(100 days)
Not Found
No
The document describes a mechanical device (a CPAP mask) and does not mention any software, algorithms, or data processing that would indicate the presence of AI/ML.
No
This device is an interface (mask) that channels airflow from a positive airway pressure device to the patient; it does not directly provide therapy itself.
No
The device is an interface (a mask) that delivers positive airway pressure from a CPAP or bilevel system. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical mask and headgear system for delivering airflow, not a software application.
Based on the provided information, the Swift FX Bella is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to channel airflow noninvasively to a patient from a positive airway pressure device. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical interface for delivering air to the patient's nose. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The Swift FX Bella is a medical device used for respiratory therapy, specifically for delivering positive airway pressure.
N/A
Intended Use / Indications for Use
The Swift FX Bella 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 Bella 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 Bella is a modified variant of the previously cleared Swift FX. It 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 nasal nares.
Swift FX Bella is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Swift FX Bella 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
patient's 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 studies confirmed that the Swift FX Bella met user requirements of comfort and stability. The CPAP seal performance is equivalent to the primary predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090244, K042403, K050359, K063122, K063011, K072940, K073638
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
DEC - 7 2011
RESMED
Swift FX Bella Special 510(k): Device Modification
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. |
| Secondary predicate
devices | Mirage Swift (K042403), Ultra Mirage II Mask (K050359),
Mirage Quattro (K063122), Mirage Liberty (K063011),
Mirage Micro (K072940), Swift LT (K073638) |
| Technological
Characteristics
comparison | Comparison with primary predicate Swift FX (K090244)
The modified device and the primary 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 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 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) |
19
l
1
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 modified device and the primary predicate device are designed to operate on the same Mirage or Swift ResMed flow generator settings. The pressure-flow characteristics and flow impedance of both the modified device and the predicate device are identical.
Both the modified device and the primary predicate device can be reused in the home and hospital / institution environment.
Use of vented nasal masks with CPAP or Bilevel therapy is proven Clinical Data technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the modified Swift FX Bella, as was the case with the primary predicate Swift FX device.
Clinical studies confirmed that the Swift FX Bella met user requirements of comfort and stability. The CPAP seal performance is equivalent to the primary predicate device.
Performance Data Comparison with primary & secondary predicates The pressure-flow characteristics of the modified Swift FX Bella device is equivalent to the secondary predicate Mirage Swift (K042403).
The CO2 performance of the modified device is equivalent to the secondary predicate Ultra Mirage II (K042403).
The STERRAD 100S and STERRAD NX reuse reprocessing performance is equivalent to the secondary predicates Mirage Quattro (K063122), Mirage Liberty (K063011) and Mirage Micro (K072940).
Silicone headgear material biocompatibility of the modified device is equivalent to the secondary predicate Swift LT (K073638).
Both the modified Swift FX Bella device and the primary predicate Swift FX device (K090244) are designed to operate on the same flow generator settings as specified in the User Guide.
Substantial Equivalence Conclusion
- Modified Swift FX Bella is as safe and effective as the previously cleared predicate devices: it has the same intended use; .
- it has identical technological characteristics to the previously . cleared devices;
- the modified device did not raise any new questions of safety or effectiveness;
- it is at least as safe and effective as the previously cleared devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kim K. Lee Regulatory Affairs Manager ResMed Limited 1 Elizabeth Macarthur Drive Bella Vista Newsouth Wales AUSTRALIA 2153
Re: K112489
Trade/Device Name: Swift™ FX Bella Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: November 4, 2011 Received: November 7, 2011
Dear Mr. Lee:
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.
DEC - 7 2011
3
Page 2 - Mr. Lee
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 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 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,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known): Swift™ FX Bella Device Name: Indication for Use
The Swift FX Bella 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 Bella is:
- to be used by adult 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 | ||
| (Division Sign-Off) | ||
| 26 th Aug, 2011 | Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | 17 | |
| 510(k) Number: | K112489 |