(136 days)
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 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.
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.
The provided text describes the regulatory submission for the ScanView device but does not contain detailed acceptance criteria or a comprehensive study plan or results that would allow for a complete answer to all parts of the request.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The document mentions "bench and clinical data demonstrate that the device meets the required specifications," but the specifications themselves are not provided.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, processing speed) are reported in the text.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned. The "Indications for Use" states the device is an "aiding tool to the pathologist or cytogeneticist," implying these are the expected users, but it doesn't specify their role in establishing ground truth for the study.
4. Adjudication Method:
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: Not indicated. The document focuses on the device as an "aiding tool" but doesn't describe a study comparing human performance with and without AI assistance.
- Effect size: Not applicable as no MRMC study details are provided.
6. Standalone Performance Study:
- Was it done?: Not explicitly stated, but the "Safety & Effectiveness" section notes "bench and clinical data demonstrate that the device meets the required specifications." This implies some form of device performance assessment, but whether it was "standalone" in detail (without human in the loop for assessment) is not clear, nor are the results provided.
7. Type of Ground Truth Used:
- Not mentioned.
8. Sample Size for the Training Set:
- Not mentioned.
9. How the Ground Truth for the Training Set Was Established:
- Not mentioned.
Summary of available information:
- Device Name: ScanView
- Intended Use: Automated scanning microscope and image analysis system for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in detecting, classifying, and enumerating cells of interest based on color, intensity, size, pattern, and shape.
- Specific Indication: Detects CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc.) and is limited to the analysis of CEP XY probes for assessing bone marrow transplantation effectiveness in opposite-sex transplants.
- Compliance: Designed, verified, and validated complying with 21CFR 820.30 regulations. Bench and clinical data were used.
- Predicate Devices: FISHView K050236 and CytoVision CEP XY K042542.
Conclusion:
The provided 510(k) summary focuses on the regulatory submission, device description, and indications for use. It makes a general claim of demonstrating safety and effectiveness through "bench and clinical data" but does not provide the specific details of the acceptance criteria, study design, sample sizes, ground truth establishment, or performance results that are requested. To answer these questions, one would need to access the full 510(k) submission document or a more detailed technical report.
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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.
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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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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 < magnification capture and analysis of interphase nuclei. CEP X Y is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplanes.
Prescription Use: YE (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)
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Concurrence of CDRH Office of Device Evaluation (ODE)
Division Siga-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K071398
§ 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).