(30 days)
The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O.
The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.
Veraseal 3 -Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)
V3 -Single patient, multi-use (home)
Mojo 2 -Single patient, multi-use (home or hospital/institutional)
The Sleepnet Veraseal 3, V3 and Mojo 2 Full Face Vented masks are identical to the predicate Veraseal 3, V3, and Mojo 2 Full Face Vented masks (K190254).
The subject of this submission is:
- Addition of a contraindication related to magnets on the Mojo 2 Full Face Vented mask .
- . Update to the warning related to magnets on the Mojo 2 Full Face Vented mask
The provided text describes a 510(k) premarket notification for a medical device, specifically full face vented masks (Mojo 2, Veraseal 3, V3 Full Face Vented Mask). This submission seeks to establish substantial equivalence to a predicate device (K190254). Crucially, the document explicitly states that no performance testing was conducted on the subject device because its design is identical to the predicate device. The only changes are the addition of a contraindication and an updated warning related to magnets, prompted by a prior recall.
Therefore, the information required to answer your query regarding acceptance criteria and the study proving the device meets those criteria (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance, ground truth type for training/test sets) is not present in the provided document. This document primarily focuses on demonstrating substantial equivalence based on identical design and leveraged predicate data, rather than new performance studies.
However, I can extract the specifications and comparison tables, which can be interpreted as the implicit "acceptance criteria" through their demonstration of identical characteristics to the predicate device. The "reported device performance" is then the stated performance of these identical characteristics.
Here's a breakdown of what can be inferred from the document, acknowledging the missing information about new performance studies:
A. Acceptance Criteria and Reported Device Performance (Inferred from Predicate Equivalence)
Since the subject device is identical to the predicate device (K190254) in design and performance, the "acceptance criteria" are effectively that the subject device's specifications match those of the predicate. The "reported device performance" is therefore the reported performance of the predicate device, which the subject device is stated to replicate.
| Acceptance Criteria Category | Specific Criteria (from Predicate) | Reported Device Performance (for Subject Device, stated as Identical to Predicate) |
|---|---|---|
| General | Identical design to predicate K190254 except for labeling changes. | Identical design. |
| Indications for Use | Intended to be used with positive airway pressure devices (CPAP/bi-level) operating at or above 3 cm H2O for adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. | Identical. |
| Patient Population | Adult (>30 kg) | Identical. |
| Patient Type | Patients prescribed non-invasive pressure therapy (CPAP or bi-level) | Identical. |
| Prescriptive | Yes | Identical. |
| Principle of Operation | Provides seal around nose and mouth for air delivery; includes exhalation port and anti-asphyxia valve. Passive until connected to CPAP blower. | Identical. |
| Therapy Pressure | Typically 3 to 25 cm H2O (determined by attached equipment) | Identical. |
| Anatomical Site | Face (seals around nose and mouth) | Identical. |
| Environment of Use | Home or hospital/institutional environment. | Identical. |
| Duration of Use | Veraseal 3: Disposable single patient use / Single patient, multi-use up to 7 days. Mojo 2 & V3: Single patient, multi-use. | Identical. |
| Useful Life | Veraseal 3: Disposable, up to 7 days. V3 & Mojo 2: Single patient use - 6 months. | Identical. |
| Sterility | Non-sterile | Identical. |
| Cleaning Methods | Mild Soap (such as Ivory) and water; Isopropyl alcohol. | Identical. |
| Available Sizes | 4 | Identical. |
| Shape | Identical to predicate | Identical. |
| Incorporates Exhaust Elbow | Yes | Identical. |
| Components | Mask shell (soft/rigid), Gel bladder, Exhalation elbow with Anti-asphyxia valve, 4-point headgear. | Identical. |
| Shell Design | Veraseal 3/V3: Rigid; Mojo 2: Soft. | Identical. |
| Patient Contact (ISO 10993-1) | Surface contact, skin; Externally Communicating, Tissue; Permanent Duration of Use. | Identical safety profile and materials. |
