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.

AI/ML Overview

This document outlines the acceptance criteria and study proving the device meets said criteria for the Neoasis active noise attenuation system.

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Neoasis device are based on its noise attenuation performance, especially within the specified frequency range, and its safety features. The direct acceptance criteria in the provided text are derived from the "Special Controls" section, which dictates the performance and safety requirements for this type of device.

Acceptance Criteria Category	Specific Acceptance Criteria (from Special Controls)	Reported Device Performance (from "Performance Testing-Bench" and "Summary of Benefits")
(1) Non-clinical performance testing: Demonstrate device performs as intended under anticipated conditions of use.	(1)(i) Verification and validation of critical acoustic parameters, including the maximum output of the device.	The device has a maximum output of 98 decibels. Software safeguards are in place to prevent malfunctioning and inappropriate noise production. The summary states that "software validation, verification, and hazard analysis was performed, and the results demonstrate that the software functions as intended, and the required specifications are met." The device outputs the calculated waveform through the speakers to cancel out environmental noise.
	(1)(ii) Verification and validation of the attenuation performance of the device, including:(A) Testing with compatible incubator model(s) and dimensions.	The device is only intended for use in the GE Healthcare Giraffe OmniBed Incubator. Performance testing was conducted simulating use with both devices on an infant mannequin within this incubator model.
	(B) Attenuation performance testing simulating different infant locations and orientations within the incubator.	Attenuation mapping across representative locations inside the incubator was performed. "Invictus Medical moved the noise sensing mannequin into different locations within the infant incubator to account for the potential movement of real infants." "The attenuation performance study described above evaluates the changes in performance within different locations of the incubator. This resulted in an attenuation map which demonstrates the device performance at different locations in the incubator." The results indicated the device performs as intended, with similar attenuation levels compared to the MiniMuffs.
	(C) Testing with relevant noise sources and room configurations.	"Invictus Medical used various sound sources that are present in a typical NICU setting" (e.g., Patient Monitor alarms, Ventilator alarms, Syringe Pump alarms, Male and Female Voices) to assess noise attenuation. The testing also evaluated situations where the infant could move. "Within the 250-1000 Hz range, the Neoasis and MiniMuffs device demonstrate similar attenuation performance." "Performance testing shows approximately a 7 decibels noise reduction, which is similar to MiniMuffs."
(2) Software validation, verification, and hazard analysis.	Software validation, verification, and hazard analysis must be performed.	"Software verification and analysis was performed, and the results demonstrate that the software functions as intended, and the required specifications are met." The software has a moderate level of concern.
(3) Electrical safety and electromagnetic compatibility (EMC) testing.	Electrical safety and electromagnetic compatibility (EMC) testing must be performed for any electrical components of the device.	The device conforms to IEC 60601-1, IEC 60601-1-2, and IEC 60950-1 standards.
(4) Biocompatibility.	The patient- or user-contacting components of the device must be demonstrated to be biocompatible.	The device is classified as intact skin contacting with transient contact duration. Biocompatibility was evaluated in accordance with ISO 10993-1:2018 and FDA Guidance. Material information and manufacturing processes were provided in lieu of testing, supporting biological safety.
(5) Labeling.	Labeling must include specific information (instructions for infant placement, expected attenuation, warnings, cleaning/disinfection, compatible incubators).	Physician labeling includes indications for use, device description, warnings and precautions, expected benefit, and instructions for safe/effective use. It instructs users to clean/disinfect parts. Reusable components are cleaned/disinfected between patients. The labeling satisfies 21 CFR 801.109 and includes a summary of attenuation performance. Warnings regarding maximum output are implicitly covered by "warnings regarding the risks of exposure to the potential maximum output of the device". Instructions for infant placement and compatible incubators are also included.

Specific Performance Requirements (from Indications for Use):
The attenuation performance of the device is for noises in the NICU with frequencies between 250 Hz to 1,000 Hz.

