(151 days)
Not Found
No
The description focuses on the physics-based signal processing of OCT data and does not mention AI or ML.
No
The device is described as an "imaging tool" that "provides two-dimensional, crosssectional, real-time depth visualization" and "creates images of tissue." Its function is solely for imaging and evaluation, not for treating or preventing disease.
Yes
Explanation: The device is intended to be used as an "imaging tool in the evaluation of external human tissue microstructure." This evaluation implies its use in diagnosing or aiding in the diagnosis of conditions by visualizing tissue structures.
No
The device description explicitly lists multiple hardware components including a cart-mounted console, foot pedal, handheld probe, imaging module (containing light source, interferometer, and detector), and an imaging computer. While software is mentioned for signal processing and the user interface, it is part of a larger hardware system.
Based on the provided information, the Foresee (4C) Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is described as "an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization." This describes a device used for in vivo imaging (imaging within a living organism), not in vitro testing (testing outside of a living organism, typically on biological samples).
- Device Description: The description details a system that uses a handheld probe to scan tissue directly on the human body. This is consistent with an in vivo imaging system.
- Anatomical Site: The anatomical site is "external human tissue," which further supports the in vivo nature of the device.
IVD devices are typically used to examine specimens such as blood, urine, tissue samples, etc., outside of the body to provide information for diagnosis, monitoring, or screening. The Foresee (4C) Imaging System operates directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The Foresee (4C) Imaging System is intended to be used as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
Product codes (comma separated list FDA assigned to the subject device)
NQQ
Device Description
The Foresee (4C) Imaging System uses optical coherence tomography (OCT) to create images of tissue. OCT is an imaging technology similar to ultrasound except that images are formed using reflected light rather than reflected sound. In place of sound waves, OCT uses a near-infrared beam of light that penetrates tissue. The light reflects off of changes in tissue microstructure. Using the principles of low-coherence interferometry, a technique that measures the interference of light from a sample arm and a reference arm to create an image, OCT produces a high-resolution depth profile. Scanning the beam across tissue produces a detailed, two-dimensional image of tissue microstructure morphology.
The Foresee (4C) Imaging System uses a broadband, swept optical source and a fixed reference arm to acquire imaging data in the frequency domain. The Foresee (4C) Imaging System has a handheid probe for the scanning of tissue. The probe has a fixed focal depth with a correction for beam diffraction employing a physics-based, software signal processing technique.
The Foresee (4C) Imaging System consists of a cart-mounted imaging console with an isolation transformer; a foot pedal; a handheld imaging probe with a single-use non-sterile disposable probe tip: an imaging module containing a light source, interferometer, and detector; and an imaging computer that implements physics-based software signal processing; and dual monitors for image display. The system user interface allows the viewing, capture, review and export of images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography, Near-Infrared Low-Coherence Beam
Anatomical Site
external human tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Foresee (4C) Imaging System is designed and tested to be in compliance with international standards (noted in Table 1 on the following page) concerning safety for electrical and mechanical safety, electromagnetic emissions and susceptibility, biocompatibility, disinfection, and laser safety. Key features of the system design related to electrical safety and electromagnetic compatibility include an isolation transformer for system power; a shielded and arounded enclosure meeting requirements for fireproof enclosure; and a double insulated probe housing and cable for patient protection. The system has been tested for electrical and mechanical safety for Medical Electrical Equipment and for electromagnetic compatibility as specified in Table 1 on the following page. The system uses a laser that is limited in power to meet the requirements of a class 1 laser device in accordance with IEC 60825-1:2007.
The handheld probe has been designed to be a reusable component and to support cleaning and low level disinfection. A process has been developed and validated for reprocessing of the reusable handheld probe (see details in Section XVI). The single use probe tip has been designed using materials that adhere to the requirements for skin surface limited (
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/2 description: The image shows the logo for Diagnostic Photonics. The logo consists of a stylized letter "d" formed by a circle with a vertical line extending downwards. To the right of the "d" are the words "DIAGNOSTIC PHOTONICS" stacked on top of each other.
510(k) SUMMARY
Diagnostic Photonics Foresee (4C) Imaging System
1. Basic Information-Submitter:
| Submitter: | Diagnostic Photonics, Inc. |
|---|---|
| Address: | 200 South Wacker Drive, 31st Floor |
| Chicago, IL 60606 | |
| Phone: (312) 854-9216 | |
| Official Contact: | Anna Lisa Somera |
| Director of Quality, Regulatory Affairs and Operations | |
| Phone: (312) 965-5472 | |
| asomera@diagnosticphotonics.com |
March 6, 2014
2. Device Name:
Date Summary Prepared:
| Trade Name: | Foresee (4C) Imaging System | |
|---|---|---|
| Common Name: | Optical Coherence Tomography Scanner | |
| Classification Name: | Ultrasonic pulsed echo imaging system | |
| Regulation Number: | 21 CFR 892.1560 | |
| Product Code: | NQQ | |
| Classification: | Class II |
3. Predicate Devices:
Imalux OCT Imaging System - K033783 Michelson Diagnostics VivoSight Topical OCT System - K093520
4. Indications for Use Statement: '
The Foresee (4C) Imaging System is intended to be used as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
1
5. Technological Characteristics:
The Foresee (4C) Imaging System uses optical coherence tomography (OCT) to create images of tissue. OCT is an imaging technology similar to ultrasound except that images are formed using reflected light rather than reflected sound. In place of sound waves, OCT uses a near-infrared beam of light that penetrates tissue. The light reflects off of changes in tissue microstructure. Using the principles of low-coherence interferometry, a technique that measures the interference of light from a sample arm and a reference arm to create an image, OCT produces a high-resolution depth profile. Scanning the beam across tissue produces a detailed, two-dimensional image of tissue microstructure morphology.
