(163 days)
No
The document describes a modified CPAP mask and its performance characteristics, with no mention of AI or ML.
Yes
The device is a mask intended for use with positive airway pressure devices (CPAP/bi-level) to deliver positive airway pressure therapy, which is a therapeutic intervention.
No
The device is a mask intended to be used with positive airway pressure devices for therapy, not for diagnosing conditions.
No
The device description clearly states it is a "Full Face mask" and details physical modifications and performance testing related to hardware components like dead space, exhaust flow, and pressure drop. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to be used with positive airway pressure devices (CPAP, bi-level) for adult patients with prescribed positive airway pressure therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a mask used for delivering air pressure. It does not involve testing samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the mask (dead space, exhaust flow, pressure drop, CO2 washout, biocompatibility, etc.), which are relevant to its use in delivering therapy, not for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SleepNet Mojo and Veraseal masks 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 (>30kg) for whom positive airway pressure therapy has been prescribed.
Veraseal -
Disposable single use (hospital/institutional)
Single patient, multi-use up to 7 days (hospital/institutional)
Mojo -
Single patient, multi-use (home or hospital/institutional)
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The SleepNet Mojo and Veraseal Full Face mask are modifications of the SleepNet Mojo Full Face mask cleared under K060273.
The modifications to the cleared Mojo Full Face mask are:
- different durations of use
- o single use, disposable (Hospital/Institutional) Veraseal
- o single patient, multi-use up to 7 days (Hospital/Institutional) Veraseal
- o single patient, multi-use (Home or Hospital/Institutional) MoJo
- a change in materials .
- updated design of the exhaust elbow used with the mask
As a result of these modifications we have established two (2) product tradenames to help distinguish them.
Veraseal model has 2 durations of use - single use, disposable or single patient, multi-use up to 7 days in the hospital.
Mojo model is single patient, multi-use (typically more than 7 days) for use in the home or hospital.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients (>30kg)
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)
We have performed comparative performance testing pre- and post- cleaning or conditioning that included:
- Dead space .
- Exhaust Flow ●
- Pressure drop ●
- Anti-asphyxia valve (AAV) pressure testing .
- Exhaust Elbow Change Performance .
- CO2 washout per ISO 17510-2 .
- ISO 10993 for biocompatibility .
- Cleaning validation ●
- Storage and aging .
The results demonstrated that the devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ETCO₂% at mask (% increase):
3 cm H₂O: Mojo - 6.1 (17%); K060273 - 5.9 (15%)
5 cm H₂O: Mojo - 5.9 (14%); K060273 - 5.8 (14%)
10 cm H₂O: Mojo - 5.8 (12%); K060273 - 5.6 (9%)
Occluded: Mojo - 6.3 (21%); K060273 - 6.0 (17%)
Deadspace:
Small: Mojo - 160 ml; K060273 - 200 ml
Medium: Mojo - 185 ml; K060273 - 245 ml
Large: Mojo - 205 ml; K060273 - 295 ml; K063122 - 242 ml
Exhaust - Pressure / Flow (Flow in lpm):
Mojo:
3 cm H₂O - 21.20
10 cm H₂O - 37.20
20 cm H₂O - 53.10
K060273:
3 cm H₂O - 32.00
10 cm H₂O - 43.00
20 cm H₂O - 55.00
Veraseal:
3 cm H₂O - 21.10
10 cm H₂O - 36.40
20 cm H₂O - 53.00
K063122:
4 cm H₂O - 22
8 cm H₂O - 32
12 cm H₂O - 41
20 cm H₂O - 54
Pressure Anti-Asphyxia Valve (AAV) Opening / Closing (cm H₂O):
Mojo: Opening - 1.10; Closing - 1.60
Veraseal: Opening - 1.29; Closing - 1.45
K060273: Opening - 0.65; Closing - 1.38
Resistance to Flow (cm H₂O):
Mojo: 50 lpm - 0.40; 100 lpm - 0.65
Veraseal: 50 lpm - 0.49; 100 lpm - 0.89
K060273: 50 lpm - 0.38; 100 lpm - 0.80
K063122: 50 lpm - 0.5; 100 lpm - 1.6
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
JUL 2 7 2012
4120463 510(k) Summary Page I of 6 6-Jul-12
| SleepNet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 | Tel - 603-758-6625
Fax - 603-758-6699 |
| ------------------------------------------------------------------------- | ------------------------------------------ |
|---|
| Official Contact: | Jennifer Kennedy - Director of Quality |
|---|---|
| Proprietary or Trade Name: | Mojo Full Face Mask |
| Veraseal Full Face mask | |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD - non-continuous ventilator (IPPB) |
| CFR 868.5905 | |
| Class II | |
| Device: | Mojo Full Face Mask |
| Veraseal Full Face mask | |
| Predicate Devices: | K060273 - SleepNet Mojo Full Face mask |
| K063122 - ResMed Mirage Quattro Full Face mask | |
| Device Description: |
The SleepNet Mojo and Veraseal Full Face mask are modifications of the SleepNet Mojo Full Face mask cleared under K060273.
