Search Results

The autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following:

• General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and . Neurosurgical
• . Postoperative treatment areas

The autoLog Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation, separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline, are pumped to a transfer bag, and may be reinfused to the patient.

Here's an analysis of the provided text regarding the autoLog Autotransfusion System and its acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a modification to an existing device, the autoLog Autotransfusion System (K972894), specifically allowing for "the use of an adjustable external vacuum regulator." As such, the submission focuses on demonstrating that this modification does not introduce new risks or alter the fundamental performance of the device. Consequently, the "acceptance criteria" are framed around maintaining the performance equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "A qualification was done to confirm that no functional differences between the predicate and the modified device exist. This testing was specific to the changes proposed." However, specific details regarding the sample size used for this test set are not provided in the summary. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of the modification (mechanical/performance testing of a vacuum regulator), it is highly probable this was laboratory-based testing rather than clinical data involving patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of this 510(k) submission. The "ground truth" here is the functionality and performance of the device components, not a diagnostic interpretation that would require expert consensus. The testing would have involved engineering and quality assurance personnel.

4. Adjudication Method for the Test Set

This information is not applicable for the type of qualification testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. The testing described here would involve objective measurements and comparisons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic AI devices where human readers interpret cases with and without AI assistance. The submitted device is an autotransfusion system, not an imaging or diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This concept is relevant for AI or software-as-a-medical-device (SaMD) where an algorithm makes a determination. The autoLog Autotransfusion System is a physical medical device; its "performance" is assessed through functional and safety testing of its mechanical and operational characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this modification essentially revolved around engineering specifications and established performance characteristics of the predicate device. The testing aimed to confirm that the modified device's performance, particularly regarding vacuum regulation, met pre-defined engineering standards and did not deviate from the predicate's established safe and effective operation. It was not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device and its modification. Training sets are used in machine learning and AI development. This submission describes a mechanical modification to an existing medical device, not the development or training of an algorithm.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of this device, this question is not applicable.

Ask a specific question about this device

The HEPtrac Electronic Quality Control, manufactured by Medtronic Blood Management, is an interactive mechanical and software controlled verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment.

The HEPtrac is an electronic control that has been developed to assist users of the Hepcon Hemostasis Management (HMS) Instrument (K894317) and associated cartridges and controls (K894317), to perform control testing as required under 42CFR493.1253. Sec. ( c ) "for all automated coagulation testing systems, the laboratory must include two levels control each eight hours of operation and each time a change in reagents occurs". The HEPtrac, electronic quality control is designed to minimize the use of liquid based controls by providing the operator a means to determine the operating condition of the instrument.

Here's a breakdown of the acceptance criteria and study information for the HEPtrac Electronic Quality Control device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria in the way one might expect for a modern AI/ML device (e.g., target specificity, sensitivity, or AUC). Instead, the performance is demonstrated by its ability to perform specific checks on the HMS instrument. The criteria are implicitly tied to the proper functioning of these checks.

1. Flag release force" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
   | Ability to check Reagent delivery | "Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions:
2. Reagent delivery" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
   | Ability to check Flag lift wire height | "Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions:
3. Flag lift wire height" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
   | Ability to check Flag sensors | "Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions:
4. Flag sensors" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
   | Substantial equivalence to the predicate device (ACTtrac) in: | The HEPtrac "is very similar to the ACTtrac electronic control for the ACT instrument in the following areas; intended use, operation, and function." The key difference is the number of channels (2 for ACTtrac vs. 6 for HEPtrac) and the addition of a "Flag release test" in HEPtrac. This implies that the device's performance is acceptable because it maintains the core functionalities of the predicate while enhancing capacity. |
   | - Control Test Type | Both are "Electronic" (Table 1.1) |
   | - Reagent delivery check | Both have "yes" (Table 1.1) |
   | - Flag Sensor check | Both have "yes" (Table 1.1) |
   | - Clot detection | Both have "yes" (Table 1.1) |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the test set. It broadly states, "Laboratory testing was done to confirm the devices performance in relation to the predicate device."
• Data Provenance: The testing was "Laboratory testing," implying it was conducted in a controlled environment. There is no information about the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Given the nature of the device (an electronic quality control for an instrument), the "ground truth" would likely be defined by engineering specifications and the instrument's known functional parameters rather than expert medical interpretation.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the device's function. The testing described focuses on functional verification against engineering parameters rather than subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an electronic quality control for a medical instrument, not an AI/ML diagnostic or assistive tool for human readers. Therefore, this type of study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is an "electronic control," which operates without human "interpretation" of results in the traditional sense of a diagnostic algorithm. Its function is to verify the performance of the main instrument. The performance testing "to verify the HEPtrac's ability to check the condition of the HMS instrument" can be considered a standalone performance evaluation of the control device in its intended function. There is no "human-in-the-loop" aspect to the HEPtrac's function itself; it's a verification tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this device's performance evaluation would be the engineering specifications and known functional parameters of the Hepcon Hemostasis Management (HMS) Instrument. The HEPtrac is designed to test if the HMS instrument is operating within its defined parameters for flag release force, reagent delivery, flag lift wire height, and flag sensors.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The HEPtrac is described as an "electronic control" and a "mechanical and software controlled verification cartridge." It does not appear to utilize machine learning or AI that would require a "training set" in the conventional sense. Its function is based on programmed logic and mechanical interactions to test an existing instrument.

