(22 days)
The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer.
For in vitro Diagnostic Use. For professional use. Rx only.
The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery operated hand-held instrument. The system is intended for use in clinical settings requiring point of care testing. Whole blood test results are displayed as clotting times (in seconds). The instrument also displays correlated Celite® equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value.
The Hemochron™ Signature Elite Whole Blood Microcoagulation System contains a test chamber which warms a test cuvette to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cuvette and the test is started by the operator. The front panel contains a keypad with various action keys as well as a number pad. The operator uses the keypad to select a command or enter information. The instrument also includes a barcode scanner for reading of barcode identifications (IDs).
Data management capabilities are included with the instrument. These capabilities include storage of up to 600 patient results and 600 quality control results, designation of quality control levels, tagging of test results with date and time, entry of Patient ID and/or Operator ID or Operator PIN and printing of results
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hemochron™ Signature Elite device.
This document describes a Special 510(k) submission for a software update (Version 2.3 to 2.4) to an already cleared device, the Hemochron™ Signature Elite (K050016). Special 510(k)s are used when the modifications do not significantly alter the device's fundamental scientific technology, indications for use, or safety and effectiveness, and when well-established methods are available to evaluate the change. This means that a full de novo study with extensive acceptance criteria and performance data is generally not required for such submissions. Instead, the focus is on demonstrating that the software change itself does not introduce new risks or affect the established performance of the device.
Therefore, the "acceptance criteria" here are primarily satisfied by demonstrating substantial equivalence to the predicate device, particularly by showing that the software update does not change the prior performance claims. The study is a comparison of the updated device to its predicate, confirming that critical specifications remain substantially equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
For this Special 510(k) with a software update, the acceptance criteria are implicitly that the updated device performs equivalently to the predicate device across all listed operational and performance characteristics. The reported device performance is that these characteristics remain "Substantially Equivalent" after the software update.
| Acceptance Criteria Category | Specific Criteria (from predicate device) | Reported Device Performance (with software v2.4) |
|---|---|---|
| Intended Use | Identical to predicate device | ✓ Substantially Equivalent |
| Assays Used | Identical to predicate device | ✓ Substantially Equivalent |
| Sample Type | Identical to predicate device | ✓ Substantially Equivalent |
| Reagents | Identical to predicate device | ✓ Substantially Equivalent |
| Reported Results | Identical to predicate device | ✓ Substantially Equivalent |
| Precision | ≤10% C.V. for whole blood samples | ✓ Substantially Equivalent |
| Results Display | Displayed on LCD screen | ✓ Substantially Equivalent |
| Timing Range | 0 seconds to 1005 seconds | ✓ Substantially Equivalent |
| Operating Environment | 15°C - 30 °C | ✓ Substantially Equivalent |
| Clot Detection Method | Mechanical-optical clot detection | ✓ Substantially Equivalent |
| Liquid QC Requirement | Two levels – Performed as directed | ✓ Substantially Equivalent |
| Power | Battery or AC operated | ✓ Substantially Equivalent |
| PC Connectivity | RS-232 and Ethernet Ports | ✓ Substantially Equivalent |
| User/Patient Data Input | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
| Data Storage Capacity | 16 OID/20 PID alphanumeric, 600 entries | ✓ Substantially Equivalent |
| Electronic QC Requirement | Internal electronic QC | ✓ Substantially Equivalent |
| Assay Parameter Input | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
| LQC Parameter Input | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
Difference Incubation Warm Up Time | 30 seconds to 90 seconds (Predicate) | Up to 200 seconds (Subject Device) - This is a noted difference, but the submission claims it does not negate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a new performance study. The submission is a Special 510(k) for a software update, claiming that "Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change." The comparison detailed is against the predicate device (K050016), implying that previously established performance characteristics of the predicate are used as the benchmark.
Therefore, no new sample size for a test set is explicitly provided or required in this summary for the software update. The data provenance is implicitly the performance data established for the predicate device (K050016) in its original clearance process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a Special 510(k) for a software update and does not describe a new clinical or analytical study requiring expert ground truth establishment for a novel test set, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As no new test set is described or required for this type of submission, no adjudication method is mentioned. The evaluation is based on a comparison to the established specifications of the predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The device, Hemochron™ Signature Elite, is a point-of-care coagulation system. It measures clotting times. There is no indication of AI or human reader interpretation involved in its operation. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was done or reported here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an AI-based algorithm for interpretation. It's an in-vitro diagnostic instrument that objectively measures clotting times. Therefore, a standalone algorithm performance study (in the context of AI) is not applicable and not mentioned. The device operates as a standalone instrument for its intended use.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For this type of device (a coagulation measurement system), the "ground truth" for its accuracy and precision would typically be established by comparing its measurements to a recognized reference method (e.g., a laboratory gold standard coagulation analyzer) or by using calibrated control materials with known values. This information would have been established during the original clearance of the predicate device (K050016). For this Special 510(k), the "ground truth" is that the updated software does not alter the device's ability to accurately perform these measurements as previously established.