Reported Performance against Indication:

"Within the 250-1000 Hz range, the Neoasis and MiniMuffs device demonstrate similar attenuation performance."
Table 1 provides detailed attenuation data across multiple octave bands, including 250 Hz, 500 Hz, and 1000 Hz, for various noise sources. For many noise sources, particularly the Patient Monitor High (1000 Hz), Ventilator Medium (500 Hz), and Ventilator High (250 Hz, 500 Hz), Neoasis shows significant positive attenuation, often outperforming earmuffs. Even for other sources, where earmuffs might show slightly higher attenuation at certain specific frequencies, the Neoasis consistently demonstrates positive attenuation within or around the 250-1000 Hz range, indicating noise reduction. The summary confirms "approximately a 7 decibels noise reduction, which is similar to MiniMuffs."

Study Proving the Device Meets Acceptance Criteria

The study described is primarily a non-clinical bench testing study.

Sample size used for the test set and the data provenance:
- Test Set Description: The test set for the performance evaluation involved various simulated NICU noise sources and a mannequin with noise sensors.
- Sample Size: The sample size is not explicitly stated in terms of number of unique noise recordings or test runs, but the study evaluated the Neoasis device against multiple alarm types (Patient Monitor, Ventilator, Syringe Pump) from different brands (Philips, Maquet, Medfusion), at various alarm priorities (High, Medium, Low), and also included Male and Female Voices. For each noise source and alarm priority, attenuation was measured across 7 octave bands (125 Hz, 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, 8000 Hz). Additionally, measurements were taken at "representative positions" within the incubator to account for infant movement, creating an "attenuation map."
- Data Provenance: The data was generated through prospective bench testing conducted by Invictus Medical. The location (country of origin) is not specified, but the sponsor information lists San Antonio, TX, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the bench testing performance study, no human experts were used to establish "ground truth" in the traditional sense of clinical label annotation. The ground truth here is the objective physical measurement of noise attenuation (reduction in decibels) using calibrated sensors (microphones) within the simulated environment. The "ground truth" is measured by the change in decibel levels of the noise before and after attenuation.
- For the Human Factors testing, 15 nurses were recruited to assess usability, but this was not for establishing "ground truth" for noise attenuation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Given that the performance testing was a benchtop measurement study using sensors and objective physical parameters, there was no need for human adjudication. The measurements of sound levels are quantitative and derived directly from instrumentation.
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:
- No MRMC comparative effectiveness study was done. The device is an active noise attenuation system; it does not involve human "readers" or AI assistance in interpreting diagnostic images. Its purpose is to directly reduce noise. The comparison was device-to-device (Neoasis vs. MiniMuffs) based on physical properties (noise attenuation).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was the primary method. The performance testing was of the Neoasis device acting independently to attenuate noise without human intervention during the "active" attenuation process. The device's software algorithm controls this process. Human factors testing was conducted to ensure safe and proper setup and use by a human, but the core function of noise attenuation is autonomous once setup.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance test was objective physical measurement of sound levels (in decibels) before and after device operation, using a mannequin equipped with noise sensors (microphones). This is a direct measurement of the device's physical effect rather than a clinical outcome or human interpretation.
The sample size for the training set:
- The document does not specify a training set sample size for the device's internal software algorithm. The description states the control unit "contains a software algorithm which calculates the sound wave necessary to cancel out the environmental noise." This suggests a rule-based or real-time adaptive algorithm for active noise cancellation, rather than a machine learning algorithm that typically requires a discrete "training set" in the context of diagnostic AI. The software's function is verified through "software verification and analysis" and its performance through benchmark testing.
How the ground truth for the training set was established:
- As there's no mention of a traditional machine learning "training set" for the core noise cancellation algorithm, the concept of establishing ground truth for a training set does not apply directly to the information provided. The algorithm appears to be designed based on principles of active noise cancellation (deconstructive interference), and its "training" or optimization is likely integrated into its design and subsequent validation through performance testing against real-world noise inputs. The "ground truth" for its operation is the accurate generation of an anti-phase sound wave to reduce noise, which is validated by the measured attenuation levels during bench testing.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR NEOASIS

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Active noise attenuation system for infant incubators. A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment.

