(22 days)
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are intended for single-patient multi-use in the home, hospital or institutional environment.
The Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are nearly identical to the Predicate Sleepnet iQ 2 and Phantom 2 Nasal Mask (K211274). The subject of this submission is: Addition of a contraindication related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask; Update to the warning related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask. Device provides a seal over the nose to allow for delivery of pressurized air from a positive airway pressure device. Device has an exhalation port for flushing out exhaled CO2. The device is passive until connected to the positive pressure device.
This document is a 510(k) Premarket Notification from the FDA regarding the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask. The primary purpose of this submission is to address regulatory changes related to the addition of a contraindication regarding magnets and an update to the warning related to magnets for these devices.
The document states that the Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are "nearly identical" to their predicate devices (Sleepnet iQ 2 and Phantom 2 Nasal Mask, K211274). Therefore, the study described here is fundamentally a comparative study to a predicate device rather than a de novo study proving the device meets new acceptance criteria independently. The acceptance criteria for the subject devices are the performance characteristics of the predicate device.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the performance of the predicate device (K211274). The reported device performance for the subject device (K241469) is stated to be "identical" to the predicate for all technical parameters, as no new performance testing was conducted.
| Attribute | Acceptance Criteria (from Predicate Device K211274) | Reported Device Performance (Subject Device K241469) | Explanation of Differences |
|---|---|---|---|
| Product Classification | BZD, CFR 868.5905 | BZD, CFR 868.5905 | Identical |
| Indications for Use | For use with positive airway pressure devices (CPAP/bi-level, operating at or above 3 cmH2O) on adult patients (>30kg) for whom PAP therapy is prescribed, single-patient multi-use in home, hospital, or institutional environment. | For use with positive airway pressure devices (CPAP/bi-level, operating at 3 cmH2O to 30 cmH2O) on adult patients (>30kg) for whom PAP therapy is prescribed, single-patient multi-use in home, hospital, or institutional environment. | Similar; "Removed 'or above' for clarity" |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Patient Type | Patients for whom positive airway pressure therapy has been prescribed. | Patients for whom positive airway pressure therapy has been prescribed. | Identical |
| Prescriptive | Yes | Yes | Identical |
| Principle of Operation | Device provides a seal over the nose to allow for delivery of pressurized air, has an exhalation port. Passive until connected to positive pressure device. | Device provides a seal over the nose to allow for delivery of pressurized air, has an exhalation port. Passive until connected to positive pressure device. | Identical |
| Contraindications & Warnings | Magnet Warning: Magnets kept at least 2.25 inches (6 cm) away from active medical implants (e.g., pacemaker, defibrillators, neurostimulators, cochlear implants, hearing aids). No explicit contraindications for magnets. | New Contraindication: Do not use if user or anyone in close physical contact has an active or metallic implant that interacts with magnets (list of examples including pacemakers, ICDs, neurostimulators, aneurysm clips, metallic stents, etc.). Updated Warning: Magnets (380nT field strength) kept at least 6 inches (16 cm) away from other medical implants/devices that can be impacted by magnetic fields (exception for devices in contraindication). | New Contraindication and updated Warning due to recall event #94169. |
| Therapy Pressure Range | 3 cm H2O to 30 cm H2O | 3 cm H2O to 30 cm H2O | Identical |
| Anatomical Site | Face (seals around nose) | Face (seals around nose) | Identical |
| User Interface to administer therapy | Standard 22mm connection | Standard 22mm connection | Identical |
| Environment of Use | Home or hospital/institutional | Home or hospital/institutional | Identical |
| Useful life | Mask cushion: 1 month; Swivel frame/tube set: 3 months; Headgear and magnetic clips: 6 months | Mask cushion: 1 month; Swivel frame/tube set: 3 months; Headgear and magnetic clips: 6 months | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Non-sterile | Yes | Yes | Identical |
| Cleaning methods | Mild Soap (such as Ivory) and warm water | Mild Soap (such as Ivory) and warm water | Identical |
| Available sizes | 1 | 1 | Identical |
