Innova Nasal Non-Vented Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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) | | |------------------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;"><b> Prescription Use (Part 21 CFR 801 Subpart D) </b></span> | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 Dryden<br>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: {4}------------------------------------------------ #### 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. {5}------------------------------------------------ # 510(k) Summary Page 3 of 7 30-Apr-21 K203601 ## 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 Classification<br>CFR | BZD<br>CFR 868.5905 | BZD<br>CFR 868.5905 | Similar | | Indications for Use | The Innova™ Nasal Non-Vented Mask is<br>intended to be used as an accessory to<br>CPAP/bi-level positive pressure systems<br>containing exhalation valves. This product is<br>indicated for use with CPAP/BI-LEVEL<br>systems that have adequate alarms for<br>positive pressure delivery failure. The mask<br>is intended for single patient, multi-use in the<br>home, hospital or institutional environment<br>on adult patients (>30kg/66 lbs.). | The iQ Ventilation Nasal Mask is to be used<br>as an accessory to CPAP/bi-level positive<br>pressure systems that have adequate alarms<br>for positive pressure delivery failure. Use of<br>this product is indicated for use with<br>CPAP/BI-LEVEL POSITIVE PRESSURE<br>SYSTEMS CONTAINING EXHALATION<br>VALVES.<br>The iQ Ventilation Nasal Mask is intended<br>for single patient multi-use in the home<br>environment and multiple patients multi-use<br>in the hospital/institutional environment. | Similar.<br>• Both devices intended for use with<br>positive pressure devices that have<br>exhalation valves.<br>• Both devices intended for use with<br>devices that have adequate alarms and<br>safety systems in case of failure.<br>• The predicate device was cleared for<br>multi-patient use in the<br>hospital/institutional environment. The<br>subject device will be single patient use<br>only. | | Patient Population | Adult (>30 kg) | Adult (>30 kg) | Similar | | Patient type | Patients who are appropriate candidates for<br>non-invasive ventilation | Patients who are appropriate candidates for<br>non-invasive ventilation | Similar | | Prescriptive | Yes | Yes | Similar | | Principle of Operation | Provides a seal over the nose to allow for<br>delivery of pressurized air from a non-invasive ventilator. Mask is used with<br>circuits that include an exhalation port for<br>flushing out exhaled CO2. | Provides a seal over the nose to allow for<br>delivery of pressurized air from a non-invasive ventilator. Mask is used with<br>circuits that include an exhalation port for<br>flushing out exhaled CO2. | Similar | | | The device is passive until connected to the<br>ventilator. | The device is passive until connected to the<br>ventilator. | | | Attributes | Subject | Predicate | Explanation of Differences | | | Innova nasal non-vented mask | iQ Ventilation nasal mask | | | Therapy Pressure Range | 4 cm H2O - 20 cm H2O.<br>Typically determined by the equipment to<br>which it is attached. | Greater than 3 cm H2O.<br>Typically determined by the equipment to<br>which it is attached. | Similar<br>This rating is dependent on the equipment<br>to which the device is attached. The<br>subject device has a minimum pressure of<br>4 cm H2O. Most new positive pressure<br>devices have a minimum pressure setting<br>of 4 cm H2O. | | Anatomical site | Face (seals around nose) | Face (seals around nose) | Similar | | User Interface to administer<br>therapy | Masks have a standard 22mm connection<br>that connects to 22mm ventilator circuits. | Mask incorporates a tapered tubing, which<br>has a standard 22mm connection that<br>connects to 22mm ventilator circuits. | Similar | | Contraindications | None | None | Similar | | Environment of Use | The masks are intended for use in the home<br>or hospital/institutional environment. | The masks are intended for use in the home<br>or hospital/institutional environment. | Similar | | Use life | Innova nasal non-vented mask<br>Home use -<br>Single patient, multi-use up to 6 months<br>Innova hospital nasal non-vented mask<br>Single patient, multi-use up to 6 months<br>Disposable, Single patient use up to 7 days | Single patient use - 6 months<br>Multi patient use - 6 months | Similar.<br>· Removed multi-patient use for the<br>subject device.<br>· Added Innova Hospital nasal non-vented<br>mask for short-term single patient use<br>(up to 7 days) and single patient. multi-<br>use for up to 6 months in the<br>hospital/institutional environment. | | Shelf life | 5 years | No shelf life stated | Similar<br>There is no shelf life for both subject and<br>predicate. 5 year shelf life has been<br>validated 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 -<br>• Mild Soap (such as Ivory) and water<br><br>Innova hospital nasal non-vented mask -<br>• Mild Soap (such as Ivory) and water<br>• 70% Isopropyl alcohol | Mild Soap/dish detergent and water | Similar<br>70% isopropyl alcohol has been added for<br>the short term hospital use mask. This<br>method has been validated. This method is<br>similar to Sleepnet Veraseal 3 full face<br>non-vented mask - K190533. | | Features | | | | | Available sizes | 2 - Small/Medium & Medium/Large | 1 | Similar<br>The Medium/Large size is similar to the<br>predicate device. The Small/Medium size<br>is smaller. The dead space of both sizes of<br>the subject device is lower than the<br>predicate device but does not raise new<br>safety concerns. | | Shape | Similar | Similar | Similar | | Incorporates an Exhaust<br>elbow | No | No | Similar | | Components of the mask | • Mask shell<br>• Gel bladder<br>• Non-vented elbow<br>• Headgear | • Mask shell<br>• Gel bladder<br>• Non-vented elbow<br>• Headgear<br>• Tubing | Similar | | Shell design | Rigid | Soft | Similar<br>Shell geometry is similar for both devices.<br>Soft shell incorporated in the predicate<br>device for comfort feature, but the<br>functionality is the same. Rigid shell in the<br>subject device uses the same material as<br>the Sleepnet V3 full face vented mask -<br>K190254, which has a similar environment<br>and duration of use. | {6}------------------------------------------------ K203601 # 510(k) Summary {7}------------------------------------------------ K203601 # 510(k) Summary Page 5 of 7 30-Apr-21 {8}------------------------------------------------ ### K203601 # 510(k) Summary Page 6 of 7 30-Apr-21 | Attributes | | Subject<br>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. | {9}------------------------------------------------ #### 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.