(148 days)
No
The summary describes a physical mask device and its intended use with existing positive airway pressure devices. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
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 air and doesn't directly provide therapy.
No.
The device is a face mask intended for use with positive airway pressure therapy devices and doesn't gather or analyze data for diagnostic purposes.
No
The device description clearly indicates it is a physical mask with hardware components (exhalation elbow, anti-asphyxia valve) and bench testing related to physical performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used with positive airway pressure devices for treating adult patients with prescribed positive airway pressure therapy. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the physical components of a mask used for delivering air pressure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and functional performance of the mask (pressure drop, CO2 washout, mechanical testing), not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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 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
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 (>30 kg.)
Intended User / Care Setting
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)
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 was performed, comparing 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
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.
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
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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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
Mojo 2 Full Face Vented Mask Veraseal 3 Full Face Vented Mask 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 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) |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1
Form Approved: OMB No. 0910-0120
3
510(k) Summary 5-July 19
| Sleepnet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 | Tel - 603-758-6625
Fax - 603-758-6699 |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Official Contact: | Jennifer Kennedy – Director of Regulatory and Quality |
| 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 for CPAP |
| Classification Code/Name: | BZD - non-continuous ventilator (IPPB)
CFR 868.5905 |
| Device: | Mojo 2 Full Face Vented Mask
Veraseal 3 Full Face Vented Mask
V3 Full Face Vented Mask |
| Predicate Devices:
Reference Devices: | K120463 - Sleepnet Veraseal and Mojo Full Face mask
K121692 - 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 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.
4
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.