iQ 2 Nasal Mask, Phantom 2 Nasal Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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. January 10, 2022 Sleepnet Corporation % Paul Dryden President ProMedic. LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704 Re: K211274 Trade/Device Name: iQ 2 and Phantom 2 Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 10, 2021 Received: December 13, 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 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) K211274 Device Name iQ 2 and Phantom 2 Nasal Mask #### Indications for Use (Describe) The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O to 30 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|--| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | #### 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}------------------------------------------------ #### Sponsor: | Sleepnet Corporation<br>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: | iQ 2 and Phantom 2 Nasal Mask | | Common/Usual Name: | Patient interface for CPAP | | Regulation Number:<br>Regulation Code:<br>Product Code:<br>Regulatory Class: | 21CFR 868.5905<br>Non-continuous ventilator (IPPB)<br>BZD<br>II | | Device: | iQ 2 and Phantom 2 Nasal Mask | | Predicate Device:<br>Regulation Number:<br>Regulation Code:<br>Product Code:<br>Regulatory Class: | K021534 - Sleepnet iQ Nasal mask<br>21CFR 868.5905<br>Non-continuous ventilator (IPPB)<br>BZD<br>II | #### Device Description: The Sleepnet iQ 2 and Phantom 2 Nasal masks are patient interfaces for use with positive pressure equipment, i.e., CPAP and bi-level. They incorporate an exhaust port in the shell. The 2 styles are similar: - Same patient population and Indications for Use ● - . Same headgear - . Same headgear connector components - Same tubing assembly ● - Same materials and manufacturing processes They differ only in: - Mask shell shape - Gel cushion shape . #### Indications for Use: The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O to 30 cmH2O. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment. {4}------------------------------------------------ #### 510(k) Summary Page 2 of 6 10-Jan-22 Patient Population: For adults (>30 kg) Environment of Use: Home or hospital / institutional environments #### Substantial Equivalence Discussion: The Sleepnet iQ 2 and Phantom 2 Nasal masks are viewed as substantially equivalent to the predicate device because: #### 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 - - Some materials have been identified as identical to similar Sleepnet masks and a material certification provided. For the head strap, following testing were performed: - o ISO 10993-5:2009 Cytotoxicity MEM - o ISO 10993-10:2010 Sensitization and Irritation. #### Performance bench testing The following performance tests were performed as per ISO 17510-2- Medical Devices - Sleep Apnoea Breathing Therapy - Masks And Application Accessories: - Internal Volume / Dead space - Exhaust flow . - Resistance to Flow . - Mechanical Drop test ISO 5356-1 ISO 5356-1:1996 - Anaesthetic and Respiratory Equipment -- Conical Connectors --Part 1: Cones And Socket {5}------------------------------------------------ #### K211274 510(k) Summary Page 3 of 6 10-Jan-22 ### Table of Comparison to Predicate | Attributes | Subject –<br>iQ 2 and Phantom 2 nasal mask | Predicate –<br>iQ nasal mask | Explanation of Differences | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K211274 | K021534 | - | | Product Classification<br>CFR | BZD<br>CFR 868.5905 | BZD<br>CFR 868.5905 | Identical | | Indications for Use | The iQ2 and Phantom 2 Nasal Mask is intended<br>to be used with positive airway pressure devices,<br>such as CPAP or bi-level, operating at or above 3<br>cm H2O to 30 cmH2O. The mask is to be used on<br>adult patients (>30kg) for whom positive airway<br>pressure therapy has been prescribed. The mask is<br>intended for single-patient multi-use in the home,<br>hospital or institutional environment. | The Sleepnet Corporation iQ® nasal mask is<br>intended to be used with positive airway pressure<br>devices, such as CPAP, operating at or above 3 cm<br>H2O for the treatment of adult obstructive sleep<br>apnea.<br>The mask is intended for single patient use, or<br>multiple patient use with proper high level<br>disinfection. The mask may be used in the home or<br>hospital/institutional environment. The mask is to<br>be used on adult patients (>30kg) for whom positive<br>airway pressure therapy has been prescribed. | Similar<br>The predicate included single<br>patient and multiple patient use,<br>whereas the subject devices will<br>be single patient use only. | | Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical | | Patient type | Patients for whom positive airway pressure<br>therapy has been prescribed | Patients for whom positive airway pressure therapy<br>has been prescribed | Identical | | Prescriptive | Yes | Yes | Identical | | Principle of Operation | Device provides a seal over the nose to allow for<br>delivery of pressurized air from a positive airway<br>pressure device. Device has an exhalation port for<br>flushing out exhaled CO2.