FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS

K121747 · Intersurgical Incorporated · BZD · Mar 14, 2013 · Anesthesiology

Device Facts

• Record ID: K121747
• Device Name: FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
• Applicant: Intersurgical Incorporated
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

FaceFit Ported NIV Mask; disposable interface for CPAP/bi-level ventilation; channels airflow to patient nose/mouth. Features: anti-asphyxiation valve for spontaneous breathing during system failure; CO2 port; auxiliary O2/pressure monitoring port; adjustable headgear with quick-release clip. Used in hospitals; operated by clinicians. Connects to standard air delivery hoses via ISO 5356-1 conical connectors. Provides seal for positive pressure delivery; vent holes flush expired CO2. Benefits: enables noninvasive respiratory support; ensures patient safety via anti-asphyxiation valve.

Clinical Evidence

Bench testing only. No clinical data. Testing included CO2 rebreathing (%), patient respiratory resistance, and valve function. Biocompatibility evaluated per ISO 10993-1 and G95-1. Connectors verified per ISO 5356-1:2004.

Technological Characteristics

Materials: polypropylene mask body, silicone seal/cap/valve, nylon bridge, laminated polyester strap. Connectivity: standard 22mm conical connectors (ISO 5356-1). Operational principle: passive seal with anti-asphyxiation valve and vent holes. Dimensions: 123 ml volume. Sterilization: not specified (disposable).

Indications for Use

Indicated for adult patients prescribed positive airway pressure treatment (CPAP or bi-level) requiring noninvasive ventilation in a hospital setting.

Regulatory Classification

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.

Predicate Devices

• Resmed Mirage Full Face Mask (K063011)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

## 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).

| Characteristic<br>Compared | [510(k) DEVICE]<br>FACEFIT MASK WITH C02 PORT | [PREDICATE DEVICE]<br>RESMED MIRAGE FULL FACE<br>MASK (K063011) |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target Patient<br>Population | Adult patients for whom positive<br>airway pressure treatment has been<br>prescribed | Adult patients for whom positive airway<br>pressure treatment has been prescribed |
| Environment of Use | Single patient re-use in the home<br>environment and/or<br>hospital/institutional environment. | Single patient re-use in the home<br>environment and/or multi-patient reuse in<br>the hospital/institutional environment. |
| Maximum Duration of<br>Use | 24 Hours | Unknown |
| Patient Use | Single Patient Use | Single /multi Patient Use |
| Material Composition | A polypropylene mask body, a silicone<br>retained cap, a silicone seal around the<br>mask, a nylon bridge, a silicone anti-<br>asphyxiation valve, a laminated<br>polyester strap and a Velcro adjustable<br>head strap. | A Polycarbonate mask body, two silicone<br>retained caps, a silicone seal around the<br>mask, a silicone anti-asphyxiation valve,<br>a laminated polyester strap and a Velcro<br>adjustable head strap, a silicon forehead<br>support cushion. |
| Specifications and<br>Dimensions | See Engineering Drawings - Appendix | See Dimensions of predicate NIV masks |
| Characteristic<br>Compared | [510(k) DEVICE]<br>FACEFIT MASK WITH C02 PORT | [PREDICATE DEVICE]<br>RESMED MIRAGE FULL FACE<br>MASK (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. |
| Physical<br>Characteristics: | | |
| Volume ml. | 123 | 174 |
| CO2 Rebreathing (%) | 0.79 (PCP Open)/0.96 (PCP Closed) | 2.14 (PCP Open)/2.06 (PCP Closed) |
| Patient Respiratory<br>Resistance mb. PCP<br>Open | 0.0 (Inhalation)/0.0 (Expiration)<br>With a Peak Flow of 20 l/min | 0.0 (Inhalation)/0.1 (Expiration)<br>With a Peak Flow of 20 l/min |
| Patient Respiratory<br>Resistance mb. PCP<br>Closed | 0.0 (Inhalation)/0.0 (Expiration)<br>With a Peak Flow of 20 l/min | 0.1 (Inhalation)/0.0 (Expiration)<br>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 |

{2}------------------------------------------------

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

{3}------------------------------------------------

## 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

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of 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 black and white and appears to be a scanned image.

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.

{5}------------------------------------------------

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 [phone] or [phone] 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

{6}------------------------------------------------

## 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

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.

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) |
|--------------------------------------------------------|
|--------------------------------------------------------|

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