(200 days)
The ScanView 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:
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CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Abbott Laboratories, Illinois, U.S.A) 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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Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysis® Path Vysion™ HER-2 DNA Probe kit.
The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
The ScanView 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. 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.
The provided 510(k) summary for the ScanView K101291 device outlines its indications for use and states that "Bench and clinical data demonstrate that the device meets the required specifications." However, it does not provide the specific acceptance criteria or the detailed results of the study to prove that the device meets those criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The specific criteria and performance metrics are not detailed.
- Sample size used for the test set and the data provenance: This information is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method for the test set: This information is not provided.
- 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: While the device is intended for "adjunctive automated enumeration," no MRMC study details or effect sizes are given.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No specific standalone performance study details are provided.
- The type of ground truth used: This information is not provided.
- The sample size for the training set: This information is not provided.
- How the ground truth for the training set was established: This information is not provided.
In summary, while the document confirms that studies were performed and that the device met specifications, the specific details of those studies, including acceptance criteria, performance results, and methodologies, are not included in this 510(k) Summary.
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510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name Proprietary Device Name:
Scan View
NOV 2 3 2010
Establishment Name and Registration Number of Submitter
Name: Applied Spectral Imaging Ltd., (ASI hereafter) Registration: 9615060 Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
Product Code: Regulation Number: Regulation Description: Regulatory class:
NTH 866.4700 Automated FISH Enumeration Systems Class II
Reason for 510(k) Submission
Traditional 510(k) Submission. Expansion of the indications for use.
Identification of Legally Marketed Equivalent Devices
ScanView K071398 Duet System K061602
Device Description
The ScanView 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. 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 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 (Abbott Laboratories, Illinois, 1. U.S.A) 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
- Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysion™ HER-2 DNA Probe kit. The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
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 affects have been detected.
Substantial Equivalency
It is Applied Spectral Imaging Ltd. opinion that the ScanView is substantially equivalent in terms of safety and effectiveness to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted as a bird-like figure with three human profiles forming the body.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Applied Spectral Imaging, LTD C/o Mr. Dan Laor Quality by Vision LTD 6 Sireni Haifa Israel 32972
NOV 2 3 2010
Re: K101291
Trade/Device Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Dated: Received:
Scan View System 21 CFR8866.4700 Automated FISH Enumeration Systems Class II NTH November 7, 2010 November 12, 2010
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 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 (reporting of
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Page 2 – Mr. Dan Laor
medical device-related 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 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 Parts 801 and 809), please contact the Office of In Viro 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.
enes mchan
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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Indications for Use
NOV 2 3 2010
510(k) Number (if known):
Device Name: ScanView System
The ScanView System is an automated scanning microscope and image analysis system. It is intended for invitro 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 (Abbott Laboratories, 1. Illinois, U.S.A) 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
Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of 2. chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysis® Path Vysion™ HER-2 DNA Probe kit.
The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
Prescription Use: YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: NO (Part 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)
Page 1 of
j mchan
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) $K/0/29$
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.