| CO2 Washout Profile (ISO 17510:2015) | At 3 cmH2O: 6.0 (15 %); At 5 cmH2O: 6.0 (15 %); At 10 cmH2O: 5.8 (12 %); SingleFault1: 6.3 (21 %); SingleFault2: 7.7 (48 %). | Identical. |
| Dead Space (nominal ml) | Mojo 2: S: 179, M: 190, L: 207, XL: 220. Veraseal 3 / V3: 184, 193, 209, 220. | Identical. |
| Exhaust - Pressure / Flow | Mojo 2: 3cmH2O/20.50lpm, 10cmH2O/36.30lpm, 20cmH2O/52.80lpm. Veraseal 3/V3: 3cmH2O/21.50lpm, 10cmH2O/36.80lpm, 20cmH2O/54.40lpm. | Identical. |
| Pressure AAV Opening / Closing | Mojo 2: Opening 1.35cmH2O, Closing 1.72cmH2O. Veraseal 3/V3: Opening 1.45cmH2O, Closing 1.80cmH2O. | Identical. |
| AAV Inspiratory/Expiratory Resistance in Single Fault Condition | Mojo 2: Inspiratory 0.8cmH2O, Expiratory 0.8cmH2O. Veraseal 3/V3: Inspiratory 0.8cmH2O, Expiratory 0.8cmH2O. | Identical. |
| Resistance to Flow | Mojo 2: 50 lpm - 0.25 cm H2O, 100 lpm - 0.50 cm H2O. Veraseal 3/V3: 50 lpm - 0.23 cm H2O, 100 lpm - 0.48 cm H2O. | Identical. |
| Sound Pressure and Sound Power Level | Mojo 2: Sound Pressure - 30.07 dBA, Sound Power - 33.09 dBA. Veraseal 3/V3: Sound Pressure - 29.98 dBA, Sound Power - 32.99 dBA. | Identical. |
| Contraindications | New contraindication for Mojo 2 related to strong magnets and proximity to active/metallic implants. | New contraindication added. |
| Warnings | Updated warning for Mojo 2 related to magnetic field strength (380 mT) and safe distance (6 inches) from implants. | Updated warning added. |
B. Study Details (Not Applicable/Information Not Provided)
- Sample size used for the test set and the data provenance: Not applicable. No new performance testing was conducted for this submission. The device design is identical to the predicate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance testing was conducted.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new performance testing was conducted.
- 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 device is a face mask, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a face mask, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance testing was conducted.
- The sample size for the training set: Not applicable. No new performance testing was conducted, and this is a physical device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the demonstration of substantial equivalence to a previously cleared predicate device (K190254). The manufacturer asserts that the subject devices (Mojo 2, Veraseal 3, V3 Full Face Vented Mask) are identical in design, indications for use, technology, principle of operation, environment of use, patient population, and performance characteristics to the predicate.
The only modifications are to the labeling, specifically the addition of a new contraindication and an updated warning statement for the Mojo 2 mask related to magnets. These changes were a proactive measure following a voluntary recall and information from post-market surveillance.
Therefore, the evidence for meeting acceptance criteria relies entirely on the prior clearance of the predicate device (K190254) and the assertion that the new device is functionally identical, with only labeling changes to address safety information not present in the original predicate's labeling. No new performance data, clinical trials, or expert consensus studies were performed or presented for this specific 510(k) submission.
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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.
July 10, 2024
Sleepnet Corporation % Paul Dryden President ProMedic. LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704
Re: K241661
Trade/Device Name: Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 6, 2024 Received: June 10, 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 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 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).
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,
Digitally signed by Binoy J.
Binoy J. Mathews -S Mathews -S
Date: 2024.07.10 10:34:29 -04'00'
For
Rachana Visaria Assistant Director
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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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241661
Device Name Mojo 2, Veraseal 3, V3 Full Face Vented Mask
Indications for Use (Describe)
The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 om H2O.
