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Infrared Hematoma Detector

Page Type
Product Code
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Physical State
This is a standard infrared handheld laser that is scanned across the scalp. The information is transmitted to a handheld Personal Digital Assistant that displays Optical Density measurements
Technical Method
Use of low level infrared laser radiation to detect hemoglobin concentration which relates to presence of a hemotoma.
Target Area
To be used on the head. The testing divides the head into 8 sections four on the left side and the corresponding 4 sites on the right side.
Regulation Medical Specialty
Ophthalmic
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1935
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1935 Near Infrared (NIR) Brain Hematoma Detector

§ 882.1935 Near Infrared (NIR) Brain Hematoma Detector.

(a) Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;

(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;

(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;

(4) Performance data should validate accuracy and precision and safety features;

(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,

(6) Appropriate software verification, validation, and hazard analysis should be performed.

[77 FR 16927, Mar. 23, 2012]

Infrared Hematoma Detector

Page Type
Product Code
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Physical State
This is a standard infrared handheld laser that is scanned across the scalp. The information is transmitted to a handheld Personal Digital Assistant that displays Optical Density measurements
Technical Method
Use of low level infrared laser radiation to detect hemoglobin concentration which relates to presence of a hemotoma.
Target Area
To be used on the head. The testing divides the head into 8 sections four on the left side and the corresponding 4 sites on the right side.
Regulation Medical Specialty
Ophthalmic
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1935
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1935 Near Infrared (NIR) Brain Hematoma Detector

§ 882.1935 Near Infrared (NIR) Brain Hematoma Detector.

(a) Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;

(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;

(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;

(4) Performance data should validate accuracy and precision and safety features;

(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,

(6) Appropriate software verification, validation, and hazard analysis should be performed.

[77 FR 16927, Mar. 23, 2012]