HARD SHELL VENTED NASAL MASK

K121321 · Sleepnet Corporation · BZD · Nov 30, 2012 · Anesthesiology

Device Facts

• Record ID: K121321
• Device Name: HARD SHELL VENTED NASAL MASK
• Applicant: Sleepnet Corporation
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level. The mask is intended for: - Single use, disposable . - . Single patient, multi-use in the home setting - . Multi-patient, multi- use in the hospital or institutional settings - Single patient, short-term use (up to 7 days) in the hospital or institutional settings ● The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.

Device Story

Innova Nasal Vented Mask (also referred to as Hard Shell Vented Nasal Mask) serves as patient interface for CPAP or bi-level positive airway pressure therapy. Device consists of rigid shell, gel cushion, headgear, and exhaust elbow with ports for CO2 washout. Used in home, hospital, or institutional environments; operated by patients or healthcare providers. Device delivers prescribed pressure (4-20 cm H2O) to patient airway. Healthcare providers use device to facilitate respiratory therapy; output is therapeutic pressure delivery. Benefits include effective airway pressure application for adult patients. Design is nearly identical to SleepNet iQ Nasal mask (K102317) with modifications to exhaust elbow and duration-of-use labeling.

Clinical Evidence

Bench testing only. Comparative performance testing included exhaust flow (pressure vs. flow), pressure drop (resistance to flow), internal deadspace, and CO2 washout per ISO 17510-2. Cleaning validation and environmental/mechanical testing (temperature, drop test) were performed. Results demonstrated equivalence to predicate; CO2 washout performance met ISO 17510-2 criteria.

Technological Characteristics

Rigid shell, gel cushion, headgear, and swivel elbow with exhaust ports. Materials identical to K102317 and K090935. Pressure range 4-20 cm H2O. Connectivity: None (mechanical interface). Sterilization: Not specified (cleaning instructions provided for soap/water or OPA).

Indications for Use

Indicated for adult patients (>66 lbs / >30 kg) requiring CPAP or bi-level positive airway pressure therapy. Intended for single-use disposable, single-patient multi-use (home), or multi-patient multi-use (hospital/institutional) settings.

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

• Respironics ComfortGel Blue nasal mask (K092835)

Reference Devices

• SleepNet iQ Nasal mask (K102317)
• SleepNet MiniMe Pediatric mask (K090935)

Submission Summary (Full Text)

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# K121321

# 510(k) Summary Page 1 of 6 19-Nov-12

| SleepNet Corporation<br>5 Merrill Industrial Drive<br>Hampton, NH 03842 | Tel - 603-758-6625<br>Fax - 603-758-6699 |
|-------------------------------------------------------------------------|-------------------------------------------------------------------|
| Official Contact: | Jennifer Kennedy – Director of Quality |
| Proprietary or Trade Name: | Innova Nasal Vented Mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD – non-continuous ventilator (IPPB)<br>21CFR 868.5905, Class 2 |
| Predicate Device: | K092835 - Respironics ComfortGel Blue nasal mask |

#### Device Description:

The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes:

- Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835.
- . A range of durations of use for marketing purposes only
- o single use, disposable
- single patient, multi-use up to 7 days o
- single patient, multi-use in home setting o
- o multi-patent, multi-use in institutional settings
- . material for shell, hard vs. soft
- a new exhaust elbow design .

#### Indications for Use:

The Innova Nasal Vented Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.

- . The mask is intended for:
- Single use, disposable .
- Single patient, multi-use in the home setting .
- Multi-patient, multi- use in the hospital or institutional settings. �
- o Single patient, short-term use (up to 7 days) in the hospital or institutional settings

· The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.

Patient Population: For adults (> 66 lbs. / >30 kg)

# NOV 3 0 2012

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# 510(k) Summary Page 2 of 6 19-Nov-12

#### Environment of Use: Home or hospital or institutional environments

## Predicate Device Comparison:

The Innova Nasal Vented Mask as compared to the predicate is viewed as substantially equivalent to the predicate device because:

#### Indications -

- The Innova Nasal Vented Mask is intended to provide a patient interface for application . of positive airway pressure therapy with CPAP or bi-level devices.
The masks are to be used on adult patients (>66)bs. />30 kg) for whom positive airway pressure therapy has been prescribed. Identical to Respironics ComfortGel Blue Nasal (K092835)

Discussion - The indications for use are identical to the predicate Respironics ComfortGel Blue Nasal (K092835)

#### Patient Population -

- The masks are to be used on adult patients (>66 lbs. />30 kg) for whom positive airway . pressure therapy has been prescribed. Identical to Respironics ComfortGel Blue Nasal (K092835)
Discussion - The patient population is identical to the predicate Respironics ComfortGel Blue Nasal (K092835).