The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.
Veraseal 3 -Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)
V3 -Single patient, multi-use (home)
Mojo 2 -Single patient, multi-use (home or hospital/institutional)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) SummaryPage 1 of 10 | |
|---|---|
| Date Prepared: | July 8, 2024 |
| Sponsor: | Sleepnet Corporation5 Merrill Industrial DriveHampton, NH 03842Tel - 603-758-6625 |
| Sponsor Contact: | Jennifer Kennedy - Director of Regulatory and Quality |
| Submission Correspondent: | Paul DrydenProMedic, LLC |
| Proprietary or Trade Name: | Mojo 2 Full Face Vented MaskVeraseal 3 Full Face Vented MaskV3 Full Face Vented Mask |
| Common/Usual Name: | Patient Interface |
| Classification Name: | Noncontinuous Ventilator (IPPB)21 CFR 868.5905 |
| Product Code: | BZD |
| Predicate Device: | Mojo 2 Full Face Vented MaskVeraseal 3 Full Face Vented MaskV3 Full Face Vented Mask |
| 510(k): | K190254 |
| Common/Usual Name: | Patient Interface |
| Classification Name: | Noncontinuous Ventilator (IPPB)21 CFR 868.5905 |
| Product Code: | BZD |
| Veraseal 3 | Disposable single use (hospital/institutional)Single patient, multi-use up to 7 days (hospital/institutional) |
| V3 | Single patient, multi-use (home) |
| Mojo 2 | Single patient, multi-use (home or hospital/institutional) |
| Patient Population: | For adult patients (>30 kg). |
| Environments of use: | Home or hospital / institutional environments. |
Device Description:
The Sleepnet Veraseal 3, V3 and Mojo 2 Full Face Vented masks are identical to the predicate Veraseal 3, V3, and Mojo 2 Full Face Vented masks (K190254).
The subject of this submission is:
- Addition of a contraindication related to magnets on the Mojo 2 Full Face Vented mask .
- . Update to the warning related to magnets on the Mojo 2 Full Face Vented mask
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Principle of Operation:
The subject devices provide a seal around the nose and mouth, and act as a patient interface for positive pressure air delivery.
Indications for Use:
The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 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 (>30 kg.) for whom positive airway pressure therapy has been prescribed.
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510(k) Summary Page 3 of 10
| Attributes | Subject - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Predicate - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Explanation of Differences |
|---|---|---|---|
| 510(k) | K190254 | ||
| Product Classification | BZD | BZD | Identical |
| CFR | Noncontinuous ventilator (IPPB)CFR 868.5905 | Noncontinuous ventilator (IPPB)CFR 868.5905 | Identical |
| Indications for Use | The Sleepnet Mojo 2 Full Face Vented Mask,Veraseal 3 Full Face Vented Mask, and V3Full Face Vented Mask are intended to beused with positive airway pressure devices,such as CPAP or bi-level, operating at orabove 3 cm H2O. | The Sleepnet Mojo 2 Full Face Vented Mask,Veraseal 3 Full Face Vented Mask, and V3Full Face Vented Mask are intended to beused with positive airway pressure devices,such as CPAP or bi-level, operating at orabove 3 cm H2O. | Identical |
| The masks are to be used on adult patients(>30 kg.) for whom positive airway pressuretherapy has been prescribed. | The masks are to be used on adult patients(>30 kg.) for whom positive airway pressuretherapy has been prescribed. | Identical | |
| Veraseal 3 -Disposable single use (hospital/institutional)Single patient, multi-use up to 7 days(hospital/institutional) | Veraseal 3 -Disposable single use (hospital/institutional)Single patient, multi-use up to 7 days(hospital/institutional) | ||
| V3 -Single patient, multi-use (home orhospital/institutional)Mojo 2 -Single patient, multi-use (home orhospital/institutional) | V3 -Single patient, multi-use (home orhospital/institutional)Mojo 2 -Single patient, multi-use (home orhospital/institutional) | ||
