This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Device Description

The Shimmer Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

The Shimmer Full Face Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. Like the predicate device, Revolution Full Face Mask (K082866), this mask covers the patients' nose and mouth, and is secured using a 4-point headgear. The mask seal directs positive pressure into the patient's nose and mouth.

The Shimmer Full Face Mask incorporated the anti-asphyxia feature into the cushion design, as opposed to the traditional full face mask anti-asphyxia feature typically located in the mask elbow component. Refer to Figure 3.

The anti-asphyxia feature incorporated into the Shimmer full face cushion is called a fresh air inlet valve (FAIV), and it is designed to work differently than other antiasphyxia valves. A traditional anti-asphyxia valve opens to atmosphere during a single fault condition, which routes inspiratory and expiratory airflow through the same open to atmosphere hole, while occluding the patient connection port. The FAIV, in a single fault condition, opens to atmosphere during inspiratory airflow and it closes to atmosphere during expiratory airflow. Since the patient connection port is no longer occluded during single fault condition, air will exhaust through the patient connection port and mask exhalation features.

AI/ML Overview

The provided document is limited to a 510(k) summary for a medical device (Shimmer Full Face Mask) and primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions design verification tests and compliance with general safety and effectiveness standards. However, it does not contain the detailed information required to answer many of your specific questions about the acceptance criteria, the study details (like sample size for test sets, data provenance, expert qualifications, adjudication methods), MRMC studies, or standalone algorithm performance.

The document indicates that the device is a physical mask, not an AI/software device, which explains the absence of data related to AI/algorithm performance.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All tests were verified to meet the required acceptance criteria," but it does not explicitly list the acceptance criteria or the specific reported device performance values for each test. It only lists the types of non-clinical tests performed.

Acceptance Criteria (Implied)	Reported Device Performance
Not explicitly stated in the document for each test. The general statement is that modifications did not affect safety/effectiveness.	Not explicitly stated as specific numerical values.
Met required criteria for:
- Pressure Drop	(Verified to meet criteria)
- Total Mask Leak	(Verified to meet criteria)
- Intentional Leak	(Verified to meet criteria)
- Anti-Asphyxia Feature Resistance	(Verified to meet criteria)
- Anti-Asphyxia Feature Activation Pressure	(Verified to meet criteria)
- Anti-Asphyxia Feature Deactivation Pressure	(Verified to meet criteria)
- Deadspace Volume	(Verified to meet criteria)
- CO2 Rebreathing	(Verified to meet criteria)
- Cleaning and Disinfection Efficacy	(Verified to meet criteria)
- Storage	(Verified to meet criteria)
Compliance with ISO 17510-2 (with deviations)	(Complies)
Compliance with ISO 10993-1	(Complies)
Compliance with ISO 14971	(Complies)

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 for Test Set: Not specified in the provided document. The tests performed are primarily engineering/performance tests on the device itself, not studies involving patient data in the typical sense of a clinical trial.
Data Provenance (country of origin, retrospective/prospective): Not applicable for the types of tests described (physical device performance testing).

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

This is not applicable as the document describes performance testing of a physical medical device (mask), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" here would be the physical properties and performance characteristics of the mask as measured in a lab setting.

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

This is not applicable for the physical device performance tests described. Adjudication methods are typically relevant for human review of data, especially in AI/imaging studies.

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, an MRMC comparative effectiveness study was not done. This is a physical respiratory mask, not an AI or imaging device with human readers.

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

No, a standalone algorithm performance test was not done. This device is a physical mask, not an algorithm.

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

The "ground truth" for the device's performance is established by engineering specifications, industry standards (e.g., ISO), and physical measurements/testing rather than clinical outcomes or expert consensus. For example, "Pressure Drop" would have a specified maximum limit, and the measured drop would be compared to that limit.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI or machine learning models that require a "training set."

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

Not applicable. As above, there is no training set for this type of device.

In summary: The provided document details a 510(k) submission for a non-continuous ventilator mask. The information focuses on showing substantial equivalence through design and non-clinical performance testing against established standards and a predicate device. It does not involve AI, software, or clinical studies with patient data adjudicated by experts, which are the typical contexts for the questions you've asked.

Summary

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

January 9, 2015

Respironics, Inc. Ms. Amy Macevoy Senior Regulatory Affairs Engineer, PI 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K142554

Trade/Device Name: Shimmer Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 8, 2014 Received: December 8, 2014

Dear Ms. Macevoy:

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.

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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 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/Resourcesfor You/Industry/default.htm. 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 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,

Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a stylized font. The name appears to be a person's name, likely a doctor, given the "M.D." abbreviation. The text is black and is set against a light background. The font is elegant and easy to read.

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

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Section 5: Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number (if known)	K142554
Device Name	Shimmer Full Face Mask

Indications for Use (Describe)

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for
single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on
patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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:

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"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 (1/14) THE END

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510(k) Summary

510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
	(724) 387-5306(724) 387-3999 (fax)
Official Contact	Amy MacevoySr. Regulatory Affairs Engineer
EstablishmentRegistration #	2518422
Proprietary Name	Shimmer Full Face Mask
Common/Usual Name	Mask Accessory to a Non-Continuous Ventilator
Classification Panel	Anesthesiology Devices
ClassificationReference	21 CFR 868.5905
Classification Name /Product Code	BZD - Ventilator, non-continuous (respirator)
Predicate Device(s)	Respironics Revolution Full Face Mask (K082866)

Indication for Use

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kq) for whom CPAP and bi-level therapy has been prescribed.

Device Description

The Shimmer Full Face Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. Like the predicate device, Revolution Full

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Section 6: 510(k) Summary

Face Mask (K082866), this mask covers the patients' nose and mouth, and is secured using a 4-point headgear. The mask seal directs positive pressure into the patient's nose and mouth.

Substantial Equivalence

The Respironics Shimmer Full Face Mask has the following similarities to the previously cleared predicate devices Respironics Revolution Full Face Mask (K082866):

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

The Shimmer Full Face Mask has the following differences in the technological characteristics to the previously cleared predicate devices Revolution Full Face Mask (K082866):

Cushion design ●
Number of sizes .
Anti-asphyxia feature .
Patient circuit connection

Design verification tests were performed on the Respironics Shimmer Full Face 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 device.

General Safety and Effectiveness

The performance and technological characteristics of the Shimmer Full Face Mask are equivalent to those of the Revolution Full Face Mask (K082866) and raise no new types of safety or effectiveness questions.

Non-Clinical Tests

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

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Section 6: 510(k) Summary

. Pressure Drop
Total Mask Leak .
Intentional Leak .
Anti-Asphyxia Feature Resistance
Anti- Asphyxia Feature Activation Pressure
. Anti- Asphyxia Feature Deactivation Pressure
Deadspace Volume
CO2 Rebreathing .
. Cleaning and Disinfection Efficacy
Storage .

The Shimmer Full Face Mask has been designed per the following standards:

ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories . o Deviations
- Clause 5.3 Protection against rebreathing .
- . Clause 5.5 Breathing during single fault condition
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

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).