STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER

K093001 · Diagnostica Stago, Incorporated · JPA · Dec 18, 2009 · Hematology

Device Facts

• Record ID: K093001
• Device Name: STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
• Applicant: Diagnostica Stago, Incorporated
• Product Code: JPA · Hematology
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Device Story

STA-R Evolution Expert Series analyzer; automated laboratory instrument for sample processing. Modifications include hardware/mechanical component updates for reliability; replacement of obsolete parts; software enhancements for user interface; bug fixes; improved data post-processing. New operational mode added: Reverse Sequence Drilling Mode (PTB) for capped tubes, supplementing existing cap piercing Standard sequence drilling mode. Device operates in clinical laboratory settings; used by trained laboratory personnel. Output provides diagnostic test results; assists clinicians in patient management. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by risk assessment and validation studies regarding the hardware and software modifications.

Technological Characteristics

Fully automatic multi-parametric analyzer. Performs chronometric and photometric assays. Features include barcoding for reagent management and a Reverse Sequence Drilling Mode (PTB) for capped tubes. Software-controlled system for data post-processing and instrument management. No specific materials or connectivity standards (e.g., ASTM, DICOM) are detailed in the provided text.

Indications for Use

Indicated for use on human plasma samples to aid in the diagnosis of coagulation abnormalities or to monitor anticoagulant therapy in patients.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• STA-R Evolution® Expert Series analyzer (K082675)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K093001

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. STA-R Evolution® Expert Series analyzer, K082675 previously cleared device.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for modifications which include; (1) changes in hardware and mechanical components to increase the reliability of operation and replacement of obsolete components, without any change in the technology or mechanical operation by which samples are processed, (2) change in the device application software to provide operator/user use enhancements, modification of the data post-processing to increase reliability of results and bug corrections. Additionally, a new option is proposed when using capped tubes i.e. implementation of a Reverse Sequence Drilling Mode (referred to as PTB), in addition to the existing cap piercing option of Standard sequence drilling mode.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and assay methods. The difference is in minor hardware and mechanical components to increase the reliability of operation, software to provide operator/user use enhancements and the addition of new option using capped tubes.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis(Attachment 5A)
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied (Attachment 3C)
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and (Attachment 1)
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. (Attachment 1)

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.