(72 days)
The Sysmex® XT-Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The XT- Series Body Fluid Application adds a quantitative, automated procedure for analyzing body fluids such as cerebrospinal fluid, serous fluid and synovial fluid to the XT- Series, providing enumeration of the WBCs and the RBCs.
The XT-Series is an automated hematology analyzer previously cleared by the FDA. The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells gives an image of each cell detected in the specimen.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table. Instead, it relies on a comparison to a predicate device. The "performance" is implicitly stated as demonstrating "equivalent performance" and "excellent correlation" to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to predicate method (Sysmex XE-Series Body Fluid Application) for Intended Use | "Results indicated equivalent performance." |
| Equivalence to predicate method for Methodology | "Same as predicate method." |
| Equivalence to predicate method for Reagents | Some reagents are the same, some differ, but overall performance shown to be equivalent. |
| Equivalence to predicate method for Specimen Type | "Same as predicate method." |
| Accuracy compared to predicate method | "Comparison to the XE-2100 Series Body Fluid Application demonstrated excellent correlation." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Studies were performed to evaluate the equivalency of the automated method to the predicate method," but does not provide details on the number of samples used in these studies.
- Data Provenance: Not explicitly stated. There is no mention of country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The study compares the new device to a predicate device, not directly to expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided. The study focuses on comparing the new instrument's performance to an already cleared predicate, rather than using an adjudication process for a new ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for an automated hematology analyzer, not a device that involves human reader interpretation for its primary function. Therefore, there's no mention of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this appears to be a standalone study of the device's performance. The device is an "automated hematology analyzer," and the evaluation is based on its direct measurement capabilities compared to a predicate automated device. There is no indication of a human-in-the-loop component in the performance evaluation.
7. Type of Ground Truth Used
The "ground truth" for this submission is the performance of the predicate device, the "Sysmex XE-Series Body Fluid Application." The study establishes substantial equivalence by demonstrating that the new device's measurements correlate well with those of the already cleared predicate device.
8. Sample Size for the Training Set
This information is not provided. As this is a comparison to a predicate device and not necessarily a machine learning algorithm that requires a separate training set, the concept of a "training set" in the context of AI (as understood today) might not apply directly here. The device is an automated analyzer.
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no explicitly mentioned "training set" in the context of an AI/ML algorithm. The "truth" for the evaluation is the predicate device's performance itself, which would have been established during its own clearance process.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in The sammer of the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
| 1. Submitted by: | Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: April 24, 2006 |
|---|---|
| 2. Name of Device: | Trade or proprietary name: Sysmex® Automated HematologyAnalyzer, XT- SeriesCommon name: Automated Hematology Analyzer.Classification name: Sysmex® XT-Series, AutomatedHematology, an Automated Differential Cell Counter (21 CFR864.5220) is a Class II medical device. |
| 3. Predicate Method: | The Sysmex® XT- Series Body Fluid Application claimssubstantial equivalence to the Sysmex XE-Series Body FluidApplication |
| 4. Device Description: | The XT-Series is an automated hematology analyzer previouslycleared by the FDA. The combination of side scatter, forwardscatter, and fluorescent intensity of nucleated cells gives an imageof each cell detected in the specimen. |
| 5. Intended Use: | The Sysmex® XT-Series Hematology Analyzer is a quantitative,automated hematology analyzer and leukocyte differentialcounter for in vitro diagnostic use in clinical laboratories. TheXT- Series Body Fluid Application adds a quantitative,automated procedure for analyzing body fluids such ascerebrospinal fluid, serous fluid and synovial fluid to the XT-Series, providing enumeration of the WBCs and the RBCs. |
| 6. Substantialequivalence-similaritiesand differences | The following table compares the XT- Series Body FluidApplication with the predicate method, XE-Series Body FluidApplication. |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Predicate Method | New Instrument Method | |
|---|---|---|
| XE-2100 Series Body FluidApplication | XT- Series Body Fluid Application | |
| Intended Use | To provide a quantitativedetermination of blood cells inbody fluids such as cerebrospinalfluid, serous fluid and synovialfluid. | Same as predicate method |
| Methodology | Cell count is performed on anautomated hematology analyzer. | Same as predicate method |
| Reagents | Cellpack, Sulfolyser,Stromatolyser-FB,Stromatolyser-4DL,Stromatolyser-4DS,Stromatolyser, NR,Stromatolyser-IM,CellsheathRet-Search II | Cellpack, Sulfolyser,Stromatolyser-FB,Stromatolyser-4DL,Stromatolyser-4DS,Ret-Search II |
| Specimen Type | Body Fluids such asCerebrospinal fluid, Serous fluid,Synovial fluid | Same as predicate method |
| Accuracy | Performance was established inthe previous 510(k) submission. | Comparison to the XE-2100 Series BodyFluid Application demonstrated excellentcorrelation |
Comparison to Predicate Method
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Clinical Performance Data: Studies were performed to evaluate the equivalency of the automated method to the predicate method. Results indicated equivalent performance.
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Conclusions: ______________________________________________________________________________________________________________________________________________________________________________
The performance data demonstrated substantial equivalence.
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The caduceus is surrounded by a circle of text that reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES, USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex Corporation of America One Nelson C. White Parkway Mundelein, Illinois 60060
JUL - 6 2006
Re: K061150 Trade/Device Name: Sysmex® XT-Series, Automated Hematology Analyzer. Body Fluid Application Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: April 24, 2006 Received: April 25, 2006
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 predicate 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 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 yours,
Robert Beckerh
Robert L. Becker, Jr., MD, Pr 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
K061150 510(k) Number (if known):
Device Name: Sysmex® XT- Series, Automated Hematology Analyzer
Indications For Use:
The Sysmex® XT-Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The XT- Series Body Fluid Application adds a quantitative, automated procedure for analyzing body fluids such as cerebrospinal fluid, serous fluid and synovial fluid to the XT - Series, providing enumeration of the WCC and the RBCs.
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Concurrence of CIIRD, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use | |
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Safety
| Body Fluid Application on Sysmex XT Series | |
|---|---|
| 510(k) FDA Submission | K061150 |
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§ 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.”