(62 days)
MINI SAMPLE PROCESSOR MSP 9000
Not Found
No
The description focuses on automated robotic pipetting and fluid handling, controlled by a microprocessor. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies evaluate mechanical positioning and liquid handling accuracy, not algorithmic performance.
No
The device is described as automating sample preparation or assay methods, involving fluid handling for laboratory analysis, not direct treatment or diagnosis of a disease or condition in a patient.
No
This device is described as a "Mini Sample Processor" intended for "automating sample preparation or assay methods" through pipetting and diluting. Its purpose is to handle fluids, not to directly provide diagnostic information about a patient.
No
The device description clearly outlines hardware components such as an enclosure, robotic modules, power supply, controller unit, fluid pumps, valves, and accessories. It is a physical instrument designed for automating sample preparation.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic) device component or accessory, but it is not a standalone IVD device that performs a diagnostic test itself.
Here's why:
- Intended Use: The intended use is "for automating sample preparation or assay methods." This directly relates to the steps involved in performing in vitro diagnostic tests. Sample preparation is a crucial part of many IVD procedures.
- Device Description: The description details a system for aspirating, dispensing, and diluting fluids, which are fundamental actions in preparing samples and running assays for diagnostic purposes.
- Performance Studies: The performance studies focus on "positioning of the sample tip and the liquid handling." These are critical performance characteristics for a device used in sample preparation and assay automation within a diagnostic workflow. The metrics evaluated (accuracy, reproducibility, inaccuracy, imprecision) are relevant to ensuring the reliability of these steps in a diagnostic context.
- Predicate Device: The predicate device is also named "MINI SAMPLE PROCESSOR," suggesting a history of similar devices being used in this context.
However, it's not a standalone IVD device because:
- It doesn't perform a diagnostic test itself (e.g., detect a specific analyte, diagnose a condition).
- It's a tool used in conjunction with other reagents, assays, and potentially other instruments to perform a diagnostic test.
In summary: The MSP 9500 Mini Sample Processor is designed to automate critical steps within an in vitro diagnostic workflow. Therefore, it falls under the scope of IVD devices as a component or accessory that enables the performance of diagnostic tests.
N/A
Intended Use / Indications for Use
It is intended to be used for automating sample preparation or assay methods and is capable of aspirating, dispensing or diluting fluids to any position on the instruments work area.
Product codes
Not Found
Device Description
The MSP 9500 Mini Sample Processor is a microprocessor controlled pipetting and diluting system. It is designed to be used for automating sample preparation or assay methods.
It is capable of aspirating, dispensing or diluting to any position on the instrument work area. An XYZ robotic positioner moves the pipetting and dispensing tip to the desired XY position then lowers it in the Z direction into the sample. A fluid pump is then used to either aspirate or dispense the desired quantity of sample or reagent.
The unit is modular, allowing customization for specific applications. It consists of an enclosure, one or two XYZ robotic modules, power supply, central controller unit, connector for interfacing with an external computer, one or more fluid pumps and may be configured with a variety of optional pumps. valves and accessories. Modular racks will accommodate many types of commonly used tubes and microwell plates. It may be private labeled to meet individual needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following data is presented to show that the device safety and effectiveness is sufficient to satisfy the needs of the intended use.
Since this device is a Sample Processor, intended to be used to automate sample preparation, there are two major performance characteristics that must be evaluated, the positioning of the sample tip and the liquid handling.
The positioning of the sample tip is evaluated by reviewing the XYZ positioning characteristics. The requirement is that the tip must be moved to the correct position on the worktable to ensure that it is over the intended test tube, micro titer plate well etc. and that it moves the correct distance in the Z direction. The summary table for Mechanical Positioning lists the specifications and test results for each of those characteristics and shows that the test results are within specification.
The liquid handling is evaluated by confirming that the volume of fluid moved is correct. The summary tables for liquid handling list the specifications and test results for each of those characteristics and show that the test results are within specification. Additional testing has been done on the unit which includes 1) linearity testing for the smallest, midsize and largest syringe, 2) imprecision testing for the same syringe sizes including both within run and between run, and 3) inaccuracy testing for all syringe sizes at full stroke. No wash carryover studies were conducted because the results are dependent upon the fluids being used. Each laboratory should verify and adjust the wash routines for their particular application.
