IQ VENTILATION NASAL MASK

K102317 · Sleepnet Corporation · BZD · May 17, 2011 · Anesthesiology

Device Facts

• Record ID: K102317
• Device Name: IQ VENTILATION NASAL MASK
• Applicant: Sleepnet Corporation
• Product Code: BZD · Anesthesiology
• Decision Date: May 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / bi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES. The IQ® Ventilation Nasal mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/institutional environment. Patient Population: Adult patients (>30 kg) Environment of Use: Home or hospital / institutional environments.

Device Story

Nasal mask interface for CPAP/bi-level positive pressure systems; delivers pressurized air to patient airways. Device consists of shell, cushion, headgear, and swivel elbow (lacks vent holes). Used in home or hospital settings by adult patients (>30 kg). Requires connection to ventilator/PAP system equipped with independent exhalation valve and safety alarms. Facilitates respiratory support for patients with respiratory failure or insufficiency. Clinician/patient attaches mask to circuit; system provides pressure; mask maintains seal to deliver therapy. Benefits include non-invasive respiratory support.

Clinical Evidence

Bench testing only. Comparative performance testing conducted against predicates, including pressure drop, unintentional/intentional leak rates, internal volume/dead space, and CO2 rebreathing. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Nasal mask with shell, cushion, headgear, and swivel elbow. Lacks integrated vent holes. Materials tested per ISO 10993. Dimensions/dead space: 120 ml. Connectivity: connects to standard CPAP/bi-level circuits. Non-powered, mechanical interface.

Indications for Use

Indicated for adult patients (>30 kg) requiring CPAP or bi-level positive pressure ventilation. Must be used with systems containing exhalation valves and adequate alarms/safety systems for delivery failure.

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

• SleepNet MoJo Non-vented Full face mask (K063806)
• SleepNet IQ® Nasal mask (K021534)
• Respironics – Contour nasal mask (Deluxe) (K991648)

Submission Summary (Full Text)

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MAY 17 2011

## 510(k) Summary Page 1 of 4 11-May-11

| SleepNet Corporation | | Indications for Use | Predicate<br>SleepNet MoJo Non-vented Full face mask<br>K063806 | Predicate<br>SleepNet<br>IQ® Nasal mask<br>K021534 | Predicate<br>Respironics – Contour nasal mask (Deluxe) –<br>K991648 | Proposed<br>SleepNet<br>IQ® Ventilation Nasal mask |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 5 Merrill Industrial Drive | Tel - 603-758-6625 | | Accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. | Intended to be used with positive airway pressure devices such as CPAP operating at or above 3 cmH2O for the treatment of adult OSA | Intended to be used with positive airway pressure devices such as CPAP or bi-level systems | Intended to be used with positive airway pressure devices such as CPAP or bi-level systems |
| Hampton, NH 03842 | Fax - 603-758-6699 | Patient population | Adults >30 kg | Adults >30 kg | Adults >30 kg | Adults >30 kg |
| Official Contact: | Jennifer Kennedy - Director of Quality | Environment of use | Hospital<br>Institutional<br>Home | Hospital<br>Institutional<br>Home | Hospital<br>Institutional<br>Home | Hospital<br>Institutional<br>Home |
| Proprietary or Trade Name: | IQ® Ventilation Nasal Mask | Single Patient, multi-use | Yes | Yes | Yes (Deluxe model) | Yes |
| Common/Usual Name: | Patient interface | Multi-patient, reusable | Yes | No | Yes | Yes |
| Classification Code/Name: | BZD - accessory to non-continuous ventilator (respirator)<br>CFR 868.5895 | Vent ports | No | Yes | No | No |
| Device: | IQ® Ventilation Nasal Mask | Equipment to which attached | Positive pressure ventilators with exhalation valves | CPAP | CPAP/bi-level Positive pressure systems with exhalation valves in circuit or system | CPAP/bi-level Positive pressure systems with exhalation valves in circuit or system |
| Predicate Devices: | K021534 – SleepNet IQ® Nasal mask<br>K063806 - SleepNet MoJo Full Face mask<br>K991648 - Respironics - Contour nasal mask (Deluxe) | | | | | |

### Device Description:

The SleepNet IQ® Ventilation Nasal mask is a standard type nasal mask but with no vent ports in the swivel elbow which allows this mask to be used with CPAP and bi-level positive pressure systems.

The IQ® Ventilation Nasal mask requires that the mask and circuit be connected to a positive pressure (CPAP / bi-level) system with its own exhalation valve having adequate alarms and safety systems for positive pressure delivery failure.

The IQ® Ventilation Nasal mask also utilizes standard headgear, swivel elbow (without vent holes) and a delivery tube.

