(146 days)
Not Found
No
The device description focuses on the physical components and function of a full face mask for noninvasive ventilation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a patient interface for noninvasive ventilation, specifically a mask, which is an accessory to a ventilator. While it aids in the delivery of therapy, it does not directly administer or perform a therapeutic action itself.
No
The device is a medical mask intended to apply noninvasive ventilation. It does not perform any diagnostic function.
No
The device description clearly details physical components such as a mask, shell, seal, headgear, elbow/swivel assembly, and adapter, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient interface for application of noninvasive ventilation." This describes a physical device used to deliver air pressure to a patient, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details the physical components of a mask designed to fit over the nose and mouth and connect to a ventilation system. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic or monitoring purposes based on sample analysis
- Measurement of biomarkers or other biological indicators
The device is a medical device used for respiratory support, specifically noninvasive ventilation.
N/A
Intended Use / Indications for Use
The Sleepnet MoJo™NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
Product codes
CBK
Device Description
The Sleepnet MoJo™ NV Full Face Mask, nonvented is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild detergent, such as Ivory® dishwasher liquid, in water. The cleaning process requires limited disassembly.
The mask consists of a molded flexible polyvinylchloride shell with a soft, resilient polyurethane encased silicone gel skin-contacting seal that conforms to the patient's facial features. The polyvinylchloride shell contains a malleable metal insert that allows the user to adjust the entire perimeter of the facial seal in any configuration.
The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source via a standard 22 mm polycarbonate elbow/swivel assembly. The elbow/swivel assembly attaches to the front of the mask with a polycarbonate split "o" clip.
The air delivery system consists of a 22mm polycarbonate swivel connector for 22mm tubing, The vent ports may be visually checked for obstruction prior to use.
An optional polypropylene adapter sold separately as an accessory may be used to connect to a pressure measurement or oxygen delivering device.
The Sleepnet MoJo™-NV Full Face Mask, Nonvented assembly will be packaged along with the applicable instructions for use sheet in a standard poly bag.
The Sleepnet MoJo™ headgear is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shelf.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose, mouth, facial features
Indicated Patient Age Range
adult patients (>30 kg)
Intended User / Care Setting
Homecare applications, institutional applications (i.e. hospital or other clinical settings)
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)
Tests performed on the Sleepnet MoJo™-NV Full Face Mask demonstrate substantial equivalence to the predicate devices listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SleepNet MoJo™-NV Full Face Mask, K060273, Respcare Hybrid NE Mask, K062019
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
MAY 1 7 2007
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter Name: | SleepNet Corp. |
|---|---|
| Submitter Address : | 5 Merrill Industrial Drive, Hampton, NH 03842 |
| Contact Person: | Frank Petruno |
| Fax Number: | (603) 758-6699 |
| Date Prepared: | November, 2006 |
| Device Trade Name: | SleepNet MoJo™-NV Full Face Mask, nonvented |
| Device Common Name: | Face Mask |
| Classification Name: | Ventilator, Noncontinuous (Respirator), 73CBK |
| Predicate devices: | SleepNet MoJo™-NV Full Face Mask, K060273 |
| Respcare Hybrid NE Mask, K062019 | |
| Reason for submission: | This device has not been previously marketed in the USA |
Device Description:
The Sleepnet MoJo™ NV Full Face Mask, nonvented is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild detergent, such as Ivory® dishwasher liquid, in water. The cleaning process requires limited disassembly.
The mask consists of a molded flexible polyvinylchloride shell with a soft, resilient polyurethane encased silicone gel skin-contacting seal that conforms to the patient's facial features. The polyvinylchloride shell contains a malleable metal insert that allows the user to adjust the entire perimeter of the facial seal in any configuration.
The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source via a standard 22 mm polycarbonate elbow/swivel assembly. The elbow/swivel assembly attaches to the front of the mask with a polycarbonate split "o" clip.
The air delivery system consists of a 22mm polycarbonate swivel connector for 22mm tubing, The vent ports may be visually checked for obstruction prior to use.
An optional polypropylene adapter sold separately as an accessory may be used to connect to a pressure measurement or oxygen delivering device.
The Sleepnet MoJo™-NV Full Face Mask, Nonvented assembly will be packaged along with the applicable instructions for use sheet in a standard poly bag.
The Sleepnet MoJo™ headgear is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shelf.
Intended Use:
1
The Sleepnet MoJo™-NV Full Face Mask, Nonvented assembly will be packaged along with the applicable instructions for use sheet in a standard poly bag.
The Sleepnet MoJo™ headgear is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shell.
Intended Use:
The Sleepnet MoJo™NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
Substantial Equivalence/ Device Technological Characteristics and Comparison to Predicate Device(s):
The technological characteristics of the Sleepnet MoJo™-NV Full Face Mask are equivalent to the predicate device listed above. Tests performed on the Sleepnet MoJo™-NV Full Face Mask demonstrate substantial equivalence to the predicate devices listed above.
Conclusion:
The Sleepnet MoJo™-NV Full Face Mask is substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Petruno Director of Sales SleepNet Corporation 5 Merrill Industrial Drive Hampton, New Hampshire 03842
Re: K063806
Trade/Device Name: Sleepnet MoJo™-NV Full Face Mask, Non-Vented Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 30, 2007 Received: May 1, 2007
MAY 1 7 2007
Dear Mr. Petruno:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Petruno
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K 0 6 3 8 0 6
Device Name: Sleepnet MoJo ™-NV Full Face Mask, non-vented
Indications For Use:
The Sleepnet MoJo™-NV Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
(Applies to the standard version):
For homecare applications, the Sleepnet MoJo™-NV Full Face Mask, Nonvented may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the disposable version):
The Sleepnet MoJo™-NV Full Face Mask, Nonvented Disposable is a single patient, single use interface.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/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)
sion of Anesthesiology. General Hospita Caon Control, Dental Devic
(k) Number S