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Patient type | Patients who have been prescribed non-invasive pressure therapy such as CPAP or bi-level therapy | Patients who have been prescribed non-invasive pressure therapy such as CPAP or bi-level therapy | Identical |
| Prescriptive | Yes | Yes | Identical |
| Principle of Operation | Provides a seal over the face (nose and mouth)to allow for delivery of pressurized air from a | Provides a seal over the face (nose and mouth)to allow for delivery of pressurized air from a | Identical |
| Attributes | Subject - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Predicate - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Explanation of Differences |
| CPAP blower. Includes an exhalation port forflushing out exhaled CO2 during normaloperation, and anti-asphyxia valve for flushingout exhaled CO2 during Fault condition (e.g.power failure) | CPAP blower. Includes an exhalation port forflushing out exhaled CO2 during normaloperation, and anti-asphyxia valve for flushingout exhaled CO2 during Fault condition (e.g.power failure) | ||
| The device is passive until connected to theCPAP blower | The device is passive until connected to theCPAP blower | ||
| Therapy Pressure | Determined by equipment to which it isattached, but typically 3 to 25 cm H2O | Determined by equipment to which it isattached, but typically 3 to 25 cm H2O | Identical |
| Anatomical site | Face (seals around nose and mouth) | Face (seals around nose and mouth) | 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 | Veraseal 3Disposable, single patient useSingle patient, multi-use up to 7 daysMojo 2Single patient, multi-useV3Single patient, multi-use | Veraseal 3Disposable, single patient useSingle patient, multi-use up to 7 daysMojo 2Single patient, multi-useV3Single patient, multi-use | Identical |
| Useful life | Veraseal 3 -Single patient use disposableUp to 7 daysV3 -Single patient use - 6 monthsMojo 2 -Single patient use - 6 months | Veraseal 3 -Single patient use disposableUp to 7 daysV3 -Single patient use - 6 monthsMojo 2 -Single patient use - 6 months | Identical |
| Non-sterile | Yes | Yes | Identical |
| Cleaning methods | • Mild Soap (such as Ivory) and water• Isopropyl alcohol | • Mild Soap (such as Ivory soap) andwater• Isopropyl alcohol | Identical |
| Attributes | Subject - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Predicate – Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Explanation of Differences |
| Features | |||
| Available sizes | 4 | 4 | Identical |
| Shape | Identical | Identical | Identical |
| Incorporates an Exhaustelbow | Yes | Yes | Identical |
| Components of mask | • Mask shell (soft or rigid)• Gel bladder• Exhalation elbow with Anti-asphyxiavalve• 4-point headgear | • Mask shell (soft or rigid)• Gel bladder• Exhalation elbow with Anti-asphyxiavalve• 4-point headgear | Identical |
| Shell design | Veraseal 3 and V3RigidMojo 2Soft | Veraseal 3 and V3RigidMojo 2Soft | Identical |
| Patient Contact perISO 10993-1 | Surface contact, skinExternally Communicating, TissuePermanent Duration of Use | Surface contact, skinExternally Communicating, TissuePermanent Duration of Use | Identical safety profile andmaterials |
| Contraindications | New Contraindication (Mojo 2 only)Do not use this mask if you or anyone(example: household members, bedpartners, caregivers, etc.) in close physicalcontact with your mask has an activemedical implant or metallic implant thatwill interact with magnets. Implantexamples include, but are not limited to,pacemakers, implantable cardioverterdefibrillators (ICD), neurostimulators,aneurysm clips, metallic stents, ocularimplants, insulin/infusion pumps, cerebral | None | New as per recall event#94169. Original K190254labeling available in Section006_Labeling. |
| Attributes | Subject - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Predicate – Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Explanation of Differences |
