The Immunicon CellTracks Analyzer II is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

Device Description

The CellTracks® Analyzer II is a semi-automated fluorescence microscope. The product consists of the CellTracks® Analyzer II, a dedicated computer loaded with CellTracks® software, monitor, keybord and mouse.

The Cell Tracks Analyzer II is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CellTracks® AutoPrep System, which automates, standading wild optimizes the sample preparation with specific reagent kits.

The CellTracks Analyzer II is used in conjunction with the CellTracks AutoPrep System and in vitro diagnostic reagent kits that contain a ferrofluid-based capture reagent and immunofluonescent my one of or the detection and characterization of the captured cells. The ferrofluid reagent consists of naro-partigles with a magnetic core surrounded by a polymeric layer coated with antibodies targeting the cells of partiers. After Immunomagnetic capture and enrichment, fluorescent reagents are added for identification and enumeration of the target cells.

The processed reagent/sample mixture is dispensed by the CellTracks AutoPrep System into a cartridge that is inserted into a MagNest® cell presentation device. The strong magnetic field of the MagNest causes the magnetically-labeled target cells to move to the surface of the CallTracks Analyzer II sans the entire surface of the cartridge with a series of fluorescence filters that are defined for the assay. Cellimages from the filter are compiled and presented in a gallery format for final cell classification busths user.

AI/ML Overview

What follows is an analysis of the provided text, outlining the acceptance criteria and study details based on the information given.

Acceptance Criteria and Device Performance

The provided text focuses on a 510(k) submission for the Immunicon CellTracks® Analyzer II, where the key modification is the change in the operating system from Microsoft Windows XP to Mandrake Linux and a new Graphical User Interface (GUI). The submission asserts that "These modifications of the CellTracks Analyzer II do not raise any new issues of safety or effectiveness. The intended use of the device is the same." The conclusion drawn is "that the CellTracks Analyzer II is as safe and effective as the predicate device."

This implies that the primary acceptance criterion is equivalence in safety and effectiveness to the predicate device (Immunicon CellTracks Analyzer II K050145). However, specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision for cell enumeration) for either the predicate or the modified device are not provided in the given document.

Therefore, the table below reflects the stated acceptance criterion based on the 510(k) summary, rather than explicit numerical targets.

Acceptance Criterion	Reported Device Performance
Performance (Safety and Effectiveness) equivalent to the predicate device (Immunicon CellTracks Analyzer II K050145)	"The conclusion drawn from these studies is that the CellTracks Analyzer II is as safe and effective as the predicate device. No new issues of safety or effectiveness have been raised."
All algorithms associated with image acquisition, analysis, cell selection, review, reporting, and archiving remain unchanged.	"What has not changed with the OS replacement are: All the algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving, the logic and interface to the PC remain the same."
Basic cell definition, count, or quality cannot be altered by the user via the new GUI.	The new GUI "does not allow [users] to alter the basic cell definition, count or quality."

Study Information

Based on the provided text, here's a breakdown of the study attributes:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size (number of cases/samples) used for testing. It describes the software testing methodology but does not quantify the test data.
- Data Provenance: Not specified. The document describes software testing against requirements and design documents, but doesn't mention if biological samples or patient data were used for performance evaluation of the new software/OS. Given that the underlying algorithms remained unchanged, the focus seems to be on software functionality and integrity rather than re-validating the biological performance with new samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document describes software validation focused on requirements, design, and fault testing of the OS and GUI changes. It does not mention any expert review or ground truth establishment for a test set in the context of the device's diagnostic performance. The device is a "semi-automated fluorescence microscope" where "Cell images from the filter are compiled and presented in a gallery format for final cell classification by the user." This indicates the user is responsible for final classification, implying the algorithm provides candidates, but the document doesn't detail how the accuracy of these candidates was validated post-OS change using expert-derived ground truth.
Adjudication method for the test set:
- Not applicable/Not specified. As no ground truth establishment by experts is described, no adjudication method is mentioned.
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:
- No. The document describes software-centric testing related to changes in the operating system and graphical user interface. It does not mention any MRMC studies or human reader performance with or without AI assistance. The device is described as semi-automated, with the user performing final cell classification.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies the core algorithms for image acquisition, analysis, and cell selection remain unchanged from the predicate device. The testing described primarily validates the new operating system and GUI, ensuring they do not negatively impact the existing algorithms' function or the system's overall operation. It does not detail a standalone performance study of the algorithm itself, likely because the algorithm itself was not modified in this submission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software changes, the "ground truth" was defined by the software requirements specification (SRS) and design documents (software and database). Tests were developed to ensure the software met these specifications. There is no mention of biological or clinical ground truth (e.g., pathology, outcomes data, expert consensus on cell enumeration) being used for the validation of these specific changes.
The sample size for the training set:
- Not applicable/Not specified. The document does not describe the development or training of new algorithms. It focuses on changes to the operating system and GUI of an existing device, where the "algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving" remain the same as the predicate device.
How the ground truth for the training set was established:
- Not applicable/Not specified, as no new training set or algorithm training is mentioned in this submission. The ground truth for the original algorithms of the predicate device would have been established during its development, but this information is not provided here.