NEW REGULATION NUMBER: 21 CFR 880.5405

CLASSIFICATION: Class II

PRODUCT CODE: OWX

BACKGROUND

DEVICE NAME: Neoasis

SUBMISSION NUMBER: DEN220048

DATE DE NOVO RECEIVED: July 25, 2022

SPONSOR INFORMATION:

Invictus Medical. Inc. 16601 Blanco Road, Suite 120 San Antonio. TX 78232

INDICATIONS FOR USE

LIMITATIONS

The sale, distribution, and use of the Neoasis is restricted to prescription use in . accordance with 21 CFR 801.109.
The Neoasis® is only intended for use in the GE Healthcare Giraffe OmniBed Incubator. .
All disposable accessories are intended to be used on a single patient only. None of the . items that are used inside the incubator should be used with more than one patient.
All incubator cables must be secured and away from the infant. .
. Use only the power supply provided by manufacturer
The accessories including the speakers should never be connected to any device except as . provided by Invictus Medical.

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DEVICE DESCRIPTION

Image /page/1/Figure/2 description: The image shows a diagram of an incubator shell with various components labeled. The diagram includes an outside noise sensor, a residual noise sensor, speakers, a rod, a mattress, and a control unit. Cables connect the control unit to the speakers and other components, and the incubator shell is depicted as a transparent enclosure.

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SUMMARY OF NONCLINICAL/BENCH STUDIES

SOFTWARE

The Neoasis device contains software to control and determine if an external noise is appropriate for the device to attenuate based on noise characteristics (duration, wavelength, sound level), calculates the appropriate waveform needed to match the external noise waveform to reduce noise and incorporates safeguards which ensure that an incorrect waveform or an unnecessarily high volume noise is not produced. The device outputs the calculated waveform through the speakers to cancels out the environmental noise. Software verification and analysis was performed, and the results demonstrate that the software functions as intended, and the required specifications are met. The software/firmware was reviewed according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The software has a moderate level of concern.

A cybersecurity evaluation was not needed as the device does not connect to external networks or devices.

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

The Neoasis device conforms to the requirements for electrical safety and electromagnetic compatibility of the following standards:

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014. Medical electrical equipment Part 1-2: General requirements . for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60950-1 Information technology equipment Safety Part 1: General . requirements

BIOCOMPATIBILITY

The Neoasis device is classified as intact skin contacting with a transient contact duration. Biocompatibility was evaluated in accordance with ISO 10993-1:2018, Biological evaluation of medical devices and FDA Guidance: Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Invictus Medical provided material information and a description of the manufacturing processes in lieu of biocompatibility testing to support the biological safety of the device. The results of these evaluations support that the biological risks of the device have been adequately mitigated.

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PERFORMANCE TESTING-BENCH

The performance of the Neoasis was compared against a 510k cleared passive noise attenuation device, the MiniMuffs (K935160) in a nonclinical bench testing which simulated use with both devices on an infant mannequin. To assess the noise attenuation performance under simulated clinical use conditions. Invictus Medical used various sound sources that are present in a typical NICU setting and a mannequin with noise sensors (microphones) to evaluate the noise attenuation. The testing also evaluated situations where the infant could move to different positions within the infant incubator by providing attenuation mapping across representative locations inside of the incubator. The table below (Table 1) provides a summary of the test results and is ordered in terms of best attenuation to worst attenuation sequences. Noise attenuation is represented by the number of decibels where a positive number represents a reduction of noise and negative numbers represent an increase/amplification of noise at the indicated frequency bands. Note that the alarm priority denotes the alarm sound from each devices play different sounds based on the alarm level, which is determined by the severity of issues. Testing the various alarm priority levels is representative of the possible alarms that the device could play in a clinical setting.

