(74 days)
The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in-vitro diagnosis as an aide to the technologist or pathologist in the detection, classification and enumeration of cells of interest based on particular characteristics such as intensity, size, shape or fluorescence. Following fully automated scanning, the system produces a summary report of the frequency of FISH signals detected from each chromosome of interest as a basis for the diagnostic conclusion. The system also provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic conclusion. The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is intended to detect amniotic cells stained by FISH using commercially available direct labeled DNA probes or chromosomes X, Y, 13, 18 and 21.
The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. Microscope slides, prepared according to the DNA probe manufacturers' specifications, are placed into a multiple slide cassette, and loaded into the Ikoniscope™ fastFISH™ Auto/Amniocyte Test System microscope system. The system loads each slide on the automated stage, scans, and returns it to the cassette automatically. During scanning, images of cells exhibiting the predetermined characteristics for FISH signals are digitally imaged and stored. After all the slides are scanned, the workstation provides a summary of the FISH signals detected from each chromosome of interest and an image gallery that displays the image of each nucleus meeting predetermined characteristics and quantity. The medical professional can review the images to evaluate the condition of the cells, and make the diagnostic determination accordingly.
The provided text describes the Ikoniscope™ fastFISH™ Auto/Amniocyte Test System, its intended use, and its substantial equivalence to predicate devices, but it contains no specific information regarding acceptance criteria, reported device performance data, or detailed study methodology to prove that the device meets acceptance criteria.
The submission is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, rather than presenting a detailed clinical study to establish new performance criteria.
Therefore, many of the requested information points cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document states that a clinical trial was performed to "determine the accuracy of the system compared with manual FISH analysis" and to "demonstrate the reproducibility of results between systems." However, it does not present the specific acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) nor the reported device performance data from these studies.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: The document mentions "a clinical trial" and a trial "to demonstrate reproducibility" but does not specify the sample sizes used for these test sets, nor the data provenance (e.g., retrospective/prospective, country of origin).
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)
- Cannot be provided: The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions comparison with "manual FISH analysis," implying human interpretation, but no details are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: The document does not describe any adjudication method used for the test set's ground truth.
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
- Partially Answered: A "clinical trial" was conducted to "determine the accuracy of the system compared with manual FISH analysis." This suggests a comparison, but it's unclear if it was a multi-reader, multi-case study in the formal sense.
- Effect Size Cannot be Provided: The document does not report any effect size or specific metrics on how much human readers improve with AI assistance from this study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied Yes, but No Data: The device is described as an "automated scanning microscope coupled with image analysis, acquisition and display functions" that "produces a summary report of the frequency of FISH signals detected." This implies a standalone algorithmic assessment. However, no standalone performance metrics are provided. The system is intended as an "aide to the technologist or pathologist," and "provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic conclusion," suggesting it's always intended for human review.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Partially Answered: The ground truth for the study was "manual FISH analysis," which implies expert human interpretation of FISH slides. It does not mention pathology, outcomes data, or a formal expert consensus process.
8. The sample size for the training set
- Cannot be provided: The document does not mention the sample size used for the training set.
9. How the ground truth for the training set was established
- Cannot be provided: The document does not describe how the ground truth for any potential training set was established. The focus is on the clinical comparison for substantial equivalence.
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510(k) Summary
lkonisys, Inc.
lkoniscope™ fastFISH™ Auto/Amniocyte Test System
510(k) Notification KQ1039
GENERAL INFORMATION
Manufacturer:
lkonisys, Inc. 5 Science Park New Haven, CT 06511 Phone: 203 776 0791
Contact Person:
S. Michael Sharp, PhD Vice President Regulatory and Clinical Affairs
Date Prepared: May 17, 2006
DEVICE INFORMATION
Trade/Proprietary Name: Ikoniscope™ fastFISH™ Auto/Amniocyte Test System
Common/Classification Name: Automated cell-locating device
Classification: 21 CFR 888.3560 - Class II
Device Product Code: JOY
USE OF THE TERM "SUBSTANTIALLY EQUIVALENT"
Any statement regarding Substantial Equivalence made in this submission Any Statement Togarding "Salestion or not the device that is the subject of this relates only to the loud of incorrected within the United States without Pre-Submission may be ideasification by the U.S. Food and Drug Administration, Market Approvar or Toolaosmeation, or any other type of evidence, in and Should The BO Interpreted as patent infringement litigation or any proceeding any patent proooounly, melaung present submission should, therefore, not be before any i attert. Smoot. The scope of any patent application, or to whether or not the device addressed in the submission, or its use, may be whether of not the dovies addressed introl perspective, from any other device, instrument or method referred to in this submission.
