(136 days)
Not Found
No
The description mentions "image analysis system" and "identification and examination of cells of interest" based on features like color, intensity, size, pattern, and shape. While this involves image processing, there is no mention of AI, ML, deep learning, or any related terms in the provided text. The analysis is described as an "aiding tool" for the pathologist or cytogeneticist, suggesting a more traditional image analysis approach rather than an autonomous AI/ML system.
No
The device is an in-vitro diagnostic tool for image analysis and does not directly treat or prevent a disease or condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist."
No
The device description explicitly states it is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation, indicating it includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is intended for "in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist".
- Specific Diagnostic Application: It is indicated for use with a specific DNA probe kit (CEP® X Spectrum Orange™/CEP® Y Spectrum Green™) for the analysis of CEP XY probes to assess the effectiveness of bone marrow transplantation. This is a clear diagnostic application performed on biological samples outside of the body.
- User: The intended users are pathologists and cytogeneticists, who are professionals involved in diagnostic testing.
The device's function of analyzing cells from biological samples using microscopy and image analysis for diagnostic purposes aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ScanView is an automated scanning microscope and image analysis System. It is intended for in-vitro diagnostic use as an uiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The Scan View is indicated to detect the following cell types: CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
Product codes (comma separated list FDA assigned to the subject device)
JOY
Device Description
The Scan View System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytogenetics experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The device has been designed, verified and validated complying with 21CFR 820.30 regulations. Bench and clinical data demonstrate that the device meets the required specifications. No adverse effects have been detected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FISHView K050236, CytoVision CEP XY K042542
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
COT 1398
OCT 4 2007
oplied SDBCtral Imaging
Bringing the Delails to Light
510(k) Summary of Safety and Effectiveness (in accordance to 21 cFR 807.87(h))
Device Name
Proprietary Device Name: Scan View
Establishment Name and Registration Number of Submitter
Name: Applied Spectral Imaging Ltd. (ASI hereafter) Registration: 9615060 Submission contact: Dan Laor 4 Hamatechet Ramat Gavriel, 10551 Israel Tel: +972-4-6547567 x 246
Device Classification
Product Code: Regulation Number: Common Name: Regulation Description:
JOY 21 CFR 864.5260 Automated cell-locating device Automated fluorescence in situ hybridization (FISH) enumeration systems Class II
Regulatory class:
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Equivalent Devices
FISHView K050236 and CytoVision CEP XY K042542
Device Description
The Scan View System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytogenetics experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.
Indications for use
The ScanView is an automated scanning microscope and image analysis System. It is intended for in-vitro diagnostic use as an uiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The Scan View is indicated to detect the following cell types: CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
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Safety & Effectiveness
The device has been designed, verified and validated complying with 21CFR 820.30 regulations. Bench and clinical data demonstrate that the device meets the required specifications. No adverse effects have been detected.
Substantial Equivalency
It is Applied Spectral Imaging Ltd.'s opinion that the ScanView System is substantially equivalent in terms of safety and effectiveness to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Applied Spectral Imaging, LTD c/o Ms. Silvia Stolarski Regulatory Affairs Officer 4 Hamatechet Ramat Gavriel, 10551 ISRAEL
AUG 26 2011
Re: K071398
Trade/Device Name: Scanview, Model SC-300 Regulation Number: 21 CFR 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: Class II Product Code: JOY Date: May 13, 2007 Received: May 21, 2007
Dear Ms. Stolarski:
This letter corrects our substantially equivalent letter of October 4, 2007.
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 class II (Special Controls), 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); medical device reporting of medical device-related
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Page 2 - Ms. Silvia Stolarski
adverse events) (21 CFR 803); 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 marting 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
eni Ma Chen
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image contains the words "applied Spectral Imaging" in bold black letters. Below this, in a smaller font, is the phrase "Bringing the Details to Light". To the left of the text is a black triangle with a dotted border.
Indications for Use
510(k) Number (if known): K071398
Device Name: ScanView
Indications For Use: The Scan View System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types:
CEP® X Spectrum Orange™CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high