The BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle. The BrainPulse is not in the diagnosis of neurological conditions, diseases, or disorders.

Device Description

The BrainPulse™ 1100 is a non-invasive device having three basic components that are provided as an entire system and all are non-sterile and reusable: . Headset with detachable cable that is patient contacting and includes: One Photoplethysmograph (PPG) sensor for o detecting the heart rate and timing; One Sound Pressure Level (SPL) sensor for o detecting ambient environment noise; and Six Accelerometer sensors to detect the o acceleration at six selected locations. ● Data Collector, which digitizes the analog signals from the headset . Computer, which incorporates the device Software and space to store the BrainPulse recording data and, . Device Software, which provides the user interface, hardware control software libraries The BrainPulse collects and stores skull motion caused by pulsatile flow from the cardiac cycle. The normal brain structure produces a motion that is driven by and synchronized with the heart rate, and is manifested by slight acceleration of the skull. The device uses piezoelectric-based accelerometer sensors that measure skull motion rather than brain sounds. The typical frequencies that are employed with the BrainPulse are below 20 Hz and mostly below 10 Hz, well below the lower limit of audible sound. The headset senses the motion and the Data Collector digitizes the signal. The computer mainly provides the user interface and stores the data for further processing. Users place the device's headset on patients and setup the user interface to perform a BrainPulse recording. Typically, a recording is about 2-3 minutes long, though users may obtain recordings up to 30 minutes long depending on their applications. Recordings may be obtained at any time.

AI/ML Overview

The provided text describes the BrainPulse 1100 device and modifications to its software, but it does not contain details about specific acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing from the provided text. The text mentions "The device met all acceptance criteria during verification and validation tests and demonstrated compliance to design inputs," but it does not specify what those acceptance criteria were or present quantitative performance data.

2. Sample size used for the test set and the data provenance:

Missing from the provided text. The text mentions "Software validation as well as system verification was performed," but does not detail the sample size or the nature of the test set (e.g., number of recordings, patients, data provenance).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing from the provided text. There is no mention of expert involvement in establishing ground truth for any testing.

4. Adjudication method for the test set:

Missing from the provided text. No adjudication method is described.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

Missing from the provided text. There is no mention of an MRMC study or any comparison of human readers with or without AI assistance. The device's intended use is to "detect, amplify and capture the skull motion," not to aid human interpretation of images or other data related to neurological conditions.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Partially addressed, though not in terms of clinical performance. The text indicates that "Software validation as well as system verification was performed to show equivalence to the previous software that was cleared in DEN140040." This suggests an evaluation of the algorithm's output in isolation to ensure it matches the previous version, but not in the context of clinical accuracy or standalone diagnostic performance. The device itself is described as collecting and storing data for "further processing," implying it's a data acquisition tool, not a diagnostic algorithm.

7. The type of ground truth used:

Missing from the provided text for performance evaluation. For the software validation, the implicitly used "ground truth" was likely the expected output of the previous software version, as the goal was to demonstrate equivalence. However, this is not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

Not applicable / Missing from the provided text. The document describes a device (BrainPulse 1100) and minor software updates, not the development of a machine learning algorithm. Therefore, there's no mention of a training set for an AI model.

9. How the ground truth for the training set was established:

Not applicable / Missing from the provided text. As above, this document does not describe the development or training of an AI algorithm.

Summary of Device and Changes (from the provided text):

The BrainPulse 1100 is a non-invasive cranial motion measurement device designed to detect, amplify, and capture skull motion caused by pulsatile flow from the cardiac cycle. It consists of a headset with sensors (PPG, SPL, six accelerometers), a data collector, a computer with device software.

The current submission (K170926) is for the same device and model (BrainPulse 1100) that was previously cleared under de novo DEN140040. The only change is to the software user interface. The hardware remains unchanged.

Software Updates:

Improved user interface with options to add metadata (hospital, patient details).
Options to view the signal in real-time.
Options to review the signal after recording.
Automatic stopping of recording based on specified time and heartbeat intervals.
Calculation and display of statistics from the signal for evaluation.

Testing Conducted:

Software validation and system verification were performed to show equivalence to the previous software cleared in DEN140040.
Risk analysis was conducted on the updated software.
Overall system verification was performed.
The software validation had a Level of Concern determined to be moderate (Level B).
The device "met all acceptance criteria during verification and validation tests and demonstrated compliance to design inputs."