| Shape | Identical to predicate | Identical to predicate | Identical |
| Incorporates an exhaust port | Yes | Yes | Identical |
| Components of the mask | Mask cushion, Mask shell, Gel bladder, Headgear, Swivel frame/tube set (tubing assembly) | Mask cushion, Mask shell, Gel bladder, Headgear, Swivel frame/tube set (tubing assembly) | Identical |
| Shell design | Soft | Soft | Identical |
| Duration of Use | Single patient, multi-use | Single patient, multi-use | Identical |
| Patient Contact per ISO 10993-1 | Skin contact, Skin and Externally Communicating with tissue (air pathway), Permanent contact | Skin contact, Skin and Externally Communicating with tissue (air pathway), Permanent contact | Identical |
| Exhaust Flow (lpm) | (Values provided in table for 4-30 cm H2O for iQ 2 and Phantom 2) | (Same values provided in table for 4-30 cm H2O for iQ 2 and Phantom 2) | Identical |
| Dead space (ml) | iQ 2: Mask – 47.3 ml, Tubing – 68.33 ml; Phantom 2: Mask – 30.7 ml, Tubing – 68.33 ml | iQ 2: Mask – 47.3 ml, Tubing – 68.33 ml; Phantom 2: Mask – 30.7 ml, Tubing – 68.33 ml | Identical |
| Resistance to flow (cm H2O) | (Values provided in table for 50-100 lpm flow for iQ 2 and Phantom 2) | (Same values provided in table for 50-100 lpm flow for iQ 2 and Phantom 2) | Identical |
| Sound pressure and Sound power level (dB) | iQ 2: Sound pressure - 30.32 dB, Sound power - 33.33 dB; Phantom 2: Sound pressure – 30.49 dB, Sound power – 33.50 dB | iQ 2: Sound pressure - 30.32 dB, Sound power - 33.33 dB; Phantom 2: Sound pressure – 30.49 dB, Sound power – 33.50 dB | Identical |
Regarding the study that proves the device meets the acceptance criteria:
The provided document describes a 510(k) Premarket Notification which focuses on demonstrating substantial equivalence to a previously cleared predicate device (K211274). The core argument for meeting acceptance criteria is that the subject devices are "nearly identical" to the predicate, with the only changes being updates to contraindications and warnings regarding magnets.
Therefore, the "study" to prove the device meets acceptance criteria is primarily a comparison of characteristics and leveraging of previous test results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: No new test set sample size is mentioned for the subject device (K241469) because "No new performance testing was conducted on the subject device, since the device designs are identical to the predicates." The acceptance criteria are based on the performance of the predicate device, for which the original testing details are not provided in this document.
- Data Provenance: Not explicitly stated for the original predicate testing, but the context implies data would have been generated as part of the K211274 submission.
- Retrospective or Prospective: Not specified, but generally, 510(k) submissions for devices leverage existing data or conduct prospective bench testing. In this case, existing data from the predicate was leveraged.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this submission. The device is a medical mask, and the evaluation relies on direct device performance metrics (e.g., exhaust flow, dead space, resistance to flow, sound levels), not on expert interpretation of medical images or data requiring ground truth establishment by clinical experts. The "ground truth" for these engineering metrics would be established by validated test methods and equipment.
- The significant change in this submission relates to the contraindication and warning for magnets, which would have been driven by post-market surveillance or new scientific understanding concerning magnet interactions with medical implants (as indicated by "New as per recall event #94169"), likely involving medical experts but not in the context of establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of subjective data (e.g., image reading) where disagreement among experts needs resolution. This submission focuses on objective engineering performance characteristics of a physical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. MRMC studies are specific to evaluating AI/CAD systems that assist human readers in tasks like image interpretation. This submission is for a physical medical device (nasal mask) and does not involve AI assistance or human readers in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This submission is for a physical medical device and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- As explained in point 3, this is not applicable in the traditional sense of medical ground truth. The "ground truth" for the device's technical specifications (exhaust flow, dead space, resistance, sound) would be established through scientific measurement and adherence to relevant industry standards (bench testing), which were performed on the predicate device and deemed sufficient for the subject device due to identical designs.
