(62 days)
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.
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.
The provided text describes the performance data for the CAVRO SCIENTIFIC INSTRUMENTS INC. MSP 9500 Mini Sample Processor. Below is a breakdown of the requested information based on the document.
1. Table of Acceptance Criteria and Reported Device Performance
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 | < 1.0% | 0.18% | < 0.05% | 0.05% |
| 125 uL Dispense | < 1.0% | 0.15% | < 0.25% | 0.13% |
| 2 uL Dispense | < 5.0% | 3.69% | < 2.5% | 2.05% |
| 1.0 mL Syringe | ||||
| 1.0 mL Dispense | < 1.0% | 0.16% | < 0.05% | 0.01% |
| 500 uL Dispense | < 1.0% | 0.50% | < 0.25% | 0.05% |
| 10 uL Dispense | < 1.0% | 0.74% | < 1.0% | 0.73% |
| 25 mL Syringe | ||||
| 25.0 mL Dispense | < 1.0% | 0.06% | < 0.05% | 0.04% |
| 12.5 mL Dispense | < 1.0% | 0.22% | < 0.05% | 0.04% |
| 250 uL Dispense | < 1.0% | 0.45% | < 0.25% | 0.23% |
Inaccuracy (at full stroke)
| Syringe Size | % Inaccuracy at Full Stroke |
|---|---|
| 250uL | 0.18% |
| 500ul | 0.41% |
| 1.0mL | 0.16% |
| 2.5mL | 0.23% |
| 5.0mL | 0.18% |
| 10.0mL | 0.10% |
| 25.0mL | 0.06% |
The study demonstrates that the device meets all specified acceptance criteria for both mechanical positioning and liquid handling, as all "Test Results" are within or better than the defined "Specification" limits.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of repetitions, specific units tested) for the test set. It mentions "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." However, the exact number of measurements or units involved in these tests is not provided.
The data provenance is not mentioned. It is likely internal testing conducted by CAVRO SCIENTIFIC INSTRUMENTS INC. given the context of a 510(k) summary for regulatory submission. There is no information on country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a robotic sample processor, and its performance is measured against objective, quantitative specifications (e.g., travel range, accuracy, imprecision of liquid volumes) rather than subjective expert interpretation from a test set.
4. Adjudication Method for the Test Set
Not applicable, as the performance criteria are objective and quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a critical component. The MSP 9500 is a robotic laboratory instrument, and its effectiveness is determined by its mechanical and fluid handling precision and accuracy, not by human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance data presented represents standalone testing of the MSP 9500 Mini Sample Processor. The device's performance is independently evaluated against its specifications, without human intervention in the execution of the measurements presented in the tables.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective, quantitative measurements against established laboratory instrument specifications for mechanical positioning and liquid handling (accuracy and imprecision). These are direct measurements of physical attributes and performance, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The MSP 9500 is a hardware device, not an AI/ML algorithm that requires a training set. The "training" in this context would refer to the engineering and calibration processes during manufacturing.
9. How the Ground Truth for the Training Set was Established
Not applicable. As noted above, this is a hardware device, not an AI/ML algorithm requiring a training set with established ground truth. Performance specifications are engineering tolerances and design goals.
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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
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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
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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.
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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.
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CAVRO SCIENTIFIC INSTRUMENTS. INC. • 242 HUMBOLDT COURT. SUNNYVALE. CA 940×9 TELEPHONE (408) 745-7400 • (800) 231-0711 • FAX (408) 745-0309
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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 | INACCURACYSPECIFICATION | INACCURACYTEST RESULTS | IMPRECISION (CV)SPECIFICATION | IMPRECISION (CV)TEST RESULTS |
|---|---|---|---|---|
| 250 uL Syringe | ||||
| 250 uL Dispense | < 1.0% | 0.18% | < 0.05% | 0.05% |
| 125 uL Dispense | < 1.0% | 0.15% | < 0.25% | 0.13% |
| 2 uL Dispense | < 5.0% | 3.69% | < 2.5% | 2.05% |
| 1.0 mL Syringe | ||||
| 1.0 mL Dispense | < 1.0% | 0.16% | < 0.05% | 0.01% |
| 500 uL Dispense | < 1.0% | 0.50% | < 0.25% | 0.05% |
| 10 uL Dispense | < 1.0% | 0.74% | < 1.0% | 0.73% |
| 25 mL Syringe | ||||
| 25.0 mL Dispense | < 1.0% | 0.06% | < 0.05% | 0.04% |
| 12.5 mL Dispense | < 1.0% | 0.22% | < 0.05% | 0.04% |
| 250 uL Dispense | < 1.0% | 0.45% | < 0.25% | 0.23% |
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RUN TO RUN IMPRECISION (at mid stroke)
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INACCURACY (at full stroke)
| Syringe Size | % Inaccuracy at Full Stroke |
|---|---|
| 250uL | 0.18% |
| 500ul | 0.41% |
| 1.0mL | 0.16% |
| 2.5mL | 0.23% |
| 5.0mL | 0.18% |
| 10.0mL | 0.10% |
| 25.0mL | 0.06% |
§ 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.