PURPLE/BLACK HEPARIN ASSAY CONTROL

K042206 · Medtronic Vascular · GGN · Oct 18, 2004 · Hematology

Device Facts

• Record ID: K042206
• Device Name: PURPLE/BLACK HEPARIN ASSAY CONTROL
• Applicant: Medtronic Vascular
• Product Code: GGN · Hematology
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

To verify the performance of the HMS instrument and HMS Heparin Assay cartridges

Device Story

Purple/Black Heparin Assay Control is an in vitro diagnostic control used to verify performance of HMS (Hemostasis Management System) instruments and associated Purple/Black HMS Heparin Assay cartridges. Device serves as quality control material to ensure system accuracy during heparin monitoring. Operated by clinical laboratory personnel or healthcare providers in clinical settings. Output is a verification of instrument/cartridge performance, ensuring reliability of heparin assay results used for clinical decision-making regarding anticoagulation therapy.

Clinical Evidence

Bench testing only. Verification testing performed on three control lots in Channels 5/6 of HMS cartridges (N=50). All lots met acceptance criteria of < 249 seconds.

Technological Characteristics

Quality control reagent containing USP porcine heparin. Used with Medtronic HMS cartridges. Verification testing conducted per ISO 14971 risk management standards and 21 CFR Part 820 quality system regulations.

Indications for Use

Indicated for verifying the performance of the HMS instrument and HMS Heparin Assay cartridges.

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

• Purple/Black HMS Control (K922031)

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 K042206

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. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) – Medtronic HMS Purple/Black Control - #K922031

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). This information is provided in pp. 2-3 of the submission.

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 replacing USP bovine heparin with USP porcine heparin, because it is no longer commercially available for manufacture of clinical use.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and storage/stability. The information is supplied on p. 3 in Table 1.

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. This information is found in Appendix C. The company submitted Failure Mode and Effects Analysis (FMEA), including a Hazards Checklist, using these documents:

PC1.48 – Product/Process Risk Management Procedure
ISO 14971 – Medical Devices; Application of Risk Management to Medical Devices
21 CFR Part 820 – Quality Systems Regulations
98/79EC – In vitro Diagnostic Device Directive
AP5514 – Product Structure, Purple/Black HMS Control

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. They also supplied test data for clotting times of (3) control lots in Channels 5/6 of cartridges (N=50). All (3) lots met the acceptance criteria of &lt; 249 seconds. This information is found in Appendix D.

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

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. The document is found in Appendix E.

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6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). These documents are found in Appendices H, F and E, respectively.

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.

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revised:8/1/03