(164 days)
Not Found
No
The summary describes a device based on near-infrared spectroscopy and comparing regional differences in absorbance. There is no mention of AI, ML, or any learning algorithms used in the device's operation or data analysis. The performance studies are based on bench testing with a phantom model, not on training or testing with clinical data using AI/ML techniques.
No
The device is indicated for the detection of hematomas and to assess patients for CT scans; it does not treat or alleviate a disease or condition.
Yes
The device is indicated for the "detection of traumatic supratentorial hematomas," which is a diagnostic purpose. It helps in the clinical evaluation of patients with suspected intracranial hematoma, serving as an adjunctive device to assess patients for CT scans.
No
The device description explicitly states it is a "noninvasive device, which uses near-infrared spectroscopy ('NRS')" and "consists of a Class I NIR-based sensor is optically coupled to the patient's head through two disposable light guides". This indicates the device includes significant hardware components (sensor, light guides) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The Infrascanner is described as a noninvasive device that uses near-infrared spectroscopy (NRS) applied directly to the patient's head. It does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use is for the detection of hematomas within the brain, as an adjunctive device to clinical evaluation. This is a direct measurement on the patient, not an analysis of a biological sample.
Therefore, the Infrascanner falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Infrascanner 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 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 device is a noninvasive device, which uses near-infrared spectroscopy ("NRS") to provide early information about the possible development of traumatic supratentorial intracranial hematomas in patients presenting to hospitals with head trauma. This technology involves comparing regional differences in absorbance of NIRS to hematoma evaluation is based on the principle that intracranial hemoglobin concentration will differ where a hematoma is present, compared to hemoglobin concentrations in normal intracranial regions. The system consists of a Class I NIR-based sensor is optically coupled to the patient's head through two disposable light guides in a "hairbrush" configuration. Examination with the Infrascanner is performed through placement of the sensor on designated areas of the head that represent the most common locations for traumatic hematoma. The examination is designed to be performed within two minutes.
Specifically, Model 2500 is the same device as the Infrascanner Model 2000 with following two categories of modifications:
- Scanner miniaturization
- System enhancements
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near-infrared spectroscopy (NRS)
Anatomical Site
Brain/Head
Indicated Patient Age Range
18 years old or greater
Intended User / Care Setting
Physicians, or under the direction of a physician, who has been trained in the use of the device. Acute hospital setting.
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
Bench testing was conducted using a hematoma model to provide an approximation of human tissue. Testing included repeatability and reproducibility. Performance was substantially similar for both models across a range of depths and sizes of hematomas, and for skin types. Additional laboratory testing demonstrated the comparability of the device and its predicate over the range of optical densities.
Four types of tests were conducted:
- Repeatability / Reproducibility: involved repeat observations with three different systems for each of the two models. Model hematomas of 5 mL and 50 mL were evaluated at depths of shallow and deep ranges at 0 cm, and 3 cm.
- Agreement test: data were collected for one system of each model for hematomas of size 5 mL and 50 mL and depths of 0-3cm below the CSF.
- Skin color test: evaluation of the potential impact of skin color was performed for both models with hematoma size of 5 mL at depths of 0 and 2 cm, and without a model hematoma in the tank. Neutral Density Filters were used to reduce light transmission similar to the behavior of skin color differences across a range of 5-5.8 OD (light-skinned patients) and 6.3-7.1 OD (dark-skinned subjects).
A 4-corners approach was used for the selection and testing of the simulated hematoma size and depth and for the simulated adult age group:
- Small (5 ml) and large (50 ml) hematomas
- Superficial (0 cm) and deep (2 and 3cm) hematomas
- Adult (>18 years old) ages were tested
A mixed multi-layered solid and liquid optical head phantom mimicking human tissue was used in the test. For brain tissue optical parameters simulation, intralipid was used to control scattering properties and calibrated ink for absorption. Layers included skin, scalp, skull and CSF with liquid brain layer and blood to simulate brain hematoma. Silicon was selected for the phantom due to mechanical properties similar to tissue. Carbon black was the absorbing agent, Titanium Dioxide the scattering agent. Optical absorption and scattering properties of each layer confirmed by optical frequency-domain measurement systems. CSF layer properties were those of water. Thin neutral density (ND) Wratten 2 film filters were placed over the signal level to OD values observed in clinical studies for patients with different skin color. The thickness of the film filters (0.1 mm) is similar to the thickness of human skin. A flat hematoma model was used, built using a rectangular frame, inserted into a ball, and filled with ovine whole blood.