Crucially, the document explicitly states: "The BrainPulse is not indicated to aid in the diagnosis of neurological conditions, diseases, or disorders." This indicates that its purpose is data acquisition, not diagnostic interpretation, which explains the absence of clinical performance metrics typically associated with diagnostic AI.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

Jan Medical, Inc. Prabhu Raghavan VP of Clinical, Quality and Regulatory 110 Pioneer Wav. Suite L Mountain View, California 94041

Re: K170926

Trade/Device Name: BrainPulse 1100 Regulation Number: 21 CFR 882.1630 Regulation Name: Cranial Motion Measurement Device Regulatory Class: Class II Product Code: POP Dated: March 27, 2017 Received: March 29, 2017

Dear Mr. Raghavan:

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 (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -S

for

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) K170926

Device Name BrainPulse 1100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
x Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

BrainPulse™ 1100

Date Prepared	March 27, 2017
Submission number	K170926
Company Name and Address	Jan Medical Inc.110 Pioneer Way, Suite LMountain View, California 94041USA
Contact Person	Prabhu RaghavanVice President of Clinical, Quality and RegulatoryPhone: 1-650-316-8813Fax: 1 650-316-8812
Device:	BrainPulse™ 1100
Trade Name:	BrainPulse
Predicate Device:	BrainPulse 1100 (de novo granted under DEN140040)
Requlation Number:	21 CFR 882.1630
Product Code:	POP
Common/Classification Name:	Cranial Motion Measurement Device
Classification AdvisoryCommittee	Neurology
Review Advisory Committee	Neurology
Requlatory Class:	-
Intended Use:	The BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the skull motion causedby pulsatile flow from the cardiac cycle. The BrainPulse is notindicated to aid in the diagnosis of neurological conditions,diseases, or disorders.

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all are non-sterile and reusable: . Headset with detachable cable that is patient contacting and includes: One Photoplethysmograph (PPG) sensor for o detecting the heart rate and timing; One Sound Pressure Level (SPL) sensor for o detecting ambient environment noise; and Six Accelerometer sensors to detect the o acceleration at six selected locations. ● Data Collector, which digitizes the analog signals from the headset . Computer, which incorporates the device Software and space to store the BrainPulse recording data and, . Device Software, which provides the user interface, hardware control software libraries The BrainPulse collects and stores skull motion caused by pulsatile flow from the cardiac cycle. The normal brain structure produces a motion that is driven by and synchronized with the heart rate, and is manifested by slight acceleration of the skull. The device uses piezoelectric-based accelerometer sensors that measure skull motion rather than brain sounds. The typical frequencies that are employed with the BrainPulse are below 20 Hz and mostly below 10 Hz, well below the lower limit of audible sound. The headset senses the motion and the Data Collector digitizes the signal. The computer mainly provides the user interface and stores the data for further processing. Users place the device's headset on patients and setup the user interface to perform a BrainPulse recording. Typically, a recording is about 2-3 minutes long, though users may obtain recordings up to 30 minutes long depending on their applications. Recordings may be obtained at any time. Patient Contacting LDPE (Low Density Poly Ethylene), PE (Poly Ethylene), Materials of Use PEEK (Polyether ether ketone) and Urethane Substantial Equivalence: The current submission is for the same device and model that was cleared by the agency in de novo, DEN140040. The only change is to the software user interface. The hardware is

The BrainPulse™ 1100 is a non-invasive device having three

basic components that are provided as an entire system and

Device Description:

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	unchanged; it is the same hardware that was cleared in DEN140040. Software validation as well as system verification was performed to show equivalence to the previous software that was cleared in DEN140040. This validation and verification testing demonstrated that the device output is equivalent to the output of the previous device version.
Changes to Predicate Device:	The device hardware elements are unchanged, i.e., there are no changes to the headset, data collector, tablet or cables. The device software was updated to provide the following: An improved user interface that includes options to add hospital and patient details such as metadata to the signal, options to view the signal in real-time, options to review the signal after completing a recording, and automatic stopping of recording based on specified time and heartbeat intervals.Calculate and display statistics from the signal that are helpful for signal evaluation.
Testing Summary:	Design Verification and Validation was performed in accordance with approved internal design controls procedures, and in accordance with 21 CFR 820.30. Risk analysis was conducted to review the updated software and to confirm that all software-based risk controls were implemented and verified. An overall system verification was also performed to ensure that the system operates as per design inputs. Software validation was performed with a Level of Concern determined to be moderate, or level B (the same level as the software that was reviewed in DEN140040). The device met all acceptance criteria during verification and validation tests and demonstrated compliance to design inputs.
Biocompatibility Summary	The changes in this submission were limited to software and therefore, no additional biocompatibility was deemed necessary. Jan Medical submitted the evaluation of biocompatibility of the BrainPulse 1100 device components for direct and indirect patient contact and for biocompatibility in compliance to ISO 10993 Part 1 Biological Evaluation of Medical Devices as part of DEN140040.

Regulation Number and Section

§ 882.1630 Cranial motion measurement device.

(a)
Identification. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed.
(ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC).
(4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment.
(5) The labeling must include:
(i) The intended use population and the intended use environment.
(ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability.
(iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.