(614 days)
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No
The description details standard signal processing and data transmission, with no mention of AI, ML, or related concepts. The data processing described is likely algorithmic and deterministic.
No
The device is indicated for detection and assessment for CT scans, not for treating any condition.
Yes
The device is indicated for the "detection of traumatic supratentorial hematomas" and to "assess patients for CT scans," which are functions consistent with diagnostic purposes.
No
The device description explicitly states that the system includes both a Sensor (hardware with a laser, detector, and electronics) and a PDA (hardware for processing and display), indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfusions, or to monitor therapeutic measures.
- Infrascanner Model 1000 operation: The Infrascanner Model 1000 uses Near Infrared (NIR) light applied directly to the patient's head (in vivo) to detect hematomas. It does not analyze specimens taken from the body.
Therefore, based on the provided information, the Infrascanner Model 1000 is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Infrascanner Model 1000 is indicated for the detection of traumatic supratentorial hematomas of greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, as an adjunctive device to the clinical evaluation in the acute hospital setting of patients 18 years old or greater with suspected traumatic supratentorial hematoma. The device is indicated to assess patients for CT scans but should not serve as a substitute for these scans. The Infrascanner Model 1000 is indicated for use by physicians, or under the direction of a physician, who has been trained in the use of the device.
Product codes
OPT
Device Description
The Infrascanner System includes two components: the Sensor and a Personal Digital Assistant (PDA). The Sensor includes an 21 CFR 1040 Class I NIR 808nm diode laser and a silicon detector. The light to and from the laser and detector are optically coupled to the patient's head through two 19mm long disposable light guides. The light guides are long enough to reach through hair and contact the scalp. The light guides are placed 4 cm apart allowing detection of hematomas. The detector light passes through an optical bandpass filter centered at 808nm to minimize background light interference. Electronic circuitry is included to control laser power and the detector signal amplifier gain. The detector signal is digitized and transmitted via a Bluetooth wireless link to the PDA. The wireless link is also used to receive and set the hardware parameters of the Sensor. The PDA receives the data from the Sensor and automatically adjusts the settings of the Sensor to ensure good data quality. The data is further processed by the PDA and the results are displayed on the PDA screen.
The Sensor has a power On/Off switch and a Measure Button. When the Sensor is turned on, pressing and releasing the Measure Button activates a measurement sequence at a given head location. The measurement includes an initial adjustment phase and then the data collection. The adjustment of laser power and detector signal gains is only done at the first head location of a pair. The contra-lateral location uses the same Sensor hardware parameters as the ipsi-lateral location. After a measurement, the PDA will display the optical density for that location. The absolute value of optical density is not relevant, just the relative difference between left and right sides of the head.
Audible signals indicate whether the data is acceptable or unacceptable. If the data is unacceptable, the measurement is to be repeated before proceeding to the next head location.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Near infrared spectroscopy
Anatomical Site
Brain (supratentorial region)
Indicated Patient Age Range
18 years old or greater
Intended User / Care Setting
Physicians, or under the direction of a physician, trained in the use of the device. Acute hospital setting.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A clinical study was carried out in five sites: four (4) sites US and one (1) site in India.
Subjects were included in the study if they had a non-contrast CT scan for evaluation of a head injury and signed informed consent to participate in the Infrascanner Model 1000 study. The Infrascan was to be completed within 30 minutes before or after the CT scan. Subjects were excluded if 12 hours or more had elapsed between the injury and CT scan. Subjects were also excluded if there were massive scalp lacerations or edema.
All of the CT scans were interpreted by an independent radiologist blinded to the result of the Infrascanner Model 1000 measurements. CT scans were evaluated for the location(s) and volume of hematomas. Infrascanner Model 1000 results were considered positive for hematomas if the maximum difference in optical density (ΔOD) for comparable skull regions was greater than 0.2.
Three hundred eighty-three (383) subjects age 18 years or older were enrolled in the study and are the primary analysis population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study. Sample size: 383 subjects.