8. The Sample Size for the Training Set
The document does not describe the development of a predictive model or an AI algorithm that would require a "training set." The submission pertains to a software update for a measurement device.
9. How the Ground Truth for the Training Set was Established
As there is no training set mentioned or implied for this device's function, this question is not applicable.
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November 22, 2019
Accriva Diagnostics, Inc. Brian James Sr. Manager, Regulatory Affairs 6260 Sequence Drive San Diego, California 92121
Re: K193041
Trade/Device Name: Hemochron Signature Elite Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: October 30, 2019 Received: October 31, 2019
Dear Brian James:
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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,
Takeesha Taylor-Bell Acting Deputy Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Hemochron™ Signature Elite
Indications for Use (Describe)
The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer.
For in vitro Diagnostic Use. For professional use. Rx only.
| 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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510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92
| Submitter's Information | Accriva Diagnostics, Inc.6260 Sequence DriveSan Diego, CA 92121, USA |
|---|---|
| ------------------------- | ------------------------------------------------------------------------------ |
| Contact Person | Brian James, Senior Manager, Regulatory Affairs |
|---|---|
| Phone: 858-263-2350 | |
| Email: bjames@ilww.com |
| Preparation Date | October 30, 2019 |
|---|---|
| ------------------ | ------------------ |
| Device Trade Name | Hemochron™ Signature Elite |
|---|---|
| ------------------- | ---------------------------- |
| Regulatory Information | Classification: | Class II |
|---|---|---|
| Regulation No.: | 21 CFR 864.5425 | |
| Common Name: | System, Multipurpose For In VitroCoagulation Studies | |
| Panel: | Hematology (81) | |
| Product Code: | JPA |
| Predicate Device | Hemochron™ Signature Elite: K050016 | |
|---|---|---|
| Indications for UseIntended Use | / The Hemochron™ Signature Elite Whole BloodMicrocoagulation System is a battery operated, hand-heldinstrument that performs individual point-of-carecoagulation tests on fresh or citrated whole blood. Thesetests include: Activated Clotting Time (ACT+ and ACT- |
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| LR), Activated Partial Thromboplastin Time (APTT andAPTT Citrate), and Prothrombin Time (PT and PT Citrate). |
|---|
| The system is intended to be used with test cuvettes that areavailable from the manufacturer. |
| For in vitro Diagnostic Use. For professional use. Rx only. |
| Device Description | The Hemochron™ Signature Elite Whole BloodMicrocoagulation System is a battery operated hand-heldinstrument. The system is intended for use inclinical settings requiring point of care testing. Whole bloodtest results are displayed as clotting times (in seconds). Theinstrument also displays correlated Celite® equivalent ACTvalues, APTT and PT plasma equivalent values, and thePT INR value. |
|---|---|
| The Hemochron™ Signature Elite Whole BloodMicrocoagulation System contains a test chamber whichwarms a test cuvette to the required temperature, and itperforms all operations to measure the clotting time of awhole blood sample after it is placed in the test cuvette andthe test is started by the operator. The front panel contains akeypad with various action keys as well as a number pad.The operator uses the keypad to select a command or enterinformation. The instrument also includes a barcode scannerfor reading of barcode identifications (IDs). | |
| Data management capabilities are included with theinstrument. These capabilities include storage of up to 600patient results and 600 quality control results, designation ofquality control levels, tagging of test results with date andtime, entry of Patient ID and/or Operator ID or OperatorPIN and printing of results |
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| Description of Modification | This Special 510(k) is being submitted to update theHemochron™ Signature Elite software from Version 2.3 toVersion 2.4. |
|---|---|
| ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
| Reason Submission Qualifiesas Special 510(k) | The submission meets the criteria for a Special 510(k) basedon the following: |
|---|---|
| The proposed change is submitted by the manufacturer legally authorized to market the existing device | |
| Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and | |
| All performance data necessary to support Substantial Equivalence (SE) can be reviewed in a summary or risk analysis format. | |
| In addition, the changes described in this submission do not introduce: | |
| Changes to indications for use or intended use | |
| Changes to operating principle | |
| Changes to analytical performance claims | |
| Changes to assay algorithms |
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Comparison to Predicate Device (K050016):
The following is a description of the similarities and differences between the predicate device; the currently marketed Hemochron™ Signature Elite (K050016), compared to the subject device, Hemochron™ Signature Elite with updated software Version 2.4, to demonstrate substantial equivalence.
