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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study used to demonstrate that the Diagnostic Photonics Foresee (4C) Imaging System meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documentation primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to international safety and performance standards, rather than defining specific numerical clinical performance acceptance criteria (e.g., sensitivity, specificity for a diagnostic task). The "acceptance criteria" here are implied by meeting the specified standards and exhibiting comparable or better physical imaging parameters.

Performance Metric / Acceptance Criteria (Implied)	Reported Device Performance (Foresee (4C) Imaging System)
Safety Standards Adherence	Fully compliant with ANSI/AAMI ES60601-1:2005, IEC 60825-1:2007 (Class 1 Laser), ISO 10993 (5, 10, 11), IEC 60601-1-2:2007, IEC 61000-3-2:2006, EN61000-3-3:2008.
Electrical & Mechanical Safety	Demonstrated compliance with standards.
Electromagnetic Compatibility (EMC)	Demonstrated compliance with standards.
Biocompatibility	Single-use probe tip tested for Biocompatibility per ISO 10993. Reusable components designed and validated for reprocessing.
Laser Safety	Class 1 laser device (meets IEC 60825-1:2007).
Cleaning and Disinfection Validation	Instructions to be validated before marketing (per FDA and internal protocols).
In-depth Spatial Resolution (Axial Resolution)	<20 µm (in air)
In-depth Image Range (z-axis)	>2.1 mm (in air)
Lateral Spatial Resolution (x-axis)	<20 µm
Lateral Image Range (Imaging Aperture)	9.6 mm
Scan Linearity Deviation	Tested and met specifications.
Scan Time	>7 frames/sec
Tissue Microstructure Visualization	Performed imaging of esophagus, bladder, and colon from healthy New Zealand white rabbit to demonstrate capabilities in tissue specimens, comparable to predicate.

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

Sample Size (Test Set): For the imaging performance evaluation, the system was tested on "the esophagus, bladder, and colon from healthy New Zealand white rabbit." The exact number of rabbits or tissue samples is not specified.
Data Provenance: The data is from in vitro testing using animal tissue (New Zealand white rabbit). This is not clinical data from human subjects. The study is prospective in the sense that the system was built and then tested on these samples.

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

The document does not mention the use of experts to establish a "ground truth" for the imaging performance tests on animal tissues. The assessment appears to be based on physical measurements of the system's imaging capabilities (resolution, range, linearity) and visual comparison of image quality to "published predicate data."

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication for a ground truth is not described. The performance assessment is based on objective physical measurements and subjective comparison to predicate data.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described. The device is an imaging system (Optical Coherence Tomography scanner), not an AI-powered diagnostic algorithm designed to assist human readers in interpretation.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented is for the device operating in a standalone capacity (imaging system performance measurements). There is no mention of an algorithm in the context of diagnostic interpretation that would require a human-in-the-loop study. The "physics-based, software signal processing technique" mentioned corrects for beam diffraction and is an integral part of the image acquisition and reconstruction, not a separate diagnostic algorithm.

7. The type of Ground Truth Used

For the imaging performance, the ground truth or reference standard would be the inherent physical properties of the system (e.g., how small an object it can resolve, its depth penetration). For the comparative animal tissue imaging, the "ground truth" appears to be the known microstructure of the rabbit tissues as understood from biological knowledge, viewed through the lens of the Foresee system and compared qualitatively against published predicate data. There is no mention of, for example, corresponding histology (pathology) for the rabbit tissues used in the imaging study.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an imaging device, not the training of a machine learning or AI algorithm in the typical sense that would involve a distinct "training set" of images to teach an algorithm to perform a task. The "physics-based, software signal processing technique" likely involves fixed algorithms based on optical principles, not data-driven machine learning that requires a training set.

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

Not applicable, as there is no mention of a training set or data-driven machine learning algorithm that requires ground truth establishment.

Summary

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510(k) SUMMARY

Diagnostic Photonics Foresee (4C) Imaging System

1. Basic Information-Submitter:

Submitter:	Diagnostic Photonics, Inc.
Address:	200 South Wacker Drive, 31st FloorChicago, IL 60606Phone: (312) 854-9216
Official Contact:	Anna Lisa SomeraDirector of Quality, Regulatory Affairs and OperationsPhone: (312) 965-5472asomera@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: '

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5. Technological Characteristics:

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 (<24 hours) contact. The complete single use probe tip has been tested for Biocompatibility per ISO 10993 based on the intended use.

The system image performance has been tested to evaluate the in-depth spatial resolution. in-depth image range, lateral spatial resolution, lateral image range and scan linearity deviation. Imaging of the esophagus, bladder, and colon from healthy New Zealand white rabbit was performed to study the performance of the Foresee (4C) Imaging System in comparison to published predicate data from the Imalux OCT Imaging System and to demonstrate the imaging capabilities of the Foresee (4C) Imaging System for the visualization of tissue microstructure in tissue specimens. The standards that the system has been tested against assure the safety of the device and are listed on the following page.

