(71 days)
The BandView 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 with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic villus, bone marrow, and tissue can be used without limitation to specific diseases. 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 BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images.
The BandView system aids the cytogenetic specialist in the preparation of karyotypes of human cells in their metaphase. By transferring images of chromosome spreads from the microscope to a computer, the labor-intensive manual processing of photographs, data archiving and document preparation is eliminated. Karyotypes are assembled by the operator with the support of the Band View analysis software.
The BandView system does not locate metaphase spreads, it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the cytogeneticist to manipulate the digitized microscope images.
The provided text does not contain a study that demonstrates the device meets specific acceptance criteria. Instead, it is a 510(k) summary for the BandView system, an automated cell-locating device. The summary focuses on establishing substantial equivalence to predicate devices and outlining the device's intended use and limitations.
Therefore, I cannot populate the table or answer most of the questions as the information about a performance study, acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.
Here's what can be extracted from the text:
1. A table of acceptance criteria and the reported device performance
The document does not specify any quantitative "acceptance criteria" or provide "reported device performance" against such criteria. It states that "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." It only mentions compliance with voluntary standards related to electromagnetic compatibility and risk analysis (EN 55022:1998, EN 55024:1998, IEC 61000-4-2:1995, EN-1441: Medical devices Risk Analysis). These are general engineering/safety standards, not specific performance criteria for karyotyping accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document states that the "BandView system does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images." This indicates it's an assistive device, not one for which an MRMC study comparing AI vs. human performance would typically be presented for its 510(k) submission. No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is explicitly stated to "require and relies completely on the operator to manipulate the digitized microscope images," meaning it's not a standalone algorithm. Its performance is intrinsically linked to human interaction.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. Given the nature of the device assisting in karyotyping, the implicit "ground truth" during clinical use would be the cytogenetic specialist's final interpretation, but how this was used for validation (if any was performed and documented here) is unknown.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
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.
SEP 1 4 2001
510(K) SUMMARY
BandView system
510(k) Number KO |al03 _______________________________________________________________________________________________________________________________________________________
Applicant's Name:
Applied Spectral Imaging Ltd. P.O.B. 101 Migdal Ha Emek 10551, Israel Tel: 972-4-6547567 Fax: 972-4-6547507
Contact Person:
Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131
Date Prepared:
June, 2001
Trade Name:
BandView system
Classification Name:
Automated cell-locating device
Classification:
The FDA has classified Automated cell-locating device as class II devices (product code 88 LNJ, Regulation No. 864.5260) and they are reviewed by the Pathology Panel.
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Predicate Device:
- · Ikaros, manufactured by MetaSystems GmbH, cleared under K940240.
- · Genevision, manufactured by Applied Imaging Corp. cleared under K902311.
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the BandView system complies with the following voluntary standards:
- · EN 55022:1998, Class A:
- · EN 55024:1998:
- · IEC 61000-4-2:1995
- · EN-1441: Medical devices Risk Analysis.
Indications:
The BandView 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 with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic villus, bone marrow, and tissue can be used without limitation to specific diseases. 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 BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images.
Device Description:
The BandView system aids the cytogenetic specialist in the preparation of karyotypes of human cells in their metaphase. By transferring images of chromosome spreads from the microscope to a computer, the labor-intensive manual processing of photographs, data archiving and document preparation is eliminated. Karyotypes are assembled by the operator with the support of the Band View analysis software.
The BandView system does not locate metaphase spreads, it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the cytogeneticist to manipulate the digitized microscope images.
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Substantial Equivalence:
Applied Spectral Imaging Ltd. believes that the BandView system is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - ISSA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Applied Spectral Imaging, Ltd. c/o Ms. Shoshanna Friedman, RAC. Managing Director Push-med Ltd. 117, Ahuza Street Ra'ananna 43373, Israel
SEP 1 4 2001
Re: K012103
Trade/Device Name: BandView system Regulation Number: 21 CFR 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: Class II Product Code: LNJ Dated: June 16, 2001 Received: July 5, 2001
Dear Ms. Shoshanna Friedman:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 Part 801 and 1 11 you active specific arrivitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 59 + 12 contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionifacturers 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Band View system Device Name:
Indications for Use: The BandView 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 braght field and fluorescent samples with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic villus, bone marrow, and tissue can be used without limitation to specific diseases. 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 BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images.
Donald A. Pape
Division Sign-Off Division of Cliffical Laboratory Devices 0/2/0 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number - - -
Prescription Use V (Per 21 CFR 801.109)
OR
Over the Counter Use
§ 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).