(209 days)
The BD Viper"™ instrument is intended for use as a sample processor designed for use with the BD ProbeTec ™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. The BD Viper instrument automates the transfer and mixing of manually prepared and lysed samples. The BD Viper instrument incorporates heating blocks to perform assay priming and prewarming incubation steps prior to the removal and transfer of the microwells to the BD ProbeTec ET instrument for amplification and detection.
The BD Viper is a sample processor designed for use with the BD ProbeTec ET system. The BD Viper automates the transfer and mixing of specimens that have been prepared and lysed according to the specific BD ProbeTec ET assay package insert. Automated specimen transfers by the BD Viper occur from the sample processing tubes to the assay priming microwells and from the priming microwells to the assay amplification microwells. The BD Viper also controls the incubation steps for priming the samples and pre-warming the amplification microwells. After the BD Viper transfers samples from the priming wells to the amplification microwells, the instrument mixes the contents of the amplification microwells. After mixing, the plates are manually sealed and removed from the BD Viper. The sealed plates are placed into the BD ProbeTec ET instrument(s) where the analyte specific amplification and detection process occurs.
The BD Viper is comprised of four major components: robotic pipetting arm, priming and warming heaters, LCD monitor with integrated touch screen, and instrument software.
The BD Viper™ Instrument is a sample processor designed for use with the BD ProbeTec™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. It automates the transfer and mixing of manually prepared and lysed samples, and incorporates heating blocks for assay priming and prewarming incubation steps.
Acceptance Criteria and Device Performance
Due to the nature of the device as an automated pipetting and processing system, the acceptance criteria are based on comparative performance to a manual method and the absence of contamination issues. The reported device performance is qualitative, indicating that the automated method performs comparably to or yields substantially equivalent results as the manual method. No specific numerical percentages or thresholds are provided for the acceptance criteria in the summary.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Performance Comparability with Manual Method (BD ProbeTec ET ET Pipettor) | Demonstrated through clinical evaluation revealing "substantially equivalent results...when performed using the BD ProbeTec ET automated and manual methods," and through analytical studies showing comparable performance. |
| Contamination Assessment | A study was performed "to evaluate the potential for contamination associated with automating particular specimen pipetting and processing steps," and it's implied that the results supported the device's acceptable performance in this area, without specific data provided in the summary. The absence of reported issues suggests this criterion was met. |
| Precision | Precision of the BD Viper was assessed, and "A variance component analysis was performed to establish overall precision." While specific precision metrics are not provided, the overall conclusion of substantial equivalence implies acceptable precision. |
| Environmental Operating Conditions | Studies were conducted to demonstrate that critical parameters were acceptable when operated in a simulated laboratory at specified environmental conditions. The conclusion implies these conditions were met satisfactorily. |
Study Details
The primary study conducted was a clinical evaluation to demonstrate the "percent agreement" between the BD ProbeTec ET automated method (using the BD Viper) and the BD ProbeTec ET manual method (using the BD ProbeTec ET Pipettor and heating blocks).
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Sample Size and Data Provenance:
- Test Set Sample Size: Over 4,000 paired CT and GC results were evaluated.
- Data Provenance: The study was conducted "internally at two clinical centers," suggesting a prospective clinical study specifically for this device. The country of origin is not explicitly stated but is implied to be the US given the FDA submission.
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Number of Experts and Qualifications: Not applicable. For this type of instrument performance study comparing an automated method to a manual method for diagnostic assays, expert interpretation of results is generally not the primary endpoint; rather, the agreement of the quantitative or qualitative assay results themselves is assessed. The "ground truth" here is the result obtained by the predicate manual method.
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Adjudication Method: Not applicable. The study design appears to be a direct comparison of results between two methods (automated vs. manual), not an expert consensus or adjudication of individual cases.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this was not an MRMC study. This study evaluated the comparative performance of an automated instrument against a manual testing method, not the impact of AI assistance on human readers.
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Standalone Performance: Yes, the study evaluates the standalone performance of the BD Viper instrument as part of the BD ProbeTec ET system, comparing it directly to the standalone performance of the manual BD ProbeTec ET system. The summary does not describe any human-in-the-loop component for the BD Viper itself; the instrument automates steps that were previously manual.
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Type of Ground Truth: The "ground truth" for the clinical evaluation was established by the results obtained from the predicate manual method (BD ProbeTec ET System using the BD ProbeTec ET Pipettor). The study aimed to show agreement between the automated and manual results.
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Training Set Sample Size: The summary does not provide specific details on a separate "training set" for the BD Viper instrument itself. Given that it automates existing assay steps, its development likely involved engineering and calibration rather than a machine learning training paradigm with a distinct training dataset in the same sense as an AI algorithm. The studies mentioned (contamination, environmental, precision, clinical) are primarily for verification and validation.
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How Ground Truth for Training Set was Established: Not applicable in the context of an AI training set. For the development and validation of the BD Viper, engineering specifications, assay performance characteristics of the manual method, and quality control standards would have guided its design and calibration. The "ground truth" for ensuring its proper functioning would be the established performance characteristics of the BD ProbeTec ET assay itself when performed manually.
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.