Results from the clinical study:
- Intracranial hematoma >3.5 mL and = 2.5cm from brain surface (N = 320)
Key Results:
- Sensitivity: 47/63; 74.6% (95% CI: 62.1, 84.7%) for ΔOD > 0.2
- Specificity: 261/320; 81.6% (95% CI: 76.9, 85.7%) for ΔOD
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR INFRASCAN, INC.'S INFRASCANNER MODEL 1000
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Near Infrared Brain Hematoma Detector. 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.
NEW REGULATION NUMBER: 882.1935
CLASSIFICATION: II
PRODUCT CODE: OPT
BACKGROUND
DEVICE NAME: INFRASCANNER MODEL 1000
SUBMISSION NUMBER: K080377
DATE OF DE NOVO: APRIL 10, 2010
Contact: Baruch Ben Dor, Ph.D. INFRASCAN, INC. 3508 MARKET STREET, SUITE 215 PHILADELPHIA, PA 19104
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II
INDICATIONS FOR USE
The Infrascanner Model 1000 is indicated for the detection of traumatic supratentorial hematomas of greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, as an adjunctive device to the clinical evaluation in the acute hospital setting of patients 18 years old or greater with suspected traumatic supratentorial hematoma. The device is indicated to assess patients for CT scans but should not serve as a substitute for these scans. The Infrascanner Model 1000 is indicated for use by physicians, or under the direction of a physician, who has been trained in the use of the device.
LIMITATIONS
In the clinical study of the device, patients were scanned with the Infrascanner Model 1000 within 30 minutes of receiving CT scan. The Infrascanner Model 1000 is intended for use as a device that
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detects hematomas by detecting differences in the absorption of near infrared light at corresponding locations on the left and right sides of the skull. It is not indicated for detection of symmetrical conditions such as may occur with bilateral hematomas, or when there is massive scalp edema or bleeding (open or subgaleal). It is not indicated to detect hematomas deeper than 2.5 cm below the cortical surface. The performance of the Infrascanner Model 1000 in detecting subarachnoid hemorrhage has not been established.
The safety and effectiveness of this device in subjects less than 18 years of age have not been adequately evaluated.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Infrascanner System
The system includes two components: the Sensor and a Personal Digital Assistant (PDA). The Sensor includes an 21 CFR 1040 Class I NIR 808nm diode laser and a silicon detector. The light to and from the laser and detector are optically coupled to the patient's head through two 19mm long disposable light guides. The light guides are long enough to reach through hair and contact the scalp. The light guides are placed 4 cm apart allowing detection of hematomas. The detector light passes through an optical bandpass filter centered at 808nm to minimize background light interference. Electronic circuitry is included to control laser power and the detector signal amplifier gain. The detector signal is digitized and transmitted via a Bluetooth wireless link to the PDA. The wireless link is also used to receive and set the hardware parameters of the Sensor. The PDA receives the data from the Sensor and automatically adjusts the settings of the Sensor to ensure good data quality. The data is further processed by the PDA and the results are displayed on the PDA screen.
The Sensor has a power On/Off switch and a Measure Button. When the Sensor is turned on, pressing and releasing the Measure Button activates a measurement sequence at a given head location. The measurement includes an initial adjustment phase and then the data collection. The adjustment of laser power and detector signal gains is only done at the first head location of a pair. The contra-lateral location uses the same Sensor hardware parameters as the ipsi-lateral location. After a measurement, the PDA will display the optical density for that location. The absolute value of optical density is not relevant, just the relative difference between left and right sides of the head.
Audible signals indicate whether the data is acceptable or unacceptable. If the data is unacceptable, the measurement is to be repeated before proceeding to the next head location.
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Image /page/2/Picture/0 description: The image shows an Infrascanner device being held in a hand, with a lightning bolt graphic connecting it to a Dell Axim X51 PDA. The PDA screen displays the Infrascanner software interface, with buttons labeled "Measure" and "Archive". The software version is indicated as 1.201.
Photographs of the Infrascanner Model 1000
Image /page/2/Figure/2 description: This image shows two views of an infrascanner sensor. The top image shows the front of the sensor, with a "Measure" button and the word "INFRASCANNER" printed on the side. The bottom image shows the back of the sensor, with an On/Off button, a rubber cover of the charging socket, inert support, and a claded lightguide. The sensor is white and blue, and it has a disposable tip.
