This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.

Device Description

The Simple T Pediatric Nasal Mask is intended to be used with positive airway pressure devices. For use of this mask with a CPAP therapy device, the patient population is limited by the intended use of the device (e.g. > 30 kg). In other words, this mask can be used with a variety of therapy devices which may have their own limitations on patient population. If the therapy device itself is limited to patients greater than 10 kg (e.g. 30 kg), then the use of this mask does not expand the intended use of that therapy device.

The mask provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with a fabric frame and an adjustable headgear. The cushion contains an adjustment dial that can be engaged to reduce minor leaks around the nose. The mask may be cleaned in the home (single-patient use) or reprocessed by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).

AI/ML Overview

This document is a 510(k) Summary for the Simple T Pediatric Nasal Mask (K151120). It details the substantial equivalence of the new device to previously cleared predicate devices. Unfortunately, the document does not contain specific acceptance criteria or study data in the format requested for AI/ML device testing.

The document discusses performance testing, but this refers to engineering tests on the physical mask (e.g., intentional leak, total mask leak, CO2 rebreathing, cleaning validation), not to the performance of an AI model. There is no mention of an algorithm or AI component in this device.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance for an algorithm.
Sample size for a test set, data provenance, number of experts, or adjudication method for an AI/ML model.
Multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance effect size.
Standalone (algorithm only) performance.
Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML model.
Sample size for the training set or how ground truth for the training set was established.

This document is for a physical medical device (a nasal mask) and outlines its substantial equivalence based on material, design, and non-clinical performance testing. It explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Simple T Pediatric Nasal Mask. Product functionality has been adequately assessed by non-clinical tests." This further confirms the absence of AI/ML or clinical efficacy studies as would be required for such devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 15, 2016

Respironics, Inc. Shaylee Masilunas Regulatory Affairs Engineer 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K151120

Trade/Device Name: Simple T Pediatric Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 2, 2015 Received: March 4, 2015

Dear Ms. Masilunas:

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.

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

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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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)
Device Name	Simple T Pediatric Nasal Mask
Indications for Use (Describe)
This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect

of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Psblishing Survices (JUI) 443-6740 ED

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TAB 6

510(K) SUMMARY

510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
Official Contact	Shaylee MasilunasRegulatory Affairs Engineer, Patient Interface
Establishment Registration #	2518422
Proprietary Name	Simple T Pediatric Nasal Mask
Common/Usual Name	Nasal Mask
Classification Name /Product Code	21 CFR 868.5905, Product Code BZD – Ventilator, non-continuous(respirator)
Predicate Device(s)	Respironics Simple T Youth Nasal Mask (K140268)Respironics Profile Lite Small Child (K093416)
Reference Device	Respironics Trilogy 200 (K093416)

Indications for Use

This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.

Device Description

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greater than 10 kg (e.g. 30 kg), then the use of this mask does not expand the intended use of that therapy device.

Substantial Equivalence

The Simple T Pediatric Nasal Mask has the following similarities to the previously cleared predicate devices Respironics Simple T Youth Nasal Mask (K140268) and Respironics Profile Lite Small Child mask (K093416):

Same operating principle
Similar intended use
. Similar materials
Similar design
Similar manufacturing process

The following modifications have been made to the previously cleared predicate devices Respironics Simple T Youth Nasal Mask (K140268) and Respironics Profile Lite Small Child mask (K093416) for the Simple T Pediatric Nasal Mask:

. The intended use population was modified to include patients greater than 10kg/22lbs
. An existing warning was converted to a contraindication to align with the definition of a contraindication. The language of that statement was revised to reflect standardized terminology.
. The mask components were modified for sizing. The cushion was modified to include a leak adjustment dial.

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Table 1 – Technological characteristics comparison of the Simple T Pediatric Nasal Mask and its predicate devices

