(45 days)
The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product 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.
The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS® software, monitor, keyboard, mouse and uninterruptible power supply (UPS). Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS 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 and standardizes the sample preparation with specific reagent kits.
Here's an analysis of the provided text regarding the CellTracks Analyzer II® device's acceptance criteria and studies:
Based on the provided 510(k) summary, the device under review (CellTracks Analyzer II®) is an upgrade to an existing predicate device (CellTracks Analyzer II® K060110). This submission primarily focuses on software verification and validation, rather than a new standalone clinical study with specific acceptance criteria in terms of diagnostic performance metrics like accuracy, sensitivity, or specificity against a clinical ground truth.
The document does not explicitly state specific acceptance criteria in terms of diagnostic performance metrics for the device. Instead, the acceptance criterion appears to be demonstrating substantial equivalence to the predicate device through software verification and validation.
The "study" that proves the device meets the acceptance criteria is the software verification and validation activities. The summary states: "Equivalence was demonstrated through software verification and validation." This implies that the software changes (upgrade from version 2.4 to 2.5.0, operating system update, anomaly solutions, new features) were thoroughly tested to ensure they did not negatively impact the device's function and continued to perform as expected, consistent with the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implied by the 510(k) Summary):
- Maintain substantial equivalence to the predicate device (CellTracks Analyzer II® K060110).
- Ensure the software upgrade (from version 2.4 to 2.5.0) does not introduce new safety or effectiveness issues.
- The software performs its intended functions (image acquisition, analysis, cell selection, review, reporting, archiving, logic and interface to PC) consistently with the predicate.
Reported Device Performance (from the 510(k) Summary):
- The performance of the CellTracks Analyzer II® (modified) is demonstrated to be substantially equivalent to the predicate device.
- No new issues of safety or effectiveness have been raised.
- Changes made include an upgraded operating system, solutions to software anomalies, new features for customer satisfaction, and software text string translations.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain substantial equivalence to predicate device. | Device demonstrated substantial equivalence to the predicate device. |
| No new issues of safety or effectiveness. | No new issues of safety or effectiveness have been raised. |
| Software functions (image acquisition, analysis, etc.) remain constant. | All algorithms and logic for image acquisition, analysis, cell selection, review, reporting and archiving, and the interface remain the same. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly mention a "test set" in the context of clinical cases or patient samples for diagnostic performance evaluation or sample sizes for such tests. Given that the submission is for a software upgrade to an already cleared device and demonstrates equivalence through software verification and validation, it's highly probable that testing involved internal software validation datasets and possibly samples used in regression testing, but no specific number of patient samples or studies on human data are described as part of this submission for establishing substantial equivalence. The data provenance is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the summary. Since the submission focuses on software changes and substantial equivalence through software verification/validation rather than a new clinical performance study, there's no mention of experts establishing ground truth for a test set of patient data.
4. Adjudication Method for the Test Set
Since no clinical "test set" with expert assessment is mentioned, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to this 510(k) summary. The submission focuses on software verification and validation to demonstrate equivalence to a predicate device, not on assessing human reader improvement with or without AI assistance. The device itself is a "semi-automated fluorescence microscope" for enumeration, implying technical functionality rather than direct AI assistance to human diagnostic interpretation in the typical MRMC study context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The 510(k) summary does not explicitly describe a standalone performance study of the algorithms. However, the device description states it is a "semi-automated fluorescence microscope" and explicitly mentions that "All of the algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving and the logic and interface to the PC remain the same" as the predicate. This suggests the algorithms have a standalone function within the semi-automated enumeration process, but formal standalone performance metrics (e.g., accuracy, precision of enumeration against a 'true' count) for the upgraded software version are not presented as part of this summary to demonstrate acceptance criteria. The verification and validation activities would have confirmed that these algorithms continue to perform their intended function.
7. The Type of Ground Truth Used
Given the nature of the device (immunomagnetic cell selection and enumeration) and the focus on software updates for an existing device, the "ground truth" during software verification and validation would likely involve:
- Reference data/simulated data: To test algorithm changes and ensure correct processing.
- Known sample counts/calibrated controls: For enumeration accuracy testing.
- Comparison to the predicate device's output: To ensure consistent results post-update.
However, the specific type of ground truth (e.g., pathology, outcomes data, expert consensus on images) is not detailed in this summary. It's more likely related to internal technical validation against established benchmarks for cell enumeration and image processing.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a training set in the context of machine learning. The device described appears to use established algorithms for image analysis and cell enumeration rather than a machine learning model that requires a "training set" in the modern sense. Therefore, this question is not applicable based on the provided document.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), this information is not applicable.
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Summary Information
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: ____________________________________________________________________________________________________________________________________________
| 1. Submitter name, address, contact | Veridex, LLC1001 U.S. Route 202Raritan, NJ 08869Contact Person: Patricia Hojnoski | |
|---|---|---|
| 2. Preparation Date | Date Special 510(k) prepared: October 27, 2011 | |
| 3. Device name | Trade or Proprietary Name: CellTracks Analyzer II®Common Name: System, immunomagnetic, circulatingcancer cell, enumerationClassification Name: Immunomagnetic circulating cancercell selection and enumeration system. (21 CFR 866.6020,Product Code NQI) | |
| 4. Predicate device | The predicate device is the CellTracks Analyzer II®(K060110, March 16, 2006) |
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510(k) Summary, Continued
:
| 5. Device Description | The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS® software, monitor, keyboard, mouse and uninterruptible power supply (UPS). Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS 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 and standardizes the sample preparation with specific reagent kits. |
|---|---|
| 6. Device intended use | The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product 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. |
| 7. Comparison to predicate device | The CellTracks Analyzer II® (modified) is substantially equivalent to the CellTracks Analyzer II® (K060110: March 16, 2006). There has been no change to intended use, fundamental scientific technology, mode of operations, or specimen type/identification. All of the algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving and the logic and interface to the PC remain the same. Changes from the predicate include: Upgrade from version 2.4 software to version 2.5.0 software: The software will include the following design changes: |
CellTracks Analyzer II® 510(k) Summary Page 2 of 3
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510(k) Summary, Continued
- -- Updated version of the operating system to support future hardware changes
- -- Solutions to software anomalies
- -- New features to enhance customer satisfaction
- -- Software text string translations to Danish
8. Conclusions
The information presented in the premarket notification demonstrates that the performance of the CellTracks Analyzer II® (modified) is substantially equivalent to the predicate device.
Equivalence was demonstrated through software verification and validation.
The information presented in the premarket notification provides assurance that the CellTracks Analyzer II® (modified) is safe and effective for the stated intended use. No new issues of safety or effectiveness have been raised.
CellTracks Analyzer II® 510(k) Summary
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Veridex, LLC c/o Patricia M. Hojnoski, MS, RAC Manager, Regulatory Affairs 1001 US Highway 202 North Raritan, NJ 08869
DEC 1 2 2011
Re: K113181
Trade Name: 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: November 28, 2011 Received: November 29, 2011
Dear Ms. Hojnoski:
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
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Page 2 - Ms. Patricia Hojnoski
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 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.goy/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,
Reena Philip
)
6
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): K11318
Device Name: CellTracks Analyzer II®
Indications For Use:
The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product 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 _ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113181
Veridex, LLC
CellTracks Analyzer II®
§ 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.