The Foresee (4C) Imaging System uses a broadband, swept optical source and a fixed reference arm to acquire imaging data in the frequency domain. The Foresee (4C) Imaging System has a handheid probe for the scanning of tissue. The probe has a fixed focal depth with a correction for beam diffraction employing a physics-based, software signal processing technique.
The Foresee (4C) Imaging System consists of a cart-mounted imaging console with an isolation transformer; a foot pedal; a handheld imaging probe with a single-use non-sterile disposable probe tip: an imaging module containing a light source, interferometer, and detector; and an imaging computer that implements physics-based software signal processing; and dual monitors for image display. The system user interface allows the viewing, capture, review and export of images.
6. Performance Data:
The Foresee (4C) Imaging System is designed and tested to be in compliance with international standards (noted in Table 1 on the following page) concerning safety for electrical and mechanical safety, electromagnetic emissions and susceptibility, biocompatibility, disinfection, and laser safety. Key features of the system design related to electrical safety and electromagnetic compatibility include an isolation transformer for system power; a shielded and arounded enclosure meeting requirements for fireproof enclosure; and a double insulated probe housing and cable for patient protection. The system has been tested for electrical and mechanical safety for Medical Electrical Equipment and for electromagnetic compatibility as specified in Table 1 on the following page. The system uses a laser that is limited in power to meet the requirements of a class 1 laser device in accordance with IEC 60825-1:2007.
The handheld probe has been designed to be a reusable component and to support cleaning and low level disinfection. A process has been developed and validated for reprocessing of the reusable handheld probe (see details in Section XVI). The single use probe tip has been designed using materials that adhere to the requirements for skin surface limited (Intended Use: Imaging of
external human tissue
microstructure (non-sterile) | Imaging tool in the evaluation
of human tissue microstructure
by providing two-dimensional,
cross-sectional, real-time depth
visualization.
Intended Use: Imaging of
human tissue microstructure
(sterile and non-sterile) | Indicated for use in the two-
dimensional, cross-sectional,
real-time imaging of external
tissues of the human body
Intended Use: Imaging of
external human tissue (non-
sterile) |
| Measurement
Technique | Optical Coherence Tomography | Optical Coherence
Tomography | Optical Coherence Tomography |
| Radiation Type | Near-Infrared Low-Coherence
Beam | Near-Infrared Low-Coherence
Beam | Near-Infrared Low-Coherence
Beam |
| Optical Source | Swept Source | Super Lumeniscent Diode
(SLD) | Swept Source |
| Near-Infrared
Wavelength (700-
1400 nm) | Yes | Yes | Yes |
| Reference Arm | Fixed reference arm, frequency-
domain signal acquisition | Scanned reference arm, time-
domain signal acquisition | Fixed reference arm,
frequency-domain signal
acquisition |
| Optical Radiation
Safety | Safe for Indicated Use Class 1
Laser | Safe for Indicated Use
Class 3R Laser | Safe for Indicated Use
Class 1 Laser |
| Lateral Range
(Imaging
Aperture) | 9.6 mm | 2 mm | 5 mm |
| In-Depth Range
(z-axis) | >2.1 mm (in air) | 2.2 mm (in air) | ~1.2 - 2 mm |
| Axial Resolution
(z-axis) | (7 frames/sec | >1 sec/frame | > 6 frames/sec |
| Information
Display | Patient ID
Operator name
Date and time stamp
Image comments
Hospital/Institution Name | Patient name
Operator name
Date and time stamp
Image comments | Patient name and ID
Clinician ID
Date and time stamp |
| Diffraction
Compensation | Uses a single fixed focal depth
imaging beam and corrects for
beam diffraction with a physics-
based software signal
processing technique | Uses a single fixed focal depth
imaging beam | Uses four separate imaging
beams, each focused at a
different fixed depth in tissue,
and corrects for beam
diffraction with software-based
signal processing that
constructs a merged image |
| Electrical
Voltage
Frequency | 120/240 V
50/60 Hz | 90-132 V, 198-264 V
50/60 Hz | 116-264 V
50/60 Hz |
| Computer-
Controlled,
IBM-PC
Compatible | Yes | Yes | Yes |
| Input devices:
Keyboard
Pointing | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
Yes |
Table 2: Summary of Technological Characteristics
4
9. Conclusion
Diagnostic Photonics, Inc. has demonstrated that the Foresee (4C) Imaging System has the same intended use and is substantially equivalent to the predicate devices listed above. The Foresee (4C) Imaging System also complies with recognized standards and guidelines for electrical safety, laser safety, cleaning and disinfection, and biocompatibility. Non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices listed above.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2014
Diagnostic Photonics Incorporated % Ms. Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K133209
Trade/Device Name: Forsec (4C) Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NOQ Dated: February 14, 2014 Received: February 20, 2014
Dear Ms. Hogan:
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 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
6
Page 2 - Ms. Janice Hogan
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
Felipe Aquel
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K133209 Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Foresee (4C) Imaging System
Indications for Use (Describe)
The Foresee (4C) Imaging System is indicated for use as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.03.14 11:35:31 -04'00'
(Division Sign-Off)
Division of Surgical Devices 510(k) Number K133209
For BSA
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