The Quattro LT 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 Quattro LT 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.

Device Description

The Quattro LT provides an interface such that airflow from a positive pressure source is directed to the patient's nose and mouth. The mask is held in place with adjustable headgear that straps the mask to the face.
The Quattro LT is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
The Quattro LT is a prescription device supplied non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Quattro™ LT, a full face mask designed for use with positive airway pressure (PAP) devices. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study with detailed acceptance criteria and performance data in the way a typical AI/ML device study would.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document. The document states that "Bench testing is sufficient to demonstrate safety and efficacy of the Quattro LT, as was the case with the predicate devices."

However, I can extract information related to the performance claims and the basis for substantial equivalence.

Here's a breakdown of what can be inferred or extracted based on the provided text, while acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" for a clinical study with numerical metrics. Instead, it defines performance equivalence to predicate devices based on functional characteristics.

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (vs. Predicate Devices)
Intended Use: Device channels airflow noninvasively from a PAP device to an adult patient (>66lb / >30kg) for prescribed positive airway pressure, for single-patient re-use in home, and multi-patient re-use in hospital/institutional environments.	The Quattro LT's intended use is identical to the predicate devices.
Technological Characteristics:
- Sealing mechanism	Both the Quattro LT and predicate Mirage Quattro provide a seal via a silicone interface.
- Fit for extended patient population	Both masks are offered in various sizes to ensure adequate fit over the extended patient population.
- CO2 Rebreathing (vent holes)	Both masks incorporate vent holes to provide continuous air leak to flush out and minimize CO2 rebreathed. The design ensures vents do not interfere with performance. The CO2 performance of the new device and the predicate device are substantially equivalent.
- Antiasphyxia valve (AAV) functionality	Both masks contain an AAV to enable patient to breathe fresh air if airflow from generator is impeded.
- Connection to air delivery hose	Both masks connect to a conventional air delivery hose via standard conical connectors (ISO 5356-1:2004).
- Material Biocompatibility	All components in both masks are fabricated using materials deemed safe (ISO 10993-1).
- Compatibility with flow generators	Both the new device and the predicate are designed to operate on the same ResMed flow generator settings.
- Pressure-flow characteristics and flow impedance	The pressure-flow characteristics and flow impedance of both devices are substantially equivalent.
- Reusability (home/hospital)	Both the new device and the predicate device can be reused in the home and hospital/institution environment.
Safety and Effectiveness: Does not raise new questions of safety and effectiveness, and is at least as safe and effective as predicate devices.	The document explicitly states this as part of the substantial equivalence conclusion. It relies on the substantial equivalence of intended use and technological characteristics, and that "Bench testing is sufficient to demonstrate safety and efficacy of the Quattro LT, as was the case with the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: Not applicable. No clinical "test set" (patient data) was used. The document mentions "bench testing."
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No expert-evaluated test set was used. The basis for safety and efficacy was "bench testing" and comparison of technical characteristics to predicate devices.

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

Not applicable. No clinical test set requiring adjudication was used.

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. The device is a physical medical mask, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. The device is a physical medical mask.

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

Not applicable in the context of an AI/ML study. For this device, the "truth" or benchmark was established by demonstrated performance of predicate devices and through "bench testing" (e.g., CO2 rebreathing tests, pressure-flow characteristics, material safety).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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1091129 AUG (13 2009

RESMED

Quattro LT Traditional 510K

	510(k) SUMMARY [As required by 21 CFR 807.92(c)]
Date Prepared	15 April 2009
Official Contact	Mr. Steven Lubke Director Regulatory Affairs
Device Trade Name	Quattro™ LT
Device Common Name/ Classification Name	Vented Full Face Mask; Accessory to Noncontinuous Ventilator (IPPB)
Classification	21 CFR 868.5905, 73 BZD (Class II)
Predicate Devices	Mirage Quattro (K063122) Ultra Mirage II Mask (K050359)
Description	The Quattro LT provides an interface such that airflow from a positive pressure source is directed to the patient's nose and mouth. The mask is held in place with adjustable headgear that straps the mask to the face.
	The Quattro LT is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
	The Quattro LT is a prescription device supplied non-sterile.
Intended Use	The Quattro LT 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 Quattro LT 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.
Technological Characteristics comparison	Comparison with predicate Mirage Quattro The new device and the Mirage Quattro predicate both provide a seal via a silicone interface. Both masks are also 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 the vent-holes does not interfere with the intended performance of the masks.

15 April 2009

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. .

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RESMED

Both masks contain an antiasphyxia valve (AAV) to enable the patient to breathe fresh air in the event that airflow from the flow generator is impeded.

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)

Both masks are constructed using molded plastic and silicone components and fabric / nylon headgear. All components in both 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 ResMed flow generator settings. The pressureflow characteristics and flow impedance of both devices are substantially equivalent.

Both the new device and the predicate device can be reused in the home and hospital / institution environment.

The main difference between the Quattro LT and the Mirage Quattro is the 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 Full Face 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 Quattro LT, as was the case with the predicate devices.

Performance Data

Substantial Equivalence Conclusion

Quattro LT is substantially equivalent to the predicate devices:

The CO2 performance of the new device and the predicate

it has the same intended use; .
Comparison with predicate Ultra Mirage II

device are substantially equivalent.

it has similar technological characteristics to both predicates;
it does not raise new questions of safety and effectiveness:
it is at least as safe and effective as the predicate devices Mirage Quattro and Ultra Mirage II.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 3 2009

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

Re: K091129

Trade/Device Name: Quattro™ LT Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 19, 2009 Received: June 24, 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.

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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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); 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

for

Susan Runner, D.D.S., M.A. Acting Division 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):

Quattro™ LT

Indication for Use

Device Name:

The Quattro LT 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 Quattro LT 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.

L. Schuler

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

510(k) Number: k 091129

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

15 April 2009

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).