| spinal fluid (CSF) shunts, embolic coils,metallic splinter, implants to restorehearing or balance with implantedmagnets (such as cochlear implants), flowdisruption devices, contact lenses withmetal, dental implants, metallic cranialplates, screws, burr hole covers, bonesubstitute device, magnetic metallicimplants/electrodes/valves placed in upperlimbs, torso, or higher, etc. If you haveany questions regarding the implant,consult your physician or themanufacturer of your implant. | |||
| Warning | Updated Warning: (Mojo 2 only)Magnets are used in the mask and headgearclips with a field strength of 380mT. Withthe exception of the devices identified inthe contraindication, ensure that the maskis kept at least 6 inches (approx.16 cm)away from any other medical implants ormedical devices that can be impacted bythe magnetic fields to avoid possibleeffects from localized magnetic fields. Forinstance, the functioning of implants maychange, or implants may move within thebody due to magnetic attraction/repulsion.This applies to you or anyone in closephysical contact with your mask. | Updated as per recall event#94169. Original K190254labeling available in Section006_Labeling. |
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510(k) Summary Page 4 of 10
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510(k) Summary Page 5 of 10
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510(k) Summary Page 6 of 10
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510(k) Summary Page 7 of 10
| Attributes | Subject – Mojo 2, Veraseal 3, V3 Full Face Vented Mask | Predicate – Mojo 2, Veraseal 3, V3 Full Face Vented Mask | Explanation of Differences | ||
|---|---|---|---|---|---|
| CO2 washout profileISO 17510:2015 | Veraseal 3 / V3 / Mojo 2 -Setting etCO2(%increase vs baseline) | Veraseal 3 / V3 / Mojo 2 -Setting etCO2(%increase vs baseline) | Identical | ||
| 3 cmH2O | 6.0 (15 %) | 3 cmH2O | 6.0 (15 %) | ||
| 5 cmH2O | 6.0 (15 %) | 5 cmH2O | 6.0 (15 %) | ||
| 10 cmH2O | 5.8 (12 %) | 10 cmH2O | 5.8 (12 %) | ||
| SingleFault1 | 6.3 (21 %) | SingleFault1 | 6.3 (21 %) | ||
| SingleFault2 | 7.7 (48 %) | SingleFault2 | 7.7 (48 %) | ||
| Dead space (nominal ml) | Mojo 2 | Mojo 2 | Identical | ||
| Small | 179 ml | 179 ml | |||
| Medium | 190 ml | 190 ml | |||
| Large | 207 ml | 207 ml | |||
| Ex-Large (XL) | 220 ml | 220 ml | |||
| Veraseal 3 / V3 | Veraseal 3 / V3 | ||||
| 184 ml | 184 ml | ||||
| 193 ml | 193 ml | ||||
| 209 ml | 209 ml | ||||
| 220 ml | 220 ml | ||||
| Exhaust - pressure / flow | Mojo 2 | Mojo 2 | Identical | ||
| Pressure (cmH2O) | Flow (lpm) | Pressure (cmH2O) | Flow (lpm) | ||
| 3 | 20.50 | 3 | 20.50 | ||
| 10 | 36.30 | 10 | 36.30 | ||
| 20 | 52.80 | 20 | 52.80 | ||
| Veraseal 3 / V3 | Veraseal 3 / V3 | ||||
| Pressure (cmH2O) | Flow (lpm) | Pressure (cmH2O) | Flow (lpm) | ||
| 3 | 21.50 | 3 | 21.50 | ||
| 10 | 36.80 | 10 | 36.80 | ||
| 20 | 54.40 | 20 | 54.40 |
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510(k) Summary Page 8 of 10
| Attributes | Subject - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Predicate - Mojo 2, Veraseal 3, V3 FullFace Vented Mask | Explanation of Differences |
|---|---|---|---|
| Pressure AAVOpening / closing | Mojo 2Opening - 1.35 cm H2OClosing - 1.72 cm H2OVeraseal 3 / V3Opening - 1.45 cm H2OClosing - 1.80 cm H2O | Mojo 2Opening - 1.35 cm H2OClosing - 1.72 cm H2OVeraseal 3 / V3Opening - 1.45 cm H2OClosing - 1.80 cm H2O | Identical |
| AAV Inspiratory/ExpiratoryResistance in Single FaultCondition | Mojo 2Inspiratory - 0.8 cm H2OExpiratory - 0.8 cm H2OVeraseal 3/ V3Inspiratory - 0.8 cm H2OExpiratory - 0.8 cm H2O | Mojo 2Inspiratory - 0.8 cm H2OExpiratory - 0.8 cm H2OVeraseal 3/ V3Inspiratory - 0.8 cm H2OExpiratory - 0.8 cm H2O | Identical |
| Resistance to Flow | Mojo 250 lpm - 0.25 cm H2O100 lpm - 0.50 cm H2OVeraseal 3/ V350 lpm - 0.23 cm H2O100 lpm - 0.48 cm H2O | Mojo 250 lpm - 0.25 cm H2O100 lpm - 0.50 cm H2OVeraseal 3/ V350 lpm - 0.23 cm H2O100 lpm - 0.48 cm H2O | Identical |
