(116 days)
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.
The modifications to the cleared Mojo Full Face mask (K120463) are:
- Addition of contraindication and updated warning related to presence of magnets
- Change to the headgear material
- Addition of an XL size
The modifications to the cleared Veraseal Full Face mask (K120463) are:
- Modified design, now called the Veraseal 2 Full Face Vented Mask
- . Addition of an XL size
Other modifications include:
- Addition of the Innova Full Face Vented Mask version
- Addition of the Ascend Full Face Vented Mask version
This document does not describe an AI/ML device or a comparative effectiveness study. It is a 510(k) summary for several full face vented masks (Mojo, Veraseal 2, Innova, Ascend) and compares them to a predicate device (Mojo Full Face Mask and Veraseal Full Face Mask, K120463).
The summary focuses on demonstrating substantial equivalence to a previously cleared device through comparisons of indications for use, patient population, environment of use, and technological characteristics. This typically involves performance testing, biocompatibility, transportation, shelf-life, and reprocessing.
Therefore, many of the requested elements for an AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided "Table of Comparison to Predicate" and "Non-Clinical Testing Summary" as they relate to these medical masks.
1. Table of Acceptance Criteria and the Reported Device Performance (as applicable to a physical medical device, not AI/ML):
| Acceptance Criteria (Typically based on ISO 17510 and predicate device performance) | Reported Device Performance (Subject Device: Mojo, Veraseal 2, Innova, Ascend Full Face Vented Mask) | Predicate Device Performance (K120463: Mojo, Veraseal Full Face Mask) | Explanation of Differences (and compliance) |
|---|---|---|---|
| Exhaust Flow Characteristics: (Comparison to predicate device) | Mojo: 3cmH2O: 17.88 lpm, 10cmH2O: 32.57 lpm, 20cmH2O: 48.90 lpm Veraseal 2: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm Innova: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm Ascend: 3cmH2O: 26.80 lpm, 10cmH2O: 41.50 lpm, 20cmH2O: 58.00 lpm | Mojo: 3cmH2O: 21.20 lpm, 10cmH2O: 37.20 lpm, 20cmH2O: 53.10 lpm Veraseal: 3cmH2O: 21.10 lpm, 10cmH2O: 36.40 lpm, 20cmH2O: 53.00 lpm | Similar. The exhaust flow characteristics of the subject devices are similar to the predicate. |
| Anti-Asphyxia Valve (AAV) Opening/Closing Pressure: (< 3 cm H2O as per ISO 17510) | Mojo: Opening - 1.10 cm H2O, Closing - 1.60 cm H2O Veraseal: Opening - 2.1 cm H2O, Closing - 2.28 cm H2O Innova: Opening - 2.1 cm H2O, Closing - 2.28 cm H2O Ascend: Opening - 1.92 cm H2O, Closing - 1.85 cm H2O | Mojo: Opening - 1.10 cm H2O, Closing - 1.60 cm H2O Veraseal: Opening - 1.29 cm H2O, Closing - 1.45 cm H2O | Similar. Pass/Fail criteria as per ISO 17510 is < 3 cm H2O. All subject devices meet the criteria. |
| Resistance to Flow (Pressure drop): (No specific acceptance criteria in ISO 17510, values are disclosed) | Mojo: 50 lpm: 0.40 cm H2O, 100 lpm: 0.65 cm H2O Veraseal 2: 50 lpm: 0.07 cm H2O, 100 lpm: 0.39 cm H2O Innova: 50 lpm: 0.07 cm H2O, 100 lpm: 0.39 cm H2O Ascend: 50 lpm: 0.11 cm H2O, 100 lpm: 0.59 cm H2O | Mojo: 50 lpm: 0.40 cm H2O, 100 lpm: 0.65 cm H2O Veraseal: 50 lpm: 0.49 cm H2O, 100 lpm: 0.89 cm H2O | Similar. There are no acceptance criteria in ISO 17510 for resistance to flow (pressure drop). The resistance values are disclosed in the IFUs. |
| CO2 Washout Profile (etCO2 % increase vs baseline) - ISO 17510:2015: (Compliance with ISO 17510) | Mojo: 3cmH2O: 5.1 (0%), 5cmH2O: 3.5 (-31%), 10cmH2O: 2.1 (-58%), SingleFault1: 7.4 (48%), SingleFault2: 7.5 (51%) Veraseal 2 / Innova: 3cmH2O: 5.9 (16%), 5cmH2O: 5.9 (16%), 10cmH2O: 5.7 (12%), SingleFault1: 6.4 (25%), SingleFault2: 7.4 (45%) Ascend: 3cmH2O: 5.0 (0%), 5cmH2O: 5.0 (0%), 10cmH2O: 4.8 (-4%), SingleFault1: 6.5 (30%), SingleFault2: 7.3 (46%) | Mojo and Veraseal: 3cmH2O: 6.1 (17%), 5cmH2O: 5.9 (14%), 10cmH2O: 5.8 (12%), SingleFault1: 6.3 (21%), SingleFault2: Not tested | Similar, complies with ISO 17510. The deadspace for all subject devices is within 5% of the predicate Mojo mask. The CO2 washout profile of all the subject devices has been verified to be adequate. |