#### Technology -

- . Technology, method of manufacture and construction of a gel cushion, hard or soft shell and elbow with exhalation holes are identical to the predicate SleepNet iQ Nasal mask -K 102317 and similar to the predicate Respironics ComfortGel Blue Nasal (K092835).
Discussion - The technology, shape, design, configuration of the mask, head strap as well as the manufacturing methods are identical to the predicate, SleepNet iQ Nasal mask (K102317).

The use of multiple ports in the elbow for exhalation and CO2 washout is substantially equivalent as demonstrated by the comparative Pressure vs. Flow curves and the CO- washout testing vs. the predicate Respironics ComfortGel Blue Nasal (K092835) and the differences are not clinically significant and do not affect safety and effectiveness.

#### Environment of Use -

- The masks are intended for use in the home or hospital or institutional environment. . Identical to predicate - Respironics ComfortGel Blue Nasal (K092835)
Discussion - The environments of use are identical to the predicate.

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510(k) Summary Page 3 of 6 19-Nov-12

# Environment of Use -

- The masks are intended for use in the home or hospital or institutional environment. . Identical to predicate - Respironics ComfortGel Blue Nasal (K092835)
Discussion - The environments of use are identical to the predicate.

| | Table of Comparison to Predicate | |
|--|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | will which beliefler under first and the below | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

| Attributes | Innova Nasal vented mask | Respironics ComfortGel Blue<br>K092835 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Innova Nasal Vented Mask is<br>intended to provide an interface for<br>application of positive airway<br>pressure therapy, such as CPAP or<br>bi-level.<br><br>The mask is intended for:<br>• Single use, disposable<br>• Single patient, multi-use in the<br>home setting<br>• Multi-patient, multi- use in the<br>hospital or institutional settings<br>• Single patient, short-term use (up to<br>7 days) in the hospital or institutional<br>settings<br><br>The masks are to be used on adult<br>patients (>66 lbs. / >30 kg) for whom<br>CPAP or bi-level therapy has been<br>prescribed. | The ComfortGel Blue Nasal Mask is<br>intended to provide an interface of<br>CPAP or bi-level therapy to patients.<br>The mask is for single patient use in<br>the home or multi-patient use in the<br>hospital / institutional environment.<br>The mask is to be used on adult<br>patients (>66 lbs. / >30 kg) for whom<br>CPAP or bi-level therapy has been<br>prescribed. |
| Patient Population | Adult (>66 lbs. / >30 kg) | Adult (>66 lbs. / >30 kg) |
| Environment of Use | The masks are intended for use in the<br>home or hospital or institutional<br>environment. | The masks are intended for use in the<br>home or hospital/institutional<br>environment. |
| Prescriptive | Yes | Yes |
| Duration of Use | Single use, disposable<br>Single patient, multi-use<br>Multi-patient, multi- use<br>Single patient, short-term use (up to<br>7 days) | Single patient, multi-use<br>Multi-patient, multi-use |
| Cleaning methods | Soap and water<br>OPA | Soap and water |
| Incorporates an Exhaust port<br>elbow | Yes | Yes |
| Delivered Pressure range | $4 - 20 cm H_2O$ | $4 - 30 cm H_2O$ |
| Available sizes | 3 | 4 |
| Shape | Similar | Similar |
| Shell | Rigid | Rigid |
| Materials | Identical to Minime K090935 or<br>iQ Nasal K102317 | |
| Attributes | Innova Nasal vented mask | Respironics ComfortGel Blue<br>K092835 |
| CO2 washout profile | Pressure | ETCO2% at |
| Tested per ISO 17510-2<br>(largest size tested, which is<br>worst case) | | mask (% increase) |
| | 4 cm H2O<br>6.0 (15%) | 4 cm H2O<br>5.6 (6%) |
| | 5 cm H2O<br>5.9 (14%) | 5 cm H2O<br>5.5 (3%) |
| | 10 cm H2O<br>5.8 (11%) | 10 cm H2O<br>5.4 (2%) |
| | Occluded<br>6.7 (30%) | Occluded<br>6.3 (19%) |
| Deadspace | | |
| Small | 82 ml | 97 ml |
| Medium | 100 ml | 99 ml |
| Large | 108 ml | 118 ml |
| Exhaust - pressure / flow | Pressure (cmH2O) Flow (lpm) | Pressure (cmH2O)<br>Flow (lpm) |
| | 4<br>18.2 | 4<br>17.3 |
| | 10<br>30.4 | 10<br>27.0 |
| | 20<br>43.8 | 20<br>38.7 |
| Pressure Drop | 30 lpm - 0.04 cm H2O | 30 lpm - 0.04 cm H2O |
| | 50 lpm - 0.16 cm H2O | 50 lpm - 0.15 cm H2O |
| | 60 lpm - 0.24 cm H2O | 60 lpm - 0.22 cm H2O |
| | 100 lpm - 0.82 cm H2O | 100 lpm - 0.74 cm H2O |
| Components | Headgear | Headgear |
| | Shell / Cushion | Shell / Cushion |
| | Swivel elbow | Swivel elbow |

