The VPAP III ST-A/Kidsta Mask system is intended to provide non-invasive ventilation for pediatric patients aged 7 years or older (>40lbs) with respiratory insufficiency or obstructive sleep apnea (OSA). The device is intended for use in the hospital or home.

Device Description

The VPAP III ST-A is a flow-cycled, pressure-limited ventilator. A blower assembly generates airway pressure. A flow sensor and a pressure sensor in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

The VPAP III ST-A has a CPAP mode in which a fixed pressure is delivered, and three bi-level operating modes which determine how the changes between IPAP (Inspiratory Positive Airway Pressure) and EPAP (Expiratory Positive Airway Pressure) pressures are made: Spontaneous, Spontaneous/Timed and Timed.

The VPAP III ST-A is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

The Mirage Kidsta cushion size and headgear has been modified from the Mirage Vista to meet the requirements of the pediatric population. The Kidsta mask provides therapy through the nose only. The Mirage Kidsta comprises the following

Mask frame, with two ports for connection to pressure sensor tubing. A 2-. ports cap can cover one or both ports.
Mask elbow, connected to short air tubing, with a swivel, which allows a 360° . rotation of the air tube. The elbow has an integral exhaust vent for flushing CO2 in order to prevent re-breathing.
Mask cushion, for patient comfort and adequate sealing between mask and . face.
Headgear, a three-layered fabric attached to the mask frame by means of . clips to enable fast release of the mask. The mask can be tilted at five different angles by pressing on the tabs and changing the slot position on the headgear clips. The headgear side straps, connected to the headgear clips, are reinforced for increased stability.

The Mirage Kidsta mask comes in one frame size and cushion.

AI/ML Overview

This 510(k) summary does not contain information on specific acceptance criteria and study results in the format requested. The document describes a submission for a pediatric indication for an existing device (VPAP III ST-A) and a modified mask (Mirage Kidsta). It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics from a specific clinical study with acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred, along with what is explicitly stated as not available.

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

Acceptance Criteria	Reported Device Performance
Specific performance metrics for pediatric use (e.g., ventilation efficacy, mask seal performance quantified)	NOT AVAILABLE: The document states that "Additional testing based on the VPAP III ST-A / Kidsta risk analysis was performed to ensure the safety and efficacy of the VPAP III ST-A / Kidsta system when used on the pediatric patient (>7 years and >40lbs)." However, it does not provide specific acceptance criteria or quantitative performance results from these tests. It only concludes that the system "can be safely and effectively used."

Acceptance Criteria

Reported Device Performance

Specific performance metrics for pediatric use (e.g., ventilation efficacy, mask seal performance quantified)

NOT AVAILABLE: The document states that "Additional testing based on the VPAP III ST-A / Kidsta risk analysis was performed to ensure the safety and efficacy of the VPAP III ST-A / Kidsta system when used on the pediatric patient (>7 years and >40lbs)." However, it does not provide specific acceptance criteria or quantitative performance results from these tests. It only concludes that the system "can be safely and effectively used."

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

Test Set Sample Size: NOT AVAILABLE. The document mentions "Additional testing" and "Human factors considerations and usability trials" but does not specify the number of subjects or cases included in these tests.
Data Provenance: NOT AVAILABLE. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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/NOT AVAILABLE. The document highlights "risk analysis" and "human factors considerations and usability trials," which likely involved expert input. However, it does not describe a process for establishing a "ground truth" for a test set in the way one would for diagnostic imaging or a comparable classification task, nor does it specify the number or qualifications of experts involved in these assessments. The focus is on safety and efficacy in the pediatric population rather than diagnostic accuracy.

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

NOT APPLICABLE/NOT AVAILABLE. As no specific "test set" for diagnostic performance or ground truth establishment is described, an adjudication method is not mentioned.

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

NO. This device is a ventilator system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The VPAP III ST-A is a medical device (ventilator), not an algorithm that performs a standalone diagnostic or predictive function. Its performance is inherent to its mechanical and software operation in delivering ventilation, which is always in conjunction with a patient and overseen by healthcare professionals or caregivers.

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

NOT APPLICABLE/NOT AVAILABLE in the context of diagnostic "ground truth." The "ground truth" for this device's efficacy and safety would be established through engineering validation, simulated use, and clinical observations to confirm that it effectively delivers non-invasive ventilation and manages respiratory insufficiency or OSA in the target pediatric population without adverse effects. This is assessed against established physiological parameters and safety standards, rather than a diagnostic gold standard like pathology. The document states "Testing confirms that the unmodified VPAP III ST-A when used with the Mirage Kidsta mask can be safely and effectively used to treat the pediatric patient (>7 years and >40lbs)." This implies successful performance against pre-defined safety and efficacy benchmarks, though these benchmarks are not detailed.

