(109 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Swift FX Nano Traditional 510(k):
Swift FX Nano - Acceptance Criteria and Supporting Study
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the device relies on substantial equivalence to predicate devices, particularly the Swift FX, Mirage FX, and Ultra Mirage II. The acceptance criteria are primarily defined by demonstrating equivalent performance to these predicates.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance (as described in the 510(k)) |
|---|---|---|
| Intended Use | Same intended use as predicate devices. | "it has the same intended use" - channels airflow noninvasively for positive airway pressure (CPAP/bilevel) for patients >66 lbs, single-patient home reuse, multipatient hospital/institutional reuse. |
| Technological Characteristics | Substantially similar to predicate devices, particularly the Swift FX and Mirage FX. | "it has identical technological characteristics to the predicate devices" - provides seal via silicone interface, cushion design (nasal vs. pillows for Swift FX), various sizes, vent holes for CO2 flush, connects to conventional air delivery hose, molded plastic/silicone/fabric components, materials deemed safe. Pressure-flow characteristics and flow impedance are "identical" to the predicate. |
| Safety - Material Biocompatibility | Materials contacting heated humidified gas pathway and permanent skin contact are biocompatible according to ISO 10993-series and FDA Guidance #G95-1. | Heated Humidified Gas Pathway: Successfully passed ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, and ISO 10993-10 Sensitization and Irritation. Permanent Skin Contact: Successfully passed ISO 10993-5 Cytotoxicity and ISO 10993-10 Sensitization and Irritation. |
| Safety - CO2 Re-breathing | Equivalent CO2 performance to predicate Ultra Mirage II. | "The CO2 performance of the new device and the predicate device are substantially equivalent." (Implicitly meets the predicate's performance.) |
| Risk Management | Application of risk management processes. | "development of the Swift FX Nano device complies with ISO 14971:2007, Medical devices - Application of risk management to medical devices." |
| New Questions of Safety/Effectiveness | No new questions of safety or effectiveness raised compared to predicates. | "the new device did not raise any new questions of safety or effectiveness" |
| Overall Safety & Effectiveness | At least as safe and effective as predicate devices. | "The new Swift FX Nano is as safe and effective as the predicate devices" and "it is at least as safe and effective as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not describe a clinical test set with a specific sample size, nor does it mention data provenance (e.g., country of origin, retrospective/prospective study). Instead, the submission relies on bench testing and comparison to predicate devices, coupled with the established safety and efficacy of CPAP/Bilevel therapy using vented nasal masks.
The statement "Bench testing is sufficient to demonstrate safety and efficacy of the new Swift FX Nano, as was the case with the predicate devices" indicates that direct patient testing for a "test set" was not performed or deemed necessary for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as there was no clinical test set described in the 510(k) summary that required expert-established ground truth. The "ground truth" for this submission is the established safety and efficacy of the predicate devices and the performance of the Swift FX Nano against known engineering standards and biocompatibility tests.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The Swift FX Nano is an interface device for CPAP/bilevel therapy, and its evaluation focuses on mechanical performance, safety, and biocompatibility, not diagnostic effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
This question is not applicable in the context of the Swift FX Nano. This device is a physical medical device (a mask) and does not involve an algorithm. The performance evaluation is based on bench testing of the physical properties and biocompatibility of the mask itself.
7. The Type of Ground Truth Used
The ground truth used in this 510(k) submission is primarily:
- Established performance and safety of legally marketed predicate devices.
- International standards and FDA Guidance for biocompatibility (e.g., ISO 10993 series, FDA Guidance #G95-1).
- Established scientific principles for mechanical performance (e.g., pressure-flow characteristics, CO2 flushing).
- Risk management principles as per ISO 14971:2007.
The "clinical data" section explicitly states "Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community," which implicitly uses the outcomes data and established efficacy of the general device category as part of its ground truth.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device and not an AI/algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
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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 CassiVice President - Quality Assurance Americas9001 Spectrum Center BlvdSan Diego CA 92123 USATel: (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 apositive pressure source is directed to the patient's nose. Themask is held in place with adjustable headgear that straps themask to the face.Swift FX Nano is safe when used under the conditions andpurposes intended as indicated in the labeling provided with theproduct.Swift FX Nano is a prescription device supplied non-sterile. | |
| Intended Use | The Swift FX Nano channels airflow noninvasively to a patientfrom a positive airway pressure device such as a continuouspositive airway pressure (CPAP) or bilevel device.The Swift FX Nano is:to be used by patients (> 66 lbs / 30 kg) for whom positiveairway pressure has been prescribedintended for single-patient re-use in the home environmentand multipatient re-use in the hospital/institutionalenvironment. | |
| TechnologicalCharacteristicscomparison | Comparison with predicate Swift FXThe new device and the predicate mask, provide a seal viasilicone interface. The new device design incorporates a cushionthat seals around the patient's nose whereas the predicate SwiftFX design comprises pillows that seal under the nasal nares. Bothmasks are offered in various sizes to ensure adequate fit over theextended patient population.Both masks incorporate vent holes to provide continuous air leakto flush out and minimize the amount of CO2 re-breathed by the | |
| TechnologicalCharacteristicscomparison | Comparison with predicate Mirage FXThe new device and the predicate Mirage FX mask provide a sealvia a silicone interface that covers over and around the patient'snose. Both the new and predicate masks are offered in variouscushion sizes to ensure adequate fit over the extended patientpopulation. | |
| Performance Data | Comparison with predicate Ultra Mirage IIThe CO2 performance of the new device and the predicate deviceare substantially equivalent. | |
| Clinical Data | Use of vented nasal masks with CPAP or Bilevel therapy isproven technology and is well accepted by the medicalcommunity. Bench testing is sufficient to demonstrate safety andefficacy of the new Swift FX Nano, as was the case with thepredicate 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
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The new Swift FX Nano is as safe and effective as the predicate devices:
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it has the same intended use; י
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it has identical technological characteristics to the predicate devices;
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the new device did not raise any new questions of safety or effectiveness;
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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.
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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
101
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) |
|---|---|---|---|
| ---------------------------------------------- | --- | -------- | -------------------------------------------------- |
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| Concurrence of CDRH; Office of Device Evaluation (ODE) |
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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 |
§ 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).