(30 days)
Not Found
No
The description focuses on data collection, processing, display, and storage, and explicitly states that validation was performed by comparing results to a predicate device's calculation algorithms. There is no mention of AI or ML techniques for analysis or interpretation.
No.
The device is described as an "in vitro diagnostic device for measuring coagulation and platelet function," whose purpose is to provide "information on the entire hemostasis process" and help "identify numerous coagulopathies." It analyzes data and provides information for diagnosis, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state multiple times that the Sonoclot Coagulation & Platelet Function Analyzer System is "an in vitro diagnostic device for measuring coagulation and platelet function." It also mentions that the information provided can "be used to identify numerous coagulopathies," which is a diagnostic purpose.
No
The device description explicitly states the system includes a "Sonoclot Analyzer," which is a hardware component, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states this multiple times in both the "Intended Use / Indications for Use" and "Device Description" sections:
- "The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function."
N/A
Intended Use / Indications for Use
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Product codes
JBP
Device Description
The Sonoclot Coaqulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Sonoclot Viewer is a data collection, storage, and retrieval program for use with Sonoclot Analyzers. Sonoclot Viewer collects serial data from one or more Sonoclot Analyzers. This data is compressed, processed for certain performance results, displayed, and stored as data files.
Sonoclot Viewer enables users to assign patient, operator, and reagent information to a test, manage patient test results and analyzer/reagent quality control data, communicate with the hospital information system, and create reports to meet billing or regulatory compliance requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation was performed to ensure that the results calculated by Sonoclot Viewer are equivalent to those calculated by the predicate software Signature Viewer. This validation used raw data collected in Signature Viewer, analyzed this data using the results calculation algorithms in Sonoclot Viewer, and compared the results generated by Sonoclot Viewer to the originally calculated Signature Viewer results. Results validation demonstrated that results calculated by Sonoclot Viewer are substantially equivalent to those calculated by the predicate software, Signature Viewer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7140 Activated whole blood clotting time tests.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 04, 2023
Sienco, Inc. Jennifer Aiken Regulatory Compliance Director 5721 Arapahoe Ave. Unit A1-A Boulder, Colorado 80303
Re: K223635
Trade/Device Name: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer Regulation Number: 21 CFR 864.7140 Regulation Name: Activated Whole Blood Clotting Time Tests Regulatory Class: Class II Product Code: JBP Dated: November 30, 2022 Received: December 5, 2022
Dear Jennifer Aiken:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Min Wu -
Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K223635 Device Name
Sonoclot Coaqulation & Platelet Function Analyzer System with Sonoclot Viewer
Indications for Use (Describe)
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(K) Summary: K223635
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Sienco, Inc. |
|---|---|
| Applicant Address | 5721 Arapahoe Ave, Unit A1-A Boulder CO 80303 United States |
| Applicant Contact Telephone | 303-420-1148 |
| Applicant Contact | Ms. Jennifer Aiken |
| Applicant Contact Email | jenn@sienco.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer |
|---|---|
| Common Name | Activated whole blood clotting time tests |
| Classification Name | Activated Whole Blood Clotting Time |
| Regulation Number | 864.7140 |
| Product Code | JBP |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary predicate is listed first) | Product Code |
|---|---|---|
| K002528 | Sonoclot Coagulation & Platelet Function Analyzer System with Signature | |
| Viewer Option | JBP | |
| K952560 | Sonoclot Coagulation & Platelet Function Analyzer | JPA |
Device Description Summary
21 CFR 807.92(a)(4)
The Sonoclot Coaqulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Sonoclot Viewer is a data collection, storage, and retrieval program for use with Sonoclot Analyzers. Sonoclot Viewer collects serial data from one or more Sonoclot Analyzers. This data is compressed, processed for certain performance results, displayed, and stored as data files.
Sonoclot Viewer enables users to assign patient, operator, and reagent information to a test, manage patient test results and analyzer/reagent quality control data, communicate with the hospital information system, and create reports to meet billing or regulatory compliance requirements.
4
Intended Use/Indications for Use
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Indications for Use Comparison
There are no changes to the indications for use from the predicate device.
Technological Comparison
The Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer has the same technological characteristics as the predicate device, Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer Option.
Sonoclot Analyzer model DP-2951 is the same analyzer model used in 510(k) K002528.
System configuration, comprised of Sonoclot Analyzer connected to a user provided computer running data collection software via serial to USB connection, is the same as the system configuration in 510(k) K002528.
There is no change in the information provided by the software. Sonoclot Viewer and Signature Viewer both provide a qualitative Sonoclot Signature graph and quantitative results for activated clotting time (ACT), rate of fibrin polymerization (Clot Rate), and platelet function information.
Non-Clinical and/or Clinical Test Summary & Conclusions
Sonoclot Viewer is a reengineered software revision of the previously cleared software program, Signature Viewer, for use with Sonoclot Analyzers. These software programs have the same intended use, software features, and results calculations. Data filtering in Sonoclot Viewer has been improved to better analyze data that Signature Viewer could not analyze for quantitative results. Validation was performed to ensure that the results calculated by Sonoclot Viewer are equivalent to those calculated by the predicate software Signature Viewer. This validation used raw data collected in Signature Viewer, analyzed this data using the results calculation algorithms in Sonoclot Viewer, and compared the results generated by Sonoclot Viewer to the originally calculated Signature Viewer results. Results validation demonstrated that results calculated by Sonoclot Viewer are substantially equivalent to those calculated by the predicate software, Signature Viewer.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(b)