Neuro Assessment System NAS-1000

K172892 · Headsense Medical, Inc. · QBE · Mar 8, 2018 · Cardiovascular

Device Facts

• Record ID: K172892
• Device Name: Neuro Assessment System NAS-1000
• Applicant: Headsense Medical, Inc.
• Product Code: QBE · Cardiovascular
• Decision Date: Mar 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in noninvasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.

Device Story

NAS-1000 System is a non-invasive, non-energy emitting medical acoustic device. It consists of a disposable, single-patient-use headset (NAS-1000H) with earbuds and a tablet-based monitor (NAS-1000M) running software (NAS-1000S). The headset passively receives acoustic signals from the brain; the monitor processes these signals and displays them as 2D acoustic waveforms. Used in clinics or hospitals by clinicians during physical examinations. The device provides visual output of brain acoustic signals in three frequency bands (0-15 Hz, 0-25 Hz, 0-45 Hz) to assist in medical assessment. It does not provide auditory output, heart rate detection, or filtering. Data can be transferred via USB. The system aids clinicians by providing a graphical representation of brain acoustic activity, potentially supporting clinical decision-making during patient monitoring.

Clinical Evidence

Performance study conducted on 50 volunteers. Each volunteer underwent 20 minutes of continuous monitoring. Raw acoustic data was recorded and retrospectively analyzed to generate 2D waveforms across three frequency bands (0-15 Hz, 0-25 Hz, 0-45 Hz). Results demonstrated the system's ability to detect and display brain acoustic signals. Bench testing using a cranial phantom head and a peristaltic pump confirmed the system's ability to monitor, detect, record, and display simulated systolic pulse waveforms comparably to the predicate device.

Technological Characteristics

Non-energy emitting, non-sterile device. Components: disposable headset (NAS-1000H) with earbuds (XS, S, M, L) and tablet monitor (NAS-1000M). Power: Lithium-ion battery (headset: CR 2032; tablet: 4000 mAh). Signal processing: Digital Signal Processor. Display: LCD showing 2D waveforms (0-15 Hz, 0-25 Hz, 0-45 Hz). Connectivity: USB cable for data transfer. Biocompatibility: Skin contact only.

Indications for Use

Indicated for any subject undergoing a physical examination in a clinic or hospital setting for noninvasive monitoring, detection, recording, and display of acoustic signals in the brain as an adjunct to standard clinical practice.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• 3M Littmann Electronic Stethoscope, Model 3200 (K083903)

Submission Summary (Full Text)

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March 8, 2018

HeadSense Medical Inc. % Kit Cariquitan Chief Regulatory Officer Experien Group. LLC 224 Airport Parkway Suite 250 San Jose, California 95110

Re: K172892

Trade/Device Name: Neuro Assessment System NAS-1000 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: QBE Dated: September 21, 2017 Received: September 22, 2017

Dear Kit Cariquitan:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - Kit Cariquitan

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

# Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172892

#### Device Name Neuro Assessment System NAS-1000

#### Indications for Use (Describe)

The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in noninvasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Notification K172892

# GENERAL INFORMATION [807.92(a)(1)]

## Applicant:

HeadSense Medical Inc. 520 S. Main Street, Suite 2457 Akron, OH 44311 USA Phone: [phone]

# Company Contact Person:

Richard A. Lotti Executive Chairman and CEO HeadSense Medical Inc. USA Phone: [phone] Email: [e-mail]

#### Regulatory Correspondent/Contact Person:

Kit Cariquitan Consultant, HeadSense Medical Inc. Chief Regulatory Officer Experien Group, LLC 11440 W Bernardo Ct., Ste. 253 San Diego, CA 92127 USA Phone: [phone] Email: [e-mail]

# Date Prepared: February 5, 2018

# DEVICE INFORMATION [807.92(a)(2)]

#### Trade Name:

Neuro Assessment System, NAS-1000

## Generic/Common Name:

Electronic Stethoscope

#### Classification:

21 CFR§870.1875

## Product Code:

QBE

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# PREDICATE DEVICE(S) [807.92(a)(3)]

The predicate device to support substantial equivalence of the NAS-1000 System is the 3M™ Littmann® Electronic Stethoscope, Model 3200 cleared under K083903.

# DEVICE DESCRIPTION [807.92(a)(4)]

The NAS-1000 System is a non-invasive, non-energy emitting device indicated for monitoring and recording of acoustic signals from the brain. The earbud passively receives the acoustic signal from the brain and the result is graphically displayed as an acoustic waveform on the monitor (NAS-1000M).

The NAS-1000 System consists of two components: a non-sterile, disposable, single patient use Headset (NAS-1000H) with four different sized earbuds (XS, S, M, L), and a tablet-based Monitor (NAS-1000M) which contains the software (NAS-1000S).

# INDICATIONS FOR USE [807.92(a)(5)]

The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in non-invasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

| Feature | HeadSense Neuro Assessment System,<br>NAS-1000<br>(K172892) | 3MTM Littmann® Electronic<br>Stethoscope, Model 3200,<br>K083903<br>(Primary predicate device) | Analysis of Differences |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation/Classification | 21 CFR §870.1875 | 21 CFR §870.1875 | No difference. |
| Regulation Name | Stethoscope, Electronic | \$tethoscope, Electronic | No difference. |
| Classification | II | II | No difference. |
| Product Code | DQD | DQD | No difference. |
| Indications for use | The NAS-1000 System is a medical<br>acoustic system intended as an adjunct to<br>standard clinical practice for use in non-<br>invasively monitoring, detecting,<br>recording and displaying acoustic signals<br>in the brain. It is used for any subject<br>undergoing a physical examination and<br>intended only for medical assessment<br>purpose in a clinic or hospital. | 3M™ LITTMANN®<br>ELECTRONIC STETHOSCOPE<br>MODEL 3200 is intended for<br>medical diagnostic purposes only. It<br>may be used for the detection and<br>amplification of sounds from the<br>heart, lungs, arteries, veins, and<br>other internal organs with the use of<br>selective frequency ranges. It can be<br>used on any person undergoing a<br>physical assessment. | Proposed intended use is<br>the same as K083903.<br>The subject device and the<br>predicate device are<br>intended for monitoring,<br>detecting and recording<br>acoustic signals / sounds<br>electronically. |
| Anatomical Location | Brain | Heart, lungs, arteries, veins, and<br>other internal organs with the use of<br>a selective frequency. | Similar to K083903. The<br>predicate device may be<br>used for other internal<br>organs (i.e., brain). The<br>subject device is to be used<br>for the brain only. |
| Environment of use | Clinic, treatment center or hospital. | Clinic or hospital. | No difference. |
| | | | |
| Device Description | The NAS-1000 System is a non-invasive, non-energy emitting device indicated for monitoring and recording of acoustic signals from the brain. The earbud passively receives acoustic signals from the brain and the result is graphically displayed as an acoustic waveform on the monitor (NAS 1000M).<br><br>The NAS-1000 System consists of two components: a non-sterile, disposable, single patient use Headset (NAS-1000H) with four different sized earbuds (XS, S, M, L), and a tablet-based Monitor (NAS-1000M) which contains the software (NAS-1000S). | The 3MTM Littmann® Electronic Stethoscope, Model 3200 is a healthcare device that picks up sounds of the heart, arteries, veins, lungs and other internal organs with the use of selective frequency ranges. After amplification and filtering, the sounds are transferred to the user's ears via an active speaker and passive sound tubes.<br><br>The Model 3200 can also exchange audio data with a personal computing device (PC) using wireless Bluetooth link.<br><br>The user interface includes a 5-button keypad and an LCD display. Sound processing is carried out with the aid of a digital signal processor. The Model 3200 does not incorporate any off-the-shelf (OTS) software. The Model 3200 operates on one (1) AA alkaline, lithium, or NiMH battery. | Similar to K083903. Both systems passively obtain acoustic signals / sounds generated by the patient's organ using a microphone.<br><br>Both systems process the acoustic signals / sounds and present them to the user.<br><br>The 3M Littmann Electronic Stethoscope presents the sounds in the form of audio signal to the user. The NAS-1000 System provides the acoustic signals / sounds in the form of a graphical (visual) output to the user. |
| Sterilization Method | Non-sterile | Non-sterile | No difference. |
| Biocompatible Blood, Body and Fluid Contacting Materials | Skin contact only | Skin contact only | No difference. |
| Power Source | | | |
| Source Type | Battery | Battery | No difference. |
| Battery Type | Lithium ion<br>CR 2032 Lithium Ion<br>Coin Cell (Headset)<br>Lithium Ion, 4000 mAh<br>(Tablet) | One AA battery | The systems use different<br>battery types sufficient for<br>operation life for intended<br>use. |