Intended Use	Primary Predicate:Device:Simple T YouthK140268Manufacturer:Respironics, Inc.The Simple T Youth Nasal Mask	Secondary Predicate:Device:Profile Lite Small Child K093416Manufacturer:Respironics, Inc.The Small Child Profile Lite	Subject Device:Device:Simple T Pediatric Nasal MaskManufacturer:Respironics, Inc.This mask is intended to provide an
	is intended to provide aninterface for Continuous PositiveAirway Pressure (CPAP) or bi-level therapy.	Nasal Mask and Softcap areintended to provide aninterface when used with CPAPor bi-level therapy.	interface for application of non-invasive ventilation to patients.
PatientPopulation	Patients 7 years or older (>40lbs/18kg)	Profile Lite Small Child Mask:Patients 1 year or older (>7 kg)Trilogy 200 Ventilator: Patientsat least 5kg/11lbs	Patients greater than 10kg/22lbs(>10kg/22lbs)
Environment ofUse	Home or Hospital/Institutional Environment	Home or Hospital/Institutional Environment	Unchanged from K140268,K093416
Patient UsageType	Single patient reuse or multi-patient use	Single Patient Use	Unchanged from K140268
Provided Sterileor Non-Sterile	Non-Sterile	Non-Sterile	Unchanged from K140268,K093416
Anatomical Sites	Nose	Nose	Unchanged from K140268,K093416
Device Design	1. Nasal cushion2. Frame3. Elbow with built-in exhalationdevice4. Tubing with 15mm to 22mmswivel connector5. Headgear	1. Nasal cushion2. Faceplate3. Elbow with built-inexhalation device4. Tubing with 15mm to 22mmswivel connector.5. Headgear	Unchanged from K1402681. Nasal Cushion with Dial2. Frame3. Elbow with built-in exhalationdevice4. Tubing with 15 mm to 22 mmswivel connector.5. Headgear
Cushion	Silicone sealing cushion that fitsaround the nose.	Encapsulated gel cushion thatfits around the nose.	Similar to K140268The cushion contains anadjustment dial.
Cushion Sizes	3 sizes	1 size	2 sizes
Frame Design	The frame stabilizes the cushionon the nose and allowsclearance of facial features.Four slots exist for insertion ofheadgear tabs.	The faceplate and foreheadarm secure the cushion to theface. Four slots exist forinsertion of headgear tabs.	Unchanged from K140268
Exhalation devicedesign	No separate exhalation device isrequired. 18 exhalation portsare integrated.	No separate exhalation deviceis required. Two exhalationports are integrated.	Unchanged from K140268
Tubing	15 mm tubing	15 to 22 mm tubing	Unchanged from K140268

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	Primary Predicate:	Secondary Predicate:	Subject Device:
	Device:	Device:	Device:
	Simple T YouthK140268	Profile Lite Small Child K093416	Simple T Pediatric Nasal Mask
	Manufacturer:Respironics, Inc.	Manufacturer:Respironics, Inc.	Manufacturer:Respironics, Inc.
Generalheadgear design	Four point headgear with hookand loop tabs for attaching toframe.	Four point bonnet with hookand loop tabs for attaching toframe.	Unchanged from K140268
Patient CircuitConnection	22 mm swivel connector	22 mm swivel connector	Unchanged from K140268 andK093416

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	Primary Predicate:	Secondary Predicate:	Subject Device:
	Device:	Device:	Device:
	Simple T Youth	Profile Lite Small Child K093416	Simple T Pediatric Nasal Mask
	K140268
		Manufacturer:	Manufacturer:
	Manufacturer:	Respironics, Inc.	Respironics, Inc.
Component	Respironics, Inc.
Cushion	Silicone	Gel encapsulated in urethane	Silicone
Frame	Polyurethane Foam, Nylon	Polycarbonate	Polyurethane Foam, Nylon
Elbow and	Polycarbonate	Polycarbonate	Polycarbonate
Swivel
Tubing	Thermoplastic Elastomer	Ethylene Vinyl Acetate	Thermoplastic Elastomer
Headgear	Polyurethane Foam,Nylon/Spandex	Nylon and Lycra	Polyurethane Foam,Nylon/Spandex

Table 2 – Material comparison for the Simple T Pediatric Nasal Mask and its predicate devices

Design verification tests were performed on the Simple T Pediatric Nasal Mask. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.

Non-Clinical Tests

Performance testing was performed before and after reprocessing treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:

Intentional Leak
. Total Mask Leak
. Mask Deadspace
. Pressure Drop
CO2 Rebreathing
Performance Post Cleaning, Disinfection and Sterilization
Cleaning and Disinfection Validation Testing
Storage

The Simple T Pediatric Nasal Mask has been designed to meet the requirements of the following standards:

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ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories ●
. ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
. ISO 14971 Medical devices – Application of risk management to medical devices

Clinical Tests

Clinical tests were not required to demonstrate the safety and effectiveness of the Simple T Pediatric Nasal Mask. Product functionality has been adequately assessed by non-clinical tests.

Conclusion

The performance and technological characteristics of the Simple T Pediatric Nasal Mask are substantially equivalent to those of the Simple T Youth Nasal Mask (K140268) and the Profile Lite Small Child (K093416). The differences described above do not raise new questions of safety and effectiveness.

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).