8. The sample size for the training set

NOT APPLICABLE. This device is a hardware and software system for ventilation, not a machine learning algorithm that requires a "training set" in the conventional sense. Its development follows traditional engineering design and testing processes.

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

NOT APPLICABLE. As there is no "training set" for a machine learning algorithm, there is no ground truth established in this manner.

Summary

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060105

APR 7 2006

510(k) Summary – AutoSet CS2 [As required by §807.92 (c) ]

Submitter Name:	ResMed Corp.
Submitter Address:	14040 Danielson Street, Poway CA 92064-6857, USA
Contact Person:	David D'Cruz, VP Regulatory & Clinical Affairs US
Phone Number:	(858) 746 2238
Fax Number:	(858) 746 2915
Date Prepared:	December 22, 2005
Device Trade Name	VPAP III ST-A/KIDSTA MASK SYSTEM
Device Common Name/Classification Reference	Bi level Positive Pressure Ventilator/ ContinuousVentilator, Passive Exhalation Port, Non-Critical Care.21 CFR868.5895
Product Code	73MNS
Predicate Devices:	VPAP III ST-A (K033276)Mirage VISTA Mask (K031047)
Reason for submission	Include pediatric (7 years and older, > 40 lbs) indication.
Intended Use:	The VPAP III ST-A/Kidsta Mask system is intended toprovide non-invasive ventilation for pediatric patientsaged 7 years or older (>40lbs) with respiratoryinsufficiency or obstructive sleep apnea (OSA). Thedevice is intended for use in the hospital or home.

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Substantial Equivalence

The VPAP III ST-A / Kidsta system has the following similarities to the previously cleared predicate device.

ﯩﺰ Similar intended use
ど Same operating principle
Y Same technologies
Y Same manufacturing process

The VPAP III ST-A was cleared in K033276. The Mirage Kidsta is a simple modification of its predicate device (Mirage VISTA) cleared in K031047. ResMed has performed a risk analysis to identify the additional considerations of using the VPAP III ST-A / Kidsta system on pediatric patients (>7 years and >40lbs). Additional testing based on the VPAP III ST-A / Kidsta risk analysis was performed to ensure the safety and efficacy of the VPAP III ST-A / Kidsta system when used on the pediatric patient (>7 years and > 40lbs). Testing confirms that the unmodified VPAP III ST-A when used with the Mirage Kidsta mask can be safely and effectively used to treat the pediatric patient (>7 years and >40lbs).

ResMed has followed the FDA's Guidance for Industry and FDA Staff document "Pre-market Assessment of Pediatric Medical devices" and applied the principle of FDA's Least Burdensome Approach to demonstrate the Substantial Equivalence of the VPAP III ST-A / Kidsta system to its predicate devices (VPAP III ST-A and Mirage Vista). We conclude that the existing and cleared adult indications for use can be safely and effectively applied to pediatric patients (>7 yrs and >40lbs).

ResMed has modified the Mirage Vista and developed the Mirage Kidsta. The development realized slight changes to the headgear and the adoption of a smaller cushion size. Human factors considerations and usability trials demonstrate that the Mirage Kidsta can be safely and effectively applied to the pediatric patient (>7yrs and > 40lbs).

Intended Use

The Indications for Use (IFU) proposed for the VPAP III ST-A / Kidsta System is

The VPAP III ST-A / Kidsta System is intended to provide non-invasive ventilation for pediatric patients 7 years or older (>40 lb) with respiratory insufficiency or obstructive sleep apnea (OSA), in the hospital or home.

Device Description

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The VPAP III ST-A is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

Mask frame, with two ports for connection to pressure sensor tubing. A 2-. ports cap can cover one or both ports.
Mask elbow, connected to short air tubing, with a swivel, which allows a 360° . rotation of the air tube. The elbow has an integral exhaust vent for flushing CO2 in order to prevent re-breathing.
Mask cushion, for patient comfort and adequate sealing between mask and . face.
Headgear, a three-layered fabric attached to the mask frame by means of . clips to enable fast release of the mask. The mask can be tilted at five different angles by pressing on the tabs and changing the slot position on the headgear clips. The headgear side straps, connected to the headgear clips, are reinforced for increased stability.

The Mirage Kidsta mask comes in one frame size and cushion.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three heads, representing health, services, and people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2006 APR

Mr. David D'Cruz ResMed Limited 14040 Danielson Street Poway, California 92064-6857

Re: K060105

Trade/Device Name: VPAP III ST-A/Kidsta Mask System Regulation Number: 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: MNS Dated: December 22, 2005 Received: January 13, 2006

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 (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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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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Cinette Y. Michaud MD

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

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Indications for Use

510(k) Number (if known):

Device Name: VPAP III ST-A/KIDSTA MASK SYSTEM

Kobo (05

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 A . Singy, General Hospil. not Datal Devices

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).