The FDA finding of substantial equivalence in your Seculon 510(k) promatics novelicate device results in a classification for your of your device to a conits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific atvice for your do not on the case note the regulation
please contact the Office of Compliance at (301) 594-4646. Also, please note the Vegalation V prease contact the Other of Ochiphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Birman (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Kein Muling
lyon Chiu Lin, Ph.D.
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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Sponsor:
Oxygen Diverter Valve
ResMed Ltd
Traditional 510(k) Premarket Notification
510(k) Number (if known):
Device Name: Oxygen Diverter Valve
Indications for Use:
The Oxygen Diverter Valve is an accessory to a CPAP or Bilevel Flow Generator intended to prevent the backflow of oxygen or water when the unit is not operating.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Alma M. Puito
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KO33914 510(k) Number:
Prescription Use
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Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).