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Safety Testing	Standard
ANSI/AAMI ES60601-1:2005(IEC 60601-1 3rd Edition)	Medical Electrical Equipment
IEC 60825-1:2007	Safety of Laser Products
AAMI/ANSI/ISO 10993-5:2009	Biological Evaluation of Medical Devices -- Part 5: Tests forIn Vitro Cytotoxicity.
AAMI/ANSI/ISO 10993-10:2010	Biological Evaluation of Medical Devices - Part 10: Tests forIrritation and Skin Sensitization.
AAMI/ANSI/ISO 10993-11:2006	Biological Evaluation of Medical Devices -- Part 11: Tests forSystemic Toxicity
IEC 60601-1-2:2007	Medical Electrical Equipment
IEC 61000-3-2:2006	Electromagnetic Compatibility (EMC), Part 3-2
EN61000-3-3:2008	Electromagnetic Compatibility (EMC), Part 3-3

Table 1: Relevant International Standards

Image performance and in vitro testing have been performed. All components, subassemblies, and/or full devices and systems have met the required specifications for the completed tests above. In all instances, the Foresee (4C) Imaging System functioned as intended and results observed were as expected.

7 Statement on the Status of the Cleaning and Disinfection Validation Studies:

The instructions for reprocessing the device will be validated before the device is marketed according to the FDA email dated March 3, 2014 and phone conference on March 6, 2014. Cleaning validation testing will demonstrate the effective cleaning of devices soiled under repeated use with a test soil including two (2) quantitative test markers. Disinfection validation testing will demonstrate a 6 log10 kill of four (4) test organisms individually. The validation of the reprocessing instructions and the final labeling will be on record at Diagnostic Photonics, Inc. located at 200 South Wacker Drive, 31st Floor, Chicago, IL 60606 and available for inspection: they will be supplied to FDA upon request. The validation will include protocols, specifications, passifail criteria, results, and procedures describing when the instructions must be requalified (e.g., if the device is modified).

8. Substantial Equivalence:

The Foresee (4C) Imaging System is as safe and effective as the Imalux OCT Imaging System and the Michelson Diagnostics VivoSight Topical OCT System. As shown in Table 2 on the following page, the Foresee (4C) Imaging System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Foresee (4C) Imaging System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Foresee (4C) Imaging System is as safe and effective as the Imalux OCT Imaging System and the Michelson Diagnostics VivoSight Topical OCT System. Thus. the Foresee (4C) Imaging System is substantially equivalent.

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K133209 Page 4 of 5

	Foresee (4C) Imaging System	Imalux OCT Imaging System(K033783)	Michelson DiagnosticsVivoSight Topical OCTSystem(K093520)
Indications forUse	Imaging tool in the evaluation ofexternal human tissuemicrostructure by providing two-dimensional, cross-sectional,real-time depth visualization.Intended Use: Imaging ofexternal human tissuemicrostructure (non-sterile)	Imaging tool in the evaluationof human tissue microstructureby providing two-dimensional,cross-sectional, real-time depthvisualization.Intended Use: Imaging ofhuman tissue microstructure(sterile and non-sterile)	Indicated for use in the two-dimensional, cross-sectional,real-time imaging of externaltissues of the human bodyIntended Use: Imaging ofexternal human tissue (non-sterile)
MeasurementTechnique	Optical Coherence Tomography	Optical CoherenceTomography	Optical Coherence Tomography
Radiation Type	Near-Infrared Low-CoherenceBeam	Near-Infrared Low-CoherenceBeam	Near-Infrared Low-CoherenceBeam
Optical Source	Swept Source	Super Lumeniscent Diode(SLD)	Swept Source
Near-InfraredWavelength (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 signalacquisition
Optical RadiationSafety	Safe for Indicated Use Class 1Laser	Safe for Indicated UseClass 3R Laser	Safe for Indicated UseClass 1 Laser
Lateral Range(ImagingAperture)	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)	(<20 $ \mu $ m in air)	10-20 $ \mu $ m [≤ 21 $ \mu $ m (in air)]	< 5 $ \mu $ m
LateralResolution (x-axis)	<20 $ \mu $ m	≤ 50 $ \mu $ m	< 7.5 $ \mu $ m
Scanning Pattern	Line	Line	Line
Scan Time	>7 frames/sec	>1 sec/frame	> 6 frames/sec
InformationDisplay	Patient IDOperator nameDate and time stampImage commentsHospital/Institution Name	Patient nameOperator nameDate and time stampImage comments	Patient name and IDClinician IDDate and time stamp
DiffractionCompensation	Uses a single fixed focal depthimaging beam and corrects forbeam diffraction with a physics-based software signalprocessing technique	Uses a single fixed focal depthimaging beam	Uses four separate imagingbeams, each focused at adifferent fixed depth in tissue,and corrects for beamdiffraction with software-basedsignal processing thatconstructs a merged image
ElectricalVoltageFrequency	120/240 V50/60 Hz	90-132 V, 198-264 V50/60 Hz	116-264 V50/60 Hz
Computer-Controlled,IBM-PCCompatible	Yes	Yes	Yes
Input devices:KeyboardPointing	YesYesYes	YesYesYes	YesYesYes

Table 2: Summary of Technological Characteristics

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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.

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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

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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

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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)

K133209

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 EP

Regulation Number and Section

§ 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.