8. The sample size for the training set
- This is not applicable. This submission is for a physical medical device and does not involve AI or machine learning that would require a training set.
9. How the ground truth for the training set was established
- This is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2024
Sleepnet Corporation % Paul Dryden President ProMedic Consulting LLC 131 Bay Point Dr NE St. Ptersburg, Florida 33704
Re: K241469
Trade/Device Name: iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 23, 2024 Received: May 24, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 -S
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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241469
Device Name
iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
Indications for Use (Describe)
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are intended for single-patient multi-use in the home, hospital or institutional environment.
| 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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| Sponsor:Sleepnet Corporation5 Merrill Industrial DriveHampton, NH 03842 | Tel - 603-758-6625 |
|---|---|
| Sponsor Contact: | Jennifer Kennedy - Director of Regulatory and Quality |
| Submission Correspondent: | Paul DrydenProMedic, LLC |
| Proprietary or Trade Name: | iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask |
| Common/Usual Name: | Patient interface for CPAP |
| Regulation Number:Regulation Code:Product Code: | 21CFR 868.5905Non-continuous ventilator (IPPB)BZD |
| Device: | iQ 2 and Phantom 2 Nasal Vented Mask |
| Predicate Device:Regulation Number:Regulation Code:Product Code: | K211274 - Sleepnet iQ 2 and Phantom 2 Nasal Mask21CFR 868.5905Non-continuous ventilator (IPPB)BZD |
Device Description:
The Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are nearly identical to the Predicate Sleepnet iQ 2 and Phantom 2 Nasal Mask (K211274).
The subject of this submission is:
· Addition of a contraindication related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
• Update to the warning related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
Indications for Use:
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are intended for single-patient multi-use in the home, hospital or institutional environment.
Patient Population: For adults (>30 kg)
Environment of Use: Home or hospital / institutional environments
Substantial Equivalence Discussion:
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The Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are viewed as substantially equivalent to the predicate device because:
Indications -
- We have updated the device name and removed "or above" in the Indications for Use which are similar.
- Similar to the predicate - K211274.
Patient Population -
- The masks are to be used on adult patients (>30 kg) for whom positive airway pressure ● therapy has been prescribed.
- Identical to the predicate K211274. ●
Environment of Use -
- The masks are intended for use in the home or hospital/institutional environment.
- Identical to the predicate K211274. ●
Technological Characteristics -
- Identical technology to the predicate K211274. ●
Non-Clinical Testing Summary -
Bench testing -
No new performance testing was conducted on the subject device, since the device designs are identical to the predicates.
Discussion - The performance test results from the predicate device were leveraged for the subject device.
Biocompatibility -
There has been no change in the materials – the subject and predicate device utilize the same materials.
Discussion - The biocompatibility test results from the predicate device were leveraged for the subject device.
Reprocessing -
There has been no change in the reprocessing - the subject and predicate device utilize the same reprocessing instructions.
Discussion - The reprocessing test results from the predicate device were leveraged for the subject device.
We have demonstrated that the proposed device is equivalent to the predicate, K211274.
