(57 days)
The RET-He parameter on the Sysmex® XE-2100, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in clinical laboratories.
The XE-2100 is an automated hematology analyzer previously cleared by the FDA. The RET-He parameter determines the hemoglobin of the reticulocytes. (Note: XE-Pro and RET Master are required to obtain results described.)
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Accuracy (comparison to predicate method) | Comparison to CHr showed excellent correlation. |
| Equivalent performance to predicate method | Studies were performed to evaluate the equivalency of the RET-He parameter to the predicate method. Results indicated equivalent performance. |
| Substantial Equivalence | The performance data demonstrated substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions that "Studies were performed to evaluate the equivalency of the RET-He parameter to the predicate method."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not mention using experts to establish ground truth or their qualifications. The study focused on comparing the new device's output (RET-He) to a predicate device's output (CHr).
4. Adjudication Method for the Test Set
The provided text does not describe an adjudication method. Since the study compared a device's output to a predicate device's output, and not to a human-established ground truth, adjudication would likely not be relevant in the same way it is for image interpretation tasks.
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. This type of study is more common for diagnostic devices where human interpretation plays a significant role and AI aims to augment that interpretation. This submission concerns a hematology analyzer, where the device performs the measurement without human-in-the-loop interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study described is effectively a standalone (algorithm only without human-in-the-loop performance) study. The RET-He parameter is determined by the Sysmex XE-2100 analyzer using its internal methodology, and its performance was evaluated by comparing its results directly to those of the predicate device (Bayer Advia 120). There is no indication of human intervention in interpreting the results from either device for the purpose of this comparison.
7. The Type of Ground Truth Used
The ground truth used in this study was the output of the predicate device (CHr parameter on the Bayer Advia 120 Hematology System). The study aimed to demonstrate "excellent correlation" and "equivalent performance" of the new RET-He parameter to this established predicate method.
8. The Sample Size for the Training Set
The provided text does not specify a sample size for any training set. This type of device (hematology analyzer) likely has its algorithms and parameters established during its initial development and validation, rather than through a separate "training set" in the context of machine learning. The submission focuses on the performance comparison of the developed device.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned in the context of this 510(k) submission, the question of how ground truth for it was established is not applicable based on the provided text. The device's methodology for deriving reticulocyte parameters is described ("using the reticulocyte forward scattered light signals from the reticulocyte measurement channel and a proprietary Sysmex calculation equation"), implying a deterministic process rather than a machine learning model trained on a ground-truthed dataset.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance The requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 10500589 .
| 1. Submitted by: | Sysmex America, Inc. |
|---|---|
| One Nelson C. White Parkway | |
| Mundelein, IL 60060 | |
| Phone: (847) 996-4675; FAX: (847) 996-4655 | |
| Contact person: Nina Gamperling | |
| Date prepared: March 7, 2005 | |
| 2. Name of Device: | Trade or proprietary name: RET-He parameter on the Sysmex®XE-2100, Automated Hematology Analyzer. |
| Common name: RET-He | |
| Classification name: RET-He parameter on the Automated | |
| Differential Cell Counter, Sysmex® XE-2100 (21 CFR 864.5220) | |
| 3. Predicate Device: | The RET-He parameter on the Sysmex® XE-2100, AutomatedHematology Analyzer, is substantially equivalent to the CHrparameter on the Bayer Advia 120 Hematology System. |
| 4. Device Description: | The XE-2100 is an automated hematology analyzer previouslycleared by the FDA. The RET-He parameter determines thehemoglobin of the reticulocytes. (Note: XE-Pro and RET Masterare required to obtain results described.) |
| 5. Intended Use: | The RET-He parameter on the Sysmex® XE-2100, AutomatedHematology Analyzer, determines the hemoglobin ofreticulocytes for in vitro diagnostic use in clinical laboratories. |
| 6. Substantialequivalence-similaritiesand differences | The following table compares the RET-He parameter withpredicate method. |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| CHr parameter on the BayerAdvia 120 | RET-He parameter on the SysmexXE-2100 | |
|---|---|---|
| PredicateK971998 | New method | |
| Intended Use | The Advia 120 HematologySystem is a quantitative,automated hematology analyzerthat provides a leukocytedifferential count and reticulocyteanalysis for in vitro diagnostic usein clinical laboratories. | The RET-He parameter on the Sysmex®XE-2100, Automated HematologyAnalyzer, determines the hemoglobin ofreticulocytes for in vitro diagnostic use inclinical laboratories. |
| Methodology | The reticulocyte parameters arederived through a combination oflaser light scatter and absorptionof a nucleic acid dye. | The reticulocyte parameters are derivedusing the reticulocyte forward scatteredlight signals from the reticulocytemeasurement channel and a proprietarySysmex calculation equation. |
| Type ofAnticoagulant | EDTA | EDTA |
| Specimen Type | Peripheral blood | Peripheral blood |
| Accuracy | Method of CHr, mean hemoglobincontent of reticulocytes, has beenestablished as the predicatemethod. | Comparison to CHr showed excellentcorrelation. |
| Comparison Table to Predicate Method | ||||
|---|---|---|---|---|
| -------------------------------------- | -- | -- | -- | -- |
| 7. Clinical Performance Data: | Studies were performed to evaluate the equivalency ofthe RET-He parameter to the predicate method. Resultsindicated equivalent performance. |
|---|---|
| 8. Conclusions: | The performance data demonstrated substantialequivalence. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nina M. Gamperling, MBA, MT(ASCP), RAC Manager, Regulatory Affairs Sysmex America, Inc. One Nelson C. White Parkway Mundelein, IL 60060
Re: K050589
Trade/Device Name: RET-He parameter on the Sysmex® XE-2100™, Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: March 7, 2005 Received: March 9, 2005
MAY
2005
Dear Ms. Gamperling:
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 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); 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 nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the viero Diaganding 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 yours,
Robert Beckerh
Robert L. Becker, Jr., MD, P& Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
KOSOS BOOK 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: RET-He parameter on the Sysmex® XE-2100™, Automated Hematology Analyzer
Indications For Use:
The RET-He parameter on the Sysmex® XE-2100, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in clinical laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRD, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
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| ------------------ | ------------------------------------------------------------------- |
OR
| Over-The-Counter Use | |
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Division Sign Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K050589
Sysmex America, Inc. 510(k) XE-2100 RET-He Submission I I
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”