SWIFT FX by RESMED LTD. | FDA 510(k) Summary

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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called Swift™ FX, a vented nasal mask. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study against specific acceptance criteria for a novel device. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission.

Analysis of the Provided Text for Acceptance Criteria and Study Information:

The document is a 510(k) summary, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It primarily relies on comparisons to existing devices and bench testing, rather than extensive clinical trials with specific acceptance criteria as might be seen for a novel, high-risk device.

Here's an breakdown based on your request, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't outline specific, quantitative acceptance criteria in a table format with corresponding numerical performance results for the Swift™ FX. Instead, it asserts "substantial equivalence" based on various characteristics:

Feature/Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Swift™ FX)
Intended Use	Same as predicate devices (Swift LT, Ultra Mirage II)	Channels airflow noninvasively to a patient from a PAP device; for adult patients (> 66 lb/30 kg); single-patient re-use in home, multi-patient re-use in hospital/institutional environment. Meets criteria by being "the same."
Technological Characteristics	Similar to predicate devices	Provides a seal via silicone interface; offered in various sizes; incorporates vent holes for continuous air leak; connects to conventional air delivery hose via standard conical connectors; constructed using molded plastic, silicone, and fabric/nylon headgear; components fabricated using materials deemed safe (ref: ISO 10993-1).
Material Safety	Materials deemed safe (ref: ISO 10993-1)	All components fabricated using materials deemed safe. Meets criteria.
Flow Generator Settings	Operates on same Mirage or Swift ResMed flow generator settings as predicate	New device and predicate are designed to operate on the same Mirage or Swift ResMed flow generator settings. Meets criteria.
Pressure-Flow Characteristics & Flow Impedance	Substantially equivalent to predicate devices	Both new device and predicate device are substantially equivalent. Meets criteria.
CO2 Performance	Substantially equivalent to predicate Ultra Mirage II	The CO2 performance of the new device and the predicate device are substantially equivalent. Meets criteria.
Reusability	Reusable in home and hospital/institution environment	New device and predicate device can be reused in the home and hospital/institution environment. Meets criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Bench testing is sufficient to demonstrate safety and efficacy of the Swift FX, as was the case with the predicate device."
Sample Size: Not specified. "Bench testing" typically refers to laboratory simulations and does not involve human subjects in a "test set" in the way clinical studies do. The number of masks or components tested is not mentioned.
Data Provenance: The data primarily comes from bench testing conducted by ResMed. There is no mention of country of origin for the data or whether it was retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable/Not provided. The "ground truth" in this context is established through engineering and performance specifications during bench testing by the manufacturer, comparing the new device against the known performance of predicate devices. There is no mention of independent "experts" adjudicating clinical data for a test set.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. Since there's no "test set" in the clinical sense needing adjudication, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study (MRMC) is typically used for diagnostic imaging devices where human readers interpret medical images. The Swift™ FX is a respiratory mask, and its assessment does not involve human readers interpreting "cases" in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The Swift™ FX is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply. Its performance is inherent in its design and physical characteristics.

7. The Type of Ground Truth Used:

The "ground truth" for the Swift™ FX's performance is essentially the engineering specifications and established performance characteristics of the predicate devices (Swift LT and Ultra Mirage II). The new device is considered "safe and effective enough" if its bench test results are "substantially equivalent" to these known and accepted predicate devices. This falls under engineering/performance data comparison rather than pathology or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, the Swift™ FX does not involve "training sets" in the context of machine learning or AI algorithms. The design and manufacturing process are guided by engineering principles and quality management systems (ResMed's 21 CFR Part 820 compliant Quality Management System).

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as above.

Summary

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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 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 is safe when used under the conditions and purposesintended 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 apositive airway pressure (PAP) device such as a continuouspositive airway pressure (CPAP) or bilevel system.The Swift FX is:to be used by adult patients (> 66 lb/30 kg) for whompositive airway 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 LTThe new device and the predicate mask, provide a seal viasilicone interface. Both masks are offered in various sizes toensure adequate fit over the extended patient population.
	Both the masks incorporate vent holes to provide continuous airleak to flush out and minimize the amount of CO2 rebreathed bythe patient. The design of the mask components is such thatthe incorporation of these vent-holes does not interfere with theintended performance of the masks.
	Both the masks connect to a conventional air delivery hosebetween the mask and the positive airway-pressure source viastandard conical connectors (ref: ISO 5356-1:2004)
	Both the masks are constructed using molded plastic andsilicone components and fabric / nylon headgear. All the

January 30, 2009

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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 IIThe CO2 performance of the new device and the predicatedevice are substantially equivalent.
Substantial EquivalenceConclusion	Swift FX is substantially equivalent to the predicate devices:- it has the same intended use;- it has similar technological characteristics to bothpredicates;- it does not raise new questions of safety andeffectiveness;

it is at least as safe and effective as the predicate devices Swift LT and Ultra Mirage II

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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.

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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

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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
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Regulation Number and Section

§ 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).