Summary of Performance Studies
Study Type: Bench testing (Repeatability/Reproducibility, Agreement, Skin color test)
Sample Size: Not explicitly stated with a single number, but mentions "three different systems for each of the two models" and "one system of each model".
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: Bench testing demonstrated that the device functioned. Results were consistent with the expected result. Performance was substantially similar for both models across a range of depths and sizes of hematomas, and for skin types. Additional laboratory testing demonstrated the comparability of the device and its predicate over the range of optical densities. The test data sets support the conclusion that the models 2500 and 2000 are substantially equivalent across a range of simulated hematoma sizes, depths, and for light and dark skin and for adult and infant age groups. The modified device is substantially equivalent to the predicate device and raises no additional or different questions of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
InfraScan Infrascanner Model 2000 (K120949)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
InfraScan, Inc. % Angela Mallery Principal Product Development Strategist NAMSA 400 US-169 Minneapolis, Minnesota 55441
Re: K200203
Trade/Device Name: Infrascanner Model 2500 Regulation Number: 21 CFR 882.1935 Regulation Name: Near Infrared (NIR) Brain Hematoma Detector Regulatory Class: Class II Product Code: OPT Dated: June 11, 2020 Received: June 12, 2020
Dear Angela Mallery:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200203
Device Name Infrascanner Model 2500
Indications for Use (Describe)
The Infrascanner 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 is indicated for use by Physicians, or under the direction of a physician, who has been trained in the use of the device.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K200203
July 8, 2020
| Submitter's Name, Address, Telephone
Number, Contact Person and Date
Prepared | InfraScan, Inc. 3508 Market Street
Philadelphia, PA 19104
Phone: 215-387-6784
Facsimile: 215-386-2327
Contact Person: Baruch Ben Dor, CEO |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Device and Name/Address of
Sponsor | Infrascanner Model 2500
InfraScan, Inc.
3508 Market Street
Philadelphia, PA 19104 |
| Common or Usual Name | Near Infrared (NIR) Brain Hematoma Detector |
| Classification Name | OPT (21 C.F.R. §882.1935) |
| Predicate Devices | InfraScan Infrascanner Model 2000 (K120949) |
| Indications for Use | The Infrascanner 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 intracranial hematoma. The device is indicated to assess patients for
CT scans but should not serve as a substitute for these scans. The Infrascanner is
indicated for useby Physicians, or under the direction of a physician, who has
been trained in the use of the device |
Technological Characteristics
The device is a noninvasive device, which uses near-infrared spectroscopy ("NRS") to provide early information about the possible development of traumatic supratentorial intracranial hematomas in patients presenting to hospitals with head trauma. This technology in volves comparing regional differences in absorbance of NIRS to hematoma evaluation is based on the principle that intracranial hemoglobin concentration will differ where a hematoma is present, compared to hemoglobin concentrations in normal intracranialregions. The systemconsists of a Class I NIR-based sensor is optically coupled to the patient's head through two disposable light guides in a "hairbrush" configuration. Examination with the Infrascanner is performed through placement of the sensor on designated areas of the head thatrepresent the most common locations for traumatic hematoma. The examination is designed to be performed within two minutes.
Specifically, Model 2500 is the same device as the Infrascanner Model 2000 with following two categories of modifications:
- Scanner miniaturization ●
- . Systemenhancements
| Summary of the technological characteristics of the new device in comparison to those of the predicate device | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Itemized description | Reason for change | ||||||||||||
| 1. | Improved battery charging | To improve charging of depleted rechargeable batteries | |||||||||||
| 2. | Update Battery icon | The NiMH battery's charge cycle shifts over time | |||||||||||
| 3. | Add Tutorial Software | To add on-screen instructions to guide the user when making scans | |||||||||||
| 4. | Modify Timing and Length | To reduce error and repeated measurements -. Increasing the number of pulses and timing reduces the number of errors and the need to make repeated measurements on dark skin and dark hair. | |||||||||||
| Predicate Current Device Laser Pulses 6 pulses 10 pulses Laser Timing 100 msec On / 200 msec off 200 msec On / 100 msec off | |||||||||||||
| 5. | Add feedback LED indicator | To provide feedback to the user when measurements are active and when they are completed. | |||||||||||
| 6. | Reduced size of device with a smaller display on the front of the unit, removal of single board computer, and design of housing and shield. | To make the device smaller. The scanner miniaturization involved arranging of components inside the scanner. | |||||||||||
| Electronic circuit size was reduced by implementing some of the analog circuits in digital. | |||||||||||||
| The Windows CE 6.0 single board computer was replaced by a small microcontroller unit (MCU). | |||||||||||||
| 7. | Incremental upgrades to the device. | Upgraded measurement buttons to rubber sealed switches. | |||||||||||
| Upgraded to permanent internal rechargeable battery and addition of snap retention. | |||||||||||||
| Upgrade to USB charger. | |||||||||||||
| 8. | Changed laser drive signal from pulsed square wave to sinusoid and digital lock-in amplifier | To reduce space, power and improve accuracy; higher sample rate | |||||||||||
| 9. | Upgrade to software | Addition of secure boot, updated architecture, upgraded screen graphics |
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Performance Data
Bench testing demonstrated that device functioned. Testing comparing to the predicate was conducted using a hematoma model to provide an approximation of human tissue. Testing included repeatability and reproducibility. Results were consistent with the expected result. Performance was substantially similar for both models across a range of depths and sizes of hematomas, and for skin types. Additional laboratory testing demonstrated the comparability of the device and its predicate over the range of optical densities.
