The Swift LT 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 LT 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 LT 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 LT is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Swift LT is a prescription device supplied nonsterile.

AI/ML Overview

The document describes the 510(k) summary for the ResMed Swift™ LT nasal mask, a medical device for channeling airflow from a positive airway pressure device to a patient. The submission asserts substantial equivalence to predicate devices (Mirage Swift and Ultra Mirage II Mask) rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria is not directly applicable or available from the provided text.

The submission states: "Bench testing is sufficient to demonstrate safety and efficacy of the Swift LT, as was the case with the predicate device." This indicates that the regulatory pathway relies on demonstrating performance comparable to existing, legally marketed devices through bench testing, rather than an independent clinical study against predefined acceptance criteria for novel performance.

However, based on the provided text, we can infer the basis for demonstrating substantial equivalence, which acts as the de facto "acceptance criteria" here:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no explicit "acceptance criteria" for a novel device performance study are presented, the "acceptance criteria" for this 510(k) submission are based on demonstrating "substantial equivalence" to the predicate devices. The reported device performance is presented as a comparison to these predicates.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (as compared to predicates)
Same/Reworded Intended Use	Swift LT has the same, though reworded, intended use as the predicate devices. (Intended Use: channels airflow noninvasively from a positive airway pressure device to adult patients (> 66 lb/30 kg); for single-patient re-use in home, multi-patient re-use in hospital/institutional environment.)
Similar Technological Characteristics	Seal Interface: New device and predicates provide a seal via silicone interface; offered in various sizes.
	Vent Holes: Both incorporate vent holes for continuous air leak to minimize CO2 rebreathing; design does not interfere with performance.
	Connectors: Both connect to conventional air delivery hoses via standard conical connectors (ISO 5356-1:2004).
	Materials: Both constructed using molded plastic, silicone components, and fabric/nylon headgear; all materials deemed safe (ISO 10993-1).
	Operation with Flow Generators: Both designed to operate on the same ResMed flow generator settings (Mirage or Swift).
	Pressure-flow characteristics and flow impedance: Substantially equivalent to predicate devices.
	CO2 performance: Substantially equivalent to predicate Ultra Mirage II.
	Reuse: Both can be reused in home and hospital/institution environment.
No New Questions of Safety and Effectiveness	The submission explicitly states "it does not raise new questions of safety and effectiveness." The differences are in the number of components, design/geometry, and component interface.
At least as Safe and Effective as Predicates	The submission explicitly states "it is at least as safe and effective as the predicate devices Mirage Swift and Ultra Mirage II." Bench testing was deemed sufficient for this demonstration.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The submission relies on "bench testing" and comparison of technological characteristics rather than a clinical "test set" with human subjects to evaluate new performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. No patient-level test set requiring expert ground truth was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. No patient-level test set requiring adjudication was described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a medical mask for positive airway pressure therapy, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect size are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a mechanical mask, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / No direct "ground truth" as described for a clinical study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, against which the new device's characteristics and performance (e.g., CO2 performance, pressure-flow characteristics) were compared via bench testing.

8. The sample size for the training set:

Not applicable / Not provided. As this is not an AI/machine learning device, there is no "training set."

9. How the ground truth for the training set was established:

Not applicable / Not provided. (See point 8)

Summary

{0}------------------------------------------------

073638

MAR 2 0 2008

RESMED

Swift LT Traditional 510k

510(k) SUMMARY[As required by 21 CFR 807.92(c)]
Date Prepared	December 18th, 2007
Official Contact	Mr. David Thomson,Senior Regulatory Affairs Manager
Device Trade Name	Swift™ LT
Device Common Name/Classification Name	Vented Nasal Mask;Accessory to Noncontinuous Ventilator (IPPB)
Classification	21 CFR 868.5905, 73 BZD (Class II)
Predicate Devices	Mirage Swift (K042403)Ultra Mirage II Mask (K050359)
Description	The Swift LT 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 LT is safe when used under the conditions and purposesintended as indicated in the labeling provided with the product.
	Swift LT is a prescription device supplied nonsterile.
Intended Use	The Swift LT channels airflow noninvasively to a patient from apositive airway pressure device such as a continuous positiveairway pressure (CPAP) or bilevel system.The Swift LT 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.
TechnologicalCharacteristicscomparison	Comparison with predicate Mirage SwiftThe new device and the 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 the 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 the 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)
	Both the masks are constructed using molded plastic and silicone components and fabric / nylon headgear. All the
December 18, 2007		17
	components of both the masks are fabricated using materialsdeemed safe. (ref: ISO 10993-1).
	Both the new device and the predicate are designed to operateon the same Mirage or Swift ResMed flow generator settings.The pressure-flow characteristics and flow impedance of boththe new device and the predicate device are substantiallyequivalent.
	Both the new device and the predicate device can be reused inthe home and hospital / institution environment.
	The main differences between Swift LT and Mirage Swift is inthe number of components, their design/geometry and howindividual components interface with each other. Both themasks are designed and constructed under ResMed's 21 CFRPart 820 compliant Quality Management System.
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 safetyand efficacy of the Swift LT, as was the case with the predicatedevice.
Performance Data	Comparison with predicate Ultra Mirage IIThe CO2 performance of the new device and the predicatedevice are substantially equivalent.
Substantial EquivalenceConclusion	Swift LT is substantially equivalent to the predicate devices:- it has the same though reworded 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 predicatedevices Mirage Swift and Ultra Mirage II

{1}------------------------------------------------

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 2 @ 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited C/O Mr. David D' Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K073638

Trade/Device Name: Swift™ LT Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 6, 2008 Received: March 10, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2 - Mr. D' Cruz

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Syutte Y. Michie Dats

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

RESMED

Swift LT Traditional 510k

Indication for Use

510(k) Number (if known): Swift™ LT Device Name: Indication for Use

The Swift LT 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 LT 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.

Min Thul

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

07363 510(k) Number: J

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)

Page 1 of__1_

December 18, 2007

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).