HEPARIN ASSAY CONTROLS

K103313 · Medtronic, Inc. · GGN · Dec 1, 2010 · Hematology

Device Facts

• Record ID: K103313
• Device Name: HEPARIN ASSAY CONTROLS
• Applicant: Medtronic, Inc.
• Product Code: GGN · Hematology
• Decision Date: Dec 1, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

To verify the performance of the HMS Plus and Heparin Assay Cartridges. For In Vitro Diagnostic use.

Device Story

Modified Heparin Assay Controls (6 levels) used with HemoTec Hepcon HMS Coagulation System; replaces old USP heparin with revised USP heparin per monograph change; 9% increase in heparin concentration across all 6 levels; device functions as quality control for coagulation monitoring; used in clinical settings by healthcare professionals; modification verified via design control activities and risk analysis to ensure fundamental scientific technology remains unchanged.

Clinical Evidence

No clinical data. Substantial equivalence supported by verification testing confirming performance characteristics remain unchanged following the update to the heparin source material.

Technological Characteristics

Quality control materials for coagulation monitoring; 6 levels of Heparin Assay Controls; modified to incorporate revised USP heparin; 9% concentration increase compared to predicate.

Indications for Use

Indicated for use as quality control materials for the HemoTec Hepcon HMS Coagulation System to monitor heparin levels.

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

• Medtronic Heparin Assay Controls (K894317)
• Medtronic Heparin Assay Controls (K042206)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k103313

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. HemoTec Hepcon HMS Coagulation System and its Associated Cartridges and Controls, k894317 and Purple/Black Heparin Assay Control, k042206; previously cleared devices.
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 modification of 6 levels of Heparin Assay Controls, replacing the old USP heparin with revised USP heparin due to the heparin monograph change.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample requirements. The difference is a 9% increase in heparin concentration in each of the 6 levels of modified Heparin Assay Controls. (see page 17)

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. (see page 19)
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. (see page 20)
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, (see page 21) 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. (see page 21)

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure. (see page 25)

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.