K Number
K203601
Device Name
Innova Nasal Non-Vented Mask
Date Cleared
2021-04-30

(142 days)

Product Code
Regulation Number
868.5905
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/BI-LEVEL systems that have adequate alarins for positive pressure delivery failure. The mask is ingle patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).
Device Description
The Sleepnet Innova™ Non-Vented Nasal mask is a patient interface for use with positive pressure equipment. There are 2 labeled versions: - Single patient, multi-use (home or hospital/institutional) up to 6 months . - Single patient, multi-use up to 7 days (hospital/institutional) .
More Information

Not Found

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on mechanical and physical properties of a mask.

No
The device is described as an "accessory" to CPAP/bi-level positive pressure systems, which are therapeutic. It is a patient interface (mask) not the therapy-delivering device itself.

No
The device is a nasal mask used as an accessory for CPAP/bi-level positive pressure systems. Its purpose is to provide an interface for delivering positive pressure, not to diagnose a medical condition.

No

The device description clearly states it is a "patient interface" and describes physical components like a mask, which are hardware. The performance studies also focus on physical characteristics and testing of a tangible device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The Innova™ Nasal Non-Vented Mask is a patient interface used with positive pressure systems (CPAP/bi-level). Its function is to deliver air pressure to the patient's airway, not to analyze biological samples.
  • Intended Use: The intended use clearly states it's an "accessory to CPAP/bi-level positive pressure systems" and is used for "positive pressure delivery." There is no mention of testing or analyzing biological samples.

Therefore, based on the provided information, the Innova™ Nasal Non-Vented Mask is a respiratory support device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/BI-LEVEL systems that have adequate alarms for positive pressure delivery failure. The mask is intended for single patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).

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

BZD

Device Description

The Sleepnet Innova™ Non-Vented Nasal mask is a patient interface for use with positive pressure equipment.

There are 2 labeled versions:

  • Single patient, multi-use (home or hospital/institutional) up to 6 months .
  • Single patient, multi-use up to 7 days (hospital/institutional) .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Face (seals around nose)

Indicated Patient Age Range

Adult (>30 kg)

Intended User / Care Setting

Home or hospital / 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)

Non-clinical testing included:
Biocompatibility - With the exception of headgear, the mask materials which are in patient contact are identical to the Sleepnet reference device. Material Certification provided to support biocompatibility evaluation in accordance with ISO 10993-1:2018 and ISO 18562-1:2017. The material of the headgear has been tested per ISO 10993-5:2009 and ISO 10993-10:2010.

Bench testing included:

  • Pressure drop
  • Unintentional leak
  • Internal Volume / Dead space
  • Mechanical drop test
  • Cleaning validation
  • Shelf-life via Accelerated aging per ASTM F1980:16
  • Testing following ISO 17510:2015

Key results:

  • Dead space (ml): Small/Medium size – 78 ml; Medium/Large size - 100 ml. The dead space of both sizes of the subject device is lower than the predicate device (120 ml).
  • Resistance to flow (pressure drop) (cm H2O): @ 30 lpm - 0.10 cm H2O; @50 lpm - 0.33 cm H2O; @ 60 lpm - 0.46 cm H2O; @100 lpm - 1.42 cm H2O. The subject device has a lower pressure drop compared to the predicate (@ 30 lpm - 0.31 cm H2O, @ 60 lpm - 1.28 cm H2O).
  • Unintentional leak (lpm): At 5 cm H2O: 4.86, at 10 cm H2O: 9.20, at 15 cm H2O: 11.43, at 20 cm H2O: 14.70, at 25 cm H2O: 17.53, at 30 cm H2O: 20.33. The subject device has a higher unintentional leak than the predicate; however, the maximum leak is below the 50 lpm threshold, which does not cause any loss of therapy given ventilator leak compensation.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K102317

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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April 30, 2021

Sleepnet Corporation % Paul Dryden President ProMedic. LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K203601

Trade/Device Name: Innova Nasal Non-Vented Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 30, 2021 Received: March 31, 2021

Dear Paul 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K203601

Device Name Innova™ Nasal Non-Vented Mask

Indications for Use (Describe)

The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/Bi-level systems that have adequate alarins for positive pressure delivery failure. The mask is ingle patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv Page 1 of 7 30-Apr-21

Sponsor:

Sleepnet Corporation
5 Merrill Industrial DriveTel - 603-758-6625
Hampton, NH 03842Fax - 603-758-6699
Sponsor Contact:Jennifer Kennedy - Director of Regulatory and Quality
Submission Correspondent:Paul Dryden
ProMedic, LLC
Proprietary or Trade Name:Innova™ Nasal Non-Vented mask
Common/Usual Name:Patient interface for CPAP
Regulation Number:21CFR 868.5905
Regulation Code:Non-continuous ventilator (IPPB)
Product Code:BZD
Regulatory Class:II
Device:Innova™ Nasal Non-Vented mask
Predicate Device:K102317 - Sleepnet iQ Ventilation Nasal mask

Device Description:

The Sleepnet Innova™ Non-Vented Nasal mask is a patient interface for use with positive pressure equipment.