9. How the Ground Truth for the Training Set was Established

As there is no indication of a "training set" for AI/ML, this question is not applicable. The device's "knowledge" of what constitutes correct instrument operation is built into its design and programming, based on the specifications of the HMS instrument it is designed to test.

Ask a specific question about this device

The autoLog™ is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following: General, Cardiovascular, . Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical Postoperative treatment areas

The autoLog™ is an autotransfusion apparatys (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and ppst-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline are pumped to a transfer bag that may be reinfused to the patient.

The Medtronic autoLog™ Autotransfusion System is a Class II device (21 CFR § 868.5830) intended for the collection, concentration, washing, and reinfusion of autologous blood during peri-operative and post-operative procedures.

The provided document does not contain a comprehensive list of acceptance criteria with numerical targets. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Sequestra and ELMD 500 autotransfusion apparatus) based on comparative features and functional testing.

However, based on the information provided, we can infer the primary acceptance criteria:

1. A table of acceptance criteria and the reported device performance

Note on Quantitative Differences:
While many features are equivalent, some quantitative differences exist with predicate devices like Centrifuge Speed (autoLog™: 10000 RPM vs. Predicates: 1000-5600 RPM), Number of Programs (autoLog™: 1 vs. Predicates: 5 or 6), Data Input (autoLog™: Push Button vs. Predicates: Touch Screen), and Blood Pump Flow (autoLog™: 0-1000 ml/min vs. Predicates: 50-500 ml/min or 10-1000 ml/min). However, these differences were deemed not to raise new questions of safety or effectiveness by the FDA, as evidenced by the substantial equivalence determination.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in terms of patient data or samples. The testing described is focused on the device's functional performance:

• Sample Size: Not applicable in the context of clinical or patient data.
• Data Provenance: Not applicable. The testing is internal to Medtronic Blood Management, likely conducted in a laboratory or simulated environment, rather than involving external data sources.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the functional and software performance tests was based on the device's design specifications and expected operational behavior. There is no indication of expert panel review for establishing ground truth in the context of clinical outcomes.

4. Adjudication method for the test set

Not applicable. The testing described (risk analysis, functional qualification, black box testing) suggests an engineering and software validation approach, not a clinical trial needing adjudication of results.

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

Not applicable. The autoLog™ is an autotransfusion apparatus, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and "human reader improvement with AI" are irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an automated medical apparatus, meaning it operates autonomously based on its programming for the processing of blood. So, in a sense, its primary function is "standalone" once initiated. The testing described (system/software risk analysis, functional system qualification, "system black box testing") evaluates this standalone performance. However, this is not in the context of an "algorithm" operating without human input in the way a diagnostic AI would be. Human operators manage the device and reinfuse the processed blood to the patient.

7. The type of ground truth used

The "ground truth" for the device's performance was established via design specifications and functional verification. This would involve:

• Engineering specifications: Defining expected centrifuge speeds, pump flow rates, sensor functionality, etc.
• Software requirements: Defining how the microprocessor should control each stage of the process (collection, concentration, washing, pumping).
• Risk analysis: Ensuring the system operates safely and effectively within predefined parameters.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed using training data. Its functionality is based on direct engineering design and programming.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Ask a specific question about this device