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 Infrascanner Model 2000 is a noninvasive device, which uses near-infrared spectroscopy ("NIRS") 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 NIR light. The application 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. The 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.

AI/ML Overview

Acceptance Criteria and Study for InfraScan's Infrascanner Model 2000

The acceptance criteria for InfraScan's Infrascanner Model 2000 are not explicitly stated as numerical performance metrics in the provided 510(k) summary. Instead, the submission focuses on demonstrating substantial equivalence to its predicate device, the Infrascanner Model 1000 (K080377). The study conducted was primarily a bench testing and comparability study rather than a clinical trial with specific performance targets.

The key acceptance criterion, implicitly, is that the Infrascanner Model 2000 functions as intended and is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Substantial Equivalence Basis)	Reported Device Performance (as per 510(k) Summary)
Function as Intended: The device should perform its intended function of detecting traumatic supratentorial hematomas.	"Bench testing demonstrated that the Infrascanner Model 2000 functioned as intended."
Similar Performance to Predicate Device: Performance in detecting hematomas should be comparable to the Infrascanner Model 1000 across relevant parameters (depth, size, skin tone).	"Testing comparing the Infrascanner Model 2000 and its predicate was conducted using a multilayer brain hematoma model... Results with the multilayer model for both the Model 2000 and the predicate were consistent with the expected result observed in clinical testing of the predicate. Performance was substantially similar for both models across a range of depths and sizes of hematomas similar to those seen in the clinical setting, and for light and dark skin types."
Comparability of Optical Densities: The device should demonstrate comparable performance across the range of optical densities observed clinically.	"Additional laboratory testing demonstrated the comparability of the device and its predicate over the range of optical densities observed in the clinical setting."
Safety and Effectiveness: No new issues of safety or effectiveness should be raised by the minor technological differences.	"The minor technological differences between the Infrascanner Model 2000 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Infrascanner Model 2000 is as safe and effective as the Infrascanner Model 1000."

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

The provided 510(k) summary does not specify a "test set" in the traditional sense of a patient cohort. The study described is primarily a bench test using a multilayer brain hematoma model. Therefore, there are no details about:

Sample size used for the test set (human subjects): Not applicable for this type of testing.
Data provenance: The "data" comes from the performance of the device on the multilayer brain hematoma model. No country of origin is mentioned for this model or its development. The testing is retrospective in the sense that it's evaluating a developed device against a model, not prospectively on new patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the "test set" was a physical model (multilayer brain hematoma model) rather than patient data requiring expert interpretation for ground truth.

4. Adjudication Method

This information is not applicable as the "test set" was a physical model, not patient data requiring adjudication of diagnostic results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed according to the provided text. The study focused on demonstrating the functional equivalence of the new device to its predicate through bench testing, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the algorithm (device) was indeed done. The "bench testing" and "testing comparing the Infrascanner Model 2000 and its predicate" using a multilayer brain hematoma model represent a standalone evaluation of the device's ability to detect hematomas in a controlled environment, without human interpretation as part of the primary measurement.

7. Type of Ground Truth Used

The ground truth used for the testing was primarily the physical characteristics of the multilayer brain hematoma model, specifically the presence, depth, and size of simulated hematomas within the model. This is an engineered ground truth within a simulated environment.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a training set nor any machine learning or AI components that would typically require one. The description of the technology ("Near-infrared spectroscopy ('NIRS') to provide early information about the possible development of traumatic supratentorial intracranial hematomas... based on the principle that intracranial hemoglobin concentration will differ where a hematoma is present") suggests a biophysical measurement device, not one that relies on a trained algorithm in the modern sense.

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

As no training set is mentioned or implied, this information is not applicable.

Summary

{0}------------------------------------------------

510(k) SUMMARY

K 120949

JAN 1 1 2013

InfraScan. Inc.'s Infrascanner Model 2000

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

Date Prepared: January 11, 2013

Name of Device and Name/Address of Sponsor

Infrascanner Model 2000

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's Infrascanner Model 1000 (K080377)

Intended Use / Indications for Use

{1}------------------------------------------------

Technological Characteristics

Performance Data

Bench testing demonstrated that the Infrascanner Model 2000 functioned as intended. Testing comparing the Infrascanner Model 2000 and its predicate was conducted using a multilayer brain hematoma model to provide an approximation of human tissue. Results with the multilayer model for both the Model 2000 and the predicate were consistent with the expected result observed in clinical testing of the predicate. Performance was substantially similar for both models across a range of depths and sizes of hematomas similar to those seen in the clinical setting, and for light and dark skin types. Additional laboratory testing demonstrated the comparability of the device and its predicate over the range of optical densities observed in the clinical setting.

Substantial Equivalence

The Infrascanner Model 2000 is as safe and effective as the Infrascanner Model 1000. The Infrascanner Model 2000 has the same intended uses and similar indications. technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Infrascanner Model 2000 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Infrascanner Model 2000 is as safe and effective as the Infrascanner Model 1000. Thus, the Infrascanner Model 2000 is substantially equivalent.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.

January 11, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Hogan Lovells US LLP % Steven B. Datlof, M.D., J.D. Official Correspondent InfraScan, Incorporated 1835 Market Street, 2 9th floor Philadelphia, PA 19103

Re: K120949

Trade/Device Name: Infrascanner Model 2000 Regulation Number: 21 CFR 882.1935 Regulation Name: Near Infrared (NIR) Brain Hematoma Detector Regulatory Class: Class II Product Code: OPT Dated: December 13, 2012 Received: December 13, 2012

Dear Dr. Datlof:

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. 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

{3}------------------------------------------------

Page 2 - Steven B. Datlof, M.D., J.D.

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Deborah L. Falls

for

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K120949

Device Name: Infrascanner Model 2000

Indications for Use:

Prescription Use _ X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deborah Falls

(Division Sign Off)
Division of Neurological and Physical Medicine Devices
(DNPMD)
510(k) Number	K120949

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.