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# 510(k) Summary Page 4 of 6 19-Nov-12

# Non-clinical Testing Summary

#### Comparative Performance -

We have performed comparative performance testing pre- and post-conditioning that included:

# Exhaust Flow (Pressure vs. Flow)

- Standard test method using CPAP unit at various flow rates and measuring the leak at the . patient interface
- No pass / fail criteria, reportable values only. It should be comparable to the predicate. .
- . Discussion - The proposed device has equivalent "Leak or Flow" rate at all pressure vs. the predicate. The differences do not have any clinical significance

# Pressure Drop (resistance to Flow)

- Standard test method of using a standard flow and measuring pressure drop .
- . No pass / fail criteria, reportable values only
- . Discussion - The proposed device is equivalent to the predicate.

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# 510(k) Summary Page 5 of 6 19-Nov-12

## Internal Volume / Deadspace

- Standard test method of measuring the volume of the parts near the patient. .
- . No pass / fail criteria, reportable values only. It should be comparable to the predicate.
- Discussion The proposed device is equivalent and CO2 washout and Pressure vs. Flow . are the key performance features for CPAP mask performance. The difference4s are not clinically significant and do not raise any new safety or effectiveness concerns.

#### CO2 washout

- Tested per ISO 17510-2 .
- Pass / fail criteria per ISO 17510-2 allow for changes in CO2 at various pressures to be < . 20% and < 60% from baseline).
- Discussion the performance of the proposed device is well within the pass / fail criteria . as stated in ISO 17510-2.

# Cleaning validation

- Repeated cleaning was performed per the recommended cleaning instructions .
- Visual and performance testing was performed and compared pre and post- cleaning . and found to be similar
- . Discussion - The proposed mask can be cleaned as intended and meet its performance specifications

## Environmental / Mechanical testing

- . Test method included subjecting samples to high and low temperatures and a drop test
- Pass / fail criteria was that they would meet the performance specifications which was . performed after the cleaning durability
- . Discussion - The proposed device met the performance specifications after conditioning and cleaning.

#### Materials -

- The materials in patient contact are identical to our own predicate devices SleepNet iQ . Nasal (K102317) and MiniMe mask (K090935).
- . Discussion - The materials are identical to the cited predicates.

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# 510(k) Summary Page 6 of 6 19-Nov-12

# Materials / Patient Coatact / Duration of Use (prolonged duration of use)

·

| Component | Patient Contact | Predicate for Biocompatibility |
|----------------|-------------------------------------------------------------------------|----------------------------------------------------|
| Gel Bladder | Surface contact Skin<br>External communicating,<br>Tissue / Gas Pathway | Identical - Sleepnet MiniMe Pediatric mask K090935 |
| Bladder film | Surface contact Skin<br>External communicating,<br>Tissue / Gas Pathway | Identical - Sleepnet IQ Ventilation mask K102317 |
| Shell | External communicating,<br>Tissue / Gas Pathway | Identical - Sleepnet MiniMe Pediatric mask K090935 |
| Elbow assembly | External communicating,<br>Tissue / Gas Pathway | Identical - Sleepnet MiniMe Pediatric mask K090935 |
| Headgear | Surface contact Skin<br>External communicating,<br>Tissue / Gas Pathway | Identical - Sleepnet IQ Ventilation mask K102317 |

# Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate can be found to be substantially equivalent.

.

.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

## November 30, 2012

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

Re: K121321

Trade/Device Name: Hard Shell Vented Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 19, 2012 Received: November 20, 2012

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.

{7}------------------------------------------------

Page 2 - Mr. Dryden

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Kwame Ø. Ulmer

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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# Indications for Use Statement

Page 1 of 1

510(k) Number:

K121321 (To be assigned)

Device Name:

Hard Shell Vented Nasal Mask

Indications for Use:

The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.

The mask is intended for:

- Single use, disposable .
- . Single patient, multi-use in the home setting
- . Multi-patient, multi- use in the hospital or institutional settings
- Single patient, short-term use (up to 7 days) in the hospital or institutional settings ●

The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.

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)

# Lester W. Schultheis Jr 2012.11.30 10:45:42 -05'00'

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

510(k) Number: