(167 days)
No
The summary describes a device that passively records and displays acoustic waveforms. There is no mention of AI/ML algorithms for analysis, interpretation, or decision support. The analysis described is limited to displaying data in different frequency bands and as a 2D waveform.
No
The device is described as "monitoring, detecting, recording and displaying acoustic signals in the brain" and is "intended only for medical assessment purposes," which indicates a diagnostic or monitoring function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the device is "intended as an adjunct to standard clinical practice for use in non-invasively monitoring, detecting, recording and displaying acoustic signals in the brain" and "intended only for medical assessment purposes." The "Device Description" also mentions it's "indicated for monitoring and recording of acoustic signals from the brain." While it doesn't explicitly use the word "diagnose," "monitoring" and "detecting" for "medical assessment purposes" are strong indicators of its role in providing data that aids in diagnosis.
No
The device description explicitly states that the system consists of two components: a Headset (NAS-1000H) with earbuds and a tablet-based Monitor (NAS-1000M) which contains the software (NAS-1000S). The headset is a hardware component that passively receives the acoustic signal.
Based on the provided information, the NAS-1000 System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- The NAS-1000 System is a non-invasive device that monitors acoustic signals from the brain. It does not analyze samples taken from the body.
- The device description explicitly states it's a "medical acoustic system" and a "non-invasive, non-energy emitting device." This aligns with a device that interacts with the body externally to gather information, rather than analyzing biological samples.
- The intended use is for "monitoring, detecting, recording and displaying acoustic signals in the brain" as an "adjunct to standard clinical practice." This describes a diagnostic tool that provides information based on physical signals, not laboratory analysis of biological material.
Therefore, the NAS-1000 System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
QBE
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.
Environment of use: Clinic, treatment center or hospital.
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)
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 representative cyclic acoustic signal/sound was generated using a peristaltic pump in the phantom bench test model and the waveforms were recorded and compared for both the NAS-1000 System and the predicate to the known input signal from the phantom bench test model. The NAS-1000 System and the 3M Littmann e-Stethoscope performed comparably and were able to graphically display the simulated systolic pulse from the phantom. The "simulated systolic pulse" refers to the pulsations generated by the motor of the phantom bench test.
The collective results of the nonclinical testing demonstrate that the device meets its performance requirements and does not raise different questions of safety or effectiveness for measuring acoustic signals in the brain or presenting information to the clinician when compared to the predicate device.
Clinical Testing Summary:
A performance testing study of the NAS-1000 System was conducted on volunteers to validate the measurement of acoustic data collected from recordings of brain acoustic signals / sounds. The study demonstrated the ability of the NAS-1000 System to detect and generate waveforms from the brain to provide a tool for monitoring brain acoustic signals / sounds over various time intervals.
A total of 50 volunteers were measured and monitored.
NAS-1000 System recording sessions were conducted for 20 minutes continuously with each volunteer, and raw data was passively recorded by the monitor software. The data was then analyzed retrospectively to display on the tablet in three frequency bands (0-15 Hz, 0-25 Hz, 0-45 Hz), and also converted and displayed the output into a 2D waveform. The tablet outputs demonstrate the ability of the NAS-1000 System to display brain acoustic signals / sounds of in the volunteers based on the analysis of waveform data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: 234-678-3888
Company Contact Person:
Richard A. Lotti Executive Chairman and CEO HeadSense Medical Inc. USA Phone: 408-202-0637 Email: richard@head-sense-med.com
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: 408-656-5985 Email: kitc@experiengroup.com
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
4
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.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
| Feature | HeadSense Neuro Assessment System,
NAS-1000
(K172892) | 3MTM Littmann® Electronic
Stethoscope, Model 3200,
K083903
(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
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
purpose in a clinic or hospital. | 3M™ LITTMANN®
ELECTRONIC STETHOSCOPE
MODEL 3200 is intended for
medical diagnostic purposes only. It
may be used for the detection and
amplification of sounds from the
heart, lungs, arteries, veins, and
other internal organs with the use of
selective frequency ranges. It can be
used on any person undergoing a
physical assessment. | Proposed intended use is
the same as K083903.
The subject device and the
predicate device are
intended for monitoring,
detecting and recording
acoustic signals / sounds
electronically. |
| Anatomical Location | Brain | Heart, lungs, arteries, veins, and
other internal organs with the use of
a selective frequency. | Similar to K083903. The
predicate device may be
used for other internal
organs (i.e., brain). The
subject device is to be used
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).
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.
The Model 3200 can also exchange audio data with a personal computing device (PC) using wireless Bluetooth link.
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.
Both systems process the acoustic signals / sounds and present them to the user.
