CYTOVISION FOR CEP XY by APPLIED IMAGING CORP.

The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.

This particular CytoVision software application is an accessory to the 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.

Device Description

AI/ML Overview

This letter does not provide the detailed study results needed to complete all sections of your request. It's a 510(k) clearance letter, which confirms substantial equivalence to a predicate device, not a full summary of performance studies.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the given document. The letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent," implying that performance data was submitted, but the specific acceptance criteria and reported device performance are not detailed here.

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 given 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 given document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given 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

This information is not provided in the given document. The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei," suggesting it operates as an aid, but no MRMC study details or effect sizes are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei." The "Indications For Use" state it is an "aid in chromosomal analysis" and "assists in the location of interphase and metaphase nuclei." This implies it's not a fully standalone diagnostic device but rather a tool to support human analysis. However, a standalone performance study of the algorithm within its assisting role is not explicitly described or quantified in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the given document. The device is used with the "CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit" for "analysis of CEP XY probes" to "assess the effectiveness of bone marrow transplantation." This suggests the ground truth would likely be related to the actual chromosomal status or transplant success, but how that ground truth was established for a study is not detailed.

8. The sample size for the training set

This information is not provided in the given document.

9. How the ground truth for the training set was established

This information is not provided in the given document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 26 2011

Applied Imaging Corp c/o Ms. Diane Day Vice President, Regulatory Affairs. Clinical and Quality 120 Baytech Drive San Jose, CA 95134-2302

Re: K042542

Trade/Device Name: Applied Imaging Cyto Vision CEP XY Regulation Number: 21 CFR 866.4700 Regulation Name: Automated Fluorescent In Situ Hybridization (FISH) Enumeration Systems Regulatory Class: Class II Product Code: JOY Date: December 21, 2004 Received: December 22, 2004

Dear Ms. Day:

This letter corrects our substantially equivalent letter of January 10, 2005.

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 adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the

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Page 2 - Ms. Diane Day

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 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,

Mana M. 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): K042542

Device Name: CytoVision™ CEP XY

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)

Mana Chow
Division Sign-Off

Office of in Vitro Diagnos Device Evaluation and Safe

510(4) K042542

Page 1 of

Regulation Number and Section

§ 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.