(29 days)
No
The summary describes a passive medical device (a mask) used for non-invasive ventilation and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is a patient interface for noninvasive ventilation, which is a therapeutic treatment.
No
The device description clearly states that these are "full face masks used with noninvasive ventilation," and their "Intended Use" is "to provide a patient interface for application of noninvasive ventilation." This indicates they are therapeutic devices for delivering ventilation, not for diagnosing medical conditions.
No
The device description clearly states it is a full face mask used with non-invasive ventilation, which is a physical hardware component. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are "intended to provide a patient interface for application of noninvasive ventilation." This describes a device used on a patient to deliver therapy, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description focuses on the physical characteristics of the mask and its function in delivering ventilation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
The device is a medical device used for therapeutic purposes (noninvasive ventilation), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 -Single patient, multi-use (home or hospital/institutional)
Product codes
CBK
Device Description
The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve.
The subject of this submission is:
- The Mojo 2 subject devices include a new contradiction and warning, which was not . included in the predicate device - K190533.
Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face (seals around nose and mouth)
Indicated Patient Age Range
Adult (>30 kg)
Intended User / Care Setting
Home or hospital / institutional environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Biocompatibility -
The medical devices in their final finished form are identical to the Moio 2 Full Face Non-Vented mask, Mojo 2 AAV Non-Vented Full Face mask, Veraseal 3 Full Face Non-Vented Mask and the Veraseal 3 Full Face AAV Non-Vented mask (previously marketed devices under K190533) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 27, 2024
Sleepnet Corporation % Paul Dryden President ProMedic LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704
Re: K241520
Trade/Device Name: Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: May 29, 2024 Received: May 29, 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,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from John S. Bender -S. The date of the signature is 2024.06.27, and the time is 12:44:58 -04'00'.
for Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
K241520
Device Name
Mojo 2 Full Face Non-Vented Mask Mojo 2 Full Face AAV Non-Vented Mask Veraseal 3 Full Face Non-Vented Mask Veraseal 3 Full Face AAV Non-Vented Mask
Indications for Use (Describe)
The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 -Single patient, multi-use (home or hospital/institutional)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| Date Prepared: | June 27, 2024 |
|---|---|
| Sponsor: | Sleepnet Corporation |
| 5 Merrill Industrial Drive | |
| Hampton, NH 03842 | |
| Tel - 603-758-6625 | |
| Sponsor Contact: | Jennifer Kennedy - Director of Regulatory & Quality |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | Veraseal 3 Full Face Non-Vented Mask |
| Veraseal 3 Full Face AAV Non-Vented | |
| Mojo 2 Full Face Non-Vented Mask | |
| Mojo 2 AAV Non-Vented Full-Face Mask | |
| Common/Usual Name: | Patient Interface |
| Classification Name: | Continuous Ventilator |
| Product Code: | 21 CFR 868.5895 |
| CBK | |
| Predicate Device: | Veraseal 3 Full Face Non-Vented Mask |
| Veraseal 3 Full Face AAV Non-Vented | |
| Mojo 2 Full Face Non-Vented Mask | |
| Mojo 2 AAV Non-Vented Full-Face Mask | |
| 510(k): | K190533 |
| Common/Usual Name: | Patient Interface |
| Classification Name: | Continuous Ventilator |
| Product Code: | 21 CFR 868.5895 |
| CBK |
Device Description:
The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve.
The subject of this submission is:
- The Mojo 2 subject devices include a new contradiction and warning, which was not . included in the predicate device - K190533.
Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)
Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)
5
Principle of Operation:
The subject device provides a seal around the nose and acts as a patient interface for positive pressure air delivery.
Indications for Use:
The Sleepnet Mojo 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)
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 |
Substantial Equivalence Discussion
The table below compares the key features of the subject devices with the identified predicate -K190533. The subject and predicate devices are identical in every way - the only difference between the devices within this submission is the addition of a contraindication and warning.
Indications for Use -The indications for use are identical for the subject device when compared to the predicate device -K190533. 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 - K190533.
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 - K190533. Discussion - The environments of use are identical.
Patient Population -
The patient population is identical to the predicate device - K190533. Discussion - The subject and predicate device patient populations are identical.
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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.
Biocompatibility -
The medical devices in their final finished form are identical to the Moio 2 Full Face Non-Vented mask, Mojo 2 AAV Non-Vented Full Face mask, Veraseal 3 Full Face Non-Vented Mask and the Veraseal 3 Full Face AAV Non-Vented mask (previously marketed devices under K190533) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Discussion of Differences
Differences between Subject and Predicate Device
The Mojo 2 subject devices include a new contradiction and warning, which was not included in the predicate device - K190533. 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 Mojo 2 subject devices were part of 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 have been no Medical Device Reports associated with the Sleepnet masks with magnets.
Modifications to Labeling:
The Mojo 2 Full Face Non-Vented mask and the Mojo 2 AAV Non-Vented Full Face mask 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
7
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.
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. This applies to you or anyone in close physical contact with your mask.
Discussion of Differences
Apart from the contraindication and updated warning there are no other differences.
Substantial Equivalence Conclusion
The Sleepnet Mojo 2 and Veraseal 3 Full Face Non- Vented and AAV Non-Vented Masks have identical indications, technological characteristics and principles of operation and performance that the proposed device is substantially equivalent to the predicate.
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510(k) Summary Page 5 of 8
| Attributes | Subject - Mojo 2, Veraseal 3 Full Face
Non-Vented and AAV Non-Vented Mask | Predicate - Mojo 2, Veraseal 3
Non-Vented and AAV Non-Vented Full
Face Mask | Explanation of Differences |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 510(k) | TBD | K190533 | |
| Product Classification | CBK
Continuous ventilator | CBK
Continuous ventilator | Identical |
| CFR | CFR 868.5895 | CFR 868.5895 | Identical |
| List of Devices | Mojo 2 Full Face Non-Vented mask
Mojo 2 Full Face AAV Non-Vented mask
Veraseal 3 Full Face Non-Vented mask
Veraseal 3 Full Face AAV Non-Vented mask | Mojo 2 Non-vented Full Face mask
Mojo 2 AAV Non-vented Full Face mask
Veraseal 3 Non-vented Full Face mask
Veraseal 3 AAV Non-vented Full Face mask | Identical |
| Indications for Use | The Sleepnet Mojo 2 and Veraseal 3 Full Face
Non- Vented and AAV Non-Vented Masks are
intended to provide a patient interface for
application of noninvasive ventilation. The mask
is to be used as an accessory to ventilators that
have adequate alarms and safety systems for
ventilator failure, and which are intended to
administer positive pressure ventilation. The
mask will be offered in a disposable version and
a multiuse version. It is intended for use on adult
patients (>30 kg), who are appropriate candidates
for noninvasive ventilation.
Veraseal 3 -
Disposable single use (hospital/institutional)
Single patient, multi-use up to 7 days
(hospital/institutional)
Mojo 2 -
Single patient, multi-use (home or
hospital/institutional) | The Sleepnet Mojo 2 and Veraseal 3 Non- Vented
and AAV Non-Vented Full Face Masks are
intended to provide a patient interface for
application of noninvasive ventilation. The mask
is to be used as an accessory to ventilators that
have adequate alarms and safety systems for
ventilator failure, and which are intended to
administer positive pressure ventilation. The
mask will be offered in a disposable version and a
multiuse version. It is intended for use on adult
patients (>30 kg), who are appropriate candidates
for noninvasive ventilation.
Veraseal 3 -
Disposable single use (hospital/institutional) Single
patient, multi-use up to 7 days
(hospital/institutional)
Mojo 2 -
Single patient, multi-use (home or
hospital/institutional) | Identical |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Attributes | Subject - Mojo 2, Veraseal 3 Full Face
Non-Vented and AAV Non-Vented Mask | Predicate - Mojo 2, Veraseal 3
Non-Vented and AAV Non-Vented Full
Face Mask | Explanation of Differences |
| Patient type | Patients who are appropriate candidates for non-
invasive ventilation | Patients who are appropriate candidates for non-
invasive ventilation | Identical |
| Prescriptive | Yes | Yes | Identical |
| Environment of Use | The masks are intended for use in the home or
hospital/institutional environment. | The masks are intended for use in the 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
Single patient, multi-use | Veraseal 3
Disposable, single patient use
Single patient, multi-use up to 7 days
Mojo 2
Single patient, multi-use | Identical |
| Principle of Operation | Provides a seal over the face (nose and mouth) to
allow for delivery of pressurized air from a non-
invasive ventilator. Mask is used with circuits
that include an exhalation port for flushing out
exhaled CO2.
The AAV Non-Vented version comes with an
anti-asphyxia valve as an additional safety
feature. This valve helps in flushing out exhaled
CO2 during Fault condition (e.g. power failure)
The device is passive until connected to the
ventilator. | Provides a seal over the face (nose and mouth) to
allow for delivery of pressurized air from a non-
invasive ventilator. Mask is used with circuits
that include an exhalation port for flushing out
exhaled CO2.
The AAV Non-Vented version comes with an
anti-asphyxia valve as an additional safety
feature. This valve helps in flushing out exhaled
CO2 during Fault condition (e.g. power failure)
The device is passive until connected to the
ventilator. | Identical |
| Therapy Pressure | Greater than 3 cm H2O
Typically determined by the equipment to which it
is attached. | Greater than 3 cm H2O
Typically determined by the equipment to which it
is attached. | Identical |
| Anatomical site | Face (seals around nose and mouth) | Face (seals around nose and mouth) | Identical |
| User Interface to administer
therapy | Masks have a standard 22mm ID connection
(compliant with ISO 5356-1) that connects to
22mm ventilator circuits. | Mask has a standard 22mm ID connection
(compliant with ISO 5356-1) that connects to
22mm ventilator circuits. | Identical |
| Attributes | Subject - Mojo 2, Veraseal 3 Full Face
Non-Vented and AAV Non-Vented Mask | Predicate - Mojo 2, Veraseal 3
Non-Vented and AAV Non-Vented Full
Face Mask | Explanation of Differences |
| Contraindications | New Contraindication (Mojo 2 only) | None | New as per recall event #94169 |
| | 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. | | |
| | Warnings | Updated Warning | Unchanged from K190533 |
| | | 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. | |
| Attributes | Subject - Mojo 2, Veraseal 3 Full Face
Non-Vented and AAV Non-Vented Mask | Predicate - Mojo 2, Veraseal 3
Non-Vented and AAV Non-Vented Full
Face Mask | Explanation of Differences |
| | This applies to you or anyone in close physical
contact with your mask. | | |
| Useful life | Veraseal 3 -
Single patient use disposable - 7 days
Mojo 2 -
Single patient use - 6 months | Veraseal 3 -
Single patient use disposable - 7 days
Mojo 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) and water
Isopropyl alcohol | Identical |
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510(k) Summary Page 6 of 8
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510(k) Summary Page 7 of 8
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