Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer

K223635 · Sienco, Inc. · JBP · Jan 4, 2023 · Hematology

Device Facts

• Record ID: K223635
• Device Name: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
• Applicant: Sienco, Inc.
• Product Code: JBP · Hematology
• Decision Date: Jan 4, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7140
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Sonoclot Coagulation & Platelet Function Analyzer System is intended for use as an in vitro diagnostic device to monitor coagulation and platelet function in whole blood samples. It is intended for use by trained healthcare professionals in clinical settings.

Device Story

System measures hemostasis process (coagulation, fibrin gel formation, clot retraction, fibrinolysis) using whole blood samples. Analyzer generates qualitative 'Sonoclot Signature' graph and quantitative metrics (Activated Clotting Time-Onset, Clot Rate, Platelet Function). System operates in two configurations: historic (thermal printer) or standard (computer with Sonoclot Viewer software). Sonoclot Viewer collects, processes, displays, and stores serial data from analyzers; enables patient/operator/reagent management and hospital information system communication. Used by clinicians to identify coagulopathies and guide clinical decision-making regarding hemostasis management.

Clinical Evidence

No clinical data. Bench testing performed to validate software equivalence. Validation compared results calculated by Sonoclot Viewer against those from the predicate Signature Viewer using raw data sets to ensure equivalent performance in calculating ACT, Clot Rate, and Platelet Function.

Technological Characteristics

Mechanical sensing for coagulation monitoring. Software-based data analysis via Sonoclot Viewer. System is an in vitro diagnostic analyzer for whole blood. Modification involves reengineering of legacy software.

Indications for Use

Indicated for monitoring coagulation and platelet function in whole blood samples for patients requiring assessment of hemostasis in clinical settings.

Regulatory Classification

Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Predicate Devices

• Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer Option (K002528)
• Sonoclot Coagulation & Platelet Function Analyzer (K952560)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K223635

B Applicant

Sienco, Inc.

C Proprietary and Established Names

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JBP | Class II | 21 CFR 864.7140 - Activated Whole Blood Clotting Time Tests | HE - Hematology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II, device requiring 510(k). The following items are present and acceptable.

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.)
2. Submitter's statement that the INDICATIONS FOR USE/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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

device has not changed. This change was for reengineering of the cleared legacy Signature Viewer software.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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.

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.

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.

K223635 - Page 2 of 2