Infrascanner Sensor (Back)
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Principles of Operation
Basic Near Infrared Theory
All biological tissue is, to a varving extent, permeable to electromagnetic (EM) radiation of different frequencies and intensities. This can also be considered permeability to photons of different energy levels. This permeability to EM energy is the basis of all imaging based on transmission/scattering characteristics such as x-ray, Computed Tomography (CT), and Near Infrared (NIR) imaging. From the principles of spectroscopy, it is also known that different molecules absorb different wavelengths of EM radiation (which is synonymously referred to as light at smaller wavelengths). Similarly, tissue scatters EM radiation to different degrees. The Infrascanner Model 1000 operates using NIR imaging of the hemoglobin molecule.
From any light source, photons follow a characteristic path through the target tissue back to a detector on the same approximate plane as the source. While the light is severely attenuated due to the scattering and absorption process, it is nonetheless encoded with the spectroscopic signatures of the molecules encountered en route to the detector. By carefully choosing the wavelengths that are produced by the source, it is possible to detect the relative concentration of hemoglobin in the target tissue. By comparing these levels to tissue in a "baseline" state, and using some basic knowledge about clinically relevant conditions for the tissue, it is possible to draw conclusions from these levels.
Image /page/3/Figure/4 description: The image shows a diagram of a source and detector positioned above intermediate tissue. The source and detector are labeled with arrows pointing to them. The intermediate tissue is a light brown color and is located below the source and detector. There is a dark, blurry area below the intermediate tissue.
Target Tissue
Figure 1: Simulated photon diffusion path through target tissue from source to detector. This simulation shows the photon path density, not the overall transmission level.
The principle used in identifying intracranial hematomas with the Infrascanner Model 1000 is that extravascular blood absorbs NIR light more than intravascular blood. This is because there is a greater (usually 10-fold) concentration of hemoglobin in an acute hematoma than in normal brain tissue where blood is contained within vessels. The Infrascanner Model 1000 compares the left and right side of the brain in four different areas. The absorbance of NIR light is greater (and therefore the reflected light less) on the side of the brain containing a hematoma, than on the uninjured side.
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Image /page/4/Picture/0 description: The image shows a medical procedure being performed on a brain. On the left, a medical device is shown with green lines indicating the area of focus. On the right, the same medical device is shown with red lines indicating the area of focus. The brain is shown in a gray color, and the medical device is white and black.
Figure 2: NIR method of detecting intracranial hematomas
Image /page/4/Figure/2 description: The image shows a graph of absorption factor versus wavelength. The x-axis represents wavelength in nanometers, ranging from 700 to 900. The y-axis represents absorption factor in cm-1, ranging from 0 to 0.10. There are two curves plotted on the graph, one for Hb and one for HbO2, as well as three peaks at wavelengths 760, 805, and 850.
Figure 3: Absorption of light by hemoglobin
The wavelength of 805nm is sensitive only to blood volume, not to oxygen saturation in the blood. The Infrascanner Model 1000 is placed successively in the left and right frontal, temporal, parietal, and occipital areas of the head and the absorbance of light at 805 nm is recorded and compared.
Left/Right forehead, above the frontal sinus Frontal In the Left/Right temporal fossa in front of the top of the Left/Right ear Temporal Parietal Above the Left/Right ear, midway between the ear and the midline of the skull Occipital Behind the top of the Left/Right ear, midway between the ear and the occipital protuberance
The difference in optical density (ΔΟD) in the different areas is calculated from the following formula:
$$\text{Deep Novo Summary (K080377)}\qquad\qquad\qquad\qquad\Delta OD = \log_{10}\left(\frac{I_N}{I_H}\right) \qquad\qquad\qquad\qquad\qquad\qquad\text{Page 5 of 14.}$$
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Where $I_N$ = the intensity of reflected light on the normal side, $I_H$ = the intensity of reflected light on the hematoma side.
Image /page/5/Figure/1 description: The image shows three diagrams of a head, labeled "LEFT SIDE", "FRONT", and "RIGHT SIDE". Each diagram has black circles indicating specific points on the head. The left and right side diagrams show a profile view of the head with four black circles each, while the front diagram shows a frontal view of the head with two black circles.
