(30 days)
Not Found
No
The 510(k) summary describes a CPAP mask with no mention of AI or ML capabilities. The changes described relate to contraindications and warnings regarding magnets.
No.
The device is a mask intended for use with positive airway pressure devices, which are therapeutic, but the mask itself is an accessory that delivers the therapy rather than providing the therapy directly.
No
This device is a full face vented mask intended to be used with positive airway pressure devices. Its purpose is to deliver therapy, not to diagnose a condition.
No
The device description clearly identifies the device as a "Full Face Vented Mask," which is a physical hardware component used in positive airway pressure therapy. The submission focuses on updates to contraindications and warnings related to magnets on the mask, not on software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are used with positive airway pressure devices (CPAP or bi-level) for treating patients with prescribed positive airway pressure therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components of the mask and updates related to contraindications and warnings about magnets. It does not mention any components or functions related to analyzing biological samples.
- 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 based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a medical device used for delivering therapy.
N/A
Intended Use / 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 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)
Product codes (comma separated list FDA assigned to the subject device)
BZD
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
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 patients (>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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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
3
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)
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
| 510(k) Summary
| Page 1 of 10 | |
|---|---|
| Date Prepared: | July 8, 2024 |
| Sponsor: | Sleepnet Corporation |
| 5 Merrill Industrial Drive | |
| Hampton, NH 03842 | |
| Tel - 603-758-6625 | |
| Sponsor Contact: | Jennifer Kennedy - Director of Regulatory and Quality |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | Mojo 2 Full Face Vented Mask |
| Veraseal 3 Full Face Vented Mask | |
| V3 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 Mask |
| Veraseal 3 Full Face Vented Mask | |
| V3 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
5
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.
6
510(k) Summary Page 3 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 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 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 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 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. | Identical |
| | The masks are to be used on adult patients
(>30 kg.) for whom positive airway pressure
therapy has been prescribed. | The masks are to be used on adult patients
(>30 kg.) for whom positive airway pressure
therapy 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 or
hospital/institutional)
Mojo 2 -
Single patient, multi-use (home or
hospital/institutional) | V3 -
Single patient, multi-use (home or
hospital/institutional)
Mojo 2 -
Single patient, multi-use (home or
hospital/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 Full
Face Vented Mask | Predicate - Mojo 2, Veraseal 3, V3 Full
Face Vented Mask | Explanation of Differences |
| | CPAP blower. Includes an exhalation port for
flushing out exhaled CO2 during normal
operation, and anti-asphyxia valve for flushing
out exhaled CO2 during Fault condition (e.g.
power failure) | CPAP blower. Includes an exhalation port for
flushing out exhaled CO2 during normal
operation, and anti-asphyxia valve for flushing
out exhaled CO2 during Fault condition (e.g.
power failure) | |
| | The device is passive until connected to the
CPAP blower | The device is passive until connected to the
CPAP blower | |
| Therapy Pressure | Determined by equipment to which it is
attached, but typically 3 to 25 cm H2O | Determined by equipment to which it is
attached, 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 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
V3
Single patient, multi-use | Veraseal 3
Disposable, single patient use
Single patient, multi-use up to 7 days
Mojo 2
Single patient, multi-use
V3
Single patient, multi-use | Identical |
| Useful life | Veraseal 3 -
Single patient use disposable
Up to 7 days
V3 -
Single patient use - 6 months
Mojo 2 -
Single patient use - 6 months | Veraseal 3 -
Single patient use disposable
Up to 7 days
V3 -
Single patient use - 6 months
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 soap) and
water
• Isopropyl alcohol | Identical |
| Attributes | Subject - Mojo 2, Veraseal 3, V3 Full
Face Vented Mask | Predicate – Mojo 2, Veraseal 3, V3 Full
Face Vented Mask | Explanation of Differences |
| Features | | | |
| Available sizes | 4 | 4 | Identical |
| Shape | Identical | Identical | Identical |
| Incorporates an Exhaust
elbow | Yes | Yes | Identical |
| Components of mask | • Mask shell (soft or rigid)
• Gel bladder
• Exhalation elbow with Anti-asphyxia
valve
• 4-point headgear | • Mask shell (soft or rigid)
• Gel bladder
• Exhalation elbow with Anti-asphyxia
valve
• 4-point headgear | Identical |
| Shell design | Veraseal 3 and V3
Rigid
Mojo 2
Soft | Veraseal 3 and V3
Rigid
Mojo 2
Soft | Identical |
| Patient Contact per
ISO 10993-1 | Surface contact, skin
Externally Communicating, Tissue
Permanent Duration of Use | Surface contact, skin
Externally Communicating, Tissue
Permanent Duration of Use | Identical safety profile and
materials |
| Contraindications | New Contraindication (Mojo 2 only)
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 | None | New as per recall event
#94169. Original K190254
labeling available in Section
006_Labeling. |
| Attributes | Subject - Mojo 2, Veraseal 3, V3 Full
Face Vented Mask | Predicate – Mojo 2, Veraseal 3, V3 Full
Face Vented Mask | Explanation of Differences |
| | 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. | | |
| Warning | Updated Warning: (Mojo 2 only)
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. | | Updated as per recall event
#94169. Original K190254
labeling available in Section
006_Labeling. |
7
510(k) Summary Page 4 of 10
8
510(k) Summary Page 5 of 10
9
510(k) Summary Page 6 of 10
10
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 profile | |||||
| ISO 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 |
11
510(k) Summary Page 8 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 |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Pressure AAV
Opening / closing | Mojo 2
Opening - 1.35 cm H2O
Closing - 1.72 cm H2O
Veraseal 3 / V3
Opening - 1.45 cm H2O
Closing - 1.80 cm H2O | Mojo 2
Opening - 1.35 cm H2O
Closing - 1.72 cm H2O
Veraseal 3 / V3
Opening - 1.45 cm H2O
Closing - 1.80 cm H2O | Identical |
| AAV Inspiratory/Expiratory
Resistance in Single Fault
Condition | Mojo 2
Inspiratory - 0.8 cm H2O
Expiratory - 0.8 cm H2O
Veraseal 3/ V3
Inspiratory - 0.8 cm H2O
Expiratory - 0.8 cm H2O | Mojo 2
Inspiratory - 0.8 cm H2O
Expiratory - 0.8 cm H2O
Veraseal 3/ V3
Inspiratory - 0.8 cm H2O
Expiratory - 0.8 cm H2O | 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 | 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 | 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 |
12
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.
13
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.
14
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.