(100 days)
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.
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.
The provided document is a 510(k) summary for a device modification (Swift FX Bella) and focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific acceptance criteria and detailed performance measurements for the modified device. Therefore, much of the requested information cannot be extracted directly from this document.
However, based on the available text, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the modified device as pass/fail thresholds in a quantitative table. Instead, it relies on demonstrating equivalence to predicate devices for various performance aspects.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Comfort and Stability (User Requirements) | Met user requirements. | "Clinical studies confirmed that the Swift FX Bella met user requirements of comfort and stability." |
| CPAP Seal Performance | Equivalent to the primary predicate device (Swift FX). | "The CPAP seal performance is equivalent to the primary predicate device." |
| Pressure-Flow Characteristics | Equivalent to the secondary predicate device (Mirage Swift, K042403) and identical to the primary predicate (Swift FX). | "The pressure-flow characteristics of the modified Swift FX Bella device is equivalent to the secondary predicate Mirage Swift (K042403)." "The pressure-flow characteristics and flow impedance of both the modified device and the predicate device [Swift FX] are identical." |
| CO2 Performance | Equivalent to the secondary predicate device (Ultra Mirage II, K042403). | "The CO2 performance of the modified device is equivalent to the secondary predicate Ultra Mirage II (K042403)." |
| STERRAD 100S and STERRAD NX Reprocessing Performance | Equivalent to secondary predicates (Mirage Quattro, K063122; Mirage Liberty, K063011; Mirage Micro, K072940). | "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)." |
| Biocompatibility (Silicone headgear material) | Equivalent to the secondary predicate device (Swift LT, K073638). | "Silicone headgear material biocompatibility of the modified device is equivalent to the secondary predicate Swift LT (K073638)." |
| Compatibility with Flow Generator Settings | Designed to operate on the same settings as the primary predicate (Swift FX). | "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." |
| Materials Safety | All components fabricated using materials deemed safe (per ISO 10993-1). | "All the components of both masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical studies confirmed that the Swift FX Bella met user requirements," but does not provide details on the sample size used for these clinical studies or the data provenance (e.g., country of origin, retrospective/prospective nature). It primarily relies on bench testing and comparison to predicate devices, stating "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."
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. Since the testing primarily involved bench testing and demonstrating equivalence to existing predicate devices, the concept of "experts establishing ground truth" in the context of diagnostic accuracy doesn't directly apply in the way it would for an AI algorithm interpreting medical images. The "clinical studies" mentioned for user comfort and stability would have involved users/patients, but details are absent.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted (or at least, not described in this document). The device is a physical nasal mask, not an AI-based diagnostic tool where human readers would improve with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the Swift FX Bella is a physical medical device (nasal mask), not an algorithm or AI.
7. Type of Ground Truth Used
For the aspects where "clinical studies" were vaguely mentioned (comfort and stability), the "ground truth" would be subjective user feedback. For other performance aspects (pressure-flow, CO2, reprocessing, biocompatibility), the "ground truth" was established through bench testing and comparison to established specifications or performance of predicate devices.
8. Sample Size for the Training Set
This is not applicable as the device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable.
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DEC - 7 2011
RESMED
Swift FX Bella Special 510(k): Device Modification
< 112489
| 510(k) SUMMARY[As required by 21 CFR 807.92(c)] | |
|---|---|
| Date Prepared | August 26th, 2011 |
| Submitter Name | Mr. Kim Kuan LEE |
| Official Contact | Mr. David D'CruzV.P., Medical & Regulatory Affairs9001 Spectrum Center BlvdSan Diego CA 92123 USATel: (858) 836-5984 |
| Device Trade Name | Swift™ FX Bella |
| Device Common Name/Classification Name | Vented Nasal Mask;Accessory to Noncontinuous Ventilator (IPPB) |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) |
| Primary predicate device | Swift FX (K090244) |
| Description | The Swift FX Bella is a modified variant of the previously cleared SwiftFX. It provides an interface such that airflow from a positive pressuresource is directed to the patient's nose. The mask is held in place withadjustable headgear that straps the mask to the nasal nares.Swift FX Bella is safe when used under the conditions and purposesintended as indicated in the labeling provided with the product.Swift FX Bella is a prescription device supplied non-sterile. |
| Intended Use | The Swift FX Bella channels airflow noninvasively to a patient from apositive airway pressure (PAP) device such as a continuous positiveairway pressure (CPAP) or bilevel system.The Swift FX Bella is:to be used by adult patients (> 66 lb/30 kg) for whom positiveairway pressure has been prescribedintended for single-patient re-use in the home environment andmultipatient re-use in the hospital/institutional environment. |
| Secondary predicatedevices | Mirage Swift (K042403), Ultra Mirage II Mask (K050359),Mirage Quattro (K063122), Mirage Liberty (K063011),Mirage Micro (K072940), Swift LT (K073638) |
| TechnologicalCharacteristicscomparison | Comparison with primary predicate Swift FX (K090244)The modified device and the primary predicate mask provide a seal viasilicone interface. Both masks are offered in various sizes to ensureadequate fit over the extended patient population.Both masks incorporate vent holes to provide continuous air leak toflush out and minimize the amount of CO2 rebreathed by the patient.The design of the mask components is such that the incorporation ofthese vent-holes does not interfere with the intended performance ofthe masks.Both masks connect to a conventional air delivery hose between themask and the positive airway-pressure source via standard conicalconnectors (ref: ISO 5356-1:2004) |
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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.
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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
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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
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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) | ||
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| (Division Sign-Off) | ||
| 26 th Aug, 2011 | Division of Anesthesiology, General HospitalInfection Control, Dental Devices | 17 |
| 510(k) Number: | K112489 |
§ 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).