(70 days)
Not Found
No
The summary describes a physical mask and headgear for delivering airflow, with no mention of software, algorithms, or AI/ML terms.
No.
The device acts as an interface to channel airflow from a PAP device, but it is not the therapeutic device itself. The PAP device, which delivers the positive airway pressure, is the therapeutic component.
No
The device, Swift FX, is described as an interface that channels airflow from a PAP device to a patient's nose. Its intended use is to deliver prescribed positive airway pressure, not to diagnose a medical condition.
No
The device description clearly states it is a mask and headgear system that channels airflow, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to channel airflow noninvasively to a patient from a PAP device. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical interface for delivering air, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
- Anatomical Site: The device interacts with the nose, which is an external interface for delivering air, not a site for collecting diagnostic samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any of these functions. It is a medical device used for respiratory therapy.
N/A
Intended Use / Indications for Use
The Swift FX channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Swift FX is:
- to be used by adult patients (> 66 lb/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.
Product codes
BZD
Device Description
The Swift FX provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
Swift FX is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Swift FX is a prescription device supplied nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose
Indicated Patient Age Range
Adult patients (> 66 lb/30 kg)
Intended User / Care Setting
single-patient re-use in the home environment
and multipatient re-use in the 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)
Clinical Data Use of vented nasal 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 Swift FX, as was the case with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Swift LT (K073638), Ultra Mirage II Mask (K050359)
Reference Device(s)
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
RESMED
| | 510(k) SUMMARY
[As required by 21 CFR 807.92(c)] |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 30th, 2009 |
| Official Contact | Mr. Steven Lubke,
Regulatory Affairs Director APR 13 2009 |
| Device Trade Name | Swift™ FX |
| Device Common Name/
Classification Name | Vented Nasal Mask;
Accessory to Noncontinuous Ventilator (IPPB) |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) |
| Predicate Devices | Swift LT (K073638)
Ultra Mirage II Mask (K050359) |
| Description | The Swift FX provides an interface such that airflow from a
positive pressure source is directed to the patient's nose. The
mask is held in place with adjustable headgear that straps the
mask to the face. |
| | Swift FX is safe when used under the conditions and purposes
intended as indicated in the labeling provided with the product. |
| | Swift FX is a prescription device supplied nonsterile. |
| Intended Use | The Swift FX channels airflow noninvasively to a patient from a
positive airway pressure (PAP) device such as a continuous
positive airway pressure (CPAP) or bilevel system.
The Swift FX is:
to be used by adult patients (> 66 lb/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 predicate Swift LT
The new device and the predicate mask, provide a seal via
silicone interface. Both masks are offered in various sizes to
ensure adequate fit over the extended patient population. |
| | Both the masks incorporate vent holes to provide continuous air
leak to flush out and minimize the amount of CO2 rebreathed 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 the masks connect to a conventional air delivery hose
between the mask and the positive airway-pressure source via
standard conical connectors (ref: ISO 5356-1:2004) |
| | Both the masks are constructed using molded plastic and
silicone components and fabric / nylon headgear. All the |
January 30, 2009
18
1
components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1).
Both the new device and the predicate are designed to operate on the same Mirage or Swift ResMed flow generator settings. The pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent.
Both the new device and the predicate device can be reused in the home and hospital / institution environment.
The main differences between Swift FX and Swift LT is in the number of components, their design/geometry and how individual components interface with each other. Both masks are designed and constructed under ResMed's 21 CFR Part 820 compliant Quality Management System.
Clinical Data Use of vented nasal 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 Swift FX, as was the case with the predicate device.
| Performance Data | Comparison with predicate Ultra Mirage II
The CO2 performance of the new device and the predicate
device are substantially equivalent. | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Substantial Equivalence
Conclusion | Swift FX is substantially equivalent to the predicate devices:
-
it has the same intended use;
-
it has similar technological characteristics to both
predicates; -
it does not raise new questions of safety and
effectiveness; | | -
it is at least as safe and effective as the predicate devices Swift LT and Ultra Mirage II
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 text "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 that suggest wings and a body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2009
ResMed Limited C/o Mr. David D'Cruz Resmed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K090244
Trade/Device Name: Swift™ FX Regulation Number: 21 CFR 868.5905 Regulatory Class: II Product Code: BZD Dated: January 30, 2009 Received: February 2, 2009
Dear Mr. D'Cruz:
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 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.
3
Page 2- Mr. D'Cruz
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 device-related 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suom Remm
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "RESMED" in bold, black font. The letters are capitalized and evenly spaced. The font appears to be sans-serif.
Indication for Use
510(k) Number (if known):
Swift™ FX
Indication for Use
Device Name:
The Swift FX channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Swift FX is:
- to be used by adult patients (> 66 lb/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.
Prescription Use X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K090244 |
| Page | 1 of 1 |