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)

Device Description

The Sleepnet Mojo 2, Veraseal 3 and V3 Full Face mask are provided with an exhalation elbow and anti-asphyxia (AAV) valve.

The subject of this submission is:

Slight redesign of the shape of the masks but no appreciable differences as the identical exhalation elbow and anti-asphyxia valve (AAV)
Add an additional size, ex-large, mask to the product line
Support useful life of the V3 and Mojo 2 up to 6 months as a single patient, multi-use mask

Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)
V3 is intended as a Single patient, multi-use (home)
Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional

AI/ML Overview

The provided document, a 510(k) summary for certain full face vented masks, focuses on demonstrating substantial equivalence to predicate devices rather than detailing a study that proves the device meets specific acceptance criteria through novel performance data. The core of this submission is about showing that the new masks are as safe and effective as pre-existing, legally marketed devices.

Therefore, many of the requested details, such as sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set information (which are typical for AI/ML device submissions or devices requiring extensive clinical performance testing), are not applicable to this 510(k) for a respiratory mask.

However, based on the principle of demonstrating substantial equivalence, we can infer the "acceptance criteria" and "device performance" relate to meeting the standards of the predicate device and relevant international standards.

Here's an interpretation of the available information in the context of the prompt:

Acceptance Criteria and Reported Device Performance

The document states that the performance of the new masks was "compared" to predicate devices and that the new masks "Meets ISO 17510 testing". This indicates that the acceptance criteria are adherence to established performance benchmarks (likely from ISO 17510) and performance comparable to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility: Materials in patient contact are safe and compatible.	"The materials in patient contact are identical to predicate devices." This implies that the biocompatibility of the new device is accepted if it uses materials already proven to be safe in the predicate device.
Internal Volume / Dead Space: Must be within acceptable limits.	"Compared performance for: Internal Volume / Dead space." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510).
Pressure Drop: Must be within acceptable limits for proper function.	"Compared performance for: Pressure drop." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510).
Anti-asphyxia valve pressure testing: AAV must function correctly.	"Compared performance for: Anti-asphyxia valve pressure testing." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510).
CO2 Washout: CO2 clearance must be adequate.	"Compared performance for: CO2 washout." (Implied: Met accepted limits, likely comparable to predicate and/or within ISO 17510).
Simulated Life Testing Post-Cleaning: Device must maintain performance after simulated use/cleaning.	"Compared performance for: Simulated life testing post-cleaning." (Implied: Met accepted limits for useful life duration, e.g., 6 months for V3 and Mojo 2, 7 days for Veraseal 3 hospital multi-use).
Mechanical Drop Test: Device must withstand typical handling/drops.	"Compared performance for: Mechanical drop test." (Implied: Met accepted limits).
Meets ISO 17510 testing: Adherence to the international standard for respiratory equipment.	"Meets ISO 17510 testing." This is a direct statement of compliance with a recognized standard, which defines numerous performance and safety criteria for respiratory masks (e.g., breathing resistance, leakage, dead space, strength, durability, material safety). This single statement encompasses a broad range of acceptance criteria.
No New Safety Concerns: The design changes do not introduce new risks.	"There are no differences between the proposed devices which would raise new safety concerns." This is a critical overall acceptance criterion for a 510(k) submission based on substantial equivalence.

Study Details (as inferable from a 510(k) for a medical device)

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a number of patients or cases but rather as a series of bench tests on device samples. For physical device testing (like pressure drop, CO2 washout, mechanical drop), typically multiple units of the device are tested to ensure consistency and reliability. The specific number of units tested for each benchmark is not provided in this summary.
Data Provenance: The data are generated from bench testing (laboratory-based performance evaluations) rather than clinical studies with patient data. The country of origin of the data is not specified but would be where the manufacturer (Sleepnet Corporation, Hampton, NH, USA) conducts its testing or where a contracted testing facility is located. The tests are prospective in the sense that they are conducted specifically for this submission to demonstrate performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For mechanical/performance bench testing of a device like a mask, "ground truth" is established through physical measurements and adherence to engineering specifications and international standards (like ISO 17510), rather than expert consensus on medical images or clinical outcomes. The "experts" would be the engineers and technicians performing and verifying the tests, ensuring compliance with established protocols and standards.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical data (e.g., radiology reads) where subjective interpretation might vary. For bench testing, test results are typically objective measurements compared against predefined pass/fail criteria or reference values.

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 is a physical medical device (mask), not an AI/ML diagnostic or assistive device that involves "human readers" or "AI assistance."

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

Not Applicable. Same as above, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for the bench tests is defined by engineering specifications, international standards (specifically ISO 17510), and the performance characteristics of the legally marketed predicate devices. For example, the acceptable range for CO2 washout is defined by ISO standards, and the performance of the predicate device serves as a comparative benchmark.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a "training set" for model development.

