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 Description

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information based on the provided text for the Tomophase OCTIS 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for a specific clinical task. Instead, the "acceptance criteria" are implied by the successful completion of various safety and bench tests, demonstrating the device's adherence to relevant standards and design objectives.

Therefore, the table below reflects what can be inferred as "acceptance criteria" from the provided document, focusing on safety and technical performance, rather than clinical diagnostic performance.

Acceptance Criteria (Implied from successful test completion)	Reported Device Performance (as stated in the document)
Safety and Standards Compliance
Risk Management per ISO 14971	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Medical Electrical Equipment per IEC 60601-1	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Electrical Safety per IEC 60601-1-1	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Electromagnetic Compatibility per IEC 60601-1-2	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Safety of Endoscopic Equipment per IEC 60601-2-18	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Laser Safety per IEC 60825-1	Laser Safety Class 3R; Optical Radiation Emission Safety: <10% of Maximum Permissible Exposure (Safe for indicated use).
Biocompatibility per ISO 10993-1	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Sterilization Validation per AAMI/ANSI/ISO 11135-1	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Ethylene Oxide Residuals per ISO 10993-7	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Sterile Package Integrity per ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F1929	Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use.
Technical Bench Performance
OCTIS Optical Radiation Safety Analysis (Doc # TES-001)	Tomophase OCTIS meets design criteria, performance objectives, and user requirements.
Digitizer Qualification (Doc # RPT-001)	Tomophase OCTIS meets design criteria, performance objectives, and user requirements.
Optical Connection Tests (Doc # RPT-002)	Tomophase OCTIS meets design criteria, performance objectives, and user requirements.
Outer Sheath Seal Tests (Doc # RPT-003)	Tomophase OCTIS meets design criteria, performance objectives, and user requirements.

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

Sample Size: Not explicitly stated for specific tests beyond the mention of individual test documents (e.g., "Digitizer Qualification," "Optical Connection Tests"). The document refers to "Beth Israel Deaconess Medical Center Report on OCTIS Procedure with Canine TBM Model" for animal testing, implying a sample was used but its size or specific details are not provided.
Data Provenance:
- Bench Testing: Performed internally by Tomophase Corporation, as indicated by "Tomophase Documents" for various tests.
- Animal Testing: Conducted at "Beth Israel Deaconess Medical Center," using a "Canine TBM Model."
- Retrospective or Prospective: Not specified, but bench and animal testing are typically prospective in nature for performance evaluation. No human clinical data was submitted.

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

This information is not provided in the document as no human clinical performance data was included in this 510(k) submission. For the animal study, the document does not specify the number or qualifications of experts involved in establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided as no human clinical performance data was included. For the animal study, the adjudication method is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

No MRMC comparative effectiveness study was mentioned or performed. This device is an imaging tool and the submission explicitly states, "This section is not applicable because Tomophase Corporation is not including any clinical performance data with this 510(k) submission." Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

Not applicable. The Tomophase OCTIS is itself the standalone imaging device. The 510(k) submission describes the hardware and its technical performance characteristics, not an "algorithm only" device that would analyze images from another source. It produces images for a human to interpret.

7. The Type of Ground Truth Used

For bench testing, the "ground truth" would be the known engineering specifications, calibrated measurements, and adherence to accepted standards.
For animal testing, while not fully detailed, the ground truth would likely involve histopathology or other diagnostic methods applied to the canine tissue, validated against the OCTIS images. The document does not specify this, however.
No human pathology or outcomes data was used because no human clinical performance data was included in the submission.

8. The Sample Size for the Training Set

Not applicable / Not provided. This 510(k) summary describes a physical imaging device, not a machine learning or AI algorithm that requires a training set. The device produces raw images.

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

Not applicable / Not provided. As mentioned above, there is no indication of a training set for an AI algorithm in this submission.

Summary

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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:	(781) 229-5700
Company Fax:	(781) 229-5737
Contact Name & Title:	Derek Beaupre, Regulatory & Quality Consultant
Contact Email:	Derek@BeaupreConsulting.com
Contact Phone:	(603) 264-3831
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 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)]

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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 ImagingSystem	Tomophase OCTIS
MeasurementTechnique	Optical CoherenceTomography (OCT)	Optical CoherenceTomography (OCT)
OpticalTechnology	Uses NIR (near infrared light)to create high resolution real-time images.	Uses NIR (near infrared light)to create high resolution real-time images.
Wavelength[NIR Range:700-1400 nm]	960 - 990 nm	1250 - 1360 nm
Optical Source	Super Luminescent Diode(SLD)	Swept Source Laser
Laser SafetyClass	3R	3R
OpticalRadiationEmission Safety	Safe for indicated use(8% of Maximum PermissibleExposure)	Safe for indicated use(<10% of MaximumPermissible 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 (800) 638-2041 or (301) 796-7100 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

Prescription Use
(Part 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 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.

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.