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)

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SleepNet Mojo and Veraseal Full Face Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices using comparative performance testing, rather than explicit acceptance criteria with numerical targets for each attribute. However, the "Comparative Performance" section and the "Table of Comparison to Predicates" implicitly serve this purpose by showing that the modified devices perform similarly to or better than the predicates.

Test / Performance Metric	Acceptance Criteria (Implicit - based on predicate performance)	Reported Device Performance (Modified Mojo and Veraseal)	Predicate Device Performance (Mojo K060273)	Predicate Device Performance (ResMed Mirage Quattro K063122)
CO2 washout (per ISO 17510-2)	Results demonstrating substantial equivalence to predicates.	Demonstrated substantial equivalence to predicates.	Performed.	Performed.
ETCO2% at mask (increase)	Similar to or lower than predicates.
- 3 cm H₂O	≤ 5.9 (15%)	Mojo: 6.1 (17%) Veraseal: N/A (not explicitly listed for Veraseal at this pressure)	5.9 (15%)	Implicitly not tested for this predicate
- 5 cm H₂O	≤ 5.8 (14%)	Mojo: 5.9 (14%) Veraseal: N/A (not explicitly listed for Veraseal at this pressure)	5.8 (14%)	Implicitly not tested for this predicate
- 10 cm H₂O	≤ 5.6 (9%)	Mojo: 5.8 (12%) Veraseal: N/A (not explicitly listed for Veraseal at this pressure)	5.6 (9%)	Implicitly not tested for this predicate
- Occluded (Mojo)	≤ 6.0 (17%)	6.3 (21%)	6.0 (17%)	Implicitly not tested for this predicate
Deadspace	Similar to or lower than predicates.
- Small (Mojo)	≤ 200 ml	160 ml	200 ml	N/A (varies by cushion size)
- Medium (Mojo)	≤ 245 ml	185 ml	245 ml	N/A (varies by cushion size)
- Large (Mojo)	≤ 295 ml or similar to ResMed (242ml)	205 ml	295 ml	242 ml
Exhaust - pressure / flow	Similar flow characteristics to predicates for given pressures.
- 3 cm H₂O	Mojo: ~32.00 lpm Veraseal: N/A	Mojo: 21.20 lpm Veraseal: 21.10 lpm	32.00 lpm	N/A
- 10 cm H₂O	Mojo: ~43.00 lpm Veraseal: N/A	Mojo: 37.20 lpm Veraseal: 36.40 lpm	43.00 lpm	8 cm H₂O: 32 lpm
- 20 cm H₂O	Mojo: ~55.00 lpm Veraseal: N/A	Mojo: 53.10 lpm Veraseal: 53.00 lpm	55.00 lpm	20 cm H₂O: 54 lpm
Pressure AAV (Anti-asphyxia valve)	Opening/closing pressures similar to predicate (Mojo K060273).	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 < 3 cm H₂O.	Mojo: 50 lpm - 0.40 cm H₂O, 100 lpm - 0.65 cm H₂O Veraseal: 50 lpm - 0.49 cm H₂O, 100 lpm - 0.89 cm H₂O	50 lpm - 0.38 cm H₂O, 100 lpm - 0.80 cm H₂O	50 lpm - 0.5 cm H₂O, 100 lpm - 1.6 cm H₂O
Biocompatibility	Tested per ISO 10993.	Tested per ISO 10993; materials in patient contact are identical to predicates or tested per ISO 10993.	Yes.	N/A.
Cleaning validation	Validated methods for different durations of use.	Performed.	Performed.	Performed.
Storage and aging	Evaluated for impact on performance and safety.	Performed.	Performed.	Performed.
Dead space	Evaluated.	Performed.	Performed.	Performed.
Exhaust Flow	Evaluated.	Performed.	Performed.	Performed.
Pressure drop	Evaluated.	Performed.	Performed.	Performed.
Anti-asphyxia valve (AAV) pressure testing	Evaluated.	Performed.	Performed.	Performed.
Exhaust Elbow Change Performance	Evaluated.	Performed.	Performed.	Performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set (number of masks tested, number of repetitions for each test). The studies mentioned were "comparative performance testing" pre- and post-cleaning or conditioning. The data provenance is not specified (e.g., country of origin) but is implied to be from internal testing by the manufacturer, SleepNet Corporation, in support of their 510(k) submission. There is no indication whether the data is retrospective or prospective, but for product performance testing, it is typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The device is a medical mask (patient interface), and the "ground truth" for its performance is established through objective engineering and biological safety testing (e.g., CO2 washout, dead space measurements, flow resistance, biocompatibility), not through expert clinical consensus or interpretation of images/data.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" involves objective performance metrics and not subjective expert judgment, which would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret results (e.g., radiologists reading medical images). The SleepNet Mojo and Veraseal Full Face Mask is a patient interface device that does not involve human interpretation in its function.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies performed were standalone performance tests of the device itself. There is no "algorithm" or "human-in-the-loop" component to this medical mask. The tests measured the physical and biological performance characteristics of the mask in isolation.

