Last synced on 27 January 2023 at 11:04 pm

Cranial Motion Measurement Device

Page Type
Product Code
Definition
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.
Physical State
Accelerometer hardware. May include headset to aid in positioning. May include additional sensors (e.g. photoplethysmography). May include hardware and software to allow for data collection and review. Does not include software that outputs any clinical interpretation of the data.
Technical Method
Uses a headset containing accelerometers positioned around the head to measure motion or acceleration, and may use a photoplethysmography sensor to detect heartbeat.
Target Area
Head
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1630
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1630 Cranial motion measurement device

§ 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.

[82 FR 35071, July 28, 2017]

Cranial Motion Measurement Device

Page Type
Product Code
Definition
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.
Physical State
Accelerometer hardware. May include headset to aid in positioning. May include additional sensors (e.g. photoplethysmography). May include hardware and software to allow for data collection and review. Does not include software that outputs any clinical interpretation of the data.
Technical Method
Uses a headset containing accelerometers positioned around the head to measure motion or acceleration, and may use a photoplethysmography sensor to detect heartbeat.
Target Area
Head
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1630
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1630 Cranial motion measurement device

§ 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.

[82 FR 35071, July 28, 2017]