TOMOPHASE OCTIS

K102599 · Tomophase Corporation · NQQ · Dec 1, 2010 · Radiology

Device Facts

• Record ID: K102599
• Device Name: TOMOPHASE OCTIS
• Applicant: Tomophase Corporation
• Product Code: NQQ · Radiology
• Decision Date: Dec 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

Device Story

Tomophase OCTIS is an optical coherence tomography (OCT) imaging system for evaluating human tissue microstructure. The system comprises an imaging console and a single-use, sterile, flexible fiber-optic probe. It utilizes near-infrared (NIR) light (1250-1360 nm) and a swept-source laser to perform low-coherence interferometry, measuring in-depth backscattering profiles to construct high-resolution, real-time, two-dimensional cross-sectional images. The console provides a user interface for image acquisition, display, storage, and reporting. The device is intended for clinical use to assist healthcare providers in visualizing tissue microstructure, which may inform clinical decision-making. It is a non-invasive imaging tool designed for diagnostic support.

Clinical Evidence

No clinical data provided. Safety and performance were established through bench testing (electrical safety per IEC 60601-1, EMC per IEC 60601-1-2, laser safety per IEC 60825-1, biocompatibility per ISO 10993-1, and sterilization validation per ISO 11135-1) and an animal study (canine TBM model) conducted at Beth Israel Deaconess Medical Center.

Technological Characteristics

System uses Optical Coherence Tomography (OCT) with a swept-source laser (1250-1360 nm). Components include a console and a single-use sterile probe with a flexible fiber optic mechanism. Complies with IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), and ISO 10993 (biocompatibility). Sterilization via ethylene oxide (ISO 11135-1).

Indications for Use

Indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization in patients.

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)

Submission Summary (Full Text)

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Tomophase OCTIS 510(k) Submission - Section 5

1 2010 DEC

510(k) Summary per 21 CFR 807.92

102599 510(k) number: _K

## A. 510(k) owner's name, address, phone and fax numbers, name of contact person, and date the summary was prepared [21 CFR 807.92(a)(1)]

| Company Name: | Tomophase Corporation |
|-----------------------|------------------------------------------------|
| Company Address: | 1 North Avenue, Burlington, MA 01803 |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Name & Title: | Derek Beaupre, Regulatory & Quality Consultant |
| Contact Email: | [e-mail] |
| Contact Phone: | [phone] |
| Date Prepared: | August 31, 2010 |

#### B. Device Name [21 CFR 807.92(a)(2)|

| Trade Name: | Tomophase OCTIS |
|-----------------------|-----------------------------------------------|
| Common Name: | Optical Coherence Tomography Imaging System |
| Device Classification | System, Imaging, Optical Coherence Tomography |
| Name: | (OCT) |
| Regulation Number: | 892.1560 |
| Product Code: | NQQ |
| Review Panel: | General & Plastic Surgery |
| Device Class: | II |

## C. Legally marketed predicate device for substantial equivalence [21 CFR 807.92(a)(3)]

| Substantial equivalence is being claimed with the | Imalux OCT Imaging |
|---------------------------------------------------|--------------------|
| following legally marketed predicate device: | System |
| Predicate device 510(k) number: | K033783 |

## D. Description of the device [21 CFR 807.92(a)(4)|

The Tomophase OCTIS is an imaging tool for the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. The system consists of an Imaging Console and a detachable Probe.

The Imaging Console contains optical and electrical components to utilize NIR light to create high resolution real-time images; and has a user interface for acquiring, displaying, saving and reporting the images.

The Probe is a single-use, sterile device consisting of a sealed sheath and a flexible fiber optic mechanism.