| Sound Pressure and Sound Power Level: (Comparison to predicate device) | Mojo: Sound Pressure – 30.07 dBA, Sound Power – 33.09 dBA Veraseal 2 / Innova / Ascend: Sound Pressure – 29.98 dBA, Sound Power – 32.99 dBA | Mojo: Sound Pressure – 30.07 dBA, Sound Power – 33.09 dBA Veraseal: Sound Pressure – 29.98 dBA, Sound Power – 32.99 dBA | From K120463 (Identical values for corresponding models). |
| AAV Inspiratory/Expiratory Resistance in Single Fault Condition: (Comparison to predicate device) | Mojo®: Inspiratory - 0.8 cm H2O, Expiratory – 0.8 cm H2O Veraseal 2 / Innova / Ascend: Inspiratory - 0.6 cm H2O, Expiratory - 0.5 cm H2O | Mojo®: Inspiratory - 0.8 cm H2O, Expiratory - 0.8 cm H2O Veraseal: Inspiratory - 0.8 cm H2O, Expiratory - 0.8 cm H2O | From K120463 (Similar values, meeting functional requirements). |
| Internal Volume / Deadspace: (Within 5% of predicate Mojo mask, adequate CO2 washout) | Mojo: Small 160 ml, Medium 185 ml, Large 205 ml, XL 210 ml Veraseal 2: Small 155.3 ml, Medium 181.7 ml, Large 196.6 ml, XL 200.6 ml Innova: Small 155.3 ml, Medium 181.7 ml, Large 196.6 ml Ascend: Small 165 ml, Medium 212 ml, Large 221 ml | Mojo: Small 160 ml, Medium 185 ml, Large 205 ml Veraseal: Small 138 ml, Medium 165 ml, Large 181 ml | Similar. XL size has been added to the Mojo and Veraseal 2 masks. The deadspace for all subject devices is within 5% of the predicate Mojo mask. The CO2 washout profile of all the subject devices has been verified to be adequate. |
| Biocompatibility: (Materials identical to cleared predicate devices K120463 and K190254) | Materials in gas pathway and skin contact for all subject devices are identical to Sleepnet's own devices cleared under K120463 and K190254. | Materials identical to K120463. | The biocompatibility test results from the predicate device were leveraged for all subject devices. |
| Transportation and Shelf-life: (Leverage predicate device testing) | No changes in transportation or shelf-life, leveraging predicate device testing. | Predicate device testing results leveraged. | The performance post transportation and shelf-life test results from the predicate device were leveraged for the subject device. |
| Reprocessing: (Utilize same reprocessing instructions as predicate) | Utilizes the same reprocessing instructions as the predicate device. | Predicate device reprocessing instructions. | The reprocessing test results from the predicate device were leveraged for the subject device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes bench testing for physical device characteristics, not a dataset for an AI/ML model. Therefore, "sample size for the test set" and "data provenance" in the context of clinical data are not applicable. The testing was conducted on samples of the manufactured devices.
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 is not applicable as the study involves physical performance testing of medical masks against engineering standards (like ISO 17510), not expert-based ground truth for clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for physical device performance testing.
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
Not applicable. This is a 510(k) submission for physical medical masks, not an AI/ML device or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) submission for physical medical masks.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" here is the adherence to established international standards (like ISO 17510) and the demonstrated equivalence to a predicate device's performance characteristics through objective bench testing. This is typically measurement-based verification against engineering specifications.