Figure 4: Head locations of NIR Measurements
SUMMARY OF NONCLINICAL/BENCH
Nonclinical performance data were provided related to the following areas: Model lab testing, Interrater Study, Biocompatibility, Electromagnetic compatibility(EMC) and Electrical Safety, and Software.
MODEL LABORATORY TESTING
InfraScan conducted three separate tests of the Infrascanner Model 1000 using a laboratory model of brain hematoma for each test. The purpose of these tests was to study the theoretical performance of NIR technology in detection of brain hematomas.
Results from this series of lab tests demonstrated that the NIR technique using the Infrascanner Model 1000 was able to detect hematomas down to about an inch (~ 2.5 cm) from the brain surface. In addition, the results showed that the Infrascanner Model 1000 is unable to reliably detect very small hematomas ( *: GCS = Glasgow Coma Scale (range 3 – 15, lower scores indicating greater impairment)
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CT Scan Results
| Infrascanner
Model 1000
results | Intracranial hematoma >3.5 mL and
0.2 (n,
%, 95% CI) | Sensitivity
47/63; 74.6% (62.1, 84.7%) | 59/320; 18.4% |
| ΔOD ≤ 0.2 (n,
%, 95% CI) | 16/63; 25.4% | Specificity
261/320; 81.6% (76.9, 85.7%) |
95% CI: 95% Confidence interval
The data above supports the specific technological characteristics and indicated use for the InfraScanner Model 1000 device. Clinical data may be required for future devices, or modifications to the InfraScanner Model 1000 device that may include: a. dissimilar indications, b. dissimilar designs, or c. different technology.
LABELING
The following information is included in the labeling for the Infrascanner Model 1000 device:
-
- Physician Labeling
- Description of the technological features of the device and all steps necessary for the a. operation, inspection and maintenance of the device. Information regarding maintenance of the device includes: duration of use; component replacement; and quality control.
- b. Identification of all device safety features and limits of use.
- Applicable warnings and precautions, including patient populations where safety and C. effectiveness have not been established; hematoma size or bleeding location where safety and effectiveness have not been established; and specific types of hemorrhage, edema, or other conditions where safety and effectiveness have not been established.
- d. Limiting device use to physicians, or those under the direction of a physician, trained in the use of the device.
-
- Operator Training
Operator training will be implemented to ensure that physicians, or those under their direction, understand appropriate device usage in the correct patient setting and patient population and understand the device limitations and patient populations where safety and effectiveness have not
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been established.
- Labeling Related to Performance Specifications
- A summary of the clinical study. a.
- Sensitivity and specificity in detecting intracranial hematomas, as well as any limitations. b.
In addition, the Infrascanner Model 1000 device complies with the labeling requirements under 21 CFR 807.87(e) and prescription device requirements under 21 CFR § 801.109. The device is exempt from having adequate directions for lay use. The device labeling bears the following: "Caution: Federal law restricts this device to sale by or on the order of a physician."
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of noninvasive, near- infrared spectroscopy devices to evaluate suspected intracranial hematomas and the measures recommended to mitigate these risks.
| Identified Risks | Recommended Mitigation Measures |
|---|---|
| Excessive laser power | Electrical Safety and Electromagnetic |
| Compatibility (EMC) | |
| Interference with other devices | Electrical Safety and EMC |
| Labeling | |
| Unit (hardware) malfunction | Performance Testing (non-clinical and clinical) |
| Software Verification, Validation and Hazard | |
| Analysis | |
| Software Malfunction | Software Verification, Validation, and Hazard |
| Analysis | |
| Operator errors | Labeling |
| Training | |
| Incorrect result (false positive and negative) | Labeling |
| Adverse tissue reaction | Biocompatibility |
| Battery Failure (Failure of device to operate) | Labeling |
SPECIAL CONTROLS:
In addition to the general controls of the Act, the Infrascanner is subject to the following special controls:
(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 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;
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(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.
CONCLUSION
The de novo for the Infrascanner Model 1000 is granted and the device is classified under the following:
| Product Code: | OPT |
|---|---|
| Device Type: | Near Infrared (NIR) Brain Hematoma Detector |
| Class: | II |
| Regulation: | 21 CFR 882.1935 |