The FaceFit Ported Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.

Device Description

The Intersurgical FaceFit Ported NIV Mask provides a seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. The Intersurgical Face Fit Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. FaceFit Ported Mask with a CO2 port for use with BIPAP and CPAP machines. The FaceFit Ported Mask features an anti-asphyxiation valve that will allow patients using a CPAP or BIPAP machine to breathe spontaneously through the mask in the event of a machine failure or system disconnection. The FaceFit ported mask is available in small, medium and large sizes.

AI/ML Overview

The Intersurgical FaceFit Ported NIV Mask (K121747) was cleared based on substantial equivalence to the Resmed Mirage Full Face Mask (K063011). The device is a non-invasive ventilation mask intended to channel airflow from a positive airway pressure device to a patient.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are implicitly defined by demonstrating similar performance characteristics to the predicate device. The following table summarizes key performance characteristics compared between the proposed device and the predicate device:

Characteristic Compared	Predicate Device (Resmed Mirage Full Face Mask K063011)	Proposed Device (FaceFit Mask with CO2 Port)	Acceptance Criteria/Performance
CO2 Rebreathing (%)	2.14 (PCP Open) / 2.06 (PCP Closed)	0.79 (PCP Open) / 0.96 (PCP Closed)	Proposed device's CO2 rebreathing should be comparable to or lower than the predicate device. The proposed device shows lower CO2 rebreathing, indicating superior performance in this aspect.
Patient Respiratory Resistance mb. PCP Open	0.0 (Inhalation) / 0.1 (Expiration) With a Peak Flow of 20 l/min	0.0 (Inhalation) / 0.0 (Expiration) With a Peak Flow of 20 l/min	Proposed device's respiratory resistance should be comparable to or lower than the predicate device. Both devices show similar, low resistance.
Patient Respiratory Resistance mb. PCP Closed	0.1 (Inhalation) / 0.0 (Expiration) With a Peak Flow of 20 l/min	0.0 (Inhalation) / 0.0 (Expiration) With a Peak Flow of 20 l/min	Proposed device's respiratory resistance should be comparable to or lower than the predicate device. Both devices show similar, low resistance.
Valve Function Close	59 l/min flow at 0.7 mb pressure	58 l/min flow at 1.5 mb pressure	Proposed device's valve function should be comparable to the predicate device. The parameters are close, but the proposed device closes at a slightly higher pressure, which may indicate a more robust seal in certain conditions.
Valve Function Open	16.8 l/min flow at 0.4 mb pressure	-0.1 mb pressure	Proposed device's valve function should be comparable to the predicate device. The proposed device opens at a slightly negative pressure, indicating it opens easily in low-pressure conditions.
Volume ml.	174	123	The proposed device has a smaller internal volume, which is generally desirable for NIV masks as it can reduce rebreathing potential. This is a beneficial difference compared to the predicate.

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

The document does not specify a "sample size" in terms of number of patients or masks tested for the performance evaluations. Instead, the testing appears to be based on a comparison of technical specifications and measured physical characteristics of the device and its predicate.

The data provenance is not explicitly stated, but as this is a premarket notification to the FDA, it is expected that the testing was conducted by the manufacturer (Intersurgical Incorporated) likely in the country of origin of the manufacturer or in accredited testing facilities. The specific type of study (retrospective or prospective) is not applicable here as these are laboratory/bench tests, not clinical evaluations on human subjects for performance comparison against the predicate.

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)

This information is not applicable. The "ground truth" for this device's performance metrics (CO2 rebreathing, respiratory resistance, valve function, volume) is established through standardized engineering and laboratory testing, not through expert clinical consensus or interpretation as would be the case for diagnostic imaging AI.

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

This information is not applicable as the "test set" in this context refers to laboratory performance measurements, not clinical interpretation or diagnostic outcomes requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human interpretation, not for physical medical devices like NIV masks.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI does not apply. The performance data provided are inherent to the device's physical design and function.