The modifications to the cleared Mojo Full Face mask are:
- different durations of use
- o single use, disposable (Hospital/Institutional) Veraseal
- o single patient, multi-use up to 7 days (Hospital/Institutional) Veraseal
- o single patient, multi-use (Home or Hospital/Institutional) MoJo
- a change in materials .
- updated design of the exhaust elbow used with the mask
As a result of these modifications we have established two (2) product tradenames to help distinguish them.
Veraseal model has 2 durations of use - single use, disposable or single patient, multi-use up to 7 days in the hospital.
Mojo model is single patient, multi-use (typically more than 7 days) for use in the home or hospital.
Indications for Use:
●
The SleepNet Mojo and Veraseal masks 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 (>30kg) for whom positive airway pressure therapy has been prescribed.
1
510(k) Summary Page 2 of 6 6-Jul-12
Veraseal -
Disposable single use (hospital/institutional)
Single patient, multi-use up to 7 days (hospital/institutional)
Mojo -
Single patient, multi-use (home or hospital/institutional)
Patient Population: For adults (>30 kg)
Environment of Use: Home or hospital / institutional environments
The SleepNet Veraseal and Mojo Full face mask are viewed as substantially equivalent to the predicates device because:
Indications -
-
The Veraseal and Mojo masks 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 (>30kg) for whom positive airway pressure therapy has been prescribed. -
Identical to ResMed Mirage Quattro (K063122) with pressure minimum identical to . SleepNet Mojo (K060273)
Patient Population -
- The masks are to be used on adult patients (>30kg) for whom positive airway pressure . therapy has been prescribed.
- Identical to SleepNet MoJo (K060273) and ResMed Mirage Quattro (K063122) .
Technology -
- Identical technology to SleepNet Mojo Full Face mask (K060273) .
Materials -
- The materials in patient contact are identical to predicate devices or have been tested in . accordance with ISO 10993.
Environment of Use -
- The masks are intended for use in the home or hospital/institutional environment .
- Identical to predicates SleepNet MoJo (K060273) and ResMed Mirage Quattro . (K063122)
Duration of Use and Cleaning Method
- The duration of use and cleaning methods for single patient Less 7 days, single patient, . multi-use, disposable are identical to the predicate - SleepNet MoJo (K060273)
Differences -
- There are no differences between the predicates and the proposed modified devices which . would raise any new safety or risks and thus can be found to be substantially equivalent.
2
510(k) Summary Page 3 of 6 6-Jul-12
Comparative Performance
We have performed comparative performance testing pre- and post- cleaning or conditioning that included:
- Dead space .
- Exhaust Flow ●
- Pressure drop ●
- Anti-asphyxia valve (AAV) pressure testing .
- Exhaust Elbow Change Performance .
- CO2 washout per ISO 17510-2 .
- ISO 10993 for biocompatibility .
- Cleaning validation ●
- Storage and aging .
The results demonstrated that the devices are substantially equivalent.
