HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

K101271 · Medtronic, Inc. · JOX · Oct 13, 2010 · Hematology

Device Facts

• Record ID: K101271
• Device Name: HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
• Applicant: Medtronic, Inc.
• Product Code: JOX · Hematology
• Decision Date: Oct 13, 2010
• 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

HMS Plus system monitors patient coagulation status; used in clinical settings by healthcare professionals. Modification involves software update to adjust quality control (QC) dispense volume from 240 µL to 220 µL when operating in International Units (IU) setting. Adjustment corrects cartridge run-time issue. Device remains substantially equivalent to original HMS Plus; fundamental scientific technology unchanged.

Clinical Evidence

No clinical data provided; device modification supported by bench testing of the updated software dispense volume.

Technological Characteristics

Microprocessor-based multichannel clot timing system; automated syringe handling; single-use cartridges; software-controlled fluidics; bench-top form factor.

Indications for Use

Indicated for use as a hemostasis management system for monitoring coagulation status in patients undergoing procedures requiring anticoagulation.

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

• Hemostasis Management System Plus (HMS Plus) (k894317)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k101271

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. Hemostasis Management System Plus (HMS Plus), k894317 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 HMS Plus software which changes the dispense volume used during quality control (QC) testing from 240 µL to 220 µL when the HMS Plus instrument is in the International Units (IU) setting. This modification corrects the volume dispense issue which causes the QC cartridge used with the HMS Plus to run longer than designed.

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 change in QC dispense volume in the IU setting from 240 µL to 220 µL.

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 23)
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 24)
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 25) 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 25)

A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure. (see page 29)

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.