(132 days)
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No
The summary describes a standard automated blood cell analyzer with a reticulocyte module. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or other sections. The analysis is based on standard blood cell counting and staining techniques.
No.
The device is described as an "In Vitro device for whole blood cell analysis" and a "screening device for identifying abnormal blood specimens," which indicates it is used for diagnostic purposes rather than for treating or curing a disease.
Yes
Explanation: The device is described as a "screening device for identifying abnormal blood specimens," which aligns with the function of a diagnostic device. It performs "whole blood cell analysis" and reports various blood parameters, providing information to medical technologists for final review of abnormal cells, indicating its role in the diagnostic process.
No
The device description clearly outlines a physical, table-top analyzer system with multiple hardware components (blood cell counting unit, reticulocyte unit, data management system, printer, sampler unit, ID bar code reader, automatic mixing/cap piercing device, SRV, detector blocks, flow cell). It also mentions the use of reagents. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "an In Vitro device for whole blood cell analysis in clinical laboratories."
- Device Description: The description details how the device analyzes blood samples (whole blood cell analysis, reticulocyte analysis) using reagents and various components to measure parameters from the blood. This process is performed outside of the living body, which is the definition of "in vitro."
- Anatomical Site: The device analyzes "whole blood," which is a biological specimen taken from the body.
- Intended User / Care Setting: The device is intended for use in "clinical laboratories" by "Medical technologists," which is a typical setting for IVD devices.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SE/RAM-1 is an In Vitro device for whole blood cell analysis in clinical laboratories. The SE-9000 portion is intended for blood cell analysis; the RAM-1 portion is intended for automated reticulocyte analysis. The instrument is a screening device for identifying abnormal blood specimens. Medical technologists are responsible for final review of abnormal cells.
Product codes
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Device Description
The SE/RAM-1 is a table-top analyzer system consisting of a blood cell counting unit (SE-9000), a reticulocyte unit (RAM-1), a Data Management System, and a printer. A Sampler Unit is attached to the SE-9000 unit, which transports samples in cassette racks to the ID bar code reader and then to the Automatic mixing/Cap piercing device.
The SE/RAM-1 system has the capability of reporting up to 23 parameters. The 23 reportable parameters are as follows: RBC, Hgb, HCT, MCV, MCH, MCHC,RDW-CV, RDW-SD. PLT. MPV. WBC. NEUT%. LYMPH%. MONO%. EO%. BASO%, NEUT#, LYMPH#, MONO#, EO#, BASO# (all from SE-9000 unit), RETIC %, RETIC# (from RAM-1 unit).
The SRV of the SE-9000 contains a port (in the original design of the instrument) by which the reticulocyte module(RAM-1) is attached. The SRV splits the blood sample into 8 aliquots. 7 aliquots are delivered to the SE-9000 system, diluted with the appropriate diluent or lyse and sent to their respective detector blocks for analysis. The 8th aliquot is sent to the RAM-1 where it is diluted and stained, then sent to the flow cell for analysis. The SE/RAM-1 system uses a total of up to 13 reagents. All reagents are the same as used on the stand-alone SE-9000 and the R-3000 analyzers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Medical technologists are responsible for final review of abnormal cells.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness
Sysmex Corporation of America Gilmer Road 6699 RFD Long Grove, IL 60047-9596 (847)726-3662 Fax: (847)726-3505 Attention: Cathy Trester Date Prepared: December 10, 1996
MAR | 3 1997
Sysmex™ SE/RAM-1, Trade name and Common name
The Sysmex™ SE/RAM-1 is substantially equivalent to the Sysmex™ SE-9000 (Premarket Notification K936023) and the R-3000 (Premarket Notification K912494). The Sysmex™ SE/RAM-1 is classified as a Class II device.
Intended Use
The SE/RAM-1 is an In Vitro device for whole blood cell analysis in clinical laboratories. The SE-9000 portion is intended for blood cell analysis; the RAM-1 portion is intended for automated reticulocyte analysis. The instrument is a screening device for identifying abnormal blood specimens. Medical technologists are responsible for final review of abnormal cells.
Device Description
The SE/RAM-1 is a table-top analyzer system consisting of a blood cell counting unit (SE-9000), a reticulocyte unit (RAM-1), a Data Management System, and a printer. A Sampler Unit is attached to the SE-9000 unit, which transports samples in cassette racks to the ID bar code reader and then to the Automatic mixing/Cap piercing device.