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

The "ground truth" for the performance characteristics of the NIV mask is derived from objective, quantitative measurements in a laboratory setting based on established engineering and physiological testing standards (e.g., measuring CO2 rebreathing as a percentage, respiratory resistance in millibars, and valve flow rates). This is analogous to "bench testing" data rather than clinical ground truth obtained from patients or experts.

8. The sample size for the training set

This information is not applicable. This device is a physical product and does not involve machine learning or AI algorithms with "training sets."

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

This information is not applicable as there is no training set for this device.

Summary

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K121747

MAR 1 4 2013

Section 5 - 510(k) Summary of Safety and Effectiveness

Name: INTERSURGICAL INCORPORATED 417 Electronics Parkway Address: Liverpool, NY 13088 Date: March 1, 2013, 2013 Contact Person: Michael Zalewski - VP RA/QA/CS Phone Number: 315-451-2900 Fax Number: 315-451-3696

Trade Name: FaceFit Ported NIV Masks

Common Name: Non-Invasive Ventilation Masks,

Classification: 21 CFR 868.5905, 73 BZD (Class II) Accessory to Ventilator.

Predicate Device: Resmed Mirage Full Face Mask (K063011) for FaceFit Ported NIV Mask.

Description: The Intersurgical FaceFit Ported NIV Mask provides a seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. The Intersurgical Face Fit Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

FaceFit Ported Mask with a CO2 port for use with BIPAP and CPAP machines. The FaceFit Ported Mask features an anti-asphyxiation valve that will allow patients using a CPAP or BIPAP machine to breathe spontaneously through the mask in the event of a machine failure or system disconnection.

The FaceFit ported mask is available in small, medium and large sizes.

Indications for Use:

Indications For Use: The FaceFit Ported Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.

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Section 5 - 510(k) Summary of Safety and Effectiveness

Technological Characteristics Summary:

The intended use of the Intersurgical NIV masks is comparable to the referenced predicate devices. The comparison of the data shows similar values for the key performance characteristics. Proposed devices show similar values for CO2 Rebreathing (%), Patient Respiratory Resistance, and valve function when compared to the legally marketed devices. The masks connect to conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1).

CharacteristicCompared	[510(k) DEVICE]FACEFIT MASK WITH C02 PORT	[PREDICATE DEVICE]RESMED MIRAGE FULL FACEMASK (K063011)
Target PatientPopulation	Adult patients for whom positiveairway pressure treatment has beenprescribed	Adult patients for whom positive airwaypressure treatment has been prescribed
Environment of Use	Single patient re-use in the homeenvironment and/orhospital/institutional environment.	Single patient re-use in the homeenvironment and/or multi-patient reuse inthe hospital/institutional environment.
Maximum Duration ofUse	24 Hours	Unknown
Patient Use	Single Patient Use	Single /multi Patient Use
Material Composition	A polypropylene mask body, a siliconeretained cap, a silicone seal around themask, a nylon bridge, a silicone anti-asphyxiation valve, a laminatedpolyester strap and a Velcro adjustablehead strap.	A Polycarbonate mask body, two siliconeretained caps, a silicone seal around themask, a silicone anti-asphyxiation valve,a laminated polyester strap and a Velcroadjustable head strap, a silicon foreheadsupport cushion.
Specifications andDimensions	See Engineering Drawings - Appendix	See Dimensions of predicate NIV masks
CharacteristicCompared	[510(k) DEVICE]FACEFIT MASK WITH C02 PORT	[PREDICATE DEVICE]RESMED MIRAGE FULL FACEMASK (K063011)
Mask Design Feature	Anti-asphyxia valve 22mm Male ventilator /patient interface Vent holes to reduce CO2 rebreathing Quick release strap clip O2 supply connection/ pressure monitoring port	Anti-asphyxia valve Swivel 22mm Male ventilator /patient interface Vent holes to reduce CO2 rebreathing Quick release strap clip O2 supply connection/pressure monitoring ports Additional forehead support
Operational Principle	The mask forms a seal around the patient's nose and mouth. An adjustable harness holds the mask securely in place. The mask connects to a CPAP ventilator that delivers positive airway pressure treatment. The mask has vent holes that allow expired CO2 to be flushed from the mask and reduce patient CO2 rebreathing. If the ventilator malfunctions the mask has an anti-asphyxiation valve that will allow the patient to continue to breath spontaneously. The harness has an easy to operate clip that allows the mask.to be removed quickly. The mask has an auxiliary connection port through which supplementary O2 can be introduced, or the mask pressure can be monitored.	The mask forms a seal around the patient's nose and mouth. An adjustable harness holds the mask securely in place. The mask connects to a CPAP ventilator that delivers positive airway pressure treatment. The mask has vent holes that allow expired CO2 to be flushed from the mask and reduce patient CO2 rebreathing. If the ventilator malfunctions the mask has an anti-asphyxiation valve that will allow the patient to continue to breath spontaneously. The harness has an easy to operate clip that allows the mask to be removed quickly. The mask has two auxiliary connection ports through which supplementary O2 can be introduced, or the mask pressure can be monitored.
PhysicalCharacteristics:
Volume ml.	123	174
CO2 Rebreathing (%)	0.79 (PCP Open)/0.96 (PCP Closed)	2.14 (PCP Open)/2.06 (PCP Closed)
Patient RespiratoryResistance mb. PCPOpen	0.0 (Inhalation)/0.0 (Expiration)With a Peak Flow of 20 l/min	0.0 (Inhalation)/0.1 (Expiration)With a Peak Flow of 20 l/min
Patient RespiratoryResistance mb. PCPClosed	0.0 (Inhalation)/0.0 (Expiration)With a Peak Flow of 20 l/min	0.1 (Inhalation)/0.0 (Expiration)With a Peak Flow of 20 l/min
Valve Function Close	58 l/min flow at 1.5 mb pressure	59 l/min flow at 0.7 mb pressure
Valve Function Open	-0.1 mb pressure	16.8 l/min flow at 0.4 mb pressure