Summary

{0}------------------------------------------------

K06001/0

510(k) Summary

Date prepared: January 12, 2006

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92 (c).

Submitter's name, address, contact

The submitter of this premarket notification is Immunicon Corporation, 3401 Masons Mill Road, Suite 100, Huntingdon Valley, PA 19006. The official correspondent is Peter J Scott, Vice President of Quality Assurance and Regulatory Affairs (215-346-8251, fax 215-830-0751).

Identification of the Device and Predicate

The subject of this summary of Safety and Effectiveness is the Immunicon CellTracks® Analyzer II. The predicate device is the Immunicon CellTracks Analyzer II K050145. The subject device, CellTracks Analyzer II, is intended for use in traditional Clinical laboratories and Research Institutions. The common and classification name for this instrument is an Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.

Intended Use

The Immunicon CellTracks Analyzer II is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

Device description

10 of 250

{1}------------------------------------------------

Technical Characteristics Summary

The changes to the CellTracks Analyzer II software architecture reside in the operating system (OS). The current CellTracks Analyzer II utilizing MS Windows XP has been changed to Mandrake Linux. The Operating system performs basic tasks, such as recognizing input from the keyboard, sending output to the display screen, keeping track of files and directories on the disk, and controlling peripheral devices such as disk drives and printers.

This new operating system (Linux) is not compatible with the current Graphical User Interface (GUI). Therefore, we have developed a new Graphical User Interface (GUI). The Graphical User Interface is a program interface that uses a computer's graphics capabilities to make the program easier to use. Graphical interfaces use a pointing device to select objects, including icons, menus, text boxes, etc. A GUJ includes standard formats for representing text and graphics. This allows users to compile defined data in namanner more usable to the operator. It does not allow them to alter the basic cell definition, count or maality.

What has not changed with the OS replacement are: All the algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving, the logic and interface to the PC remain the same,

These modifications of the CellTracks Analyzer II do not raise any new issues of safety or effectiveness. The intended use of the device is the same.

Discussion of testing

The software testing methodology for validating CellTracks Analyzer II (Linux) was developed and executed using GAMP 4 Guide for Validation of Automated Systems approach. Test scripts were developed using the software requirements specification (SRS) and the design documents (software and database) to ensure that the software addresses all system requirements and the design elements have satisfied the software requirements. In addition to testing against the requirement and design documents, fault testing was performed on the instrument to ensure the software responds to power interruptions in different areas of the hardware. A Trace Matrix was developed to trace requirements thru design and testing.

Conclusion

The conclusion drawn from these studies is that the CellTracks Analyzer II is as safe and effective as the predicate device. No new issues of safety or effectiveness have been raised.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 16 2006

Immunicon Corp. c/o Mr. Peter Scott Vice President of Quality assurance and Regulatory Affairs 3401 Masons Mill Rd, Ste 100 Huntington Valley, PA 19006-3574

Re: K060110

Trade/Device Name: Immunicon CellTracks® Analyzer II Regulation Number: 21 CFR 866.6020 Regulation Name: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System Regulatory Class: Class II Product Code: NQI Dated: January 13, 2006 Received: January 18, 2006

Dear Mr. Scott:

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.

{3}------------------------------------------------

Page 2 –

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 Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Robert M. Becker, Jr.

Robert L. Becker, Jr., M.D., Ph Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

KO 60110 510(k) Number (if known):

Device Name: Immunicon CellTracks® Analyzer II

Indications For Use: The Immunicon CellTracks Analyzer II is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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 Clar

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

Koboilo

7 of 750

Regulation Number and Section

§ 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.

(a)
Identification. An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.