Four types of tests were conducted in order to evaluate substantial equivalence between Infrascanner Model 2500.
- Repeatability / Reproducibility to assess the degree of agreements conducted on the same device. The repeatability and reproducibility test data in volved repeat observations with three different systems for each of the two models. Model hematomas of 5 mL and 50 mL were evaluated at depths of shallow and deep ranges at 0 cm, and 3 cm
- A greement test to assess the degree of agreement between measurements conducted by Model 2000. The agreement test data were collected for one systemof each model for hematomas of size 5 mL and 50 mL and depths of 0-3cm below the CSF.
- Skin color test to assess theeffect of the skin color on the measurements conducted by Model 2000. The ● evaluation of the potential impact of skin color was performed for both models with hematoma size of 5 mL at depths of 0 and 2 cm, and without a model hematoma in the tank. The thickness of the film filters (0.1 mm) is similar to the thickness of human skin. Neutral Density Filters were used in to reduce light transmission similar to the behavior of skin color differences. Us ing those filters the OD values in the new lab tests covered the range of 5-5.8 OD to simulate lightskinned patients and 6.3-7.1 OD to simulate dark skinned subjects.
The test data sets support the conclusion that the models 2500 and 2000 are substantially equivalent across a range of simulated hematoma sizes, depths, and for light and dark skin and for adult and infant age groups.
A 4-comers approach was used for the selection and testing of the simulated hematoma size and depth and for the simulated adult age group
- Small (5 ml) and large (50 ml) hematomas
- Superficial (0 cm) and deep (2 and 3cm) hematomas
- . Adult (>18 years old) ages were tested
A mixed multi-layered solid and liquid optical head phantommimicking human tissue was used in the test. For brain tissue optical parameters simulation of an intralipid was used to control the scattering properties and a calibrated ink to control absorption properties. Including the layers of skin, scalp, skull and CSF with the liquid brain layer and blood to simulate brain hematoma.
Silicon was selected for building the phantomdue to a close match to the mechanical properties of tissue. Carbon black was used as the absorbing agent, and Titanium Dioxide was used as the scattering agent. The optical absorption and scattering properties of each layer were confirmed further by optical frequency-domain measurement systems. The CSF layer were those of water. Thin neutral density (ND) Wratten 2 film filters were placed over the signal level to OD values observed in the clinical studies for patients with differents kin color. The thickness of the thickness of human skin. Using those filters, the OD values in the new lab tests covered the range of OD to simulate light-s kinned patients and OD to simulate dark skinned subjects. The attenuation values of the filters were selected to match the OD values observed in the clinical studies. The brain model was filled with water, intralipid for scattering and a black ink for absorption. This mixture created a simulation of brain tissue. Our approachis to use ovine whole blood as a hematoma. Following prior FDA guidance, a flat hematoma model was used in this test. The flat hematoma model was built using a rectangular frame, inserted into a ball, and filled with blood. The rectangular frame forced the shape of the hematoma to remain relatively flat.
Substantial Equivalence
The subject device is as safe andeffective as the predicate device has the same indication for use, technological characteristics, and principles of operation as its predicate device.
The enhancements (such as size of the physical device, the type of charging station) of the Model 2500 raise no new issues of safety or effectiveness. Bench data demonstrate the substantially equivalent to the predicate.
Conclusion
Based on the intended use, technological characteristics, comparison to the predicate device and performance testing, the modified device is substantally equivalent to the predicate device and raises no additional or different questions of safety or effectiveness