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

Not Applicable. (See point 8).

In summary, this 510(k) relies heavily on demonstrating that the new mask designs maintain the same essential safety and performance characteristics as the previously cleared predicate device, and that they meet relevant international standards through various bench tests. The "study" here is a series of engineering and performance evaluations designed to prove this equivalence, rather than a clinical trial or AI model validation study.

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). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

July 5, 2019

Sleepnet Corporation % Paul Dryden. Consultant ProMedic. LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K190254

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 5, 2019 Received: June 6, 2019

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

for

James Lee, PhD Assistant Director DHT1C: Division of ENT, 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

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Indications for Use

510(k) Number (if known)

K190254

Device Name

Mojo 2 Full Face Vented Mask Veraseal 3 Full Face Vented Mask V3 Full Face Vented Mask

Indications for Use (Describe)

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)

Type of Use (Select one or both, as applicable)

_ Over-The-Counter Use (21 CFR 801 Subpart C) XX Prescription Use (Part 21 CFR 801 Subpart D)

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Form Approved: OMB No. 0910-0120

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510(k) Summary 5-July 19

Sleepnet Corporation5 Merrill Industrial DriveHampton, NH 03842	Tel - 603-758-6625Fax - 603-758-6699
Official Contact:	Jennifer Kennedy – Director of Regulatory and Quality
Proprietary or Trade Name:	Mojo 2 Full Face Vented MaskVeraseal 3 Full Face Vented MaskV3 Full Face Vented Mask
Common/Usual Name:	Patient interface for CPAP
Classification Code/Name:	BZD - non-continuous ventilator (IPPB)CFR 868.5905
Device:	Mojo 2 Full Face Vented MaskVeraseal 3 Full Face Vented MaskV3 Full Face Vented Mask
Predicate Devices:Reference Devices:	K120463 - Sleepnet Veraseal and Mojo Full Face maskK121692 - MiniMe 2 nasal

Device Description:

The Sleepnet Mojo 2, Veraseal 3 and V3 Full Face mask are provided with an exhalation elbow and anti-asphyxia (AAV) valve.

The subject of this submission is:

Slight redesign of the shape of the masks but no appreciable differences as the identical . exhalation elbow and anti-asphyxia valve (AAV)
· Add an additional size, ex-large, mask to the product line
. Support useful life of the V3 and Mojo 2 up to 6 months as a single patient, multi-use mask

Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)

V3 is intended as a Single patient, multi-use (home)

Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional

Indications for Use:

The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.

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510(k) Summary

Veraseal 3 -Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)

V3 -Single patient, multi-use (home)

Moio 2 -Single patient, multi-use (home or hospital/institutional

Patient Population: For adults (>30 kg)

Environment of Use: Home or hospital / institutional environments

Substantial Equivalence Discussion:

We discuss the major attributes for demonstrating substantial equivalence below. These refer to the table below this discussion.

The Sleepnet Veraseal 3, V3, and Mojo 2 Full face mask are viewed as substantially equivalent to the predicate device because:

Indications -

The Veraseal 3, V3, and Mojo 2 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 (>30 kg) for whom positive airway pressure therapy has been prescribed.
Identical to Sleepnet masks K120463 ●

Patient Population -

The masks are to be used on adult patients (>30kg) for whom positive airway pressure ● therapy has been prescribed.
Identical to Sleepnet - K120463

Environment of Use -

The masks are intended for use in the home or hospital/institutional environment. ●
. Identical to predicates - Sleepnet - K120463

Technology -

. Identical technology to - Sleepnet mask - K120463

Non-clinical testing

Biocompatibility -

The materials in patient contact are identical to predicate devices. ●

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510(k) Summary

Bench testing

We compared performance for:

Internal Volume / Dead space
Pressure drop
Anti-asphyxia valve pressure testing ●
CO2 washout
Simulated life testing post-cleaning
Mechanical drop test ●
. Meets ISO 17510 testing

Differences –

There are no differences between the proposed devices which would raise new safety concerns. The subject devices are found to be substantially equivalent to the identified predicate device.

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).

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance

Study Details (as inferable from a 510(k) for a medical device)

2. Sample size used for the test set and the data provenance

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

4. Adjudication method for the test set

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

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

7. The type of ground truth used

8. The sample size for the training set

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

Indications for Use

Indications for Use (Describe)

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. *

510(k) Summary 5-July 19

Device Description:

Indications for Use:

510(k) Summary

Substantial Equivalence Discussion:

Indications -

Patient Population -

Environment of Use -

Technology -

Non-clinical testing

Biocompatibility -

510(k) Summary

Bench testing

Differences –

§ 868.5905 Noncontinuous ventilator (IPPB).

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.