The Simple T Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.

Device Description

The Simple T Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It 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 frame and adjustable headgear. The mask components may be cleaned by the patient in the home or disinfected by the professional in the hospital/institutional environment (multi-patient use). The fabric headgear and frame may be cleaned by low-level disinfection processes (multi-patient use).

The design consists of a silicone nasal cushion designed to fit over the patient's nose. The cushion is connected to a nasal cushion support (frame) that rests along the sides of the patient's face and supports the cushion. The frame is covered in a fabric material for comfort purposes. An elbow is connected at the frame via a snap lock attachment feature. The fabric headgear is connected to the mask through slots in the frame. The nasal cushion and elbow are designed in such a way that it can be easily removed from the frame for cleaning or replacement purposes.

The elbow is attached to 15mm tubing that is fitted at the end with a 22mm swivel connector. This fitting is used to connect conventional air delivery hose between the mask and pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees.

The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Simple T Nasal Mask, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance and Study Conclusion
Performance and Functionality	Device performance and functionality must be unaffected by proposed design changes and expanded multi-patient use in a hospital/institutional environment. This included testing pre- and post-cleaning and disinfection treatments.	"Results from this testing concluded that the verification testing performed verified that the Simple T Mask meets its performance specifications..." The document implies performance and functionality were maintained.
Cleaning and Disinfection Efficacy	The mask must be effectively disinfected in accordance with industry standards: AAMI TIR No. 12-2010, AAMI TIR 30-2011, ASTM E1837-96 (2007), and the FDA CDRH guidance "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants."	"cleaning and disinfection efficacy testing was performed to ensure that the mask could be disinfected, in accordance with [listed standards]... Results from this testing concluded that the verification testing performed verified that the Simple T Mask meets its performance specifications..." (This indicates successful disinfection).
Biocompatibility	All skin-contacting materials must be biocompatible, as assessed in accordance with ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.	"A biocompatibility assessment in accordance with ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing was completed for all skin-contacting materials." (Implies successful assessment).
Substantial Equivalence	The device must demonstrate substantial equivalence to the identified predicate devices (Respironics Simple T Nasal Mask K120145 and Respironics GoLife Nasal Mask K110008) in terms of safety and effectiveness, despite the design changes and expanded use.	"...raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates." The FDA's 510(k) clearance letter confirms this determination.

Study Details

This submission relies on non-clinical bench testing rather than clinical trials for demonstrating the device's acceptance criteria. The information below reflects the type of testing performed.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "performance testing" and "efficacy testing" being performed on the device or its components. It does not provide specific numbers of masks or components tested.
- Data Provenance: The testing was conducted by Respironics, Inc. ("Non-Clinical Test Submitted, Referenced or Relied on in the 510(k)"). This would be considered prospective testing, as it was performed specifically to evaluate the modified device for its 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer's location in Murrysville, Pennsylvania, USA.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable in the traditional sense of human readers for image-based diagnostics. For non-clinical bench testing, the "ground truth" is established by the accepted scientific and engineering standards (e.g., AAMI, ASTM, ISO) and the expertise of the engineers and scientists conducting the tests and interpreting the results within Respironics. The document does not specify the number or qualifications of these internal experts.
Adjudication Method for the Test Set:
- Not applicable. This was bench testing against predefined specifications and industry standards, not a diagnostic study requiring adjudication of expert opinions.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted. The device is a physical medical device (nasal mask), not an AI/diagnostic software.
- The document states, "Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Simple T Nasal Mask, as was the case with the predicate devices." This explicitly rules out the need for a clinical comparative effectiveness study involving human readers.
Standalone (Algorithm Only) Performance Study:
- Not applicable. This is a physical medical device, not an algorithm or AI.
Type of Ground Truth Used:
- For the performance, cleaning/disinfection, and biocompatibility testing, the "ground truth" was established by objective measurements against predefined engineering specifications and recognized industry standards (e.g., AAMI TIR No. 12-2010, AAMI TIR 30-2011, ASTM E1837-96 (2007), ISO 10993-1: 2009). For substantial equivalence, the comparison was against the performance characteristics of predicate devices.
Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The device was designed and then tested.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.

Summary

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2012

Date of Submission	30 May 2012
510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
	(724) 387-4146(724) 387-3999 (fax)
Official Contact	Michelle BrinkerRegulatory Affairs Manager, Patient Interface
Proprietary Name	Simple T Nasal Mask
Common/Usual Name	Nasal Mask
Classification Name /Product Code	BZD - Ventilator, non-continuous (respirator)
Classification / RegulationNumber	Class II - 21 CFR 868.5905
Predicate Device(s)	Respironics Simple T Nasal Mask (K120145)
	Respironics GoLife Nasal Mask (K110008)

Device Description

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the cushion. The frame is covered in a fabric material for comfort purposes. An elbow is connected at the frame via a snap lock attachment feature. The fabric headgear is connected to the mask through slots in the frame. The nasal cushion and elbow are designed in such a way that it can be easily removed from the frame for cleaning or replacement purposes.

The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.

Indications for Use

The Simple T Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospitalinstitutional environment. This mask is to be used on patients greater than 66lbs /30kg.

Summary of Technological Characteristics of Device Compared to the Predicate Device

The Simple T Nasal Mask has the following similarities in the technological characteristics to the previously cleared device (Simple T, K120145):

. Same intended use
. Same operating principle
. Same technology
l Same cushion, elbow, and swivel materials used
Similar device design and physical properties ■
Same scientific concepts that form the basis for the device i

The Simple T Nasal Mask has the following differences in the technological characteristics to the previously cleared device (Simple T, K120145): *

. Usage of the Simple T Nasal Mask is being expanded from single patient use in the home or hospital/institutional environment to also include multi-patient use in the hospital/institutional

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environment. The secondary predicate for this submission, GoLife Nasal Mask (K110008), is intended for single patient reuse in the home or multi-patient, multi-use in the hospital/institutional environment.

Design modification to cushion
Design modification to frame
Design modification to exhalation device .
Design modification to headgear 1
Modification of frame and headgear materials

Summary of the Non-Clinical Test Submitted, Referenced or Relied on in the 510(k)

To demonstrate performance and functionality was unaffected as a result of these changes, performance testing was completed. Testing was performed pre and post cleaning and disinfection freatments. Additionally, cleaning and disinfection efficacy testing was performed to ensure that the mask could be disinfected, in accordance with AAMI TIR No. 12-2010, AAMI TIR 30-2011, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" - FDA CDRH, January 3, 2000. A biocompatibility assessment in accordance with ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing was completed for all skin-contacting materials.

Results from this testing concluded that the verification testing performed verified that the Simple T Mask meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates.

Clinical Data

Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Simple T Nasal Mask, as was the case with the predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the Department of Health & Human Services.

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

Respironics, Incorporated
Ms. Michelle Brinker
Regulatory Affairs Manager, Patient Interface
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668

Re: K121631

Trade/Device Name: Simple T Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 7, 2012 Received: September 10, 2012

Dear Ms. Brinker:

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.

OCT
5 2012

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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); 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/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

F. Pelletier
F. Smith Jr.

Anthony D. Watson, B.S., M.S., M.B.A. 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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Page 1 of_1

Indications for Use

510(k) Number (if known): ر

Device Name: ___Simple T Nasal Mask

The Simple T-Nasal-Mask-is-intended-to-provide-an-interface-for-Gontinuous-Positive-Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.

Over-The-Counter Use _ Use Prescription AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Af. Rache

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

510(k) Number:

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).