AlarmDevice	AlarmBrand	AlarmPriority	OctaveBand(Hz)	NeoasisAttenuation(dB)	EarmuffsAdhered OverMannequinEarsAttenuation(dB)	EarmuffsAdhered OverMannequinEars andHuman HairAttenuation(dB)
PatientMonitor	Philips	High	125	0.49	-0.72	-1.19
			250	0.3	-0.05	-0.12
			500	1.32	1.37	0.17
			1000	11.68	3.44	-1.27
			2000	1.23	1.8	0.2
			4000	0.44	1.73	1.23
			8000	-0.19	0.02	0.01
Ventilator	Maquet	Medium	125	0.35	-1.59	0.1
			250	3.18	3.18	1.01
			500	9.38	7.45	2.54
			1000	0.14	2.35	0.6
			2000	-0.02	0.33	-1.39

Table 1: Performance Testing - Attenuation Comparison
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De Novo Summary (DEN220048)

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AlarmDevice	AlarmBrand	AlarmPriority	OctaveBand(Hz)	NeoasisAttenuation(dB)	EarmuffsAdhered OverMannequinEarsAttenuation(dB)	EarmuffsAdhered OverMannequinEars andHuman HairAttenuation(dB)
			4000	0.01	0.15	-0.04
			8000	-0.02	0.02	0.01
		High	125	-0.12	-0.69	-0.16
			250	5.07	1.93	1.06
Ventilator	Maquet		500	8.64	2.43	1.36
			1000	0.6	2.64	0.45
			2000	0.16	0.76	-1.64
			4000	0.07	0.3	-0.31
			8000	-0.05	0.02	-0.13
		HighHigh	125	-0.66	-0.39	-0.13
			250	3.5	1.39	0.44
SyringePump	MedfusionMaquet		500	7	1.14	0.58
Ventilator			1000	0.35	4.36	-0.05
			2000	0.3	3.03	-0.09
			4000	0.11	0.88	0.27
			8000	-0.21	0.09	-0.15
	MedfusionMaquetPhilips	HighHighHigh	125	-0.76	-1.74	-0.96
SyringePump			250	1.44	0.27	0.31
VentilatorPatient			500	6.52	5.03	5.39
			1000	1.49	-0.29	0.53
			2000	0.45	0.58	-0.27
Monitor			4000	-0.13	1.86	-0.66
			8000	-0.43	0.06	0.04
	MedfusionMaquet	LowHigh	125	-0.09	-0.26	-0.83
			250	2.12	0.89	0.3
SyringePumpVentilator			500	5.07	0.2	0.5
			1000	-0.18	2.42	1.06
			2000	-0.27	1.94	0.2
			4000	-0.05	0.42	0.39
			8000	-0.24	0.04	-0.11
Male and	N/A	N/A	125	-0.05	-0.06	0.35
AlarmDevice	AlarmBrand	AlarmPriority	OctaveBand(Hz)	NeoasisAttenuation(dB)	EarmuffsAdhered OverMannequinEarsAttenuation(dB)	EarmuffsAdhered OverMannequinEars andHuman HairAttenuation(dB)
FemaleVoices			250	-0.02	1.2	-0.18
			500	-0.01	4.7	0.98
			1000	0.13	1.66	0.03
			2000	0	0.31	-1.16
			4000	0.02	0.09	0.02
			8000	0.01	0.03	0.01
SyringePumpPatientMonitor	MedfusionPhilips	HighMedium	125	-0.31	-0.55	-0.56
			250	0.75	1.04	0.07
			500	3.31	2.69	1.64
			1000	-0.92	0.22	-0.78
			2000	-0.83	0.08	-1.35
			4000	0.37	0.09	-0.86
			8000	-0.07	0.06	0.02
PatientMonitor	Philips	Medium	125	-0.21	0.07	0.04
			250	-0.15	0.35	0.31
			500	-0.13	2.04	1.97
			1000	0.13	-0.12	0.65
			2000	0.04	-0.07	0.55
			4000	-0.03	0.03	0.02
			8000	-0.12	0.02	0
SyringePump	Medfusion	Low	125	0.12	-0.99	-0.63
			250	-0.1	-0.05	-0.04
			500	0	1.46	1.11
			1000	-0.04	0.44	-0.05
			2000	-0.01	-0.01	-1.6
			4000	0	0.04	-0.64
			8000	0.02	0.04	0.03
SyringePump	Medfusion	High	125	0.07	-0.59	-0.31
			250	0.01	0.41	0.04
			500	0.03	1.95	1.15
			1000	-0.04	0.84	-1.51
AlarmDevice	AlarmBrand	AlarmPriority	OctaveBand(Hz)	NeoasisAttenuation(dB)	EarmuffsAdhered OverMannequinEarsAttenuation(dB)	EarmuffsAdhered OverMannequinEars andHuman HairAttenuation(dB)
			2000	-0.3	-0.3	-2.03
			4000	-0.15	0.24	-0.9
			8000	-0.01	0.02	0.03