7. Type of Ground Truth Used

The "ground truth" for the performance of the device was established through:

Objective engineering measurements: Such as pressure drop, exhaust flow, AAV pressure, dead space calculation.
Standardized testing procedures: Like CO2 washout performed per ISO 17510-2, and biocompatibility testing per ISO 10993.
Comparison to predicate device performance: The primary method for demonstrating substantial equivalence, meaning the performance of the predicate devices served as a de facto "ground truth" for acceptable performance.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" for this type of device. Training sets are typically used for machine learning algorithms, which are not involved in the design or evaluation of a medical mask.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above (no training set).

Summary

{0}------------------------------------------------

JUL 2 7 2012

4120463 510(k) Summary Page I of 6 6-Jul-12

SleepNet Corporation5 Merrill Industrial DriveHampton, NH 03842	Tel - 603-758-6625Fax - 603-758-6699
-------------------------------------------------------------------------	------------------------------------------

Official Contact:	Jennifer Kennedy - Director of Quality
Proprietary or Trade Name:	Mojo Full Face MaskVeraseal Full Face mask
Common/Usual Name:	Patient interface
Classification Code/Name:	BZD - non-continuous ventilator (IPPB)CFR 868.5905Class II
Device:	Mojo Full Face MaskVeraseal Full Face mask
Predicate Devices:	K060273 - SleepNet Mojo Full Face maskK063122 - 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	ModifiedMojo and VerasealFull Face Mask	Mojo Full Face MaskK060273	ResMed Mirage QuattroK063122
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	VerasealRigid for single patient models	Soft only
				Materials ISO 10993CO₂ washout profileTested per ISO 17510-2	MojoSoftYes	Yes	N/A
					Pressure	Pressure	Not tested as this predicate for duration ofuse, environment of use, and cleaningmethod only
					ETCO₂% at mask(% increase)	ETCO₂% at mask(% increase)
			evel system		3 cm H₂O6.1 (17%)	3 cm H₂O5.9 (15%)
					5 cm H₂O5.9 (14%)	5 cm H₂O5.8 (14%)
					10 cm H₂O5.8 (12%)	10 cm H₂O5.6 (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		Occluded6.3 (21%)	Occluded6.0 (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		321.20	332.00	422
escriptive uration of U					1037.20	1043.00	832
					2053.10	2055.00	1241
					Veraseal		2054
	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			321.10
					1036.40
	patient, multi-use (hon្រទេសចរនា ជា ជាចំនួនដែន ស្ថិតនៅក្នុងស្រុក និង ស្រីបន្ត ស្រុកស្រីប ស	ingle patient, multi-use (hom			2053.00
		hospital)
eaning metho	Soap and water	oap and wate
	Isopropyl alcoho Yes	sopropyl alcoh	OPA
corporates an Exhaust elbo		Yes	Yes

Page 16

{4}------------------------------------------------

510(k) Summary

Page 17

{5}------------------------------------------------

510(k) Summary

Attributes	Modified Mojo and Veraseal Full Face Mask	Mojo Full Face MaskK060273	ResMed Mirage QuattroK063122
Pressure AAVOpening / closing	MojoOpening - 1.10 cm H₂OClosing - 1.60 cm H₂OVerasealOpening - 1.29 cm H₂OClosing - 1.45 cm H₂O	Opening - 0.65 cm H₂OClosing - 1.38 cm H₂O	Not disclosed
Resistance to Flow	Pass / Fail criteria is <3 cm H₂OMojo50 lpm - 0.40 cm H₂O100 lpm - 0.65 cm H₂OVeraseal50 lpm - 0.49 cm H₂O100 lpm - 0.89 cm H₂O	Pass/Fail criteria is < 3 cm H₂O50 lpm - 0.38 cm H₂O100 lpm - 0.80 cm H₂O	50 lpm - 0.5 cm H₂O100 lpm - 1.6 cm H₂O
Components	HeadgearShell / CushionSwivel elbow	HeadgearShell / CushionSwivel elbow	HeadgearShell / CushionSwivel elbow

Page 18

ﺷﺮ ﺍﻟ

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 2 7 2012

Sleepnet Corporation C/O Mr. Paul Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K120463

Trade/Device Name: Veraseal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 6, 2012 Received: July 9, 2012

Dear Mr. 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 (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. 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.

{7}------------------------------------------------

Page 2 - Mr. Dryden

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm_for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use Statement

Page 1 of 1

510(k) Number:

K120463

Device Name:

Mojo Mask Veraseal Mask

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)

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

Regulation Number and Section

§ 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).