8. The sample size for the training set
Not applicable. This document is not about an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This document is not about an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
October 18, 2024
Sleepnet Corporation % Paul Dryden President ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K241830
Trade/Device Name: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 19, 2024 Received: September 19, 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.
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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" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
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 QS 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).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is from Binoy J. Mathews. The signature was created on October 18, 2024 at 15:47:34 with a time zone offset of -04'00'.
For
Rachana Visaria Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices 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) K241830
Device Name
Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask, Ascend Full Face Vented Mask
Indications for Use (Describe)
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/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 Corporation 5 Merrill Industrial Drive Hampton, NH 03842 | Tel - 603-758-6625 |
|---|---|
| Sponsor Contact: | Jennifer Kennedy – Director of Regulatory and Quality |
| Submission Correspondent: | Paul DrydenProMedic, LLC |
| Proprietary or Trade Name: | Mojo Full Face Vented MaskVeraseal 2 Full Face Vented MaskInnova Full Face Vented MaskAscend Full Face Vented Mask |
| Common/Usual Name: | Patient interface for CPAP |
| Regulation Number:Regulation Code:Product Code: | 21CFR 868.5905Non-continuous ventilator (IPPB)BZD |
| Predicate Device:Regulation Number:Regulation Code:Product Code: | K120463 - Mojo Full Face Mask and Veraseal Full Face Mask21CFR 868.5905Non-continuous ventilator (IPPB)BZD |
Device Description:
The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.
The modifications to the cleared Mojo Full Face mask (K120463) are:
- Addition of contraindication and updated warning related to presence of magnets ●
- Change to the headgear material ●
- Addition of an XL size ●
The modifications to the cleared Veraseal Full Face mask (K120463) are:
- Modified design, now called the Veraseal 2 Full Face Vented Mask ●
- . Addition of an XL size
Other modifications include:
- Addition of the Innova Full Face Vented Mask version ●
- Addition of the Ascend Full Face Vented Mask version ●
Indications for Use:
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O.
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510(k) Summary Page 2 of 12 18-Oct-24
The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment. Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital/institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
Patient Population: For adults (>30 kg)
Environment of Use: Home or hospital / institutional environments
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510(k) Summary Page 3 of 12
18-Oct-24
Table of Comparison to Predicate
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend FullFace Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,K120463 | Explanation of Differences |
|---|---|---|---|
| Product ClassificationCFR | BZDCFR 868.5905 | BZDCFR 868.5905 | Identical |
| List of Devices | Mojo Full Face Vented MaskVeraseal 2 Full Face Vented MaskInnova Full Face Vented MaskAscend Full Face Vented Mask | Mojo Full Face maskVeraseal Full Face mask | Identical |