| Sound Pressure and soundPower Level | Mojo 2Sound Pressure - 30.07 dBASound Power - 33.09 dBAVeraseal 3/ V3Sound Pressure - 29.98 dBASound Power - 32.99 dBA | Mojo 2Sound Pressure - 30.07 dBASound Power - 33.09 dBAVeraseal 3/ V3Sound Pressure - 29.98 dBASound Power - 32.99 dBA | Identical |
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Substantial Equivalence Discussion
The table above compares the key features of the subject devices with the identified predicate - K190254. The subject and predicate devices are identical- the only difference between the devices within this submission is the addition of a contraindication and warning pertaining to the presence of permanent magnets within the mask.
Indications for Use -
The indications for use are identical for the subject device when compared to the predicate device - K190254. Discussion - The indications for use are identical.
Technology and construction -
The technology and principle of operation is identical for the subject device when compared to the predicate device - K190254.
Discussion - Both the subject and predicate device have identical principles of operation.
Environment of Use -
The environments of use are identical to the predicate device - K190254. Discussion - The environments of use are the identical.
Patient Population -
The patient population is identical to the predicate device - K190254. Discussion - The subject and predicate device patient populations are identical.
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.
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Discussion of Differences
The subject device includes a new contradiction and updated warning, which was not included in the predicate device – K190254. There are no other differences between the subject and predicate devices.
In March 2024, Sleepnet underwent a voluntary recall (Event 94169) of its masks that contained magnets. Specifically, the subject device was part of this recall. This recall was initiated based on information obtained from post market surveillance indicating a possible risk to patients and anyone in close physical contact with the subject device, having an active medical implant or metallic implant that can be impacted by the magnetic field.
The magnets in these masks provide a quick and easy method of attaching and detaching the mask from the headgear. However, when a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant. This could potentially lead to serious injury or death.
Therefore. Sleepnet intends to update its contraindications and warnings as a proactive measure to provide additional safety information to patients and healthcare professionals. To date, there has been no Medical Device Reports associated with the Sleepnet masks with magnets.
Modifications Made to device: No modifications have been made to the device.
Modifications to Labeling:
The Instructions for Use (IFU) have been updated with the following new contraindication and revised warning statement.
New Contraindication
Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.
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Updated Warning
Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx.16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. For instance, the functioning of implants may change, or implants may move within the body due to magnetic attraction/repulsion. This applies to you or anyone in close physical contact with your mask.
Discussion of Differences
Apart from the contraindication and updated warning above, there are no other differences between the subject devices and the predicate K190254 devices.
Substantial Equivalence Conclusion
The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask have identical indications, technological characteristics and principles of operation and performance to the predicate and performance testing demonstrates that the subject device is substantially equivalent to the predicate.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).