(63 days)
Not Found
No
The description focuses on the physical components and function of a mask system for positive airway pressure therapy, with no mention of AI or ML.
No.
The device description clearly states it is an "accessory used for channelling air-flow [...] to a patient from a positive airway pressure device such as Continuous Positive Airway Pressure (CPAP) or bilevel system." This indicates it is a component of a therapeutic system rather than a therapeutic device itself.
No
A diagnostic device is used to identify or detect a disease or condition. The Quattro Air Mask System is an accessory used for delivering airflow from a positive airway pressure device for treatment, not for diagnosis.
No
The device description clearly states it is an externally placed mask covering the mouth and nose, held in place with adjustable headgear, which are physical hardware components. The performance studies also focus on physical and mechanical testing of the mask.
Based on the provided information, the Quattro Air Mask System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Quattro Air Function: The Quattro Air Mask System is a non-invasive accessory that channels air-flow to a patient for respiratory therapy (CPAP/bilevel). It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for delivering air-flow for positive airway pressure therapy, not for diagnostic testing.
- Device Description: The description focuses on its physical function of providing a seal and delivering pressure, not on analyzing biological samples.
Therefore, the Quattro Air Mask System falls under the category of a respiratory therapy device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Quattro Air is:
- to be used by patients (> 66 lbs / 30 kg) for whom positive airway pressure has been prescribed
- intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
The Quattro Air Mask System is a non-invasive accessory used for channelling air-flow (with or without supplemental oxygen) to a patient from a positive airway pressure device such as Continuous Positive Airway Pressure (CPAP) or bilevel system.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Quattro Air is an externally placed mask covering the mouth and the nose of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and/or mouth. It is held in place with an adjustable headgear that straps the mask to the face.
Quattro Air is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Quattro Air is a prescription device supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth and nose
Indicated Patient Age Range
patients (> 66 lbs / 30 kg)
Intended User / Care Setting
Home environment and hospital/institutional environment.
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)
Non-Clinical Testing Data:
- CO2 performance testing: The CO2 performance of the new device was tested to ensure the mask design provides adequate venting to flush out the expired CO2. The testing included physical and functional dead-space measurements. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
- Anti-Asphyxia Valve (AAV) performance testing: The Anti-Asphyxia Valve (AAV) performance was tested to ensure the patient can continue to breathe fresh air if ever the airflow from the flow generator is impeded. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
- Pressure-flow characteristics and through impedance testing: The pressure-flow characteristics and through impedance of the mask were tested to ensure clinicians are able to prescribe the appropriate therapy using the new device. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
- Mechanical integrity and performance testing: The mechanical integrity and performance of the new device was tested during normal use and reasonable abuse scenarios. The device was also tested to demonstrate that the mask can withstand the effects of storage temperature, humidity and transportation shock & vibration. The device satisfied the pass/fail criteria based on defined system specifications and FDA Guidance and was shown to be substantial equivalent to the predicate devices.
- Validation of cleaning: Validation of the cleaning of the device was completed to establish that the device can be safely reused by a single patient, or used for multipatient re-use in the hospital/institutional environment following validated disinfection protocols. After 20 cycles of cleaning/disinfection in accordance with the methods described in the cleaning/disinfection guide, the device has been shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
- Biocompatibility testing: In accordance with the present version of ISO 10993-1, all externally communicating components with either prolonged (24 hours - 30 days) or permanent (>30 days) tissue contact were validated with cytoxicity, sensitization, irritation, genotoxicity and implantation tests as required. Components with skin contact underwent cytotoxicity, sensitization and irritation testing. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
Clinical Data:
- Use of vented masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the new Quattro Air mask, as was the case with the predicate devices.
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.
Mirage Quattro (K063122), Mirage FX (K102746), Ultra Mirage FFM (K023244)
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
§ 868.5905 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).
0
K123979
Quattro Air
Traditional 510(k)
| | 510(k) SUMMARY
[As required by 21 CFR 807.92(c)] | FEB 2 7 2013 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date Prepared | February 25th, 2013 | |
| Submitter Name | Mr. Jean-Nicolas Boudaud | |
| Official Contact | Mr. Jim Cassi
Vice President - Quality Assurance Americas
9001 Spectrum Center Blvd
San Diego CA 92123 USA
Tel: (858) 836 6081 | |
| Device Trade Name | QuattroTM Air | |
| Device Common Name/
Classification Name | Vented Full Face Mask;
Accessory to Noncontinuous Ventilator (IPPB) | |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) | |
| Predicate Devices | Mirage Quattro (K063122)
Mirage FX (K102746)
Ultra Mirage FFM (K023244) | |
| Description | The Quattro Air is an externally placed mask covering the mouth
and the nose of the patient. It provides a seal such that positive
pressure from a positive pressure source is directed to the
patient's nose and/or mouth. It is held in place with an adjustable
headgear that straps the mask to the face.
Quattro Air is safe when used under the conditions and purposes
intended as indicated in the labeling provided with the product.