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K241469 510(k) Summary Page 3 of 7 15-Jun-24
Table of Comparison to Predicate
| Attributes | Subject -iQ 2 Nasal Vented Mask and | Predicate -iQ 2/ Phantom 2 Nasal Mask | Explanation of Differences |
|---|---|---|---|
| Phantom 2 Nasal Vented Mask | |||
| 510(k) | K241469 | K211274 | |
| ProductClassificationCFR | BZDCFR 868.5905 | BZDCFR 868.5905 | Identical |
| Indications for Use | The iQ 2 Nasal Vented Mask and Phantom 2Nasal Vented Mask are intended to be used withpositive airway pressure devices, such as CPAPor bi-level, operating at 3 cmH2O to 30 cmH2O.The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapyhas been prescribed. The masks are intended forsingle-patient multi-use in the home, hospital orinstitutional environment. | The iQ 2/ Phantom 2 Nasal Mask is intended tobe used with positive airway pressure devices,such as CPAP or bi-level, operating at or above 3cm H2O. The mask is to be used on adult patients(>30kg) for whom positive airway pressuretherapy has been prescribed. The mask isintended for single- patient multi-use in thehome, hospital or institutional environment. | SimilarRemoved "or above" for clarity |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Patient type | Patients for whom positive airway pressure therapyhas been prescribed | Patients for whom positive airway pressuretherapy has been prescribed | Identical |
| Prescriptive | Yes | Yes | Identical |
| Principle of Operation | Device provides a seal over the nose to allow fordelivery of pressurized air from a positive airwaypressure device. Device has an exhalation port forflushing out exhaled CO2.The device is passive until connected to thepositive pressure device. | Device provides a seal over the nose to allow fordelivery of pressurized air from a positive airwaypressure device. Device has an exhalation portfor flushing out exhaled CO2.The device is passive until connected to thepositive pressure device. | Identical |
| Contraindication andWarnings | New ContraindicationDo not use this mask if you or anyone (example:household members, bed partners, caregivers, etc.)in close physical contact with your mask has anactive medical implant or metallic implant that willinteract with magnets. Implant examples include,but are not limited to, pacemakers, implantable | There were no contraindications in K211274. | New as per recall event #94169Original K211274 labelingavailable in Section006_Labeling. |
| cardioverter defibrillators (ICD), neurostimulators,aneurysm clips, metallic stents, ocular implants,insulin/infusion pumps, cerebral spinal fluid (CSF)shunts, embolic coils, metallic splinter, implants torestore hearing or balance with implanted magnets(such as cochlear implants), flow disruptiondevices, contact lenses with metal, dental implants,metallic cranial plates, screws, burr hole covers,bone substitute device, magnetic metallicimplants/electrodes/valves placed in upper limbs,torso, or higher, etc. If you have any questionsregarding the implant, consult your physician orthe manufacturer of your implant.Updated WarningMagnets are used in the mask and headgear clipswith a field strength of 380mT. With the exceptionof the devices identified in the contraindication,ensure that the mask is kept at least 6 inches(approx.16 cm) away from any other medicalimplants or medical devices that can be impacted bythe magnetic fields to avoid possible effects fromlocalized magnetic fields. For instance, thefunctioning of implants may change, or implantsmay move within the body due to magneticattraction/repulsion. This applies to you or anyonein close physical contact with your mask. | Magnet WarningMagnets are used in the swivel frame/tube set andthe headgear clips. The magnetic field strength is380 mT. Ensure that the magnets are kept at least2.25 inches (6 cm) away from any active medicalimplant or medical device that can be impacted bythe magnetic field (e.g., pacemaker, defibrillators,neurostimulators, cochlear implants, hearing aids)to avoid possible effects from localized magneticfields | ||