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Section 5 - 510(k) Summary of Safety and Effectiveness

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Section 5 - 510(k) Summary of Safety and Effectiveness

Summary of Testing:

Nonclinical tests submitted to demonstrate substantial equivalence for the NIV masks include CO2 Rebreathing (%), Patient Respiratory Resistance, and valve function when compared to the legally marketed devices. All materials used in the NIV masks have been evaluated according to tests outlined in ISO 10993-1 and meet the requirements of Bluebook Memo, General Program Memorandum G95-1 biocompatibility testing for cytotoxicity, sensitization, and irritation. The mask connectors meet the requirements of Anesthetic and respiratory equipment - conical connectors: Part 1: Cones and Sockets ISO 5356-1:2004.

Substantial Equivalence:

Intersurgical Incorporated has demonstrated that the proposed devices are safe and effective. They are considered to be substantially equivalent to the currently marketed predicate devices which have been previously reviewed for market clearance by the FDA.

K121747

Premarket Notification [510(k)] Number

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

March 14. 2013

Mr. Michael Zalewski Vice President - RA/OA/CS Intersurgical Incorporated 417 Electronics Parkway LIVERPOOL NY 13088

Re: K121747

Trade/Device Name: Product #2250030 - FaceFit NIV Mask with port Small Product #2251030 – FaceFit NIV Mask with port Medium Product #2252030 - FaceFit NIV Mask with port Large Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 1, 2013 Received: March 5, 2013

Dear Mr. Zalewski:

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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Page 2 - Mr. Zalewski

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 devicerelated 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/CDRHQffices/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,

Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a bold, sans-serif font. The letters "O" and "U" are stylized with a decorative pattern. To the right of the name, the word "for" is written in a smaller, plain font.

Anthony D. Watson, B.S., M.S., M.B.A. 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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Section 4 Indications for Use Statement

510(k) Number (if known): K121747

Device Name:

Product # 2250030 - FaceFit NIV Mask with port Small Product # 2251030 - FaceFit NIV Mask with port Medium Product # 2252030 - FaceFit NIV Mask with port Large

This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Lester W. Schultheis Jr2013.03.13 15:38:42 -04'00'(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthosions.org/? Infection Control

510(k) Number: K121747

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).