(109 days)
Not Found
No
The document describes a physical mask and headgear for delivering positive airway pressure and does not mention any software, algorithms, or AI/ML components.
No
The device is a mask that channels airflow from a positive airway pressure device; it does not itself generate the therapeutic pressure or treat a condition, but rather acts as an accessory to a therapeutic device.
No
Explanation: The device is described as an interface (mask) for channeling airflow from a positive airway pressure device to a patient. Its purpose is to deliver therapy (airflow), not to diagnose a condition.
No
The device description clearly describes a physical mask and headgear, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Swift FX Nano is a mask that delivers airflow to a patient's nose from a positive airway pressure device. It is an interface for delivering therapy, not a device that analyzes biological samples.
- Intended Use: The intended use is to channel airflow for positive airway pressure therapy, not to diagnose or monitor a condition based on in vitro analysis.
Therefore, based on the provided information, the Swift FX Nano is a respiratory therapy device, not an IVD.
N/A
Intended Use / Indications for Use
The Swift FX Nano channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Swift FX Nano is:
- to be used by patients (>66lb / >30kg) 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 (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Swift FX Nano 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 Nano is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Swift FX Nano is a prescription device supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
patient's nose
Indicated Patient Age Range
patients (> 66 lbs / 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
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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)
Bench testing is sufficient to demonstrate safety and efficacy of the new Swift FX Nano, as was the case with the predicate devices.
Comparison with predicate Ultra Mirage II
The CO2 performance of the new device and the predicate device are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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
Swift FX Nano Traditional 510(k)
| 510(k) SUMMARY
| [As required by 21 CFR 807.92(c)] | MAR 2 9 | |
|---|---|---|
| Date Prepared | March 28th, 2013 | |
| Submitter Name | Mr. Kim Kuan LEE | |
| 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 | Swift™ FX Nano | |
| 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 FX (K090244) | |
| Mirage FX (K102746) | ||
| Ultra Mirage II (K050359) | ||
| Description | The Swift FX Nano 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 Nano is safe when used under the conditions and
purposes intended as indicated in the labeling provided with the
product.
Swift FX Nano is a prescription device supplied non-sterile. | |
| Intended Use | The Swift FX Nano channels airflow noninvasively to a patient
from a positive airway pressure device such as a continuous
positive airway pressure (CPAP) or bilevel device.
The Swift FX Nano is:
to be used by patients (> 66 lbs / 30 kg) for whom positive
airway pressure has been prescribedintended 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 FX
The new device and the predicate mask, provide a seal via
silicone interface. The new device design incorporates a cushion
that seals around the patient's nose whereas the predicate Swift
FX design comprises pillows that seal under the nasal nares. 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 | |
| Technological
Characteristics
comparison | Comparison with predicate Mirage FX
The new device and the predicate Mirage FX mask provide a seal
via a silicone interface that covers over and around the patient's
nose. Both the new and predicate masks are offered in various
cushion sizes to ensure adequate fit over the extended patient
population. | |
| Performance Data | Comparison with predicate Ultra Mirage II
The CO2 performance of the new device and the predicate device
are substantially equivalent. | |
| 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 new Swift FX Nano, as was the case with the
predicate devices. | |
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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 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).
Materials that contact the heated humidified gas pathway are considered to be external communication permanent duration (tissue/bone/dentin). The biological tests for warm wet air path application, in accordance with FDA Guidance #G95-1 were:
- ISO 10993-3 Genotoxicity, .
- ISO 10993-5 Cytotoxicity, .
- ISO 10993-6 Implantation and .
- ISO 10993-10 Sensitisation and Irritation. .
The biological tests for materials considered to have permanent skin contact, in accordance with FDA Guidance #G95-1, were:
- ISO 10993-5 Cytotoxicity .
- ISO 10993-10 Sensitisation and Irritation .
In addition, development of the Swift FX Nano device complies with ISO 14971:2007, Medical devices - Application of risk management to medical devices.
Both the new mask and the predicate device are designed to operate on the same Pillows, Mirage or Swift ResMed flow generator settings. The pressure-flow characteristics and flow impedance of both devices are identical.
Both the new mask and the predicate device can be reused in the home and hospital / institution environment.
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Substantial Equivalence Conclusion
،
-
The new Swift FX Nano is as safe and effective as the predicate devices:
. -
it has the same intended use; י
-
it has identical technological characteristics to the predicate devices;
-
the new device did not raise any new questions of safety or effectiveness;
-
it is at least as safe and effective as the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2013
ResMed Limited C/O Mr. Jim Cassi Vice President Quality Assurance Americas 9001 Spectrum Center Boulevard SAN DIEGO CA 92123
Re: K123789
Trade/Device Name: Swift™ FX Nano Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 22, 2013 Received: February 25, 2013
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer -S for
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
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Enclosure
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Indication for Use
1023789 510(k) Number (if known): Swift™ FX Nano Device Name: Indication for Use
The Swift FX Nano channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Swift FX Nano is:
- to be used by patients (>66lb / >30kg) 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 (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (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) |
|---|
| -------------------------------------------------------- |
| Page 1 of 1 | |
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| 6th Dec, 2012 | Albert E. Moyal (for LS) 17 |
| (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K123789 |