| Battery Operation Time | Up to 260 Hrs (Headset)<br>Up to 74 Hrs (tablet) | 50-60 Hours | The systems have similar<br>operation times and have<br>sufficient operation life for<br>intended use. |
| Functional | | | |
| Binaural Headset | Yes | Yes | No Difference. |
| Chest-Piece | No | Yes | The NAS-1000 System<br>utilizes an earbud design<br>optimized for use in the<br>head not the chest. |
| Sound Processing | Digital Signal Processor | Digital Signal Processor | No Difference. |
| Display Function | Yes | Yes | No Difference. |
| Display of Waveform | 3 views of total energy from spectrogram<br>(vertical axes: 0-15 Hz, 0-25 Hz, and 0-45<br>Hz; horizontal axis: time (6 second<br>intervals for all charts) | Can Toggle between phonogram<br>and spectrogram (vertical axes: 0-<br>500 Hz, horizontal axis: time). | Both display axes for<br>frequency (Hz) and time<br>(sec). The NAS-1000<br>System displays<br>frequencies specific to<br>acoustic signals /sounds<br>generated in the brain while<br>the 3M Littmann displays<br>sounds for pulmonary,<br>cardiovascular, or general<br>use. |
| Signal to Noise Ratio | 23 dBv | 20 dBv | The NAS-1000 System<br>signal to noise ratio is 3<br>dBv higher than the 3M<br>Littmann. Since the NAS-<br>1000 System has a<br>higher signal to noise ratio<br>then the 3M Littmann, the<br>NAS-1000 System would<br>be expected to be at least as<br>good as the 3M Littmann at<br>distinguishing signal from<br>noise. |
| Display Type | LCD | LCD | No Difference. |
| Select Filter | There is no selectable filter for the NAS-<br>1000 System. | Bell (20-1000 Hz)<br>Diaphragm (20-2000 Hz)<br>Extend range (50-500 Hz) | The NAS-1000 System<br>design records pre-<br>specified frequencies (0-15<br>Hz, 0-25 Hz, 0-45 Hz) in<br>the brain. The 3M<br>Littmann filters are specific<br>for frequency values for<br>pulmonary, cardiovascular<br>or general use. |
| Detect and Display<br>Heart Rate Function | N/A | Yes | The NAS-1000 System<br>displays acoustic signals /<br>sound waveforms from the<br>brain and does not detect or<br>display heart rate function. |
| Detect and Display Heart<br>Rate Range | N/A | 30-199 bpm | The NAS-1000 System<br>displays acoustic signals /<br>sounds from the brain and |
| | | | does not detect or display<br>heart rate function. |
| Record and Playback<br>Function | N/A | Yes | Not a required feature. |
| Number of Record and<br>Playback Sounds | N/A | Save up to twelve, 30-second sound<br>tracks;<br>Latest 12 sound tracks for playback. | Not a required feature |
| Sound Amplifier | N/A | Yes, up to 24X | No sound is outputted |
| Volume Control | N/A | Yes | No sound is outputted |
| Volume Control Level | N/A | 1-9 level | No sound is outputted |
| Automatic<br>Power Off | Yes | Yes | The tablet automatically<br>powers off after 10<br>minutes. |
| Monitor Battery<br>Life Function | Yes | Yes | Monitored on tablet user<br>interface |
| Monitor Battery<br>Life Degrees | 100 (percentage) | 4 degrees | The tablet displays battery<br>life in increments of 1%,<br>the Littman has an<br>indicator for each ¼ of<br>remaining life (for the 3M<br>Littmann, each indicator is<br>termed a "degree": 4<br>indicators represents full<br>charge, 1 indicator<br>represents 1/4 charge, etc.,) |
| Sound Track Transfer<br>Function | Yes | Yes | Wav files saved |
| Sound Track Transfer<br>Interface | USB Cable | Bluetooth | Wav files may be<br>transferred from the tablet<br>via a USB cable |

# Comparison of NAS-1000 System to Predicate Device

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# 510(k) SUMMARY

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# SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the NAS-1000 System is substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the NAS-1000 System is substantially equivalent to the predicate device.

# PERFORMANCE DATA [807.92(b)]

All necessary nonclinical testing was conducted on the NAS-1000 System to support a determination of substantial equivalence to the predicate device.

# [807.92(b)(1)] Nonclinical Testing Summary:

The nonclinical bench testing included:

- . Performance bench and functional testing
- . Software testing
- Biocompatibility
- . Electrical Safety and Electromagnetic Compatibility testing

Phantom Bench Testing was also performed to verify that the NAS-1000 System is able to monitor, detect, record and displaying an acoustic signal / sound. A Cranial Phantom Head test model was designed and used during this testing to compare the NAS-1000 System and the predicate device. A represent…