There are 2 labeled versions:

  • Single patient, multi-use (home or hospital/institutional) up to 6 months .
  • Single patient, multi-use up to 7 days (hospital/institutional) .

Indications for Use:

The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/BI-LEVEL systems that have adequate alarms for positive pressure delivery failure. The mask is intended for single patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).

Patient Population: For adults (>30 kg)

Environment of Use: Home or hospital / institutional environments

Substantial Equivalence Discussion:

We discuss the major attributes for demonstrating substantial equivalence below. These refer to the table below this discussion.

The Sleepnet Innova™ Nasal Non-Vented mask is viewed as substantially equivalent to the predicate device because:

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510(k) Summary Page 2 of 7 30-Apr-21

Indications -

  • The masks are to be used on adult patients (>30 kg) for whom positive airway pressure . therapy has been prescribed.
  • Similar to the predicate. ●

Patient Population -

  • . The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed.
  • Similar to the predicate. ●

Environment of Use -

  • The masks are intended for use in the home or hospital/institutional environment.
  • Similar to the predicate. .

Technological Characteristics -

  • . Similar technology to the predicate.

Non-clinical testing

Biocompatibility -

  • . With the exception of headgear, the mask materials which are in patient contact are identical to the Sleepnet reference device.
  • . Material Certification provided to support biocompatibility evaluation in accordance with ISO 10993-1:2018 and ISO 18562-1:2017
  • The material of the headgear has been tested per ISO 10993-5:2009 and ISO 10993-. 10:2010

Bench testing

  • Pressure drop .
  • Unintentional leak .
  • Internal Volume / Dead space .
  • Mechanical drop test .
  • . Cleaning validation
  • . Shelf-life via Accelerated aging per ASTM F1980:16
  • . Testing following ISO 17510:2015

We have demonstrated that the proposed device is equivalent to the predicate, K102317.

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510(k) Summary Page 3 of 7

30-Apr-21

K203601

Table of Comparison to Predicate

AttributesSubjectPredicateExplanation of Differences
Innova nasal non-vented maskiQ Ventilation nasal mask
510(k)K203601K102317-
Product Classification
CFRBZD
CFR 868.5905BZD
CFR 868.5905Similar
Indications for UseThe Innova™ Nasal Non-Vented Mask is
intended to be used as an accessory to
CPAP/bi-level positive pressure systems
containing exhalation valves. This product is
indicated for use with CPAP/BI-LEVEL
systems that have adequate alarms for
positive pressure delivery failure. The mask
is intended for single patient, multi-use in the
home, hospital or institutional environment
on adult patients (>30kg/66 lbs.).The iQ Ventilation Nasal Mask is to be used
as an accessory to CPAP/bi-level positive
pressure systems that have adequate alarms
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.Similar.
• Both devices intended for use with
positive pressure devices that have
exhalation valves.
• Both devices intended for use with
devices that have adequate alarms and
safety systems in case of failure.
• The predicate device was cleared for
multi-patient use in the
hospital/institutional environment. The
subject device will be single patient use
only.
Patient PopulationAdult (>30 kg)Adult (>30 kg)Similar
Patient typePatients who are appropriate candidates for
non-invasive ventilationPatients who are appropriate candidates for
non-invasive ventilationSimilar
PrescriptiveYesYesSimilar
Principle of OperationProvides a seal over the nose to allow for
delivery of pressurized air from a non-invasive ventilator. Mask is used with
circuits that include an exhalation port for
flushing out exhaled CO2.Provides a seal over the nose to allow for
delivery of pressurized air from a non-invasive ventilator. Mask is used with
circuits that include an exhalation port for
flushing out exhaled CO2.Similar
The device is passive until connected to the
ventilator.The device is passive until connected to the
ventilator.
AttributesSubjectPredicateExplanation of Differences
Innova nasal non-vented maskiQ Ventilation nasal mask
Therapy Pressure Range4 cm H2O - 20 cm H2O.
Typically determined by the equipment to
which it is attached.Greater than 3 cm H2O.
Typically determined by the equipment to
which it is attached.Similar
This rating is dependent on the equipment
to which the device is attached. The
subject device has a minimum pressure of
4 cm H2O. Most new positive pressure
devices have a minimum pressure setting
of 4 cm H2O.
Anatomical siteFace (seals around nose)Face (seals around nose)Similar
User Interface to administer
therapyMasks have a standard 22mm connection
that connects to 22mm ventilator circuits.Mask incorporates a tapered tubing, which
has a standard 22mm connection that
connects to 22mm ventilator circuits.Similar
ContraindicationsNoneNoneSimilar
Environment of UseThe masks are intended for use in the home
or hospital/institutional environment.The masks are intended for use in the home
or hospital/institutional environment.Similar
Use lifeInnova nasal non-vented mask
Home use -
Single patient, multi-use up to 6 months
Innova hospital nasal non-vented mask
Single patient, multi-use up to 6 months
Disposable, Single patient use up to 7 daysSingle patient use - 6 months
Multi patient use - 6 monthsSimilar.
· Removed multi-patient use for the
subject device.
· Added Innova Hospital nasal non-vented
mask for short-term single patient use
(up to 7 days) and single patient. multi-
use for up to 6 months in the
hospital/institutional environment.
Shelf life5 yearsNo shelf life statedSimilar
There is no shelf life for both subject and
predicate. 5 year shelf life has been
validated for the subject device
Non-sterileYesYesIdentical
AttributesSubjectPredicateExplanation of Differences
Innova nasal non-vented maskiQ Ventilation nasal mask
Cleaning methodsInnova nasal non-vented mask -
• Mild Soap (such as Ivory) and water

