FORESEE (4C) IMAGING SYSTEM

K133209 · Diagnostic Photonics, Inc. · NQQ · Mar 17, 2014 · Radiology

Device Facts

• Record ID: K133209
• Device Name: FORESEE (4C) IMAGING SYSTEM
• Applicant: Diagnostic Photonics, Inc.
• Product Code: NQQ · Radiology
• Decision Date: Mar 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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, cross-sectional, real-time depth visualization.

Device Story

Foresee (4C) Imaging System is an optical coherence tomography (OCT) scanner for external human tissue. System uses near-infrared light beam to penetrate tissue; low-coherence interferometry measures light reflection to create high-resolution depth profiles. Device consists of cart-mounted console, imaging module (light source, interferometer, detector), imaging computer, dual monitors, and handheld probe with single-use disposable tip. Operator uses handheld probe to scan tissue; system processes signals via physics-based software to correct for beam diffraction. Output is real-time, 2D cross-sectional image of tissue microstructure displayed on monitors. Used in clinical settings to assist healthcare providers in visualizing tissue morphology. Benefits include non-invasive, real-time assessment of external tissue microstructure.

Clinical Evidence

Bench testing only. System evaluated for electrical/mechanical safety (IEC 60601-1), electromagnetic compatibility, laser safety (IEC 60825-1), and biocompatibility (ISO 10993). Image performance validated via in-depth spatial resolution, range, and scan linearity tests. Imaging of esophagus, bladder, and colon from healthy New Zealand white rabbits demonstrated visualization capabilities compared to published predicate data.

Technological Characteristics

OCT imaging system using broadband, swept optical source and fixed reference arm for frequency-domain data acquisition. Near-infrared light beam. Handheld probe with single-use non-sterile disposable tip. Physics-based software signal processing for beam diffraction correction. System includes isolation transformer, imaging computer, and dual monitors. Class 1 laser device per IEC 60825-1. Biocompatible materials per ISO 10993. Electrical safety per IEC 60601-1.

Indications for Use

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.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Imalux OCT Imaging System (K033783)
• Michelson Diagnostics VivoSight Topical OCT System (K093520)

Submission Summary (Full Text)

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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<br>Chicago, IL 60606<br>Phone: [phone] |
| Official Contact: | Anna Lisa Somera<br>Director of Quality, Regulatory Affairs and Operations<br>Phone: [phone]<br>[e-mail] |

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.

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#### 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 (<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<br>(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 for<br>In Vitro Cytotoxicity. |
| AAMI/ANSI/ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests for<br>Irritation and Skin Sensitization. |
| AAMI/ANSI/ISO 10993-11:2006 | Biological Evaluation of Medical Devices -- Part 11: Tests for<br>Systemic 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<br>(K033783) | Michelson Diagnostics<br>VivoSight Topical OCT<br>System<br>(K093520) |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Imaging tool in the evaluation of<br>external human tissue<br>microstructure by providing two-<br>dimensional, cross-sectional,<br>real-time depth visualization.<br><i>Intended Use:</i> Imaging of<br>external human tissue<br>microstructure (non-sterile) | Imaging tool in the evaluation<br>of human tissue microstructure<br>by providing two-dimensional,<br>cross-sectional, real-time depth<br>visualization.<br><i>Intended Use:</i> Imaging of<br>human tissue microstructure<br>(sterile and non-sterile) | Indicated for use in the two-<br>dimensional, cross-sectional,<br>real-time imaging of external<br>tissues of the human body<br><i>Intended Use:</i> Imaging of<br>external human tissue (non-<br>sterile) |
| Measurement<br>Technique | Optical Coherence Tomography | Optical Coherence<br>Tomography | Optical Coherence Tomography |
| Radiation Type | Near-Infrared Low-Coherence<br>Beam | Near-Infrared Low-Coherence<br>Beam | Near-Infrared Low-Coherence<br>Beam |
| Optical Source | Swept Source | Super Lumeniscent Diode<br>(SLD) | Swept Source |
| Near-Infrared<br>Wavelength (700-<br>1400 nm) | Yes | Yes | Yes |
| Reference Arm | Fixed reference arm, frequency-<br>domain signal acquisition | Scanned reference arm, time-<br>domain signal acquisition | Fixed reference arm,<br>frequency-domain signal<br>acquisition |
| Optical Radiation<br>Safety | Safe for Indicated Use Class 1<br>Laser | Safe for Indicated Use<br>Class 3R Laser | Safe for Indicated Use<br>Class 1 Laser |
| Lateral Range<br>(Imaging<br>Aperture) | 9.6 mm | 2 mm | 5 mm |
| In-Depth Range<br>(z-axis) | >2.1 mm (in air) | 2.2 mm (in air) | ~1.2 - 2 mm |
| Axial Resolution<br>(z-axis) | (<20 $ \mu $ m in air) | 10-20 $ \mu $ m [≤ 21 $ \mu $ m (in air)] | < 5 $ \mu $ m |
| Lateral<br>Resolution (x-<br>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 |
| Information<br>Display | Patient ID<br>Operator name<br>Date and time stamp<br>Image comments<br>Hospital/Institution Name | Patient name<br>Operator name<br>Date and time stamp<br>Image comments | Patient name and ID<br>Clinician ID<br>Date and time stamp |
| Diffraction<br>Compensation | Uses a single fixed focal depth<br>imaging beam and corrects for<br>beam diffraction with a physics-<br>based software signal<br>processing technique | Uses a single fixed focal depth<br>imaging beam | Uses four separate imaging<br>beams, each focused at a<br>different fixed depth in tissue,<br>and corrects for beam<br>diffraction with software-based<br>signal processing that<br>constructs a merged image |
| Electrical<br>Voltage<br>Frequency | 120/240 V<br>50/60 Hz | 90-132 V, 198-264 V<br>50/60 Hz | 116-264 V<br>50/60 Hz |
| Computer-<br>Controlled,<br>IBM-PC<br>Compatible | Yes | Yes | Yes |
| Input devices:<br>Keyboard<br>Pointing | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes |

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 [phone] or [phone] 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 [phone] or [phone] 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

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