(82 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML image processing or analysis. The performance studies focus on safety and basic device functionality, not algorithmic performance metrics.
No
The device is described as an "imaging tool" indicated for "evaluation" of human tissue microstructure, which are diagnostic functions, not therapeutic ones.
Yes
The device is described as an "imaging tool in the evaluation of human tissue microstructure," which aims to provide visualization for assessment, and this falls under the definition of diagnostic purposes.
No
The device description explicitly states that the system consists of an "Imaging Console" and a "detachable Probe," both of which contain physical components (optical, electrical, fiber optic mechanism). This indicates it is a hardware-based imaging system, not software-only.
Based on the provided information, the Tomophase OCTIS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization." This describes a device used in vivo (within the living body) for imaging, not a device used in vitro (outside the living body) to examine specimens like blood, urine, or tissue samples.
- Device Description: The description of the system, including the Imaging Console and a detachable Probe used for real-time depth visualization of human tissue microstructure, further supports its use for in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Tomophase OCTIS is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
NQQ, NOO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Optical Coherence Tomography (OCT) utilizing NIR (near infrared light)
Anatomical Site
human tissue microstructure
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
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Summary of Performance Studies
Safety testing, bench testing, and animal testing were used to evaluate the safety and performance of the Tomophase OCTIS. These tests include:
Safety Testing: ISO 14971 (Risk Management), IEC 60601-1 (Medical Electrical Equipment), IEC 60601-1-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-2-18 (Safety of Endoscopic Equipment), IEC 60825-1 (Laser Safety), ISO 10993-1 (Biocompatibility), AAMI/ANSI/ISO 11135-1 (Sterilization Validation), ISO 10993-7 (Ethylene Oxide Residuals), ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F1929 (Sterile Package Integrity).
Bench Testing: 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: Beth Israel Deaconess Medical Center Report on OCTIS Procedure with Canine TBM Model (Tomophase Report dated August 6, 2010).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 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.
1
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
System | Tomophase OCTIS |
|-------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Measurement
Technique | Optical Coherence
Tomography (OCT) | Optical Coherence
Tomography (OCT) |
| Optical
Technology | 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 Safety
Class | 3R | 3R |
| Optical
Radiation
Emission Safety | Safe for indicated use
(8% of Maximum Permissible
Exposure) | Safe for indicated 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
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510(k) Number.