### E. Intended use of the device |21 CFR 807.92(a)(5)]

The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

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## 510(k) Summary per 21 CFR 807.92

**510(k) number:** K102599

## F. Technological characteristics of the device as compared to predicate device (21 CFR 807.92(a)(6)]

Both the new Tomophase OCTIS and the predicate Imalux OCT utilize Optical Coherence Technology to create high resolution cross-sectional real-time iphages of tissue microstructure. Both devices also use low coherence interferometry to measure in-depth backscattering profiles to construct the images.

| Criteria | Imalux OCT Imaging<br>System | Tomophase OCTIS |
|-------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Measurement<br>Technique | Optical Coherence<br>Tomography (OCT) | Optical Coherence<br>Tomography (OCT) |
| Optical<br>Technology | Uses NIR (near infrared light)<br>to create high resolution real-<br>time images. | Uses NIR (near infrared light)<br>to create high resolution real-<br>time images. |
| Wavelength<br>[NIR Range:<br>700-1400 nm] | 960 - 990 nm | 1250 - 1360 nm |
| Optical Source | Super Luminescent Diode<br>(SLD) | Swept Source Laser |
| Laser Safety<br>Class | 3R | 3R |
| Optical<br>Radiation<br>Emission Safety | Safe for indicated use<br>(8% of Maximum Permissible<br>Exposure) | Safe for indicated use<br>(<10% of Maximum<br>Permissible Exposure) |

A summary of the technological characteristics is provided the following table:

## G. Non-clinical performance data [21 CFR 807.92(b)(1)]

Safety testing, bench testing, and animal testing were used to evaluate the safety and performance of the Tomophase OCTIS. These tests include the following

| Safety Testing | Recognized Standard |
|--------------------------------|----------------------------------------------------|
| Risk Management | ISO 14971 |
| Medical Electrical Equipment | IEC 60601-1 |
| Electrical Safety | IEC 60601-1-1 |
| Electromagnetic Compatibility | IEC 60601-1-2 |
| Safety of Endoscopic Equipment | IEC 60601-2-18 |
| Laser Safety | IEC 60825-1 |
| Biocompatibility | ISO 10993-1 |
| Sterilization Validation | AAMI/ANSI/ISO 11135-1 |
| Ethylene Oxide Residuals | ISO 10993-7 |
| Sterile Package Integrity | ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F1929 |

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## 510(k) Summary per 21 CFR 807.92

**510(k) number:**

Image /page/2/Picture/3 description: The image shows the text '510(k) number:' followed by the handwritten number 'K102599'. The number is underlined. The text indicates that the image is likely related to a medical device or product that has been submitted for FDA approval under section 510(k) of the Food, Drug, and Cosmetic Act.

| Bench Testing | Tomophase Documents |
|---------------------------------------------|-------------------------|
| OCTIS Optical Radiation Safety Analysis | Tomophase Doc # TES-001 |
| Digitizer Qualification | Tomophase Doc # RPT-001 |
| Optical Connection Tests | Tomophase Doc # RPT-002 |
| Outer Sheath Seal Tests | Tomophase Doc # RPT-003 |
| Animal Testing | Tomophase Document |
| Beth Israel Deaconess Medical Center Report | Tomophase Report dated |
| on OCTIS Procedure with Canine TBM Model | August 6, 2010 |

### H. Clinical performance data |21 CFR 807.92(b)(2)|

This section is not applicable because Tomophase Corporation is not including any clinical performance data with this 510(k) submission.

## I. Conclusions from performance data |21 CFR 807.92(b)(3)[

Performance data from the tests listed in section G above show that the Tomophase OCTIS meets the design criteria, the performance objectives, and the user requirements.

The Tomophase OCTIS is a safe and effective device for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The emblem is rendered in black and white.

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

DEC 1 2010

Tomophase Corporation % Beaupre Consulting Mr. Derek Beaupre 14 Burgundy Drive Hampton, New Hampshire 03842

Re: K102599

Trade/Device Name: Tomophase OCTIS, Model 100002 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NOO Dated: November 02, 2010 Received: November 12,-2010

Dear Mr. Beaupre:

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

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Page 2 - Mr. Derek Beaupre

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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor-You/Industry/default.htm.

Sincerely vou

For Odd Dennis

Mark N. Melker Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

102599

Tomophase OCTIS 510(k) Submission - Section 4

Page 4-1

#### DEC 1-2010

510(k) Number (if known):

Device Name:

Indications For Use:

Tomophase OCTIS (Optical Coherence Tomography Imaging System), Model 100002

The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

| Prescription Use | <div></div> |
|-----------------------------|-------------|
| (Part 21 CFR 801 Subpart D) | <div></div> |

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic; and Restorative Devices

Page 1 of *_*_1

510(k) Number.