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)

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)

AI/ML Overview

The provided text describes a 510(k) premarket notification for Sleepnet Corporation's Mojo 2 and Veraseal 3 Full Face Masks. This submission primarily focuses on changes to contraindications and warnings due to a previous recall, rather than new device performance data.

Therefore, the document explicitly states: "No new performance testing was conducted on the subject device, since the device designs are identical to the predicates." This means there is no study described that proves the device meets new acceptance criteria. The acceptance criteria and reported device performance are based on the predicate device (K190533) and its original clearance.

However, I can extract the information related to the device and the comparison to its predicate as requested in your format, noting the absence of new performance data.

Here's the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since no new performance testing was conducted, there are no new specific acceptance criteria or reported performance data for the subject devices presented in this summary beyond the fact that their design is identical to the predicate. The "acceptance criteria" for this specific 510(k) submission revolve around demonstrating substantial equivalence, especially concerning the updated labeling.

The following table summarizes the key attributes and their comparison to the predicate device, implying that the acceptance for these attributes is "identical" to the predicate, which had presumably met its own performance acceptance criteria during its original clearance (K190533).

Attributes (Acceptance Criteria by Equivalence)	Reported Device Performance (Identical to Predicate K190533)	Explanation of Differences
Product Classification	CBK Continuous ventilator	Identical
CFR	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	Identical
Indications for Use	Provide a patient interface for application of noninvasive ventilation for adult patients (>30 kg) suitable for noninvasive ventilation. Used as an accessory to ventilators with adequate alarms and safety systems for ventilator failure. Offered in disposable and multi-use versions. 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)	Identical
Patient type	Patients who are appropriate candidates for non-invasive ventilation	Identical
Prescriptive	Yes	Identical
Environment of Use	Home or hospital/institutional environments	Identical
Duration of Use	Veraseal 3: Single patient use disposable - 7 days. Mojo 2: Single patient use - 6 months.	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 used with circuits including an exhalation port. AAV Non-Vented version includes an anti-asphyxia valve for CO2 flushing during fault conditions. Device is passive until connected to the ventilator.	Identical
Therapy Pressure	Greater than 3 cm H2O (typically determined by attached equipment)	Identical
Anatomical site	Face (seals around nose and mouth)	Identical
User Interface to administer therapy	Standard 22mm ID connection (ISO 5356-1 compliant) to 22mm ventilator circuits.	Identical
Contraindications	New Contraindication (Mojo 2 only): Do not use if the patient or anyone in close physical contact has an active medical implant or metallic implant that will interact with magnets. Examples include pacemakers, ICDs, neurostimulators, aneurysm clips, etc.	New as per recall event #94169
Warnings	Updated Warning: Magnets are used in the mask and headgear clips with a field strength of 380mT. Except for devices in the contraindication, ensure mask is kept at least 6 inches (approx. 16 cm) away from other medical implants/devices that can be impacted by magnetic fields. Applies to user and anyone in close physical contact.	Unchanged in K190533, but updated with magnetic field information
Useful life	Veraseal 3: Single patient use disposable - 7 days. Mojo 2: Single patient use - 6 months.	Identical
Non-sterile	Yes	Identical
Cleaning methods	Mild Soap (such as Ivory) and water, Isopropyl alcohol	Identical

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no new test set or data provenance information provided in this submission, as "No new performance testing was conducted." The basis of this submission is the identical design to a predicate device and updated labeling.

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)

Not applicable. No new test set and no ground truth establishment for a test set are described. The updated contraindications and warnings were established due to information from post-market surveillance related to a voluntary recall (Event 94169).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set is described.

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 device is a patient interface for ventilation, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical patient interface, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for new data. The primary "ground truth" for the new contraindication/warning was post-market surveillance data leading to a voluntary recall (Event 94169), which indicated potential risks from magnets interacting with medical implants. This implicitly relies on real-world outcomes and expert clinical judgment regarding patient safety.

8. The sample size for the training set

Not applicable. This device is a mechanical patient interface, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a mechanical patient interface, not an AI/ML device.

Summary

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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

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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

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)

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.

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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:

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Date Prepared:	June 27, 2024
Sponsor:	Sleepnet Corporation5 Merrill Industrial DriveHampton, NH 03842Tel - 603-758-6625
Sponsor Contact:	Jennifer Kennedy - Director of Regulatory & Quality
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	Veraseal 3 Full Face Non-Vented MaskVeraseal 3 Full Face AAV Non-VentedMojo 2 Full Face Non-Vented MaskMojo 2 AAV Non-Vented Full-Face Mask
Common/Usual Name:	Patient Interface
Classification Name:	Continuous Ventilator
Product Code:	21 CFR 868.5895CBK
Predicate Device:	Veraseal 3 Full Face Non-Vented MaskVeraseal 3 Full Face AAV Non-VentedMojo 2 Full Face Non-Vented MaskMojo 2 AAV Non-Vented Full-Face Mask
510(k):	K190533
Common/Usual Name:	Patient Interface
Classification Name:	Continuous Ventilator
Product Code:	21 CFR 868.5895CBK

Device Description:

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)

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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

