MINI SAMPLER PROCESSOR

K970616 · Cavro Scientific Instruments, Inc. · JQW · Apr 21, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970616
• Device Name: MINI SAMPLER PROCESSOR
• Applicant: Cavro Scientific Instruments, Inc.
• Product Code: JQW · Clinical Chemistry
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2750
• Device Class: Class 1

Intended 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.

Device Story

MSP 9500 Mini Sample Processor is a microprocessor-controlled robotic system for automating laboratory sample preparation and assay methods. Device utilizes XYZ robotic positioners to move pipetting/dispensing tips to specific coordinates on a work table; integrated liquid detection sensors determine tip depth. Digital-controlled pumps perform aspiration, dispensing, or dilution of reagents and samples into tubes or microwell plates. System is modular, consisting of an enclosure, robotic modules, power supply, and central controller with external computer interface. Operated by laboratory personnel in clinical settings to improve precision and throughput of fluid handling tasks. Output is the physical preparation of samples for subsequent analysis; device does not perform diagnostic interpretation.

Clinical Evidence

Bench testing only. Performance evaluated through mechanical positioning accuracy/reproducibility (X, Y, Z axes) and liquid handling accuracy/imprecision (CV) across various syringe sizes (250uL, 1mL, 25mL). Testing included linearity, within-run and between-run imprecision, and inaccuracy at full stroke. All results met pre-defined specifications.

Technological Characteristics

Microprocessor-controlled robotic pipetting and diluting system. Features XYZ robotic positioners, liquid detection sensors, and digital-controlled fluid pumps. Modular configuration includes enclosure, power supply, and central controller with external computer interface. Supports various tubes and microwell plates. Operates via programmed XYZ coordinates and fluid volume control.

Regulatory Classification

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.

Predicate Devices

• Mini Sample Processor MSP 9000

Submission Summary (Full Text)

{0}

CAVRO SCIENTIFIC INSTRUMENTS, INC. • 242 HUMBOLDT COURT, SUNNYVALE, CA 94089
TELEPHONE [phone] • [phone] • FAX [phone]
CAVRO.
K970616
APR 21 1997

510(k) SUMMARY

510(k) SUBMITTER INFORMATION

COMPANY: CAVRO SCIENTIFIC INSTRUMENTS INC.
ADDRESS: 242 HUMBOLDT COURT
SUNNYVALE, CA 94089
PHONE: [phone]
FAX: [phone]
CONTACT: FRED WOLCOTT
MANAGER OF REGULATORY AFFAIRS
SUMMARY PREPARED: FEBRUARY 7, 1997

A TECAN GROUP COMPANY

{1}

CAVRO SCIENTIFIC INSTRUMENTS, INC. • 242 HUMBOLDT COURT, SUNNYVALE, CA 94089
TELEPHONE [phone] • [phone] • FAX [phone]
CAVRO

# 510(k) SUMMARY

## DEVICE IDENTIFICATION

| TRADE NAME: | MINI SAMPLE PROCESSOR |
| --- | --- |
| MODEL NUMBER: | MSP 9500 |
| COMMON NAME: | ROBOTIC SAMPLE PROCESSOR |
| CLASSIFICATION NAME: | PIPETTING AND DILUTING SYSTEM FOR CLINICAL USE |
| 510(k) NUMBER: | |

## SUBSTANTIALLY EQUIVALENT DEVICE

| TRADE NAME: | MINI SAMPLE PROCESSOR |
| --- | --- |
| MODEL: | MSP 9000 |
| MANUFACTURER: | CAVRO SCIENTIFIC INSTRUMENTS INC. |

A TECAN GROUP COMPANY

{2}

CAVRO SCIENTIFIC INSTRUMENTS, INC. • 242 HUMBOLDT COURT, SUNNYVALE, CA 94089
TELEPHONE [phone] • [phone] • FAX [phone]
CAVRO

# 510(k) SUMMARY

## 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.

A TECAN GROUP COMPANY

{3}

CAVRO SCIENTIFIC INSTRUMENTS, INC. • 242 HUMBOLDT COURT, SUNNYVALE, CA 94089
TELEPHONE [phone] • [phone] • FAX [phone]
CAVRO

# 510(k) SUMMARY

## 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.

A TECAN GROUP COMPANY

{4}

CAVRO SCIENTIFIC INSTRUMENTS, INC. • 242 HUMBOLDT COURT, SUNNYVALE, CA 94089
TELEPHONE [phone] • [phone] • FAX [phone]
CAVRO

# 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 | ±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% |

A TECAN GROUP COMPANY

{5}

CAVRO SCIENTIFIC INSTRUMENTS, INC. • 242 HUMBOLDT COURT, SUNNYVALE, CA 94089
TELEPHONE [phone] • [phone] • FAX [phone]
CAVRO.

# 510(k) SUMMARY

RUN TO RUN IMPRECISION (at mid stroke)

| Syringe Size | 250uL Syringe | 1mL Syringe | 25mL Syringe |
| --- | --- | --- | --- |
| Coef. of Variation (%) | 0.489% | 0.619% | 0.195% |

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% |

A TECAN GROUP COMPANY