(16 days)
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
- · Bacterial vaginosis (BV) markers (Individual markers are not reported)
- o Lactobacillus spp. (L. crispatus and L. jensenii)
- o Gardnerella vaginalis
- o Atopobium vaginae
- o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
- o Megasphaera-1
- · Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups)
o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
- o Candida glabrata
- o Candida krusei
- · Trichomonas vaginalis (TV)
The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.
The BD MAX™ Vaginal Panel performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacterial vaginosis (qualitative results reported based on detection and of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
- · Bacterial vaginosis markers (Individual markers not reported)
- o Lactobacillus spp. (L. crispatus and L. jensenii)
- o Gardnerella vaginalis
- o Atopobium vaginae
- o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
- o Megasphaera-1
- · Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups)
- o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis)
- o Candida glabrata
- o Candida krusei
- • Trichomonas vaginalis (TV)
The assay may be used to detect BV, VVC, and/or TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD MAX™ Vaginal is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
The BD Vaginal Panel is an automated, qualitative in vitro diagnostic test for bacterial vaginosis markers. Candida species associated with vulyovaginal candidiasis, and Trichomonas vaginalis. From a single specimen, a vaginal swab collected from a patient who is symptomatic for vaginitis or vaginosis, the test provides qualitative (positive) results for the presence of the following conditions and/or organisms:
- Bacterial vaginosis (based on detection of Lactobacillus spp. (L. crispatus and L. . jensenii), Gardnerella vaginalis, Atopobium vaginae, Bacterial Vaginosis Associated Bacteria-2, and Megasphaera-1)
- Candida spp. (C. albicans, c. tropicalis, C. parapsilosis, and C. dubliniensis) .
- Candida glabrata ●
- Candida krusei ●
- Trichomonas vaginalis ●
The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System under the trade names BD MAX™ Vaginal Panel and BD Vaginal Panel, respectively. The assay previously provided results for all five targets for every specimen run, regardless of whether the ordering clinician desires evaluation of all reported conditions. After clearance of this 510(k) submission, BD will release updates to the BD MAX™ and BD COR ™ software to allow users the versatility to mask results, per specimen, based on the order received from the clinician. This change allows a laboratory to use the BD Vaginal Panel to test a specimen for an individual target group (BV, VVC, or TV) or any two of the three targeted conditions, in addition to the current configuration that reports all three conditions simultaneously.
The provided text describes a 510(k) premarket notification for the BD Vaginal Panel, an in vitro diagnostic test. While the document details the device's intended use, technological principles, and comparison to a predicate device, it does not contain specific acceptance criteria and detailed study results in the format usually provided for device performance evaluation against such criteria. Instead, it states that "The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001" and that enabling a subset of results to be masked "has no clinical impact," implying that performance data was previously established and still applies.
Therefore, I cannot extract a table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or expert involvement for the test set.
However, I can describe the basis for the claim of continued performance and what typically would be found in a complete submission to address these points.
Based on the provided text, here's what can be inferred and what information is missing:
Inferred Information Regarding Acceptance Criteria and Study to Prove Device Meets Them:
The core of the argument for "acceptance" in this submission (K243725) is that the changes to the BD Vaginal Panel (specifically, the ability to mask results for certain conditions based on clinician order) do not impact the analytical or clinical performance that was already established for the predicate device (BD Vaginal Panel, referenced by DEN160001, K191957, K201017, K223653).
The text states:
- "The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001."
- "BD has determined that introducing the capability to order a subset of the conditions evaluated by the Vaginal Panel while masking the results for those conditions that are not ordered has no clinical impact."
- "Enabling the assay to report results for only a subset of the conditions does not change the specimen type, the test conditions, or the logic that is used to determine whether a specimen is positive or negative for the associated condition: conditions that are not ordered are simply not reported to the user."
- "Therefore, analytical and clinical performance of the assays is not impacted."
This implies that the previous submissions (DEN160001, K191957, K201017, K223653) would contain the detailed study data that established the acceptance criteria and demonstrated the device's performance against them. The current submission is a modification where the manufacturer asserts that the modification does not alter the already proven performance.
Unavailable Information from the Provided Text:
Since this submission argues "no impact" on performance rather than providing new performance data, the following specific details are not present in the provided document:
- A table of acceptance criteria and the reported device performance: This information would be in the predicate device's summary (e.g., DEN160001). The current submission leverages the established performance.
- Sample sizes used for the test set and the data provenance: Not provided for this submission's changes, as it relies on previous data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided for this submission's changes.
- Adjudication method for the test set: Not provided for this submission's changes.
- 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: This is a molecular diagnostic test, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not relevant here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as an "automated qualitative in vitro diagnostic test," meaning its performance is its standalone performance without continuous human interpretation of raw data. The "human-in-the-loop" aspect here is the clinician receiving the final positive/negative result. The change highlighted in this 510(k) is masking results, not altering the fundamental detection algorithm.
- The type of ground truth used: Not explicitly stated for this submission's changes, but for molecular diagnostics, ground truth typically involves a combination of clinical diagnosis, other laboratory methods (e.g., microscopy, culture, or other validated molecular assays), and sometimes expert clinical assessment.
- The sample size for the training set: Not applicable as this is not an AI/ML device that requires a separate "training set" in that context. The "training" in molecular diagnostics refers to assay development and optimization, which isn't sample-size driven in the same way.
- How the ground truth for the training set was established: See point 8.
Summary of what is present in the document relevant to the assertion of continued performance:
The basis of acceptance for this 510(k) submission (K243725) is that the modifications to the BD Vaginal Panel (specifically, the software update to allow result masking) do not compromise the established performance of the predicate device. The detailed performance data, acceptance criteria, study designs, and ground truth methodologies would be found in the original and subsequent predicate device submissions (DEN160001, K191957, K201017, K223653). The current submission serves to inform the FDA that a software change introducing result masking does not require new efficacy studies because it does not alter the underlying test's analytical or clinical capability to detect the specified targets.
§ 866.3975 Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.
(a)
Identification. A device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis is a qualitative in vitro diagnostic device intended for the detection of microbial nucleic acid sequences in vaginal specimens collected from patients with signs and symptoms of vaginitis or bacterial vaginosis. This device is intended to aid in the diagnosis of vaginitis or bacterial vaginosis when used in conjunction with clinical signs and symptoms and other laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) Documentation with a detailed device description of device components; ancillary reagents required but not provided; and explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.
(ii) Documentation with information that demonstrates the performance characteristics of the device, including:
(A) Limit of Detection;
(B) Precision (reproductivity);
(C) Analytical specificity;
(D) Analytical reactivity (inclusivity);
(E) Specimen stability; and
(F) Effects of interfering substances.
(iii) Detailed documentation from a prospective clinical study. As appropriate to the intended use, the prospective clinical study must be performed on an appropriate study population, including women of various ages and ethnicities. The prospective clinical study must compare the device performance to results obtained from well-accepted comparator methods.
(iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed explanation of the interpretation of results and acceptance criteria;
(ii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, clinical performance stratified by patient demographics such as race, ethnicity, age, and pregnancy status.
(iii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, a summary of device results in an asymptomatic population with demographic characteristics appropriate to the intended use population.
(iv) For devices with an intended use that includes detection of either Candida species or bacteria associated with bacterial vaginosis, a limitation that
Candida species and bacterial compositions associated with bacterial vaginosis can be present as part of normal vaginal flora and results should be considered in conjunction with available clinical information.