### Indications for Use:

The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / bi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES.

Adult patients (>30 kg) Patient Population:

Environment of Use: Home or hospital / institutional environments.

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510(k) Summary

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510(k) Summary

| | Predicate<br>SleepNet MoJo Non-<br>vented Full face mask<br>K063806 | Predicate<br>SleepNet<br>IQ® Nasal mask<br>K021534 | Predicate<br>Respironics – Contour<br>nasal mask (Deluxe) –<br>K991648 | Proposed<br>SleepNet<br>IQ® Ventilation Nasal<br>mask |
|-----------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Comparative Performance Testing | | | | |
| Unintentional leak | $5 cm H_2O - 5.8 lpm$<br>$15 cm H_2O - 9.5 lpm$<br>$30 cm H_2O - 14.2 lpm$ | N/A | $3 cm H_2O - 2.3 lpm$<br>$10 cm H_2O - 5.4 lpm$<br>$20 cm H_2O - 9.6 lpm$<br>$30 cm H_2O - 15.9 lpm$<br>$40 cm H_2O - 25.9 lpm$ | $3 cm H_2O - 1.8 lpm$<br>$10 cm H_2O - 4.3 lpm$<br>$20 cm H_2O - 7.9 lpm$<br>$30 cm H_2O - 13.7 lpm$<br>$40 cm H_2O - 22.9 lpm$ |
| Intentional leak | N/A | This model has vent holes | $3 cm H_2O - 1.5 lpm$<br>$10 cm H_2O - 3.6 lpm$<br>$20 cm H_2O - 5.8 lpm$<br>$30 cm H_2O - 7.5 lpm$<br>$40 cm H_2O - 9.1 lpm$ | $3 cm H_2O - 1.5 lpm$<br>$10 cm H_2O - 3.9 lpm$<br>$20 cm H_2O - 6.4 lpm$<br>$30 cm H_2O - 8.5 lpm$<br>$40 cm H_2O - 10.2 lpm$ |
| Internal volume /<br>Dead space<br>(measured) | N/A | N/A | 120 ml | 120 ml |
| Pressure Drop | This mask covers the full face vs. nasal<br>$0.08 cm H_2O @ 30 lpm$<br>$0.15 cm H_2O @ 60 lpm$ | N/A | $0.25 cm H_2O @ 30 lpm$<br>Tested with extension tube<br>$1.02 cm H_2O @ 60 lpm$ | $0.31 cm H_2O @ 30 lpm$<br>$1.28 cm H_2O @ 60 lpm$ |
| Components | Headgear<br>Shell / Cushion<br>Swivel elbow | Headgear<br>Shell / Cushion<br>Swivel elbow | Headgear<br>Shell / Cushion<br>Swivel elbow | Headgear<br>Shell / Cushion<br>Swivel elbow |
| Materials | Tested to ISO 10993 | Tested to ISO 10993 | | Tested to ISO 10993 |

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### 510(k) Summary Page 4 of 4 11-May-11

The IQ® Ventilation Nasal Mask is viewed as substantially equivalent to the predicate devices because:

### Indications -

- Similar to Respironics Contour nasal mask (Deluxe) K991648 .
#### Patient Population -

- Identical to SleepNet MoJo K063806 and Respironics Contour nasal mask (Deluxe) -. K991648
#### Technology -

- Identical technology to SleepNet IQ® Nasal mask K021534 .
#### Materials -

- The materials in patient contact are identical to predicate device or have been tested per . ISO 10993
#### Environment of Use -

- . Identical to predicates - SleepNet MoJo - K063806 and Respironics - Contour nasal mask (Deluxe) - K991648
#### Differences -

There are no differences between the predicates and the proposed device.

### Comparative Performance

We have performed comparative performance testing including - Pressure Drop, Unintentional leak, Internal volume / dead space, CO2 rebreathing, and ISO 10993 biocompatibility testing,

The results demonstrated that the device is substantially equivalent to legally marketed predicates.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a semi-circle around the left side of the eagle. The logo is black and white.

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

Sleepnet Corporation C/O Mr. Paul E. Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

MAY 17 2011

Re: K102317

Trade/Device Name: IQ® Ventilation Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 11, 2011 Received: May 12, 2011

Dear Mr. Dryden:

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.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,

h for

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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# Indications for Use Statement

510(k) Number: K102317

Device Name: IQ® Ventilation Nasal Mask

Indications for Use:

The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / bi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES.

The IQ® Ventilation Nasal mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/institutional environment.

Patient Population: Adult patients (>30 kg)

Environment of Use:

Home or hospital / institutional environments.

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Achuttn

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

10(k) Number: k102317