(287 days)
No
The description focuses on the use of near-infrared spectroscopy (NIRS) and the comparison of regional absorbance differences to detect hematomas. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The Infrascanner is indicated for the detection of hematomas and to assess patients for CT scans, rather than to treat or cure a disease or condition. It serves as an adjunctive diagnostic device.
Yes.
The device is used for the detection of traumatic supratentorial hematomas, indicating its role in identifying a medical condition.
No
The device description explicitly states that the system consists of a "Class I NIR-based sensor" and "two disposable light guides," indicating the presence of hardware components 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.
- Infrascanner's Function: The Infrascanner is a noninvasive device that uses near-infrared spectroscopy (NIRS) to directly examine the patient's head. It does not analyze samples taken from the body.
The device's description clearly states it's a "noninvasive device" and that "Examination with the Infrascanner is performed through placement of the sensor on designated areas of the head". This aligns with the definition of an in vivo diagnostic device, not an in vitro one.
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 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.
Product codes
OPT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near Infrared (NIR)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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
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.
1
Technological Characteristics
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.
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:
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.
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 |