De Novo Summary (DEN220048)

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De Novo Summary (DEN220048)

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Additionally, Invictus Medical moved the noise sensing mannequin into different locations within the infant incubator to account for the potential movement of real infants. The attenuation performance study described above evaluates the changes in performance within different locations of the incubator. This resulted in an attenuation map which demonstrates the device performance at different locations in the incubator. See below for a summary of locations tested.

Figure 1: Attenuation Mapping Results by Octave Band

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Image /page/7/Picture/0 description: The image contains four plots showing attenuation in decibels at different frequencies. The frequencies are 500 Hz, Lower 1,000 Hz, Upper 1,000 Hz, and 2,000 Hz. Each plot shows several data points with corresponding attenuation values, such as 8.3 and 10.6 at 500 Hz, and 0.9 and 0.6 at 2,000 Hz. Each plot also contains labels for "Speaker" and "Residual Noise Sensor (RNS)".

As shown in the results table above, within the 250-1000 hz range, the Neoasis and MiniMuffs device demonstrate similar attenuation performance. Representative positions were also tested in order to accommodate infant movement and account for performance differences based on location using a mannequin. These different positions tested are represented by the different colored circles in the incubator above. The numbers above the open circles represent the sound attenuation measured in decibels for the loudest ear of the mannequin across different locations when using the Neoasis device. The results indicate that the device performs as intended, with similar attenuation levels compared to the MiniMuffs. Based on the above testing results, the attenuation performance of the Neoasis device is similar to that of the MiniMuffs device.

REPROCESSING AND SHELF LIFE

The Neoasis is not provided sterile. Performance testing with accelerated aging confirmed the Neoasis maintained device performance over the 6 month labeled shelf life. Invictus Medical provided reprocessing and disinfection instructions to the end user which were evaluated per the 2015 FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" under clinical worst-case conditions. Cleaning and disinfection validation was provided and met the recommendations of the guidance above.

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SUMMARY OF CLINICAL INFORMATION

No clinical testing was performed to support the submission. Instead, literature was relied on to support the developmental. sleep. and health benefits associated with noise reduction for infants in the NICU from passive noise attenuation devices, like earmuffs. In addition, the American Academy for Pediatrics (AAP) recommends keeping sound levels below 45 dB and notes that higher noise environments can lead to adverse effects on the growth and neurodevelopment of neonates. Overall, it is well understood that high noise environments can lead to hearing damage, reduced sleep, and can negatively impact various physiological and behavioral states.

Invictus Medical conducted Human Factors testing by recruiting 15 nurses to assess the user's ability to set up the system and place the infant correctly. The Human Factors study was carried out following FDA 2016 guidance "Applying Human Factors and Usability Engineering to Medical Devices". The participants were successful in setting up and using the Neoasis system with infants. Major tasks included attaching/setting up the device, placing the infant correctly inside the incubator. being able to read the current and past noise levels. using the talk to infant feature and handling various errors. All participants were able to complete all of the identified tasks.

Pediatric Extrapolation

In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.

LABELING

Physician labeling includes the device indications for use, a description of the device, warnings and precautions, the expected benefit of the device, and instructions for the safe and effective use of the device. The labeling instructs users to clean or, for components placed inside the incubator, clean and disinfect all parts of the device prior to use and at least weekly during use. In addition. reusable components of the device are also cleaned and disinfected between patients. The labeling satisfies the requirements of 21 CFR 801.109 Prescription devices. Per the special controls for this generic type of device, labeling includes a summary of the attenuation performance.