| Therapy PressureRange | 3 cm H2O to 30 cm H2O. | 3 cm H2O to 30 cm H2O. | Identical |
| Anatomical site | Face (seals around nose) | Face (seals around nose) | Identical |
| User Interfaceto administertherapy | Masks have a standard 22mm connection thatconnects to 22mm CPAP/bi-level circuits. | Masks have a standard 22mm connection thatconnects to 22mm CPAP/bi-level circuits. | Identical |
| Environment of Use | The masks are intended for use in the home orhospital/institutional environment. | The masks are intended for use in the home orhospital/institutional environment. | Identical |
| Attributes | Subject -iQ 2/ Phantom 2 nasal vented mask | Predicate -iQ 2/ Phantom 2 nasal mask | Explanation of Differences |
| Useful life | Mask cushion - 1 monthSwivel frame/tube set - 3 months Headgearand magnetic clips – 6 months | Mask cushion - 1 monthSwivel frame/tube set - 3 months Headgearand magnetic clips - 6 months | Identical |
| Shelf life | 5 years. | 5 years. | Identical |
| Non-sterile | Yes | Yes | Identical |
| Cleaning methods | Mild Soap (such as Ivory) and warm water | Mild Soap (such as Ivory) and warm water | Identical |
| Available sizes | 1 | 1 | Identical |
| Shape | Identical | Identical | Identical |
| Incorporates an Exhaust port | Yes | Yes | Identical |
| Components of the mask | Mask cushion Mask shell Gel bladder HeadgearSwivel frame/tube set (tubing assembly) | Mask cushion Mask shell Gel bladder HeadgearSwivel frame/tube set (tubing assembly) | Identical |
| Shell design | Soft | Soft | Identical |
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K241469 510(k) Summary
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K241469 510(k) Summary
| Duration of Use | Single patient, multi-use |
|---|---|
| Single patient, multi-use | |
| Identical |
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K241469 510(k) Summary Page 6 of 7
15-Jun-24
| Attributes | Subject -iQ 2/ Phantom 2 nasal vented mask | Predicate -iQ 2/ Phantom 2 nasal mask | Explanation of Differences | ||||
|---|---|---|---|---|---|---|---|
| Patient Contact perISO 10993-1 | Skin contact, Skin andExternally Communicating with tissue (airpathway)Permanent contact | Skin contact, Skin andExternally Communicating with tissue (airpathway)Permanent contact | Identical | ||||
| Exhaust Flow | Pressure(cm H2O) | Exhaust flow (lpm) | Pressure(cm H2O) | Exhaust flow (lpm) | Identical | ||
| iQ 2 | Phantom 2 | iQ 2 | Phantom 2 | ||||
| 4 | 18.2 | 18.9 | 4 | 18.2 | 18.9 | ||
| 8 | 26.3 | 27.5 | 8 | 26.3 | 27.5 | ||
| 12 | 34.3 | 35.2 | 12 | 34.3 | 35.2 | ||
| 16 | 39.6 | 39.2 | 16 | 39.6 | 39.2 | ||
| 20 | 44.0 | 45.3 | 20 | 44.0 | 45.3 | ||
| 24 | 49.8 | 50.6 | 24 | 49.8 | 50.6 | ||
| 28 | 53.4 | 55.3 | 28 | 53.4 | 55.3 | ||
| 30 | 55.6 | 56.8 | 30 | 55.6 | 56.8 | ||
| Dead space | iQ 2 –Mask – 47.3 mlTubing – 68.33 ml | iQ 2 –Mask – 47.3 mlTubing – 68.33 ml | Identical | ||||
| Phantom 2 –Mask – 30.7 mlTubing – 68.33 ml | Phantom 2 –Mask – 30.7 mlTubing – 68.33 ml | ||||||
| Resistance to flow (pressuredrop) | Flow rate(lpm) | Pressure drop (cm H2O) | Flow rate(lpm) | Pressure drop (cm H2O) | Identical | ||
| iQ 2 | Phantom 2 | iQ 2 | Phantom 2 | ||||
| 50 | 0.45 | 0.45 | 50 | 0.45 | 0.45 | ||
| 100 | 2.05 | 2.06 | 100 | 2.05 | 2.06 | ||
| Sound pressure and Soundpower level | iQ 2 –Sound pressure - 30.32 dBSound power - 33.33 dB | iQ 2 –Sound pressure - 30.32 dBSound power - 33.33 dB | Identical | ||||
| Phantom 2 –Sound pressure – 30.49 dB Sound power –33.50 dB | Phantom 2 –Sound pressure – 30.49 dB Sound power –33.50 dB |
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K241469 510(k) Summary Page 7 of 7 15-Jun-24
Substantial Equivalence Conclusion:
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Ventical indications, technological characteristics and principles of operation and performance to the predicate and performance testing demonstrates that the subject device is use 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).