(147 days)
No
The summary explicitly states that the system does not automatically classify chromosomes and relies on the operator for analysis. While it performs image processing, there is no mention of AI/ML techniques.
No
The device is intended for diagnostic purposes (karyotyping, classification of stained cells) to aid in the diagnosis of birth defects, genetic diseases, and cancer, rather than for directly treating or managing a disease or condition.
Yes
The intended use explicitly states that "Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment." This indicates that the device is used to aid in the diagnosis of diseases and conditions.
No
The device description explicitly states that the FISHView System is a "fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation," indicating it includes hardware components beyond just software.
Based on the provided information, the FISHView system is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is for karyotyping and aiding in the digital visualization, processing, counting, and classification of stained cell specimens from various human tissues (amniotic fluid, peripheral blood, chorionic villus, bone marrow, and solid tumor). These analyses are performed for the diagnosis of birth defects, chromosome abnormalities, genetic diseases, and cancer. This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Specimens: The system is designed to work with specific human specimens (amniotic fluid, blood, etc.), which are typical samples used in IVD testing.
- Diagnostic Purpose: The results obtained from using the FISHView system are intended to provide information for the diagnosis of various medical conditions.
While the system requires operator analysis and doesn't perform automatic classification, its function is to process and present data from biological specimens for diagnostic interpretation by a qualified professional. This falls squarely within the scope of an IVD.
N/A
Intended Use / Indications for Use
The FISHView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes.
In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.
The FISHView system does require and relies on the operator to analyze the digitized microscope images.
Product codes
LNJ
Device Description
The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.
Mentions image processing
Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.
In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.
The FISHView system does require and relies on the operator to analyze the digitized microscope images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
real-time microscope images, bright field and fluorescent samples
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist or Cytogeneticist
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and clinical data demonstrate that the FISHView meets the required specifications. No adverse affects have been detected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name: FISHView
Establishment Name and Registration Number of Submitter
Name: Applied Spectral Imaging Ltd. Registration: 9615060 Submission contact: Dan Laor Sireni 6, Haifa
Device Classification
Device Code: CFR Section: Name: Classification: LNJ 864.5260 Automated cell-locating device. Class II Product
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Equivalent Devices
BANDView system K012103
Duet system K040591,
Device Description
The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.
Indications for use
The FISHView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase.
The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes.
1
In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for rol dignal Productions, provinces, "
storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.
The FISHView system does require and relies on the operator to analyze the digitized microscope images.
Safety & Effectiveness
The device has been designed verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that the FISHView meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is Applied Spectral Imaging opinion that the FISHView is substantially equivalent in terms of safety and effectiveness to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JUN 27 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Applied Spectral Imaging, Limited c/o Mr. Dan Laor Managing Director Quasar Quality Limited Sirni 6 Street Haifa 32972 Israel
K050236 Re: Trade/Device Name: FISHView Regulation Number: 21 CFR § 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: II Product Code: LNJ Dated: May 16, 2005 Received: May 19, 2005
Dear Mr. Laor:
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); labeling (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.
3
Page 2 -
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 of quotions on career Device Evaluation and Safety at (240) 276-0484. Also, please note the vial Diagnostic De Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain 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,
loburt Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K050236
Device Name: FISHView
Indications For Use: The FISHView system is intended to be used for karyotyping with realtime microscope images from cultured and stained cell specimens in their metaphase. time microscope mages from cattered and fluorescent samples. Specimens suitable for banding The system works with bright freid and blood, chorionic villus, bone marrow and solid tumor. analysis are, annuotte fruit, perfeneral erre and postnatal diagnosis of birth defects, chromosome Karyotypling is normally applied for the pown's syndrome), cancer, and for the follow up of abliothianties, genette diseases (saen as 2 a 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 given cells according to quality; nor does it automatically classify chromosomes.
In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for If addition the PIST Viow is meeties and classification of stained cells and for storage of urgital Visualizing, processing, counting specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.
The FISHView system does require and relies on the operator to analyze the digitized microscope images.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K050236 |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X 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)