BD VIPER SYSTEM

• K Number: K052481
• Device Name: BD VIPER SYSTEM
• Manufacturer: BECTON, DICKINSON & CO.
• Date Cleared: 2005-11-28 ( 80 days)
• Product Code: LSL
• Regulation Number: 866.3390
• Type: Special
• Panel: MI
• Reference & Predicate Devices: K984631 , K023955
• Predicate For: N/A

Intended Use

The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoege, or of co-infection with both C. trachomatis and N. gonorrhoege. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument.

The BD Viper System, when used with BD ProbeTec™ ET amplified nucleic acid assays, is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).

Device Description

The BD ProbeTec ET CT/GC Amplified DNA Assays utilize homogeneous SDA technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC DNA in clinical specimens.

The BD Viper System is comprised of a standalone lysing heater and a BD Viper Instrument. The BD Viper Instrument is comprised of five major subsystems: robotic pipetting arm, priming and warming heaters (two sets), liquid crystal display (LCD) monitor with touch screen, instrument software and two thermally controlled fluorescent readers.

AI/ML Overview

The provided text describes the BD Viper™ System, a modification of existing devices (BD ProbeTec™ ET System and BD Viper™ Instrument) used for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA. The 510(k) summary explains that the modifications did not introduce new issues of safety or effectiveness and that the system met acceptance criteria across various parameters.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Lysing Heater	Meet operating specifications across various environmental conditions.	The BD Viper System met operating specifications across various environmental conditions.
Optical Linearity	Meet optical and linearity specifications.	The BD Viper System met optical and linearity specifications.
Hardware Environmental	Meet thermal, pipetting, and optical specifications across various environmental conditions.	The BD Viper System met thermal, pipetting, and optical specifications across various environmental conditions.
Instrument Contamination	Meet specifications with regard to control and experimental conditions.	The BD Viper System met specifications with regard to control and experimental conditions.
System Environmental	Meet expected results with BD ProbeTec ET CT/GC controls across various environmental conditions.	The BD Viper System met expected results with BD ProbeTec ET CT/GC controls (i.e., positive, negative) across various environmental conditions.
Analytical Limit of Detection (Diluent)	Have an equivalent analytical limit of detection to the BD ProbeTec ET System for both CT and GC assays in a clean system matrix.	The BD Viper System had an equivalent analytical limit of detection to the BD ProbeTec ET System for both the BD ProbeTec ET CT and GC assays in a clean system matrix (i.e., BD ProbeTec ET diluent).
Precision	Be established and meet expected results (positive, negative) for the BD ProbeTec ET CT/GC assays.	The precision of the BD Viper instrument was established and met expected results (i.e. positive, negative) for the BD ProbeTec ET CT/GC assays.
Analytical Limit of Detection (Clinical Matrices)	Have an equivalent analytical limit of detection to the BD ProbeTec ET System for both CT and GC assays in clinical matrices.	The BD Viper System had an equivalent analytical limit of detection to the BD ProbeTec ET System for both BD ProbeTec ET CT/GC assays in clinical matrices.
Individual Spiked Specimen	Meet expected results (positive, negative) for the BD ProbeTec ET CT/GC assays.	The BD Viper System met expected results (i.e., positive, negative) for the BD ProbeTec ET CT/GC assays.
Clinical Agreement	Show equivalent performance between the BD Viper System and the BD ProbeTec ET System for the BD ProbeTec ET CT/GC assay.	The BD ProbeTec ET CT/GC assay performance was equivalent between the BD Viper System and the BD ProbeTec ET System.

Study Details for Device Performance Evaluation

The study described is a comparison of the modified BD Viper System to the predicate BD ProbeTec ET System or to expected results through spiked specimen studies. The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays were used for clinical performance evaluation.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify the exact sample size for the clinical test set. It mentions "clinical matrices" for the Analytical Limit of Detection and "Clinical Agreement" studies, but without specific numbers.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective.

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

   • This information is not provided in the text. The methods described are laboratory-based comparisons and spiked specimen studies, typical for molecular diagnostic device evaluations. There is no mention of "experts" establishing ground truth in the context of diagnostic interpretation.

3. Adjudication method for the test set:

   • This information is not applicable and therefore not provided, as the studies involve direct comparison of analytical detection capabilities and system performance with a predicate device or spiked samples, not human interpretation requiring adjudication.

4. 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 conducted. This applies to diagnostic imaging devices where human interpretation is involved. The BD Viper System is an automated molecular diagnostic platform.

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

   • Yes, the studies described are inherently standalone performance evaluations. The device's analytical capabilities (e.g., limit of detection, precision, instrument contamination, clinical agreement with a predicate system) were assessed without human-in-the-loop performance measurement. The system is an automated diagnostic instrument.

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

   • For analytical performance (e.g., limit of detection, precision, instrument contamination), the ground truth was established by known concentrations of target DNA (spiked specimens) or known positive/negative controls.
   • For clinical agreement, the ground truth was essentially the results obtained from the legally marketed predicate device (BD ProbeTec ET System), as the study aimed to show equivalence.

7. The sample size for the training set:

   • This information is not applicable as the BD Viper System is a molecular diagnostic instrument, not an AI or machine learning model that requires a "training set" in the conventional sense. The "training" in this context refers to the development and optimization of the instrument's components and assays, rather than an algorithmic training phase with labeled data.

8. How the ground truth for the training set was established:

   • This information is not applicable for the reasons stated above. The system's design and optimization would rely on engineering principles, analytical chemistry, and molecular biology, validated through rigorous testing against known standards and the predicate device.

Regulation Number and Section

§ 866.3390

Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).