(142 days)
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.).
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) .
The Sleepnet Innova™ Nasal Non-Vented Mask is evaluated for substantial equivalence to the predicate device, K102317 - Sleepnet iQ Ventilation Nasal Mask. The evaluation relies on non-clinical bench testing to demonstrate similar performance characteristics.
1. Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: iQ Ventilation Nasal Mask) | Reported Device Performance (Subject: Innova Nasal Non-Vented Mask) | Explanation of Differences |
|---|---|---|---|
| Dead Space (ml) | 120 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. |
| Resistance to Flow (Pressure Drop) (cm H2O) | @ 30 lpm - 0.31 cm H2O; @ 60 lpm - 1.28 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. No specific performance requirements for pressure drop, but disclosed in labeling consistent with ISO 17510:2015. |
| Unintentional Leak (lpm) | @ 5 cm H2O - 3.2 lpm; @ 10 cm H2O - 5.6 lpm; @ 15 cm H2O - 9.0 lpm; @ 20 cm H2O - 10.8 lpm; @ 25 cm H2O - 12.5 lpm; @ 30 cm H2O - 14.3 lpm | @ 5 cm H2O - 4.86 lpm; @ 10 cm H2O - 9.20 lpm; @ 15 cm H2O - 11.43 lpm; @ 20 cm H2O - 14.70 lpm; @ 25 cm H2O - 17.53 lpm; @ 30 cm H2O - 20.33 lpm | The subject device has a higher unintentional leak than the predicate. However, it is stated that so long as the unintentional leak is lower than 50 lpm (the leak compensation capability of positive pressure ventilators), it does not cause any loss of therapy. The maximum reported leak (20.33 lpm) is below this threshold, implying acceptance. |
2. Sample Size and Data Provenance:
The provided document does not specify a distinct sample size for a test set. The data presented are reported performance characteristics of the Innova Nasal Non-Vented Mask, which are compared against known performance characteristics of the predicate device. The information is derived from non-clinical bench testing. The country of origin of the data is not specified, but the submission is to the US FDA, implying compliance with US regulatory standards. The data is prospective, generated from tests on the subject device.
3. Number of Experts and Qualifications:
Not applicable. The study involves non-clinical bench testing and performance measurements, not expert evaluation of medical cases or images.
4. Adjudication Method:
Not applicable. The study involves non-clinical bench testing and performance measurements, not expert evaluation of medical cases or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. This submission pertains to a medical device (nasal mask) and its performance characteristics through bench testing, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone Performance Study:
Yes, a standalone performance study in the form of non-clinical bench testing was done for the device. This includes measurements for:
- Pressure drop
- Unintentional leak
- Internal Volume / Dead space
- Mechanical drop test
- Cleaning validation
- Shelf-life via Accelerated aging per ASTM F1980:16
- Biocompatibility testing in accordance with ISO 10993-1:2018 and ISO 18562-1:2017 (for mask materials) and ISO 10993-5:2009 and ISO 10993-10:2010 (for headgear material).
- Testing following ISO 17510:2015
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical bench testing is established through standardized testing methodologies and physical measurements, and comparison against the performance of a predicate device. For example, dead space is a direct measurement, resistance to flow is measured using specific flow rates, and unintentional leak is measured at different pressures. The predicate device's performance data serves as the comparative "truth" for demonstrating substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set." The performance data is based on physical testing of the device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
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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
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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
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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 Drive | Tel - 603-758-6625 |
| Hampton, NH 03842 | Fax - 603-758-6699 |
| Sponsor Contact: | Jennifer Kennedy - Director of Regulatory and Quality |
| Submission Correspondent: | Paul DrydenProMedic, 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
Table of Comparison to Predicate
| Attributes | Subject | Predicate | Explanation of Differences |
|---|---|---|---|
| Innova nasal non-vented mask | iQ Ventilation nasal mask | ||
| 510(k) | K203601 | K102317 | - |
| Product ClassificationCFR | BZDCFR 868.5905 | BZDCFR 868.5905 | Similar |