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
CR 2032 Lithium Ion
Coin Cell (Headset)
Lithium Ion, 4000 mAh
(Tablet) | One AA battery | The systems use different
battery types sufficient for
operation life for intended
use. |
| Battery Operation Time | Up to 260 Hrs (Headset)
Up to 74 Hrs (tablet) | 50-60 Hours | The systems have similar
operation times and have
sufficient operation life for
intended use. |
| Functional | | | |
| Binaural Headset | Yes | Yes | No Difference. |
| Chest-Piece | No | Yes | The NAS-1000 System
utilizes an earbud design
optimized for use in the
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
(vertical axes: 0-15 Hz, 0-25 Hz, and 0-45
Hz; horizontal axis: time (6 second
intervals for all charts) | Can Toggle between phonogram
and spectrogram (vertical axes: 0-
500 Hz, horizontal axis: time). | Both display axes for
frequency (Hz) and time
(sec). The NAS-1000
System displays
frequencies specific to
acoustic signals /sounds
generated in the brain while
the 3M Littmann displays
sounds for pulmonary,
cardiovascular, or general
use. |
| Signal to Noise Ratio | 23 dBv | 20 dBv | The NAS-1000 System
signal to noise ratio is 3
dBv higher than the 3M
Littmann. Since the NAS-
1000 System has a
higher signal to noise ratio
then the 3M Littmann, the
NAS-1000 System would
be expected to be at least as
good as the 3M Littmann at
distinguishing signal from
noise. |
| Display Type | LCD | LCD | No Difference. |
| Select Filter | There is no selectable filter for the NAS-
1000 System. | Bell (20-1000 Hz)
Diaphragm (20-2000 Hz)
Extend range (50-500 Hz) | The NAS-1000 System
design records pre-
specified frequencies (0-15
Hz, 0-25 Hz, 0-45 Hz) in
the brain. The 3M
Littmann filters are specific
for frequency values for
pulmonary, cardiovascular
or general use. |
| Detect and Display
Heart Rate Function | N/A | Yes | The NAS-1000 System
displays acoustic signals /
sound waveforms from the
brain and does not detect or
display heart rate function. |
| Detect and Display Heart
Rate Range | N/A | 30-199 bpm | The NAS-1000 System
displays acoustic signals /
sounds from the brain and |
| | | | does not detect or display
heart rate function. |
| Record and Playback
Function | N/A | Yes | Not a required feature. |
| Number of Record and
Playback Sounds | N/A | Save up to twelve, 30-second sound
tracks;
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
Power Off | Yes | Yes | The tablet automatically
powers off after 10
minutes. |
| Monitor Battery
Life Function | Yes | Yes | Monitored on tablet user
interface |
| Monitor Battery
Life Degrees | 100 (percentage) | 4 degrees | The tablet displays battery
life in increments of 1%,
the Littman has an
indicator for each ¼ of
remaining life (for the 3M
Littmann, each indicator is
termed a "degree": 4
indicators represents full
charge, 1 indicator
represents 1/4 charge, etc.,) |
| Sound Track Transfer
Function | Yes | Yes | Wav files saved |
| Sound Track Transfer
Interface | USB Cable | Bluetooth | Wav files may be
transferred from the tablet
via a USB cable |
Comparison of NAS-1000 System to Predicate Device
6
4
7
8
6
9
510(k) SUMMARY
7
10
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 representative cyclic acoustic signal/sound was generated using a peristaltic pump in the phantom bench test model and the waveforms were recorded and compared for both the NAS-1000 System and the predicate to the known input signal from the phantom bench test model. The NAS-1000 System and the 3M Littmann e-Stethoscope performed comparably and were able to graphically display the simulated systolic pulse from the phantom. The "simulated systolic pulse" refers to the pulsations generated by the motor of the phantom bench test.
The collective results of the nonclinical testing demonstrate that the device meets its performance requirements and does not raise different questions of safety or effectiveness for measuring acoustic signals in the brain or presenting information to the clinician when compared to the predicate device.
[807.92(b)(2)] Clinical Testing Summary:
A performance testing study of the NAS-1000 System was conducted on volunteers to validate the measurement of acoustic data collected from recordings of brain acoustic signals / sounds. The study demonstrated the ability of the NAS-1000 System to detect and generate waveforms from the brain to provide a tool for monitoring brain acoustic signals / sounds over various time intervals.
A total of 50 volunteers were measured and monitored.
11
510(k) SUMMARY
NAS-1000 System recording sessions were conducted for 20 minutes continuously with each volunteer, and raw data was passively recorded by the monitor software. The data was then analyzed retrospectively to display on the tablet in three frequency bands (0-15 Hz, 0-25 Hz, 0-45 Hz), and also converted and displayed the output into a 2D waveform. The tablet outputs demonstrate the ability of the NAS-1000 System to display brain acoustic signals / sounds of in the volunteers based on the analysis of waveform data.
CONCLUSIONS [807.92(b)(3)]
In summary, the NAS-1000 System and the 3M Littmann have the same intended use and similar technological characteristics. Differences in the technological characteristics have been evaluated and supported with appropriate testing. The collective performance testing including the phantom bench testing and clinical testing on volunteers demonstrate substantial equivalence to the predicate device. The NAS-1000 Systems meets its performance requirements and the differences in technological characteristics do not raise different questions of safety or effectiveness for displaying acoustic signals / sounds from the brain or presenting information to the clinician when compared to the predicate device.
SUMMARY
The NAS-1000 System is substantially equivalent to the predicate device.