3
510(k) Summary
Table of Comnarison to Predicates
| ante of Compal Boll | | | | Attributes | Modified
Mojo and Veraseal
Full Face Mask | Mojo Full Face Mask
K060273 | ResMed Mirage Quattro
K063122 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------|
| ttributes | | | ResMed Mirage Quat K063122 | Features | | | |
| | Modified Modernets Marka Morith Mojio masks are The United Manika Movich positi as The United Maska Movith positi as announds and research are are ar Sboray pressure de | Mojo Full Face M. K060273 | | Available sizes | 3 | 3 | 4 |
| | | | | Shape | Similar | Similar | Similar |
| ications for | | | e Mirage Quattro channels airflow ninvasively to a patient from a possive way pressure device such as comments of the many pressure airway pressure airway pressure airway pre | Shell | Veraseal
Rigid for single patient models | Soft only | |
| | | | | Materials ISO 10993
CO₂ washout profile
Tested per ISO 17510-2 | Mojo
Soft
Yes | Yes | N/A |
| | | | | | Pressure | Pressure | Not tested as this predicate for duration of
use, environment of use, and cleaning
method only |
| | | | | | ETCO₂% at mask
(% increase) | ETCO₂% at mask
(% increase) | |
| | | | evel system | | 3 cm H₂O
6.1 (17%) | 3 cm H₂O
5.9 (15%) | |
| | | | | | 5 cm H₂O
5.9 (14%) | 5 cm H₂O
5.8 (14%) | |
| | | | | | 10 cm H₂O
5.8 (12%) | 10 cm H₂O
5.6 (9%) | |
| | The masks are to be used on adult patients (230kg) for whom positive airway pressure therapy has been prescribed | The Sin Bir More More Maria Massal Massal Massa Short All Properti Andress Marin Marian Managing Marian Managiri Marian Manakar Manakar Manakar Manakari Marin Marian Manakari | The Mirage Quattro is to be used by adult patients (> 66 lbs. /> 30 Kg) for whom positive airway pressure has been | | Occluded
6.3 (21%) | Occluded
6.0 (17%) | |
| | | | | Deadspace | Mojo | | Varies according to cushion size |
| | | | prescribed | Small | 160 ml | 200 ml | |
| tient Populati | Adult (≥30 kg) The masks are intended for use in the home or hospital/institutional environment. | dult (>30 kg | dult (>30 kg | Medium | 185 ml | 245 ml | |
| vironment of | | | | Large | 205 ml | 295 ml | 242 ml |
| | | The masks are intended for use in the nome or hospital/institutional | he masks are intended for use ome or hospital/institutional | Exhaust - pressure / flow | Mojo | | |
| | | environment | environment | | Pressure (cmH₂O) Flow (lpm) | Pressure (cmH₂O) Flow (lpm) | Pressure (cmH₂O) Flow (lpm) |
| | Yes | Yes | Y es | | 3
21.20 | 3
32.00 | 4
22 |
| escriptive uration of U | | | | | 10
37.20 | 10
43.00 | 8
32 |
| | | | | | 20
53.10 | 20
55.00 | 12
41 |
| | | | | | Veraseal | | 20
54 |
| | Veraseal Disposable, single patient use (hospital) Single patient, multi-use up to 7 days (hospital) | Single patient, multi-use (home | Single patient, multi-use but does not the length of re-use (home / hospital) | | Pressure (cmH₂O) Flow (lpm) | | |
| | | hospital | | | 3
21.10 | | |
| | | | | | 10
36.40 | | |
| | patient, multi-use (hon
្រទេសចរនា ជា ជាចំនួនដែន ស្ថិតនៅក្នុងស្រុក និង ស្រីបន្ត ស្រុកស្រីប ស | ingle patient, multi-use (hom | | | 20
53.00 | | |
| | | hospital) | | | | | |
| eaning metho | Soap and water | oap and wate | | | | | |
| | Isopropyl alcoho Yes | sopropyl alcoh | OPA | | | | |
| corporates an Exhaust elbo | | Yes | Yes | | | | |
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510(k) Summary
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5
510(k) Summary
| Attributes | Modified Mojo and Veraseal Full Face Mask | Mojo Full Face Mask
K060273 | ResMed Mirage Quattro
K063122 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Pressure AAV
Opening / closing | Mojo
Opening - 1.10 cm H₂O
Closing - 1.60 cm H₂O
Veraseal
Opening - 1.29 cm H₂O
Closing - 1.45 cm H₂O | Opening - 0.65 cm H₂O
Closing - 1.38 cm H₂O | Not disclosed |
| Resistance to Flow | Pass / Fail criteria is 30kg) for whom positive airway pressure therapy has been prescribed.
Veraseal -
Disposable single use (hospital/institutional)
Single patient, multi-use up to 7 days (hospital/institutional)
Mojo -
Single patient, multi-use (home or hospital/institutional)
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulten
(Division Sign-Off) Division of Anestheslology, General Hospital Intection Control, Dental Devices
510(k) Number: K120463