(30 days)
Not Found
No
The summary describes the device's hardware components, data acquisition process, and software for user interface and data storage. It does not mention any AI or ML algorithms used for data analysis or interpretation. The focus is on capturing and storing the skull motion data.
No.
The device is described as non-invasively detecting, amplifying, and capturing skull motion, and expressly states it is "not in the diagnosis of neurological conditions, diseases, or disorders." It collects data related to skull motion caused by cardiac pulsatile flow, rather than providing any therapeutic action or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "The BrainPulse is not in the diagnosis of neurological conditions, diseases, or disorders." Instead, it is intended to "detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle."
No
The device description explicitly states that the BrainPulse™ 1100 is a system with three basic components: a headset with sensors, a data collector, and a computer with device software. This includes significant hardware components (headset, sensors, data collector) in addition to the software.
Based on the provided information, the BrainPulse device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the BrainPulse is used "on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle." It also clearly states, "The BrainPulse is not in the diagnosis of neurological conditions, diseases, or disorders." This describes a device that interacts with the patient's body externally to measure a physical phenomenon.
- Device Description: The description details sensors that are placed on the patient's head (PPG, SPL, Accelerometers) to measure physical signals (heart rate, ambient noise, acceleration). It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is a hallmark of IVD devices.
- Lack of Biological Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The BrainPulse does not fit this definition.
N/A
Intended Use / Indications for Use
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 indicated to aid in the diagnosis of neurological conditions, diseases, or disorders.
Product codes
POP
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:
o One Photoplethysmograph (PPG) sensor for detecting the heart rate and timing;
o One Sound Pressure Level (SPL) sensor for detecting ambient environment noise; and
o Six Accelerometer sensors to detect the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's head / skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single, abstract shape.
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
1
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
2
Indications for Use
510(k) Number (if known) K170926
Device Name BrainPulse 1100
Indications for Use (Describe)
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.
| 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 L | |
| Mountain View, California 94041 | |
| USA | |
| Contact Person | Prabhu Raghavan |
| Vice President of Clinical, Quality and Regulatory | |
| Phone: 1-650-316-8813 | |
| Fax: 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 Advisory | |
| Committee | 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 caused | |
| by pulsatile flow from the cardiac cycle. The BrainPulse is not | |
| indicated to aid in the diagnosis of neurological conditions, | |
| diseases, or disorders. |
4
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:
5
| 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. |