| Indications for Use | The Sleepnet Mojo Full Face Vented Mask, Veraseal2 Full Face Vented Mask, Innova Full Face VentedMask and Ascend Full Face Vented Mask areintended to be used with positive airway pressuredevices, such as CPAP or bilevel, operating at orabove 3 cm H2O.The masks are to be used on adult patients (>30kg)for whom positive airway pressure therapy has beenprescribed.Mojo -Single patient, multi-use in the home orhospital/institutional environment.Veraseal 2 -Short Term Single Patient use (maximum of 7 days)in the hospital/institutional environment.Innova -Single patient, multi-use in the home orhospital/institutional environment.Ascend -Single patient, multi-use in the home orhospital/institutional environment. | The Sleepnet Mojo and Veraseal masks are intendedto be used with positive airway pressure devices, suchas CPAP or bilevel, operating at or above 3 cm H2O.The masks are to be used on adult patients (>30kg) forwhom positive airway pressure therapy has beenprescribed.Mojo -Single patient, multi-use and Multi-patient, multi-useVeraseal -Disposable single use; Single patient, multi-use up to7 daysThe masks are intended for use in the home orhospital/institutional environment. | Similar.The multi-patient use is beingremoved. |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend FullFace Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,K120463 | Explanation of Differences |
| Patient type | Patients who are appropriate candidates for positivepressure therapy | Patients who are appropriate candidates for positivepressure therapy | Identical |
| Prescriptive | Yes | Yes | 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 |
| Duration of Use | Mojo -Single patient, multi-useVeraseal 2 -Short Term Single Patient use (maximum of 7 days)Innova -Single patient, multi-useAscend -Single patient, multi-use | Mojo -Single patient, multi-use and Multi-patient, multi-useVeraseal -Disposable single use; Single patient, multi-use up to7 days | Similar.Multi-patient use for the Mojomask is being removed.Single use for the Verasealmask is being removed. |
| Principle of Operation | Provides a seal over the face (nose and mouth) toallow for delivery of pressurized air from a positivepressure device. Mask includes an exhalation portand AAV for flushing out exhaled CO2. | Provides a seal over the face (nose and mouth) toallow for delivery of pressurized air from a positivepressure device. Mask includes an exhalation port andAAV for flushing out exhaled CO2. | Identical |
| Therapy Pressure | Greater than 3 cm H2OTypically determined by the equipment to which it isattached. | Greater than 3 cm H2OTypically determined by the equipment to which it isattached. | Identical |
| Anatomical site | Face (seals around nose and mouth) | Face (seals around nose and mouth) | Identical |
| User Interface toadminister therapy | Masks have a standard 22mm connector (compliantwith ISO 5356-1) that connects to 22mm CPAPcircuits. | Mask has a standard 22mm connector (compliant withISO 5356-1) that connects to 22mm CPAP circuits. | Identical |
| Contraindications | Mojo has an contraindication that is identical to thepredicate K120463. Veraseal 2, Innova and Ascenddo not have contraindications. | Mojo mask has a contraindication. | Similar. The firstcontraindication in the Mojomask is identical to the predicate.New contraindication related topresence of magnets added asper recall event #94169. |
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend FullFace Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,K120463 | Explanation of Differences |
| New Contraindication (Mojo only)Do not use this mask if you or anyone (example:household members, bed partners, caregivers, etc.) inclose physical contact with your mask has an activemedical implant or metallic implant that will interactwith magnets. Implant examples include, but are notlimited to, pacemakers, implantable cardioverterdefibrillators (ICD), neurostimulators, aneurysm clips,metallic stents, ocular implants, insulin/infusionpumps, cerebral spinal fluid (CSF) shunts, emboliccoils, metallic splinter, implants to restore hearing orbalance with implanted magnets (such as cochlearimplants), flow disruption devices, contact lenses withmetal, dental implants, metallic cranial plates, screws,burr hole covers, bone substitute device, magneticmetallic implants/electrodes/valves placed in upperlimbs, torso, or higher, etc. If you have any questionsregarding the implant, consult your physician or themanufacturer of your implant. | |||