Key Metrics
MECHANICAL POSITIONING
| CHARACTERISTIC | SPECIFICATION | TEST RESULTS |
|---|---|---|
| X-AXIS TRAVEL RANGE, 1 ARM (MIN.) | 643 mm (25.31 in) | 650 mm (25.6 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.18 mm (0.007 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.05 mm (0.002 in) |
| X-AXIS TRAVEL RANGE, 2 ARM (MIN.) | 563 mm (22.17 in) | 574 mm (22.60 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.18 mm (0.007 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.05 mm (0.002 in) |
| Y-AXIS TRAVEL RANGE (MINIMUM) | 300 mm (11.81 in) | 303 mm (11.9 in) |
| ACCURACY | ± 0.20 mm (0.008 in) | ± 0.10 mm (0.004 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.07 mm (0.003 in) |
| Z-AXIS TRAVEL RANGE (MINIMUM) | 165 mm (6.50 in) | 167 mm (6.6 in) |
| ACCURACY | ± 0.40 mm (0.016 in) | ± 0.11 mm (0.004 in) |
| REPRODUCIBILITY | ± 0.10 mm (0.004 in) | ± 0.06 mm (0.002 in) |
LIQUID HANDLING (STANDARD UNIT, USING MODEL XL3000 PUMP) WITHIN RUN INACCURACY AND IMPRECISION
| DISPENSE VOLUME | INACCURACY SPECIFICATION | INACCURACY TEST RESULTS | IMPRECISION (CV) SPECIFICATION | IMPRECISION (CV) TEST RESULTS |
|---|---|---|---|---|
| 250 uL Syringe | ||||
| 250 uL Dispense |
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
CA VRO SCIENTIFIC INSTRUMENTS, INC. . 242 HUMBOLDT COURT, SUNNY VALE, CA 94089 TELEPHONE (408) 745-7400 · (800) 231-0711 · FAX (408) 745-0309
Image /page/0/Picture/1 description: The image shows the word "CAVRO." in a bold, serif font. To the left of the word is a solid black circle with a small white crescent shape cut out of the bottom. A smaller solid black circle is to the right of the word.
21 1997
510(k) SUMMARY
510(k) SUBMITTER INFORMATION
COMPANY:
ADDRESS:
PHONE:
FAX:
CONTACT:
SUMMARY PREPARED:
CAVRO SCIENTIFIC INSTRUMENTS INC.
242 HUMBOLDT COURT SUNNYVALE, CA 94089
(408) 745-7400
(408) 745-0309
FRED WOLCOTT MANAGER OF REGULATORY AFFAIRS
FEBRUARY 7, 1997
1
Image /page/1/Picture/1 description: The image shows the word "CAVRO." in a bold, serif font. To the left of the word is a solid black circle with a small white crescent shape cut out of the bottom. To the right of the word is a period.
DEVICE IDENTIFICATION
TRADE NAME:
MODEL NUMBER:
COMMON NAME:
CLASSIFICATION NAME:
510(k) NUMBER:
SUBSTANTIALLY EQUIVALENT DEVICE
TRADE NAME:
MODEL:
MANUFACTURER:
MINI SAMPLE PROCESSOR
NSP 9500
ROBOTIC SAMPLE PROCESSOR
PIPETTING AND DILUTING SYSTEM FOR CLINICAL USE
MINI SAMPLE PROCESSOR MSP 9000 CAVRO SCIENTIFIC INSTRUMENTS INC.
A TECAN GROUP COMPANY
2
Image /page/2/Picture/1 description: The image shows the word "CAVRO." in a bold, sans-serif font. To the left of the word is a circular shape with a smaller, crescent-shaped cutout at the bottom. To the right of the word is a small, solid circle, similar to a period. The text and shapes are all in black against a white background.
DEVICE DESCRIPTION
The MSP 9500 Mini Sample Processor is a microprocessor controlled pipetting and diluting system. It is designed to be used for automating sample preparation or assay methods.
It is capable of aspirating, dispensing or diluting to any position on the instrument work area. An XYZ robotic positioner moves the pipetting and dispensing tip to the desired XY position then lowers it in the Z direction into the sample. A fluid pump is then used to either aspirate or dispense the desired quantity of sample or reagent.
The unit is modular, allowing customization for specific applications. It consists of an enclosure, one or two XYZ robotic modules, power supply, central controller unit, connector for interfacing with an external computer, one or more fluid pumps and may be configured with a variety of optional pumps. valves and accessories. Modular racks will accommodate many types of commonly used tubes and microwell plates. It may be private labeled to meet individual needs.
INTENDED USE OF THE DEVICE
It is intended to be used for automating sample preparation or assay methods and is capable of aspirating, dispensing or diluting fluids to any position on the instruments work area.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE.
