K Number

Device Name

HARD SHELL VENTED NASAL MASK

Manufacturer

SLEEPNET CORPORATION

Date Cleared

2012-11-30

(212 days)

Product Code

BZD

Regulation Number

868.5905

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 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 .

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K092835

Reference Devices

K102317, K090935

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and performance of a CPAP mask, with no mention of AI or ML technologies.

Therapeutic

No
The device is described as an interface for applying positive airway pressure therapy, not a therapeutic device itself. It does not generate the therapy but facilitates its delivery.

Diagnostic

The device is a nasal mask intended for the application of positive airway pressure therapy (CPAP or bi-level), which is a treatment. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like a shell and exhaust elbow, and the performance studies focus on physical characteristics like exhaust flow, pressure drop, and CO2 washout. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states the device is a "Hard Shell Vented Nasal Mask" intended to "provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level." This is a device used externally on the patient to deliver air pressure, not to analyze biological samples.
Intended Use: The intended use is for delivering therapy for conditions like sleep apnea, not for diagnosing or monitoring conditions through analysis of bodily fluids or tissues.

The information provided focuses on the physical characteristics of the mask, its intended use for delivering therapy, and performance testing related to airflow and safety, all of which are consistent with a non-IVD medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.
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.

Product codes (comma separated list FDA assigned to the subject device)

BZD

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
- 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 .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult (>66 lbs. / >30 kg)

Intended User / Care Setting

Home or hospital or institutional environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparative Performance:

Exhaust Flow (Pressure vs. Flow): Standard test method using CPAP unit at various flow rates and measuring the leak at the patient interface. The proposed device has equivalent "Leak or Flow" rate at all pressure vs. the predicate, with differences having no clinical significance.
Pressure Drop (resistance to Flow): Standard test method of using a standard flow and measuring pressure drop. The proposed device is equivalent to the predicate.
Internal Volume / Deadspace: Standard test method of measuring the volume of the parts near the patient. The proposed device is equivalent, and CO2 washout and Pressure vs. Flow are key performance features for CPAP mask performance. Differences are not clinically significant and do not raise new safety or effectiveness concerns.
CO2 washout: Tested per ISO 17510-2. Performance of the proposed device is well within the pass / fail criteria as stated in ISO 17510-2 (

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).

Summary

K121321

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

| SleepNet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 | Tel - 603-758-6625
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)
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

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.

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
K092835 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
• Single patient, short-term use (up to
7 days) in the hospital or institutional
settings

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.

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 66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.

Prescription Use XX (Part 21 CFR 801 Subpart D)

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: