HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

K111339 · Medtronic, Inc. · JOX · Jun 8, 2011 · Hematology

Device Facts

• Record ID: K111339
• Device Name: HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
• Applicant: Medtronic, Inc.
• Product Code: JOX · Hematology
• Decision Date: Jun 8, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5680
• Device Class: Class 2

Indications for Use

The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.

Device Story

The HMS Plus is a microprocessor-based, multichannel clot timing system designed for clinical use. It automates blood pipetting into single-use cartridges to perform heparin sensitivity evaluations, heparin assays, and activated clotting times. The device processes blood samples to provide coagulation data, which clinicians use to manage patient hemostasis. This submission covers hardware modifications, including a new printer, updated PCBA components (Display Adapter Hantronix, Power Interconnect, and ADU Controller), and a transition to a Windows CE 5.0 operating system to address component obsolescence.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by system and software verification testing following hardware modifications.

Technological Characteristics

Microprocessor-based multichannel clot timing system. Hardware includes integrated Interface PCBA (combining Display Adapter Hantronix and Power Interconnect PCBA), ADU Controller PCBA (using Common Processing Platform), and a 7V printer. Operates on Windows CE 5.0. Complies with IEC 61010-1: 2001, 2nd Edition.

Indications for Use

Indicated for in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times using blood samples in a clinical setting.

Regulatory Classification

Identification

An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

Special Controls

*Classification.* Class II (special controls).

Predicate Devices

• Medtronics Hemostasis Management System (HMS Plus) (K101271)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k111339

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:

1. Medtronics Hemostasis Management System (HMS Plus), k101271; 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 the modification of the current HMS Plus hardware to replace several obsolete hardware components including the print circuit board assembly (PBCA), the ADU and printer controller. The HMS software was modified due to software unavailability requiring replacement of the operating system software, HMS Plus Boot Rom software, and software to run on the new microcontroller. Software modification also reflects removal of the porcine instrument setting to support easier device operation and eliminate operator confusion. The HMS Plus printer and mounts were modified due to obsolescence and its compatibility to the new computer PCBA. A reduction of the voltage settings was implemented to accommodate the new printer. Labeling was modified to update of the operator's manual and device labels to reference IEC 61010-1:2001, 2nd Edition standard, addition of the IVD symbols, and revision of the UL and MFR symbols.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample requirements. The differences are change in the HMS hardware, software, and removal of the porcine instrument setting. The mechanical differences are different mounts for the new printer and printer controller and the position of the printer controller PCBA from the base to the front enclosure of the device. (See section 6, page 1-22)

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 Section 7, pages 1-26 &1-27)
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 Appendix E, pages 1-284 through 1-311)
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 section 8, page 1-28) 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 section 8, page 1-29)

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure). (Listed respectively under sections 11, 5 and page 1-7)

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

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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.