| Warnings | Updated WarningMagnets are used in the mask and headgear clips witha field strength of 380mT. With the exception of thedevices identified in the contraindication, ensure thatthe mask is kept at least 6 inches (approx.16 cm)away from any other medical implants or medicaldevices that can be impacted by the magnetic fields toavoid possible effects from localized magnetic fields.For instance, the functioning of implants may change,or implants may move within the body due tomagnetic attraction/repulsion. This applies to you oranyone in close physical contact with your mask | Unchanged from K120463 | Updated warning for magnets tolabeling |
| Attributes | Subject - Mojo, Veraseal 2, Innova, Ascend FullFace Vented Mask | Predicate - Mojo, Veraseal Full Face Mask,K120463 | Explanation of Differences |
| Useful life | Mojo -Single patient use - 6 monthsVeraseal 2 -Short Term Single Patient use (maximum of 7 days)Innova -Single patient use - 6 monthsAscend -Single patient use - 6 months | Mojo -Single patient, multi-use and Multi-patient, multi-use– 6 monthsVeraseal -Disposable single use; Single patient, multi-use up to7 days | Similar.Multi-patient use for Mojomask has been removed.Single use for Veraseal maskhas been removed. |
| Non-sterile | Yes | Yes | Identical |
| Cleaning methods | Mojo -Mild Soap and waterVeraseal 2 -Mild Soap and waterIsopropyl alcoholInnova -Mild Soap and waterAscend -Mild Soap and water | Mojo -Mild Soap and waterVeraseal -Mild Soap and waterIsopropyl alcohol | Identical |
| Features | |||
| Available sizes | Mojo - 4Veraseal 2 - 4Innova - 3Ascend - 3 | Mojo - 3Veraseal - 3 | Similar.XL size has been added to theMojo and Veraseal 2 masks.These sizes utilize all the samecomponents as thecorresponding large size,except for the gel cushionwhich is slightly larger inlength and width. |
| Shape | Similar | Similar | Similar |
| Incorporates an Exhaustport | Yes | Yes | Identical |
| Attributes | Subject – Mojo, Veraseal 2, Innova, Ascend Full Face Vented Mask | Predicate – Mojo, Veraseal Full Face Mask, K120463 | Explanation of Differences |
| Components of the mask | • Mask shell• Gel bladder (cushion)• Vented elbow assembly• Forehead arm/forehead pad• Headgear | • Mask shell• Gel bladder (cushion)• Vented elbow assembly• Forehead arm/forehead pad• Headgear | Similar |
| Shell design | Mojo – soft shellVeraseal 2 – hard shellInnova – hard shellAscend – hard shell | Mojo – soft shellVeraseal 2 – hard shell | Identical |
| Patient Contact perISO 10993-1 | Skin contactExternally Communicating with tissue (air pathway)Permanent contact | Skin contactExternally Communicating with tissue (air pathway)Permanent contact | Identical |
| Performance Characteristics | |||
| Deadspace | MojoSmall 160 mlMedium 185 mlLarge 205 mlXL 210 mlVeraseal 2Small 155.3 mlMedium 181.7 mlLarge 196.6 mlXL 200.6 mlInnovaSmall 155.3 mlMedium 181.7 mlLarge 196.6 mlAscendSmall 165 mlMedium 212 mlLarge 221 ml | MojoSmall 160 mlMedium 185 mlLarge 205 mlVerasealSmall 138 mlMedium 165 mlLarge 181 ml | Similar.XL size has been added to theMojo and Veraseal 2 masks.The deadspace for all subjectdevices is within 5% of thepredicate Mojo mask. The CO2washout profile of all thesubject devices has beenverified to be adequate. |
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| Attributes | Subject – Mojo, Veraseal 2, Innova, Ascend FullFace Vented Mask | Predicate – Mojo, Veraseal Full Face Mask,K120463 | Explanation of Differences | ||
|---|---|---|---|---|---|
| Exhaust flowcharacteristics | MojoPressure (cmH2O)31020Veraseal 2Pressure (cmH2O)31020InnovaPressure (cmH2O)31020AscendPressure (cmH2O)31020 | Flow (lpm)17.8832.5748.90Flow (lpm)22.0838.5054.30Flow (lpm)22.0838.5054.30Flow (lpm)26.8041.5058.00 | MojoPressure (cmH2O)31020VerasealPressure (cmH2O)31020 | Flow (lpm)21.2037.2053.10Flow (lpm)21.1036.4053.00 | Similar.The exhaust flowcharacteristics of the subjectdevices are similar to thepredicate. |
| AAV Opening/ClosingPressure | MojoOpening - 1.10 cm H2OClosing - 1.60 cm H2OVerasealOpening - 2.1 cm H2OClosing - 2.28 cm H2OInnovaOpening - 2.1 cm H2OClosing - 2.28 cm H2OAscendOpening - 1.92 cm H2OClosing - 1.85 cm H2O | MojoOpening - 1.10 cm H2OClosing - 1.60 cm H2OVerasealOpening - 1.29 cm H2OClosing - 1.45 cm H2O | Similar.Pass/Fail criteria as per ISO17510 is < 3 cm H2O. Allsubject devices meet thecriteria. |