The technology used in the MSP9500 and the MSP 9000 is the same. The racks which hold the samples and prepared samples are fixed in position on a work table. An XYZ robotic positioner moves the pipetting and dispensing tip to the desired XY position then lowers it in the Z direction into the sample. Both offer liquid detection, to allow the tip to lower the desired distance into the liquid. The fluid movement is accomplished through the use of digital controlled pumps.
Both units use robotic, XYZ, positioners and liquid detectors which were designed by Tecan AG and both use fluid pumps designed and manufactured by Cavro.
3
Image /page/3/Picture/1 description: The image shows the word "CAVRO." in a bold, sans-serif font. To the left of the word is a circular shape with a smaller, semi-circular cutout at the bottom, resembling an eye. A small dot is placed to the right of the word.
PERFORMANCE DATA
The following data is presented to show that the device safety and effectiveness is sufficient to satisfy the needs of the intended use.
Since this device is a Sample Processor, intended to be used to automate sample preparation, there are two major performance characteristics that must be evaluated, the positioning of the sample tip and the liquid handling.
The positioning of the sample tip is evaluated by reviewing the XYZ positioning characteristics. The requirement is that the tip must be moved to the correct position on the worktable to ensure that it is over the intended test tube, micro titer plate well etc. and that it moves the correct distance in the Z direction. The summary table for Mechanical Positioning lists the specifications and test results for each of those characteristics and shows that the test results are within specification.
The liquid handling is evaluated by confirming that the volume of fluid moved is correct. The summary tables for liquid handling list the specifications and test results for each of those characteristics and show that the test results are within specification. Additional testing has been done on the unit which includes 1) linearity testing for the smallest, midsize and largest syringe, 2) imprecision testing for the same syringe sizes including both within run and between run, and 3) inaccuracy testing for all syringe sizes at full stroke. No wash carryover studies were conducted because the results are dependent upon the fluids being used. Each laboratory should verify and adjust the wash routines for their particular application.
The summary tables are on the following page.
4
CAVRO SCIENTIFIC INSTRUMENTS. INC. • 242 HUMBOLDT COURT. SUNNYVALE. CA 940×9 TELEPHONE (408) 745-7400 • (800) 231-0711 • FAX (408) 745-0309
Image /page/4/Picture/1 description: The image shows the word "CAVRO." in a bold, serif font. To the left of the word is a solid black circle with a small white circle inside, creating the illusion of a light source. To the right of the word is a small, solid black circle.
510(k) SUMMARY
MECHANICAL POSITIONING
| CHARACTERISTIC | SPECIFICATION | TEST RESULTS |
|---|---|---|
| X-AXIS TRAVEL RANGE, 1 ARM (MIN.) | 643 mm (25.31 in) | 650 mm (25.6 in) |
| ACCURACY | $\pm$ 0.20 mm (0.008 in) | $\pm$ 0.18 mm (0.007 in) |
| REPRODUCIBILITY | $\pm$ 0.10 mm (0.004 in) | $\pm$ 0.05 mm (0.002 in) |
| X-AXIS TRAVEL RANGE, 2 ARM (MIN.) | 563 mm (22.17 in) | 574 mm (22.60 in) |
| ACCURACY | $\pm$ 0.20 mm (0.008 in) | $\pm$ 0.18 mm (0.007 in) |
| REPRODUCIBILITY | $\pm$ 0.10 mm (0.004 in) | $\pm$ 0.05 mm (0.002 in) |
| Y-AXIS TRAVEL RANGE (MINIMUM) | 300 mm (11.81 in) | 303 mm (11.9 in) |
| ACCURACY | $\pm$ 0.20 mm (0.008 in) | $\pm$ 0.10 mm (0.004 in) |
| REPRODUCIBILITY | $\pm$ 0.10 mm (0.004 in) | $\pm$ 0.07 mm (0.003 in) |
| Z-AXIS TRAVEL RANGE (MINIMUM) | 165 mm (6.50 in) | 167 mm (6.6 in) |
| ACCURACY | $\pm$ 0.40 mm (0.016 in) | $\pm$ 0.11 mm (0.004 in) |
| REPRODUCIBILITY | $\pm$ 0.10 mm (0.004 in) | $\pm$ 0.06 mm (0.002 in) |
LIQUID HANDLING (STANDARD UNIT, USING MODEL XL3000 PUMP)
WITHIN RUN INACCURACY AND IMPRECISION
| DISPENSE VOLUME | INACCURACY
SPECIFICATION | INACCURACY
TEST RESULTS | IMPRECISION (CV)
SPECIFICATION | IMPRECISION (CV)
TEST RESULTS |
|------------------|-----------------------------|----------------------------|-----------------------------------|----------------------------------|
| 250 uL Syringe | | | | |
| 250 uL Dispense |