| Indications for Use | The Innova™ Nasal Non-Vented Mask isintended to be used as an accessory toCPAP/bi-level positive pressure systemscontaining exhalation valves. This product isindicated for use with CPAP/BI-LEVELsystems that have adequate alarms forpositive pressure delivery failure. The maskis intended for single patient, multi-use in thehome, hospital or institutional environmenton adult patients (>30kg/66 lbs.). | The iQ Ventilation Nasal Mask is to be usedas an accessory to CPAP/bi-level positivepressure systems that have adequate alarmsfor positive pressure delivery failure. Use ofthis product is indicated for use withCPAP/BI-LEVEL POSITIVE PRESSURESYSTEMS CONTAINING EXHALATIONVALVES.The iQ Ventilation Nasal Mask is intendedfor single patient multi-use in the homeenvironment and multiple patients multi-usein the hospital/institutional environment. | Similar.• Both devices intended for use withpositive pressure devices that haveexhalation valves.• Both devices intended for use withdevices that have adequate alarms andsafety systems in case of failure.• The predicate device was cleared formulti-patient use in thehospital/institutional environment. Thesubject device will be single patient useonly. |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Similar |
| Patient type | Patients who are appropriate candidates fornon-invasive ventilation | Patients who are appropriate candidates fornon-invasive ventilation | Similar |
| Prescriptive | Yes | Yes | Similar |
| Principle of Operation | Provides a seal over the nose to allow fordelivery of pressurized air from a non-invasive ventilator. Mask is used withcircuits that include an exhalation port forflushing out exhaled CO2. | Provides a seal over the nose to allow fordelivery of pressurized air from a non-invasive ventilator. Mask is used withcircuits that include an exhalation port forflushing out exhaled CO2. | Similar |
| The device is passive until connected to theventilator. | The device is passive until connected to theventilator. | ||
| Attributes | Subject | Predicate | Explanation of Differences |
| Innova nasal non-vented mask | iQ Ventilation nasal mask | ||
| Therapy Pressure Range | 4 cm H2O - 20 cm H2O.Typically determined by the equipment towhich it is attached. | Greater than 3 cm H2O.Typically determined by the equipment towhich it is attached. | SimilarThis rating is dependent on the equipmentto which the device is attached. Thesubject device has a minimum pressure of4 cm H2O. Most new positive pressuredevices have a minimum pressure settingof 4 cm H2O. |
| Anatomical site | Face (seals around nose) | Face (seals around nose) | Similar |
| User Interface to administertherapy | Masks have a standard 22mm connectionthat connects to 22mm ventilator circuits. | Mask incorporates a tapered tubing, whichhas a standard 22mm connection thatconnects to 22mm ventilator circuits. | Similar |
| Contraindications | None | None | Similar |
| Environment of Use | The masks are intended for use in the homeor hospital/institutional environment. | The masks are intended for use in the homeor hospital/institutional environment. | Similar |
| Use life | Innova nasal non-vented maskHome use -Single patient, multi-use up to 6 monthsInnova hospital nasal non-vented maskSingle patient, multi-use up to 6 monthsDisposable, Single patient use up to 7 days | Single patient use - 6 monthsMulti patient use - 6 months | Similar.· Removed multi-patient use for thesubject device.· Added Innova Hospital nasal non-ventedmask for short-term single patient use(up to 7 days) and single patient. multi-use for up to 6 months in thehospital/institutional environment. |
| Shelf life | 5 years | No shelf life stated | SimilarThere is no shelf life for both subject andpredicate. 5 year shelf life has beenvalidated for the subject device |
| Non-sterile | Yes | Yes | Identical |
| Attributes | Subject | Predicate | Explanation of Differences |
| Innova nasal non-vented mask | iQ Ventilation nasal mask | ||
| Cleaning methods | Innova nasal non-vented mask -• Mild Soap (such as Ivory) and waterInnova hospital nasal non-vented mask -• Mild Soap (such as Ivory) and water• 70% Isopropyl alcohol | Mild Soap/dish detergent and water | Similar70% isopropyl alcohol has been added forthe short term hospital use mask. Thismethod has been validated. This method issimilar to Sleepnet Veraseal 3 full facenon-vented mask - K190533. |
| Features | |||
| Available sizes | 2 - Small/Medium & Medium/Large | 1 | SimilarThe Medium/Large size is similar to thepredicate device. The Small/Medium sizeis smaller. The dead space of both sizes ofthe subject device is lower than thepredicate device but does not raise newsafety concerns. |
| Shape | Similar | Similar | Similar |
| Incorporates an Exhaustelbow | 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 | SimilarShell geometry is similar for both devices.Soft shell incorporated in the predicatedevice for comfort feature, but thefunctionality is the same. Rigid shell in thesubject device uses the same material asthe Sleepnet V3 full face vented mask -K190254, which has a similar environmentand duration of use. |
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510(k) Summary
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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 | SubjectPredicate | 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.
§ 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).