(30 days)
The Imalux Niris Imaging System is intended to be used as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
The Imalux Niris Imaging System utilizes near infrared (NIR) light to create high spatial resolution, real-time images of human tissue microstructure. The Niris Imaging System consists of an Imaging Console and a detachable, flexible fiberoptic Probe. The Imaging Console consists of internal optical and electrical components and a user interface system. The Niris Imaging Console contains optical and electrical components, including a super luminescent diode (SLD) light source. The NIR light is directed from the Console 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 a reference, to produce a high spatial resolution image of the tissue microstructure. By using a small lateral scanning mechanism contained within the Probe, the optical beam scans laterally across the tissue surface while simultaneously acquiring an in-depth profile at each lateral position. By combining in-depth and lateral scanning, the Niris Imaging 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.
The provided text describes the Imalux Niris™ Imaging System and its clearance as substantially equivalent to a predicate device, the Imalux OCT Imaging System (K033783). However, the document does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, beyond general statements about verification and validation.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
- Information not available in the provided text. The document states that "Image performance specifications have remained unchanged" from the predicate device and that "These design modifications have been verified and validated to fulfill the performance requirements of the device." However, no specific performance metrics or acceptance criteria are listed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not available in the provided text. There is no mention of a test set, sample size, or data provenance for any performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information not available in the provided text. Since no test set or ground truth establishment is described, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not available in the provided text. No adjudication method 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
- Information not available in the provided text. This document describes an imaging system, but it does not mention any AI component, let alone an MRMC study comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not available in the provided text. The device is an "imaging tool" intended for human evaluation of tissue microstructure. There is no mention of standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not available in the provided text. No ground truth is described.
8. The sample size for the training set
- Information not available in the provided text. No training set is mentioned as this device is not described as having a machine learning component.
9. How the ground truth for the training set was established
- Information not available in the provided text. No training set or associated ground truth establishment is mentioned.
Summary of what is available:
The provided document is a 510(k) summary for the Imalux Niris™ Imaging System. It focuses on demonstrating substantial equivalence to an existing predicate device (Imalux OCT Imaging System, K033783) rather than detailing specific performance studies with acceptance criteria.
Key points mentioned regarding performance validation are:
- The system uses near infrared (NIR) light to create high spatial resolution, real-time images of human tissue microstructure.
- "Image performance specifications have remained unchanged" from the predicate device.
- "These design modifications have been verified and validated to fulfill the performance requirements of the device."
- "the device has been tested for compliance to applicable safety testing standards."
However, the specific details of these verifications and validations, including methods, acceptance criteria, sample sizes, or ground truth establishment, are not included in this summary. Such details would typically be found in more extensive technical documentation submitted to the FDA, but not necessarily in the publicly available 510(k) summary.
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Imalux Corporation
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3 510(k) SUMMARY
NOV 1 9 2004
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 |
B. Device Name, Common Name
1. Common/Usual Name
Optical Coherence Tomography (OCT) Imaging System
2. Device Name
Imalux Niris™ Imaging System
3. Classification Name
| Name | ClassificationRegulation | Product Code | Class |
|---|---|---|---|
| System, Imaging, OpticalCoherence Tomography (OCT) | 892.1560 | NQQ | II |
ं Identification of the predicate or legally marketed device
| Device Name | 510(k) Number |
|---|---|
| Imalux OCT Imaging System | K033783 |
D. Device Description
The Imalux Niris Imaging System utilizes near infrared (NIR) light to create high spatial resolution, real-time images of human tissue microstructure. The Niris Imaging System consists of an Imaging Console and a detachable, flexible fiberoptic Probe. The Imaging Console consists of internal optical and electrical components and a user interface system.
The Niris Imaging Console contains optical and electrical components, including a super luminescent diode (SLD) light source. The NIR light is directed from the Console 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 a reference, to produce a high spatial resolution image of the tissue microstructure. By using a small lateral scanning mechanism contained within the Probe, the optical beam scans laterally across the tissue surface while simultaneously
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acquiring an in-depth profile at each lateral position. By combining in-depth and lateral scanning, the Niris Imaging 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.
E. Intended Use
The Imalux Niris Imaging System is intended to be used as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
F. Comparison to Predicate Device:
The Niris Imaging System is substantially equivalent in its intended use, technologies, principle of operation, and functionality to the Imalux OCT Imaging System, cleared under 510(k) premarket notification number K033783. It has the same technological characteristics, key safety and performance features, physical design, construction, and has the same intended uses and operating modes as the predicate device.
Both Systems include an Imaging Console and a detachable, reusable Probe. Within the Console, both System designs are based on the principles of Optical Coherence Tomography, which utilizes low coherence interferometry. In addition, both Systems use Near Infrared (NIR) light, albeit at slightly different central wavelengths. A modification in the optical topology has enabled Probes of different lengths to be used with the same Console, without impacting the performance specifications. Image performance specifications have remained unchanged. The Probe distal design is the same for both devices; however, the proximal end connector to the console has been integrated from two separate connectors into one for ease of use. Minor software enhancements, such as image scrolling, have been added to facilitate ease-of-use.
These design modifications have been verified and validated to fulfill the performance requirements of the device. In addition, the device has been tested for compliance to applicable safety testing standards.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wavy lines extending from its body, representing the agency's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Ms. Stephanie A.S. Harrington Vice President, Regulatory and Clinical Affairs Imalux Corporation 1771 East 300 Street Cleveland, Ohio 44114
Re: K042894
Trade/Device Name: Imalux Niris™ Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: NOQ Dated: October 18, 2004 Received: October 20, 2004
Dear Ms. Harrington:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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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4 INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Imalux Niris™ Imaging System
Indications For Use:
The Imalux Niris 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.
KO42
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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K042894
§ 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.