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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 FaceNon-Vented and AAV Non-Vented Mask	Predicate - Mojo 2, Veraseal 3Non-Vented and AAV Non-Vented FullFace Mask	Explanation of Differences
510(k)	TBD	K190533
Product Classification	CBKContinuous ventilator	CBKContinuous ventilator	Identical
CFR	CFR 868.5895	CFR 868.5895	Identical
List of Devices	Mojo 2 Full Face Non-Vented maskMojo 2 Full Face AAV Non-Vented maskVeraseal 3 Full Face Non-Vented maskVeraseal 3 Full Face AAV Non-Vented mask	Mojo 2 Non-vented Full Face maskMojo 2 AAV Non-vented Full Face maskVeraseal 3 Non-vented Full Face maskVeraseal 3 AAV Non-vented Full Face mask	Identical
Indications for Use	The Sleepnet Mojo 2 and Veraseal 3 Full FaceNon- Vented and AAV Non-Vented Masks areintended to provide a patient interface forapplication of noninvasive ventilation. The maskis to be used as an accessory to ventilators thathave adequate alarms and safety systems forventilator failure, and which are intended toadminister positive pressure ventilation. Themask will be offered in a disposable version anda multiuse version. It is intended for use on adultpatients (>30 kg), who are appropriate candidatesfor 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 orhospital/institutional)	The Sleepnet Mojo 2 and Veraseal 3 Non- Ventedand AAV Non-Vented Full Face Masks areintended to provide a patient interface forapplication of noninvasive ventilation. The maskis to be used as an accessory to ventilators thathave adequate alarms and safety systems forventilator failure, and which are intended toadminister positive pressure ventilation. Themask will be offered in a disposable version and amultiuse version. It is intended for use on adultpatients (>30 kg), who are appropriate candidatesfor noninvasive ventilation.Veraseal 3 -Disposable single use (hospital/institutional) Singlepatient, multi-use up to 7 days(hospital/institutional)Mojo 2 -Single patient, multi-use (home orhospital/institutional)	Identical
Patient Population	Adult (>30 kg)	Adult (>30 kg)	Identical
Attributes	Subject - Mojo 2, Veraseal 3 Full FaceNon-Vented and AAV Non-Vented Mask	Predicate - Mojo 2, Veraseal 3Non-Vented and AAV Non-Vented FullFace 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 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-use	Veraseal 3Disposable, single patient useSingle patient, multi-use up to 7 daysMojo 2Single patient, multi-use	Identical
Principle of Operation	Provides a seal over the face (nose and mouth) toallow for delivery of pressurized air from a non-invasive ventilator. Mask is used with circuitsthat include an exhalation port for flushing outexhaled CO2.The AAV Non-Vented version comes with ananti-asphyxia valve as an additional safetyfeature. This valve helps in flushing out exhaledCO2 during Fault condition (e.g. power failure)The device is passive until connected to theventilator.	Provides a seal over the face (nose and mouth) toallow for delivery of pressurized air from a non-invasive ventilator. Mask is used with circuitsthat include an exhalation port for flushing outexhaled CO2.The AAV Non-Vented version comes with ananti-asphyxia valve as an additional safetyfeature. This valve helps in flushing out exhaledCO2 during Fault condition (e.g. power failure)The device is passive until connected to theventilator.	Identical
Therapy Pressure	Greater than 3 cm H2OTypically determined by the equipment to which itis attached.	Greater than 3 cm H2OTypically determined by the equipment to which itis attached.	Identical
Anatomical site	Face (seals around nose and mouth)	Face (seals around nose and mouth)	Identical
User Interface to administertherapy	Masks have a standard 22mm ID connection(compliant with ISO 5356-1) that connects to22mm ventilator circuits.	Mask has a standard 22mm ID connection(compliant with ISO 5356-1) that connects to22mm ventilator circuits.	Identical
Attributes	Subject - Mojo 2, Veraseal 3 Full FaceNon-Vented and AAV Non-Vented Mask	Predicate - Mojo 2, Veraseal 3Non-Vented and AAV Non-Vented FullFace 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 anactive medical implant or metallic implant thatwill interact with magnets. Implant examplesinclude, but are not limited to, pacemakers,implantable cardioverter defibrillators (ICD),neurostimulators, aneurysm clips, metallic stents,ocular implants, insulin/infusion pumps, cerebralspinal fluid (CSF) shunts, embolic coils, metallicsplinter, implants to restore hearing or balancewith implanted magnets (such as cochlearimplants), flow disruption devices, contact lenseswith metal, dental implants, metallic cranialplates, screws, burr hole covers, bone substitutedevice, magnetic metallicimplants/electrodes/valves placed in upper limbs,torso, or higher, etc. If you have any questionsregarding the implant, consult your physician orthe manufacturer of your implant.
	Warnings	Updated Warning	Unchanged from K190533
		Magnets are used in the mask and headgear clipswith a field strength of 380mT. With theexception of the devices identified in thecontraindication, ensure that the mask is kept atleast 6 inches (approx.16 cm) away from anyother medical implants or medical devices that canbe impacted by the magnetic fields to avoidpossible effects from localized magnetic fields.
Attributes	Subject - Mojo 2, Veraseal 3 Full FaceNon-Vented and AAV Non-Vented Mask	Predicate - Mojo 2, Veraseal 3Non-Vented and AAV Non-Vented FullFace Mask	Explanation of Differences
	This applies to you or anyone in close physicalcontact with your mask.
Useful life	Veraseal 3 -Single patient use disposable - 7 daysMojo 2 -Single patient use - 6 months	Veraseal 3 -Single patient use disposable - 7 daysMojo 2 -Single patient use - 6 months	Identical
Non-sterile	Yes	Yes	Identical
Cleaning methods	Mild Soap (such as Ivory) and waterIsopropyl alcohol	Mild Soap (such as Ivory) and waterIsopropyl 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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510(k) Summary Page 8 of 8

Regulation Number and Section

§ 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).