Innova hospital nasal non-vented mask -
• Mild Soap (such as Ivory) and water
• 70% Isopropyl alcohol | Mild Soap/dish detergent and water | Similar
70% isopropyl alcohol has been added for
the short term hospital use mask. This
method has been validated. This method is
similar to Sleepnet Veraseal 3 full face
non-vented mask - K190533. |
| Features | | | |
| Available sizes | 2 - Small/Medium & Medium/Large | 1 | Similar
The Medium/Large size is similar to the
predicate device. The Small/Medium size
is smaller. The dead space of both sizes of
the subject device is lower than the
predicate device but does not raise new
safety concerns. |
| Shape | Similar | Similar | Similar |
| Incorporates an Exhaust
elbow | No | No | Similar |
| Components of the mask | • Mask shell
• Gel bladder
• Non-vented elbow
• Headgear | • Mask shell
• Gel bladder
• Non-vented elbow
• Headgear
• Tubing | Similar |
| Shell design | Rigid | Soft | Similar
Shell geometry is similar for both devices.
Soft shell incorporated in the predicate
device for comfort feature, but the
functionality is the same. Rigid shell in the
subject device uses the same material as
the Sleepnet V3 full face vented mask -
K190254, which has a similar environment
and duration of use. |

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K203601

510(k) Summary

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K203601

510(k) Summary Page 5 of 7

30-Apr-21

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K203601

510(k) Summary Page 6 of 7

30-Apr-21

| Attributes | | Subject
Predicate | | Explanation of Differences | |
|--------------------------|----------------------------------|-------------------------------------------|----------------------------------|-------------------------------------------|---------------------------------------------|
| | | Innova nasal non-vented mask | iQ Ventilation nasal mask | | |
| Patient Contact per | Surface contact with intact skin | | Surface contact with intact skin | | Similar safety profile |
| ISO 10993-1 | | Externally Communicating with tissue (gas | | Externally Communicating with tissue (gas | |
| | pathway) | | pathway) | | |
| | Permanent contact | | Permanent contact | | |
| | Performance Characteristics | | | | |
| Dead space (ml) | Small/Medium size – 78 ml | | 120 ml | | The dead space of both sizes of the subject |
| | Medium/Large size - 100 ml | | | | device is lower than the predicate device. |
| Resistance to flow | (a) 30 lpm - 0.10 cm H2O | | (@ 30 lpm - 0.31 cm H2O | | The subject device has a lower pressure |
| (pressure drop) (cm H2O) | (@50 lpm - 0.33 cm H2O | | @ 60 lpm - 1.28 cm H2O | | drop compared to the predicate. There are |
| | (a) 60 lpm - 0.46 cm H2O | | | | no performance requirements for pressure |
| | (@100 lpm - 1.42 cm H2O | | | | drop. The pressure drop for a device is |
| | | | | | disclosed in labeling consistent with the |
| | | | | | ISO 17510:2015 requirements. |
| Unintentional leak (lpm) | Pressure | Unintentional leak (Ipm) | Pressure | Unintentional leak (Ipm) | The subject device has a higher |
| | (cm H2O) | | (cm H2O) | | unintentional leak than the predicate. |
| | 5 | 4.86 | 5 | 3.2 | Positive pressure ventilators have leak |
| | 10 | 9.20 | 10 | 5.6 | compensation to account for this |
| | ા ર | 11.43 | ા ર | 9.0 | unintentional leak. Leak compensation |
| | 20 | 14.70 | 20 | 10.8 | found on these devices is 50 lpm or |
| | 25 | 17.53 | 25 | 12.5 | greater. So long as the unintentional leak |
| | 30 | 20.33 | 30 | 14.3 | of the mask is lower than 50 lpm, this leak |
| | | | | | does not cause any loss of therapy. The |
| | | | | | maximum leak is below this threshold. |

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510(k) Summary Page 7 of 7 30-Apr-21

Substantial Equivalence Conclusion:

The Innova™ Nasal Non-Vented mask has similar indications, technological characteristics and principles of operation and performance to the predicate and performance testing demonstrates that the proposed device is substantially equivalent to the predicate.