The Imalux OCT (Optical Coherence Tomography) Imaging System is intended to be used as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

Device Description

The Imalux OCT (Optical Coherence Tomography) Imaging System utilizes near infrared (NIR) light to create high spatial resolution, real-time images near infrared (1127) be Imalux OCT Imaging System consists of an Imaging Console and a detachable, flexible fiberoptic Probe. The Imaging Console Console and a detailsptical and electrical components and a user interface system. The user interface system includes a keyboard, display, and standard Ethernet and USB ports for image data transfer.

As various tissue structural elements absorb, reflect, and scatter light As various NIR light that is backscattered from the tissue is collected and analyzed to present an image of the tissue microstructure. By analyzing andly200 to probesity as a function of tissue depth, over a lateral surface, a 2-dimensional image is constructed.

At any one lateral position, the in-depth OCT image is analogous to an At any one accrar presents backscattering intensity as a function of depth. By combining the in-depth scanning with lateral movement of the depth. Dy connemional image is created that is analogous to that of ultrasound B-scan, except that OCT uses light in lieu of sound waves. By using light instead of sound, the Imalux OCT Imaging System can achieve higher spatial resolution, but to a more shallow imaging depth, than ultrasound imaging since light is more readily attenuated in the tissue.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, while noting the limitations of the given document:

This 510(k) Summary does not contain a study specifically designed to demonstrate that the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested sections (like sample size of test set, expert qualifications, HRMC study, standalone performance) are not explicitly addressed in the document as they would be for a direct performance study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing the fundamental technology and intended use.

Criteria/Characteristic	Imalux OCT Imaging System Performance	Predicate Device (Humphrey OCT Scanner) Performance	Comparison Outcome
Technology	Optical Coherence Tomography (OCT)	Optical Coherence Tomography (OCT)	Same
Light Source	Near Infrared (NIR)	NIR	Same
Imaging Mechanism	Real-time depth visualization, 2D cross-sectional images by analyzing backscattered light intensity as a function of depth and lateral movement.	Real-time depth visualization, 2D cross-sectional images using similar principles.	Same fundamental mechanism
Intended Use	Evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.	Evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. (Specifically ocular tissue for predicate)	Same general intended use, though specific target tissues differ.
Spatial Resolution	Achieves high spatial resolution.	Achieves high spatial resolution.	Comparable
Imaging Depth	Shallower imaging depth than ultrasound (due to light attenuation).	Shallower imaging depth than ultrasound.	Comparable
Probe/Imaging Head	Detachable, flexible fiberoptic Probe, facilitates imaging from different target tissues and reprocessing.	Fiberoptic imaging head, connected to console, requires patient positioning close to head (suitable for ocular use).	Design difference, but both transport NIR light and acquire images. Imalux design supports broader tissue types.
Safety Standards	Complies with EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60825-1, AAMI/ANSI/ISO 10993-1, AAMI/ANSI ST35.	(Not explicitly detailed for predicate in this summary, but assumed to meet standards for market clearance)	Imalux demonstrates compliance.

The "study" or justification provided is the substantial equivalence argument presented in the 510(k) summary, which posits that because the Imalux device employs the same technology and has the same intended use as the legally marketed Humphrey OCT Scanner, it is "at least as safe and effective."

2. Sample size used for the test set and the data provenance

Not applicable/Not specified. The document does not describe a clinical performance study with a dedicated test set in the traditional sense (e.g., patient images interpreted by experts). The assessment is based on comparing technical characteristics and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. No such test set or expert ground truth establishment is described in this 510(k) summary.

4. Adjudication method for the test set

Not applicable/Not specified. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

Not applicable. As an imaging system, its "performance" is in generating images. Its effectiveness is based on the quality of these images for human interpretation, not on an algorithm's standalone diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The submission does not describe a study involving ground truth for disease detection or diagnosis. The ground truth, in the context of device function, is implied to be the physical principles of OCT for accurate microstructure visualization.

8. The sample size for the training set

Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The core of this 510(k) submission is the demonstration of substantial equivalence to a predicate device (Humphrey Optical Coherence Tomography (OCT) Scanner, K944523). The "acceptance criteria" are implicitly met by proving this substantial equivalence, meaning the new device is as safe and effective as the existing legally marketed device.

The "study" presented is not a traditional clinical trial with acceptance criteria for sensitivity/specificity, but rather an engineering and technological comparison to show equivalence. Key points of this comparison include:

Same fundamental technology: Both utilize Optical Coherence Tomography (OCT) with Near Infrared (NIR) light.
Same intended use: Both are for evaluating human tissue microstructure by providing 2D, cross-sectional, real-time depth visualization.
Similar functional characteristics: Both achieve high spatial resolution and offer shallow imaging depth.
Differences are not significant: The primary difference highlighted is the Imalux's detachable, flexible fiberoptic probe, which allows for imaging different tissue types (skin, mucosal membranes) and facilitates reprocessing, compared to the predicate's fixed imaging head designed for ocular tissue. This difference is presented as an enhancement that doesn't alter the fundamental safety or effectiveness for the stated intended use.
Safety Standards Compliance: The device meets relevant electrical, laser, and biocompatibility standards.