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| Resistance to Flow(Pressure drop) | Mojo50 lpm - 0.40 cm H2O100 lpm - 0.65 cm H2OVeraseal 250 lpm - 0.07 cm H2O100 lpm - 0.39 cm H2OInnova50 lpm - 0.07 cm H2O100 lpm - 0.39 cm H2OAscend50 lpm - 0.11 cm H2O100 lpm - 0.59 cm H2O | Mojo50 lpm - 0.40 cm H2O100 lpm - 0.65 cm H2OVeraseal50 lpm - 0.49 cm H2O100 lpm - 0.89 cm H2O | Similar.There are no acceptancecriteria in ISO 17510 forresistance to flow (pressuredrop). The resistance valuesare disclosed in the IFU's. |
|---|---|---|---|
| Magnets | Mojo only4 Magnets are used in the mask (2) and headgearclips (2) with a field strength of 380mT. These areidentical to K190254. | No magnets | Reference K190254 |
| CO2 washout profileISO 17510:2015 | Mojo -Setting etCO2(%increase vs baseline)3 cmH2O 5.1 (0 %)5 cmH2O 3.5 (-31 %)10 cmH2O 2.1 (-58 %)SingleFault1 7.4 (48 %)SingleFault2 7.5 (51 %)Veraseal 2 / InnovaSetting etCO2(%increase vs baseline)3 cmH2O 5.9 (16 %)5 cmH2O 5.9 (16 %)10 cmH2O 5.7 (12 %)SingleFault1 6.4 (25 %)SingleFault2 7.4 (45 %) | Mojo and Veraseal -Setting etCO2(%increase vs baseline)3 cmH20 6.1 (17 %)5 cmH2O 5.9 (14 %)10 cmH2O 5.8 (12 %)SingleFault1 6.3 (21 %)SingleFault2 Not tested | Similar, complies with ISO17510 |
| AscendSetting | etCO2(%increase vs baseline) | ||
| 3 cmH2O | 5.0 (0 %) | ||
| 5 cmH2O | 5.0 (0 %) | ||
| 10 cmH2O | 4.8 (-4 %) | ||
| SingleFault1 | 6.5 (30 %) | ||
| SingleFault2 | 7.3 (46 %) | ||
| Sound Pressure andSound Power Level | Mojo | Mojo | From K120463 |
| Sound Pressure – 30.07 dBA | Sound Pressure – 30.07 dBA | ||
| Sound Power – 33.09 dBA | Sound Power – 33.09 dBA | ||
| Veraseal 2 / Innova / Ascend | Veraseal | ||
| Sound Pressure – 29.98 dBA | Sound Pressure – 29.98 dBA | ||
| Sound Power – 32.99 dBA | Sound Power – 32.99 dBA | ||
| AAVInspiratory/ExpiratoryResistance in Single FaultCondition | Mojo® | Mojo® | From K120463 |
| Inspiratory - 0.8 cm H2O | Inspiratory - 0.8 cm H2O | ||
| Expiratory – 0.8 cm H2O | Expiratory - 0.8 cm H2O | ||
| Veraseal 2 / Innova / Ascend | Veraseal | ||
| Inspiratory - 0.6 cm H2O | Inspiratory - 0.8 cm H2O | ||
| Expiratory - 0.5 cm H2O | Expiratory - 0.8 cm H2O |
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510(k) Summary Page 11 of 12 18-Oct-24
Substantial Equivalence Discussion:
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are viewed as substantially equivalent to the predicate device because:
Indications -
- The Indications for are similar to the predicate. ●
- Similar to the predicate - K120463.
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 - K120463.
Environment of Use -
- The masks are intended for use in the home or hospital/institutional environment. ●
- Identical to the predicate K120463. ●
Technological Characteristics -
- Identical technology to the predicate K120463. ●
Non-Clinical Testing Summary -
Bench testing - Testing demonstrating conformance to ISO 17510 - Medical Devices - Sleep Apnoea Breathing Therapy - Masks And Application Accessories:
- Exhaust flow ●
- Resistance to Flow
- Anti-asphyxia valve (AAV) pressure test
- AAV Inspiratory/Expiratory Resistance in Single Fault Condition ●
- . Internal Volume / Dead space
- CO2 rebreathing .
Discussion - The performance test results from the predicate device were leveraged for the Mojo and Veraseal 2 models. New testing was conducted for the Innova and Ascend models.
Biocompatibility -
The materials in gas pathway and skin contact for all subject devices are identical to Sleepnet's own devices cleared under K120463 and K190254, which have similar intended use, environment of use, and duration of use as the subject devices using material certifications.
Discussion - The biocompatibility test results from the predicate device were leveraged for all subject devices.
Transportation and Shelf-life -
There have been no changes in the transportation or shelf-life - the subject devices leverage the predicate device testing for transportation and shelf-life.
Discussion - The performance post transportation and shelf-life test results from the predicate device were leveraged for the subject device.
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510(k) Summary Page 12 of 12 18-Oct-24
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.
Substantial Equivalence Conclusion
We have demonstrated that the subject devices are equivalent to the predicate, K120463.
§ 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).