The SE/RAM-1 system has the capability of reporting up to 23 parameters. The 23 reportable parameters are as follows: RBC, Hgb, HCT, MCV, MCH, MCHC,RDW-CV, RDW-SD. PLT. MPV. WBC. NEUT%. LYMPH%. MONO%. EO%. BASO%, NEUT#, LYMPH#, MONO#, EO#, BASO# (all from SE-9000 unit), RETIC %, RETIC# (from RAM-1 unit).
The SRV of the SE-9000 contains a port (in the original design of the instrument) by which the reticulocyte module(RAM-1) is attached. The SRV splits the blood sample into 8 aliquots. 7 aliquots are delivered to the SE-9000 system, diluted with the appropriate diluent or lyse and sent to their respective detector blocks for analysis. The 8th aliquot is sent to the RAM-1 where it is diluted and stained, then sent to the flow cell for analysis. The SE/RAM-1 system uses a total of up to 13 reagents. All reagents are the same as used on the stand-alone SE-9000 and the R-3000 analyzers.
Similarities and Differences of the SE/RAM-1 to SE-9000 and R-3000
Technology employed in the SE/RAM-1 system is exactly the same as is used in the SE-9000 and R-3000 analyzers. Differences are in software and minor tubing connections. All similarities and differences are described in Table 1.
Conclusion
In conclusion, the Sysmex™ SE/RAM-1 is a combination of the SE-9000 and R-3000 analyzers in one operating unit. The modifications of the instrument do not raise new issues of safety and effectiveness. The data presented shows the SE/RAM-1 to be substantially equivalent to the SE-9000 and R-3000.
1
Table 1: Comparison of Sysmex™ SE/RAM-1 System to Stand-alone SE-9000 and R-3000
| | SE-9000 | SE/RAM-1
SE-9000 portion | R-3000 | SE/RAM-1
RAM-1 portion |
|-----------------------------|---------------------------------------------------------------|-----------------------------|--------------------------------------------------------|-------------------------------------------------------------------|
| Intended use | In Vitro Device
for CBC analysis | same | In Vitro Device
for reticulocyte
analysis | same |
| Sample type | EDTA
anticoagulated
whole blood | same | EDTA
anticoagulated
whole blood | same |
| Sample pathway | Open or closed
mode, through
SE-9000 SRV | same | Open or closed
mode, through R-
3000 SRV | Open or closed mode,
through SE-9000 SRV |
| Physical safety | See 510(k)
#K936023 | same | See 510(k)
#K912494 | same |
| Performance | #K936023 | same | #K912494 | same |
| Principles of Operation | | | | |
| -Biosensor system | RF/DC | same | n/a | n/a |
| -Sheath flow | used in RBC/Plt
counting | same | used in counting
system | same |
| -Scattergram/histo-
gram | See description | same | See description | Scattergram now in
color; discriminator
lines not displayed |
| -Fluorescence intensity | n/a | n/a | used in counting | same |
| -Forward scatter | n/a | n/a | used in counting | same |
| Physical hardware | | | | |
| -Main unit | | | | |
| | Hydraulic system
Electronic
system-PROM
and PC based | same | Hydraulic system
Electronic
system-PROM
based | Electronic system-
PROM and PC based |
| -Power unit | power unit | same | n/a | n/a |
| -Laser power unit | n/a | n/a | LPU | same |
| -Pneumatic Unit | PU-1 | same | same as SE | share PU with SE |
| -Sampler/barcode reader | 10 rack sampler,
LED | same | 5 rack sampler,
LED | Uses SE
sampler/barcode
reader |
| Software Programs | | | | All R software is part
of SE-DMS |
| -Display | full color display | Same elements as
SE-9000 | monochrome
display | Same elements as R-
3000 (now part of SE-
DMS display) |
| -Stored Data | 10000 sample
storage | same | 500 sample
storage | 10000(same as SE) |
| -QC program | 15 files, 180
points/file | same | 4 QC files, 60
points/file | 12 files, 180 points/file |
| -QC material | SE-Check | same | Ret-Check | same |
| -Maintenance | See 510(k)
#K936023 | same | See 510(k)
#K912494 | see description and
RAM-1 Ops manual, |