The FDA's decision to clear the device (K033783) confirms their agreement that substantial equivalence was adequately demonstrated, thus implicitly accepting the device's safety and effectiveness compared to the predicate.

Summary

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510(k) SUMMARY

This summary is being submitted in accordance with 21 CFR 807.92.

Submitter's name, address, telephone number, initial importer, contact person A.

Submitter's Name:	Imalux Corporation
Address:	1771 East 30th Street
Address:	Cleveland, OH 44114
Official Contact:	Stephanie A. S. Harrington
Title:	Vice President, Regulatory & Clinical Affairs
Telephone:	216 502-0755
Fax:	216 622-0723
E-mail:	harrington@imalux.com

Device Name, Common Name B.

1. Common/Usual Name

Optical Coherence Tomography Scanner

2. Device Name

Imalux OCT Imaging System

3. Classification Name

Name	ClassificationRegulation	Product Code	Class
Ultrasonic pulsed echoimaging system	892.1560	IYO	II

Identification of the predicate or legally marketed device C.

Device Name	510(k) Number
Humphrey Optical Coherence Tomography (OCT)Scanner	K944523

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Device Description D.

1. Summary

Design 2.

The Scanner contains optical and electrical components, including a super luminescent diode (SLD) light source. The NIR light is directed from the Scanner through the Probe's optical fiber to the patient's tissue. The optical light is backscattered from the patient's tissue, collected by the Probe's fiber, and, combined with an internal reference signal, to produce a high spatial resolution image of the superficial tissue microstructure. By using a spatial lateral scanning mechanism contained within the probe, the optical Strain scans laterally across the tissue surface while simultaneously acquiring an in-depth profile at each lateral position. By combining inacquiring an in-depth profits at cash internet System produces a two-dimensional cross-sectional image of the tissue microstructure.

The Imaging Console has a user interface for acquiring, displaying, and reporting images. Image data is stored onto the system and can be exported via Ethernet or USB data ports on the console.

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3. Materials

The external materials of the Probe distal tip are commonly used medical device materials and have been evaluated for biocompatibility. This evaluation, supported with biocompatibility testing, has demonstrated that these materials are safe for the Probe's intended use.

Intended Use E.

While the Humphrey's indication is for ocular use, imaging of sensitive eye tissue, the Imalux OCT Imaging System is indicated for use on tissue types such as skin and mucosal membranes. While the indications are different, the indications for the Imalux OCT device and the Humphrey OCT device are both within the same intended use and a comparison of their respective technologies and functional characteristics shows that the Imalux device is at least as safe and effective as the Humphrey device for this intended use.

Safety & Performance F.

To assure the safety of the device, the System has been tested to and complies with the standards listed below:

EN / IEC 60601-1 EN / IEC 60601-1-2 EN / IEC 60825-1 AAMI / ANSI / ISO 10993-1 AAMI / ANSI ST35

The Imalux OCT Imaging System is substantially equivalent to the Humphrey OCT Scanner as both devices employ the same technology, Optical Coherence Tomography, and have the same intended use of revealing tissue structural information by providing two-dimensional, crosssectional, real-time depth visualization.

Both the Imalux OCT Imaging System and the Humphrey OCT Scanner employ NIR light that is transported through a fiberoptic connection. The Imalux device uses a detachable, fiberoptic Probe that facilitates the transport of NIR light between the Imaging Console and the patient tissue; whereas, the Humphrey OCT Scanner has a fiberoptic imaging head that is connected to the console. By using a detachable, fiberoptic Probe, the

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Imalux device can acquire images from different target tissues and facilitate reprocessing; whereas, the Humphrey device requires that the patient be positioned in close proximity to the imaging head, a design which is compatible for the device's indication for scanning ocular tissue. The Imalux device permits tissue image sampling, consistent with its indication for use, while employing the same fundamental OCT technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Ms. Stephanie A.S. Harrington Vice President, Regulatory and Clinical Affairs Imalux Corporation 1771 East 30th Street Cleveland, Ohio 44114

Rc: K033783

Trade/Device Name: Imalux OCT Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: NQQ Dated: December 3, 2003 Received: December 4, 2003

Dear Ms. Harrington:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the eneksbare) to the enactment date of the Medical Device Amendments, or to commerce price to May 20, 1978, the excordance with the provisions of the Federal Food, DINAA de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, market the act include requirements for annual registration, listing of general controls provisions of vactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device ts clashinod (600 a00 royols. Existing major regulations affecting your device can may be subject to such additional controller Lifting - Parts 800 to 898. In addition, I'DA may be found in are be obserning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Ficase oe advised that 1171 5 issualite or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I coleral statutes and regalations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI'N I at 607), adomig (21 OF N Part 820), and if applicable, the elcottonic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Stephanie A.S. Harrington

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your he FDA finding of substantial equivalence of your device to a legally prematical predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please it you active of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark A. Millenson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE 4

K033783 510(k) Number (if known):

Device Name:

Imalux OCT Imaging System

Indications For Use:

The Imalux OCT (Optical Coherence Tomography) Imaging System is The Imatux OUT (Option of in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

AND/OR Prescription Use _ V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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for (Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K033783
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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.