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510(k) Data Aggregation
K Number
DEN220048Device Name
Neoasis
Manufacturer
Date Cleared
2023-06-16
(326 days)
Regulation Number
880.5405Why did this record match?
Applicant Name (Manufacturer) :
Invictus Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Neoasis® device is intended to reduce noise levels inside an infant incubator in the neonatal intensive care unit (NICU). The attenuation performance of the device is for noises in the NICU with frequencies between 250 Hz to 1,000 Hz.
Device Description
The Neoasis is comprised of an outside noise sensor, a control unit, two speakers, and a residual noise sensor. All components are connected to the control unit with different cables. The outside noise sensor captures the environmental noise and transmits the information to the control unit. The control unit determines if the noise should be attenuated and contains a software algorithm which calculates the sound wave necessary to cancel out the environmental noise. If cancelation is appropriate, the control unit plays the corresponding sound wave through the speakers inside of the incubator, attenuating the noise via deconstructive interference. The residual noise sensor then captures the resulting noise inside of the incubator and communicates it to the control unit. Additionally, the device contains a voice pass through feature which allows parents or healthcare practitioners to communicate with the infant from the outside using the control unit and speakers.
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K Number
K150243Device Name
Invictus Medical GelShield
Manufacturer
Date Cleared
2015-05-01
(88 days)
Product Code
Regulation Number
880.6450Why did this record match?
Applicant Name (Manufacturer) :
Invictus Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Invictus Medical, Inc. GelShield is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
Device Description
Invictus Medical, Inc. (Invictus) has developed the Invictus Medical, Inc. GELShield to reduce pressure localization on the heads of infants in Neonatal Intensive Care Units (NICU). The Invictus device is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated. The product achieves this through two design characteristics: first to reduce overall friction between the outer laver of skin covering the skull and external surface; and second, to evenly redistribute external pressures over boney prominences of the skull.
The device wraps around the back of the head starting just behind the ears. It has a three dimensional curvature from foam panels that creates a curved surface of the primary outer material, Recovery5™ HF Healthcare Fabric, a low-friction material that is also used on surgical mattresses. Coupled with silicone appliques on the inner surface, the design helps the device stay in place on the head allowing the infant to move normally. This is augmented through the use of Velcro™ (as part of the device) which is used to snugly secure the device to the head. The Velcro allows the nursing staff to easily remove and re-secure the device as part of the usual care of the patient. The device also contains panels of hydrogel encased in Versaflex designed to reduce pressure localization. The Invictus Medical GELShield is not sterile when used. The device is single patient use, but can be worn by a given patient for multiple use periods during the patient's stay in NICU.
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