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PREDICATE DEVICES
The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is substantially equivalent to FDA-approved predicate devices with regard to regulatory status, indications for use and technological characteristics. The predicate devices indications for use and toom: (1) Ikoniscope™ fastFISH™ Amnio Test System (K052577); (2) BioView Duet™ System (K040591)
INTENDED USE
The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is an automated The ikonisoope coupled with image analysis, acquisition and display Scanning miorecoped for in-vitro diagnosis as an aide to the technologist or pathologist in the detection, classification and enumeration of cells of interest pathologist in the dolootion, sizes such as intensity, size, shape or fluorescence. Following fully automated scanning, the system produces a summary report of r onowing Tally datomals detected from each chromosome of interest as a the irequency of Y Terreignate ass. The system also provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic Sounnou The Ikoniscope™ fastFISH™ Amnio Test System is intended to conclusion. The increasing by FISH using commercially available directly labeled DNA probes or chromosomes X, Y, 13, 18 and 21.
PRODUCT DESCRIPTION
The Ikoniscope™ fastFISH™ Auto Test System is intended to increase the rree "Romleoope" - reall analysis methods, by decreasing the amount of time an enoticley or canning slides in search of the cells of interest. The operator open identifies chromosome presence by identifying the colors operatorreador (acrimes ence In Situ Hybridization ("FISH") probes, and provided by the number of chromosomes appearing within each cell containing such signals.
The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is an automated THC iKomioopo low and high magnification scanning to identify targets of interest and digital iow and high magnined with an image analysis workstation. Microscope inides, prepared according to the DNA probe manufacturers' specifications, are shaced into a multiple slide cassette, and loaded into the Ikoniscope™ fastFISH™ Auto/Amniocyte Test System microscope system. The system loads each slide on the automated stage, scans, and returns it to the cassette cutomatically. During scanning, images of cells exhibiting the predetermined characteristics for FISH signals are digitally imaged and stored. After all the slides are scanned, the workstation provides a summary of the FISH signals Shocs are ourned, the nome of interest and an image gallery that displays the image of each nucleus meeting predetermined characteristics and quantity. The image of oach habled mostwate the condition of the cells, and make the diagnostic determination accordingly.
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The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System combines elements of existing technologies to perform its function.
- Fluorescence In-Situ Hybridization (FISH) uses commercially available DNA . I labressente in Old hybhallest system) for identifying chromosomes 13, 18, 21, X and Y.
- Automatic Cell Locating/Counting using pattern recognition algorithms to . identify the signal characteristics of interest.
The Ikoniscope™ software automatically captures several sets of images of each The Konisoope - oontware addemand stores its location on the slide. These images containing New Signals and analysis.
Currently, FISH probes are approved for use as adjunct measures to accompany currently, Horrproboo are as of amniocytes, i.e. metaphase cell karyotyping. The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System will be used to assist The fitoriooope - Tabliring the FISH analysis, and will not change its adjunctive role.
SUBSTANTIAL EQUIVALENCE
Technological Characteristics
The technological characteristics of the Ikoniscope™ fastFISH™ Auto/Amniocyte The connological characterial aspects to those of the cited predicate rest System are Similar in an Socchild's a microscope, scanning capability and image display as an adjunct to FISH Analysis by a trained operator or pathologist.
Indications for Use
Substantial equivalence is also supported for the Ikoniscope™ fastFFISH™ Substantial Cquivalorio is also the predicate devices previously cited and Auto/Allings - Fost automated cell-locating devices with similar indications for use.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System was evaluated in a rice ikensoope - haste mine the accuracy of the system compared with manual FISH analysis. This clinical trial provided information that supports a finding of analyois. This equivalence between the subject device and the cited predicates Substantial clinical performance. In addition, a trial to demonstrate the reproducibility of results between systems was also conducted.
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SUMMARY
Based on the similarities in design, function, and intended use, the lkoniscope™ Dased on the Similantion in accigit, System is substantially equivalent for the devices currently marketed under the Federal Food, Drug and Cosmetic Act and cited in this submission as predicates. In addition, the Ikoniscope™ fastFISH™ Cled in this Submission as proises no new safety or effectiveness issues.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the department's name, "U.S. Department of Health & Human Services, USA."
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Petros Tsipouras CEO Ikonisys, Inc. 5 Science Park New Haven, CT 06511
AUG 9 1 2006
Re: K061392 Trade/Device Name: Ikoniscope™ fastFISH™ Auto/Amniocyte Test System Regulation Number: 21 CFR § 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: II Product Code: JOY Dated: May 18, 2006
Dear Dr. Tsipouras:
Received: May 22, 2006
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); labcling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number: K
Device Name: Ikoniscope™ fastFISH™ Auto/Amniocyte Test System
Indications for Use:
The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in-vitro diagnosis as an aide to the technologist or pathologist in the detection, classification and enumeration of cells of interest based on particular characteristics such as intensity, size, shape or fluorescence. Following fully automated scanning, the system produces a summary report of the frequency of FISH signals detected from each chromosome of interest as a basis for the diagnostic conclusion. The system also provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic conclusion. The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is intended to detect amniotic cells stained by FISH using commercially available direct labeled DNA probes or chromosomes X, Y, 13, 18 and 21.
Prescription Use _______________________________________________________________________________________________________________(21 CFR 801 Sub (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Josephine Buututi
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061392
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).