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 use by Physicians, or under the direction of a physician, who has been trained in the use of the device.

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

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the InfraScanner Model 2500, a Near Infrared (NIR) Brain Hematoma Detector. However, it does not contain specific acceptance criteria tables, detailed study results (like sensitivity, specificity, AUC), or information on multi-reader multi-case (MRMC) studies, ground truth establishment methods for large datasets, or expert qualifications as typically seen in clinical validation studies for AI/CADe devices.

The document focuses on demonstrating substantial equivalence to a predicate device (InfraScanner Model 2000) based on technological characteristics and bench testing using a physical hematoma model, rather than a clinical study with human patients and expert ground truth.

Therefore, I cannot fulfill most of the request based on the provided text. The information is not present. I can only infer what kind of testing was done to support substantial equivalence.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of precise acceptance criteria (e.g., minimum sensitivity/specificity thresholds) and specific performance metrics (like sensitivity, specificity, or AUC) from a clinical study on human patients. The "Performance Data" section discusses bench testing results, not clinical performance metrics against a defined ground truth in patients.

Acceptance Criteria (Not explicitly stated for clinical performance)	Reported Device Performance (From Predicate Comparison Bench Testing)
(Not defined in the document for clinical metrics)	Repeatability/Reproducibility: Consistent across repeat observations with three different systems for each model (Model 2000 & 2500) using 5mL and 50mL hematomas at 0cm and 3cm depths.
	Agreement Test: Good agreement between measurements by Model 2000 and 2500 for 5mL and 50mL hematomas at 0-3cm depths.
	Skin Color Test: Performance was "substantially similar for both models" across a range of simulated skin types (light and dark) using neutral density filters to simulate OD values from clinical studies.
	Simulated Hematoma Range: Substantially equivalent performance for small (5ml) and large (50ml) hematomas, and superficial (0 cm) and deep (2 and 3cm) hematomas in an adult age group.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of a human clinical test set. The testing described is bench testing using a physical phantom model, not a human patient test set. The "test set" here refers to configurations of the phantom.
- Repeatability/Reproducibility: Involved "three different systems for each of the two models."
- Agreement Test: "one system of each model."
Data Provenance: Not applicable as it's bench testing with a phantom model, not human patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The ground truth for the bench testing was the physical configuration of the phantom model (e.g., presence, size, and depth of simulated hematoma). No human experts were involved in establishing "ground truth" for this type of test.

4. Adjudication Method for the Test Set:

Not applicable. This was bench testing with a physical phantom; there was no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe any MRMC study. The study presented here is a bench test comparing the new device (Model 2500) to a predicate device (Model 2000) using a physical phantom. There is no mention of human readers or AI assistance in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

The device itself is a "Near Infrared (NIR) Brain Hematoma Detector" which provides an output. The "performance data" section describes the device's ability to "detect" simulated hematomas in a phantom. This could be considered akin to a standalone performance evaluation in a controlled environment, but it's not a clinical standalone study. The device's output is intended to be adjunctive to clinical evaluation.

7. Type of Ground Truth Used:

Simulated Phantom Model: The ground truth for this study was established using a precisely controlled, mixed multi-layered solid and liquid optical head phantom mimicking human tissue. This phantom contained simulated hematomas of known size (5 mL, 50 mL) and depth (0 cm, 2 cm, 3 cm). The "ground truth" was the known physical state of the phantom.
- Ovine whole blood was used to simulate hematomas.
- The phantom was built with silicone, carbon black, and titanium dioxide to mimic optical and mechanical properties of tissue.

8. Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (hardware with embedded firmware) and its physical performance comparison to a predicate device. There is no mention of an "AI algorithm" being trained on a dataset. The device uses near-infrared spectroscopy; it's not a machine learning model in the conventional sense requiring a training set for algorithm development described here.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of an AI model with a training set.

Summary

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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

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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, TelephoneNumber, Contact Person and DatePrepared	InfraScan, Inc. 3508 Market StreetPhiladelphia, PA 19104Phone: 215-387-6784Facsimile: 215-386-2327Contact Person: Baruch Ben Dor, CEO
Name of Device and Name/Address ofSponsor	Infrascanner Model 2500InfraScan, Inc.3508 Market StreetPhiladelphia, 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 supratentorialhematomas of greater than 3.5 mL in volume that are less than 2.5 cm from thebrain surface, as an adjunctive device to the clinical evaluation in the acutehospital setting of patients 18 years old or greater with suspected traumaticsupratentorial intracranial hematoma. The device is indicated to assess patients forCT scans but should not serve as a substitute for these scans. The Infrascanner isindicated for useby Physicians, or under the direction of a physician, who hasbeen 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

Regulation Number and Section

§ 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.