| InstrumentCharacteristics | Hemochron™ Signature Elite(Predicate Device - K050016) | Hemochron™ Signature Elite(Subject Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Hemochron™ Signature Elite WholeBlood Microcoagulation System is abattery-operated, hand-held instrumentthat performs individual point-of-carecoagulation tests on fresh or citrated wholeblood. These tests include: ActivatedClotting Time (ACT+ and ACT-LR),Activated Partial Thromboplastin Time(APTT and APTT Citrate), andProthrombin Time (PT and PT Citrate).The system is intended to be used with testcuvettes that are available from themanufacturer.For in vitro Diagnostic Use. Forprofessional use. Rx only. | ✓ Substantially EquivalentThe HemochronTM Signature EliteWhole Blood MicrocoagulationSystem is a battery-operated, hand-held instrument that performsindividual point-of-carecoagulation tests on fresh orcitrated whole blood. These testsinclude: Activated Clotting Time(ACT+ and ACT-LR), ActivatedPartial Thromboplastin Time(APTT and APTT Citrate), andProthrombin Time (PT and PTCitrate). The system is intended tobe used with test cuvettes that areavailable from the manufacturer.For in vitro Diagnostic Use. Forprofessional use. Rx only. |
| Assays used | Activated Clotting Time(ACT+ and ACT-LR)Activated Partial Thromboplastin Time(APTT and APTT Citrate)Prothrombin Time(PT and PT Citrate) | ✓ Substantially EquivalentActivated Clotting Time(ACT+ and ACT-LR)Activated PartialThromboplastin Time(APTT and APTT Citrate)Prothrombin Time(PT and PT Citrate) |
| Sample Type | Fresh Whole Blood | ✓ Substantially Equivalent |
| Citrated Whole Blood | Fresh Whole BloodCitrated Whole Blood | |
| Reagents | Supplied in self-contained disposable cuvette | Supplied in self-contained disposable cuvette✓ Substantially Equivalent |
| Reported Results | Celite ACT Equivalent Time – ACT+,ACT-LRInternational Normalized Ratios (INR) –PT, citrate-PTWhole Blood values - APTT, citrate-APTT,PT, citrate-PTPlasma Equivalent (PE) Values – APTT,citrate-APTT, PT, citrate-PT | Celite ACT Equivalent Time – ACT+,ACT-LRInternational Normalized Ratios (INR) - PT, citrate-PTWhole Blood values - APTT, citrate-APTT, PT, citrate-PTPlasma Equivalent (PE) Values –APTT, citrate-APTT, PT, citrate-PT✓ Substantially Equivalent |
| Precision | ≤10% C.V. for whole blood samples | ✓ Substantially Equivalent |
| Results | Displayed on LCD screen | ✓ Substantially Equivalent |
| Timing Range | 0 seconds to 1005 seconds | ✓ Substantially Equivalent |
| OperatingEnvironment | 15°C - 30 °C | ✓ Substantially Equivalent15°C - 30 °C |
| Clot detection method | Mechanical-optical clot detection | ✓ Substantially Equivalent |
| Liquid QCRequirement | Two levels – Performed as directed | ✓ Substantially Equivalent |
| Power | Battery or AC operated | ✓ Substantially Equivalent |
| PC Connectivity | RS-232 and Ethernet Ports | ✓ Substantially Equivalent |
| User/Patient DataInput | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
| Data Storage Capacity | 16 OID/20 PID alphanumeric characters600 entries | ✓ Substantially Equivalent |
| Electronic QCRequirement | Internal electronic QC | ✓ Substantially Equivalent |
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| Assay Parameter Input | User keypad or barcode scanner entry | Substantially Equivalent | ||
|---|---|---|---|---|
| LQC Parameter Input | User keypad or barcode scanner entry | ✓ | Substantially Equivalent | |
| Differences | ||||
| Incubation Warm UpTime | 30 seconds to 90 seconds | Up to 200 seconds |
Conclusion:
Based on the identical indications for use, operating principle, analytical performance claims, and assay algorithms, the Hemochron™ Signature Elite with software Version 2.4 can be concluded to be substantially equivalent to the cleared and currently marketed predicate device, Hemochron™ Signature Elite (K050016).
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.