<br>The device is passive until connected to the<br>positive pressure device. | Device provides a seal over the nose to allow for<br>delivery of pressurized air from a positive airway<br>pressure device. Device has an exhalation port for<br>flushing out exhaled CO2.<br>The device is passive until connected to the positive<br>pressure device. | Identical | | Attributes | Subject –<br>iQ 2 and Phantom 2 nasal mask | Predicate –<br>iQ nasal mask | Explanation of Differences | | Therapy Pressure | 3 cm H2O to 30 cm H2O. | 3 cm H2O to 20 cm H2O. | Similar. The lower limits are<br>identical. The upper limits is<br>determined by the equipment to<br>which the mask is attached.<br>Most CPAP machines today<br>have a higher upper limit of 30<br>cm H2O | | Anatomical site | Seals around nose | Seals around nose | Identical | | User Interface to<br>administer therapy | Masks have a standard 22mm connection that<br>connects to 22mm CPAP/bi-level circuits. | Masks has a standard 22mm connection that<br>connects to 22mm CPAP/bi-level circuits. | Identical | | Contraindications | None | None | Identical | | Environment of Use | The masks are intended for use in the home or<br>hospital/institutional environment. | The masks are intended for use in the home or<br>hospital/institutional environment. | Identical | | Duration of Use | Single patient, multi-use | Single patient, multi-use<br>Multi-patient, multi-use | Similar<br>Removed multi-patient use for<br>the subject device. | | Useful life | Mask cushion - 1 month<br>Swivel frame/tube set - 3 months<br>Headgear and magnetic clips - 6 months | 6 months | Components of the subject<br>device will be offered<br>individually as replacements | | Shelf life | 5 years | No shelf life stated. | Similar<br>5 year shelf life has been<br>validated for the subject devices. | | Non-sterile | Yes | Yes | Identical | | Cleaning methods | Mild Soap and warm water | Mild detergent and warm water | Cleaning method is identical to<br>the predicate as previously<br>cleared | | Features | | | | | Available sizes | 1 | 1 | Identical | | Shape | Similar | Similar | Similar | | Attributes | Subject –<br>iQ 2 and Phantom 2 nasal mask | Predicate –<br>iQ nasal mask | Explanation of Differences | | Incorporates an Exhaust<br>port | Yes | Yes | Identical | | Components of the mask | • Mask cushion<br>o Mask shell with vent holes<br>o Gel bladder<br>• Headgear<br>• Swivel frame/tube set (tubing assembly) | • Mask shell<br>• Gel bladder<br>• Vented elbow<br>• Headgear<br>• Tubing | Similar | | Shell design | Soft | Soft | Similar | | Patient Contact per<br>ISO 10993-1 | Skin contact, Skin and<br>Externally Communicating with tissue (air<br>pathway)<br>Permanent contact | Skin contact, Skin and<br>Externally Communicating with tissue (air<br>pathway)<br>Permanent contact | Some materials are identical and<br>the headgear is new and tested<br>per ISO 10993-1 | | Performance Characteristics | | | | | Exhaust flow (vent flow) | Exhaust flow (lpm) | | Similar.<br>The exhaust flow of the<br>predicate is slightly higher.<br>There are no acceptance criteria<br>for exhaust flow in ISO<br>17510:2015. | | | Pressure<br>(cm H2O) | iQ 2 | Phantom 2 | | | 4 | 18.2 | 18.9 | | | 8 | 26.3 | 27.5 | | | 12 | 34.6 | 35.2 | | | 16 | 39.6 | 39.2 | | | 20 | 44.0 | 45.3 | | | 24 | 49.8 | 50.6 | | | 28 | 53.4 | 55.3 | | | 30 | 55.6 | 56.8 | | | Pressure<br>(cm H2O) | Exhaust flow (lpm) | | | | 4 | 22.1 | | | | 8 | 28.7 | | | | 12 | 37.1 | | | | 16 | 44.3 | | | | 20 | 49.8 | | | | 24 | 54.2 | | | | 28 | 58.7 | | | | 30 | 60.4 | | | Dead space | iQ 2 –<br>Mask – 47.3 ml<br>Tubing – 68.33 ml | Mask – 68.6 ml<br>Tubing – 62 ml | Similar | | | Phantom 2 –<br>Mask – 30.7 ml<br>Tubing – 68.33 ml | | | {6}------------------------------------------------ ## K211274 510(k) Summary Page 4 of 6 10-Jan-22 {7}------------------------------------------------ # K211274 510(k) Summary {8}------------------------------------------------ #### K211274 510(k) Summary Page 6 of 6 10-Jan-22 | Resistance to flow<br>(pressure drop) | Flow rate<br>(lpm) | Pressure drop (cm H2O) | | Flow rate<br>(lpm) | Pressure drop<br>(cm H2O) | | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------|-----------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 50 | 0.443 | 0.447 | 50 | 0.86 | The subject devices have a lower<br>pressure drop compared to the<br>predicate. There are no<br>acceptance criteria for pressure<br>drop in ISO 17510:2015. The<br>pressure drop for a device is<br>disclosed in the labeling This<br>aids therapists in deciding the<br>appropriate pressure setting<br>based on the desired therapy<br>pressure for the patient. | | | 100 | 2.043 | 2.057 | 100 | 3.06 | | | Sound pressure and Sound<br>power level | iQ 2 -<br>Sound pressure - 30.32 dB<br>Sound power - 33.33 dB<br><br>Phantom 2 -<br>Sound pressure – 30.49 dB<br>Sound power - 33.50 dB | | | Sound pressure – 29.90 dB<br>Sound power – 37.90 dB | | Similar.<br>There are no acceptance criteria<br>specified in ISO 17510:2015 for<br>sound levels. | | Operating Range | Operating Temperature: Do not expose the mask to temperatures above 122°F (50°C). | | | | | Similar | #### Substantial Equivalence Conclusion: The iQ2 and Phantom 2 Nasal masks have 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.