RISKS TO HEALTH

Table 2 identifies the risks to health that may be associated with use of an active noise attenuation system for infant incubators, and the measures necessary to mitigate these risks.

Risks to Health	Mitigation Measures
Hearing loss from high deviceoutput or ineffective deviceattenuation	Non-clinical performance testingSoftware validation, verification, and hazard analysisElectrical safety and electromagnetic compatibility testing
Infection	Labeling
Adverse tissue reaction	Biocompatibility evaluation

Table 2 Identified Risks to Health and Mitigation Measures
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De Novo Summary (DEN220048)

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SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, an active noise attenuation system for infant incubators is subject to the following special controls:

(1) Non-clinical performance testing under anticipated conditions of use must demonstrate that the device performs as intended, including:
- (i) Verification and validation of critical acoustic parameters, including the maximum output of the device:
- (ii) Verification and validation of the attenuation performance of the device, including:
  - Testing with compatible incubator model(s) and dimensions; (A)
  - Attenuation performance testing simulating different infant locations and (B) orientations within the incubator; and
  - (C) Testing with relevant noise sources and room configurations.
Software validation, verification, and hazard analysis must be performed. (2)
Electrical safety and electromagnetic compatibility (EMC) testing must be performed for (3) any electrical components of the device.
The patient- or user-contacting components of the device must be demonstrated to be (4) biocompatible.
Labeling for the device must include: (5)
- Instructions for infant placement and the expected attenuation performance of the (1) device:
- (ii) Warnings regarding the risks of exposure to the potential maximum output of the device:
- Methods and instructions for cleaning and disinfection; and (iii)
- (iv) Identification of the incubator(s) that the device is intended to be used with.

BENEFIT-RISK DETERMINATION

Nonclinical laboratory studies as well as literature were used to evaluate the safety and effectiveness of the Neoasis.

Summary of Benefits

The device reduces noise at the 250-1000 Hertz range and the benefit of noise reduction for infants is well understood. Invictus Medical cites literature which concludes that there are benefits to infants from passive noise attenuation devices like earmuffs. These benefits relate to development, healing, sleep and overall health of infants in high noise environments such as the NICU. Furthermore. NIOSH guidance recommends 85 dBA for <8 hours and 100 dBA for <15 minutes to avoid hearing damage for adults. The American Academy of Pediatrics recommendation of noise level is <45db. Invictus Medical performed testing with some expected De Novo Summary (DEN220048) Page 10 of 11

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noise sources and compared it to earmuffs. Invictus Medical has demonstrated through performance testing that the reduction in noise is comparable to passive noise canceling devices such as the MiniMuffs. Although the attenuation performance varies depending on the acoustic waveform and the environmental volume, performance testing shows approximately a 7 decibels noise reduction, which is similar to MiniMuffs.

Summary of Risks

The device is overall a low risk device. There are two probable safety risks which were identified and subsequently mitigated by Invictus Medical. Firstly, in order to attenuate noise, the device has a maximum output of 98 decibels. During use, this output would be activated when the environmental noise is high which is needed to reduce the noise levels. In addition, there are software safeguards in place to prevent the device from malfunctioning and producing noise inappropriately. Secondly, based on the way the acoustic waveforms are matched, FDA was concerned the device use may result in noise amplification. If this occurred, it would lead to the infant experiencing a higher noise than the environmental noise. However, due to the geometry and movement of the wayeforms inside the incubator, it would be improbable that a noise waveforms match would lead to amplification.

Benefit/Risk Conclusion

The Neoasis performance testing demonstrates a meaningful noise attenuation, similar in impact to the cleared MiniMuffs device. Considering that device risks are mitigated through software and device performance controls, there is an overall favorable benefit-risk profile that supports granting this De Novo request.

CONCLUSION

The De Novo request for the Neoasis is granted and the device is classified as follows:

Product Code: OWX Device Type: Active noise attenuation system for infant incubators Regulation Number: 21 CFR 880.5405 Class: II

Regulation Number and Section

N/A