Quattro Air is a prescription device supplied non-sterile. | |
| Intended Use | The Quattro Air is:
- to be used by patients (> 66 lbs / 30 kg) for whom positive
airway pressure has been prescribed - intended for single-patient re-use in the home environment
and multipatient re-use in the hospital/institutional
environment. | |
| Technological
Characteristics
comparison | Comparison with the predicate Mirage Quattro
The new device and the predicate mask, provide a seal around
the nose and the mouth via silicone interface. Both masks are
offered in various sizes to ensure adequate fit over the extended
patient population.
Both masks incorporate vent holes to provide continuous air leak
to flush out and minimize the amount of CO2 re-breathed by the
patient. The design of the mask components is such that the
incorporation of these vent-holes does not interfere with the
intended performance of the masks.
Both masks contain an anti-asphyxia valve (AAV) to enable the | |
RESMED
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patient to breathe fresh air in the event that airflow from the flow generator is impeded.
Both masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors.
Both masks are constructed using molded plastic and silicone components and fabric / nylon headgear. All the components of both masks are fabricated using materials deemed safe. (ref. ISO 10993-1).
Both the new mask and the predicate device are designed to operate on the same "Mir Full" or "Full Face" ResMed flow generator settings. The pressure-flow characteristics and flow impedance of both devices are very similar.
Both the new mask and the predicate device can be reused in the home and hospital / institution environment.
The main differences between Quattro Air and the predicate mask Mirage Quattro are in the number of components, their geometry and how individual components interface with each other. These technological characteristics do not impact the fundamental operating principle of the device nor its therapeutic effect. Performance data is available to show that no new questions of safety or efficacy have been raised as a result of these differences.
Technological Characteristics comparison
Non-Clinical Testing Data
Comparison with predicate Mirage FX
The construction of the Quattro Air mask components and the way they interface with each other are very similar to that of the predicate device Mirage FX.
Comparison with predicate devices
The CO2 performance of the new device was tested to ensure the mask design provides adequate venting to flush out the expired CO2. The testing included physical and functional dead-space . measurements. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
The Anti-Asphyxia Valve (AAV) performance was tested to ensure the patient can continue to breathe fresh air if ever the airflow from the flow generator is impeded. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
The pressure-flow characteristics and through impedance of the mask were tested to ensure clinicians are able to prescribe the appropriate therapy using the new device. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
The mechanical integrity and performance of the new device was tested during normal use and reasonable abuse scenarios. The
2
RESMED
device was also tested to demonstrate that the mask can withstand the effects of storage temperature, humidity and transportation shock & vibration. The device satisfied the pass/fail criteria based on defined system specifications and FDA Guidance and was shown to be substantial equivalent to the predicate devices.
· Validation of the cleaning of the device was completed to establish that the device can be safely reused by a single patient, or used for multipatient re-use in the hospital/institutional environment following validated disinfection protocols. After 20 cycles of cleaning/disinfection in accordance with the methods described in the cleaning/disinfection guide, the device has been shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
In accordance with the present version of ISO 10993-1, all externally communicating components with either prolonged (24 hours - 30 days) or permanent (>30 days) tissue contact were validated with cytoxicity, sensitization, irritation, genotoxicity and implantation tests as required. Components with skin contact underwent cytotoxicity, sensitization and irritation testing. The device satisfied the pass/fail criteria and was shown to be substantial equivalent to the predicate devices.
Clinical Data
Use of vented masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the new Quattro Air mask, as was the case with the predicate devices.
Substantial Equivalence Conclusion
The new Quattro Air is as safe and effective as the predicate devices:
- it has the same intended use; -
- it has identical technological characteristics to the । predicate devices;
- it does not raise any new questions of safety or effectiveness;
- it is at least as safe and effective as the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2013
ResMed Limited C/O Mr. Jim Cassi Vice President - Quality Assurance Americas ResMed Corporation 9001 Spectrum Canter Boulevard SAN DIEGO CA 92123
Re: K123979
Trade/Device Name: Quattro Air Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 18, 2012 Received: December 26, 2012
Dear Mr. Cassi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/4/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a stylized font. The name is written in black, with the letters "O" and "U" having a unique design. The letters are surrounded by a geometric pattern that adds a decorative element to the image.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Quattro Air Traditional 510(k)
Indications for Use
510(k) Number (if known): K123979
Device Name:
Quattro Air
Indications For Use:
The Quattro Air Mask System is a non-invasive accessory used for channelling air-flow (with or without supplemental oxygen) to a patient from a positive airway pressure device such as Continuous Positive Airway Pressure (CPAP) or bilevel system.
The Quattro Air Mask System is:
- . to be used by patients (weighing >66 lb/30 kg) for whom positive airway pressure therapy has been prescribed.
- intended for single patient re-use in the home environment and multi-patient re-use in ● the hospital/institutional environment ..
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Chan O. Lee -S | 2013.02.25 15:22:29 |
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| -05'00' For LS |
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(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number Dec. 2012
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