FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Teal Wand is a device for the self-collection of vaginal specimens for the purpose of collecting and transporting specimens for use in an FDA approved HPV molecular assay with which the collection device has been validated.

The Teal Wand can be used at-home or in any private setting. Specimens can be collected, stored, and shipped dry in an empty vial.

Device Description

The Teal Wand is a single patient use device intended for a person to self-collect vaginal specimens. The device consists of a plastic casing containing a swab-like projection with a foam sponge that is designed to collect the vaginal specimen. Also included are: an empty polypropylene specimen vial with a label for patient name, date of birth, and collection date, nitrile gloves, pen, product information including Instructions for Use, rigid safety bag, and return mailer. The self-collected specimen is then transported dry to a laboratory for processing and subsequent downstream high-risk HPV molecular testing as per the assay manufacturer's instructions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the Teal Wand meets those criteria, based on the provided decision summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Teal Wand Reported Performance
Analytical Performance
Interfering Substances (Hand Contaminants)	No interference observed with tested substances (lotions, hand sanitizers, hand soaps) at 1% v/v concentration, across both HPV16 (SiHa) and HPV18 (HeLa) cell lines. (5/5 agreement for all tested substances).
Shelf-life Stability	Demonstrated stability for up to one year when stored at 59°F to 86°F based on mechanical robustness tests (force to deploy, torque to rotate, force to retract rotor, deployment cycle testing, swab pull off force, speculum/petal spread width) and foam shear force.
Sample Shipping Stability	Expected results obtained for all negative and positive samples (HPV-negative, HPV16 at 2x LoD and 10x LoD, HPV18 at 2x LoD and 10x LoD) after exposure to extreme cold and hot temperatures for 154 hours (representing 5-day shipping + 24-hr lab wait).
Limit of Detection (LoD) at Clinical Cutoff	LoD for HPV16 (SiHa) = 104 cells/mL (19/20 replicates positive).
LoD for HPV18 (HeLa) = 54 cells/mL (19/20 replicates positive).
Analytical equivalency demonstrated to standard-of-care cervical collection device (Rovers Cervex-brush) for LoD.
Inclusivity (High-Risk Genotypes)	All 12 tested high-risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) were detected when tested close to LoD in HPV negative CVM.
Clinical Performance (Agreement with Clinician-Collected Specimens)	14 HR HPV PPA: 95.2% (278/292) (95% CI: 92.1% - 97.1%)
HPV 16/18 PPA: 95.8% (69/72) (95% CI: 88.5% - 98.6%)
12 other HR HPV PPA: 94.1% (207/220) (95% CI: 90.2% - 96.5%)
NPA: 90.0% (261/290) (95% CI: 86.0% - 92.9%)
Invalid rate for self-collected vaginal specimens = 2.3% (14/599).
Clinical Performance (Sensitivity/Specificity vs. Histopathology)	Ratio of sensitivities for CIN3: 0.97 (95% CI: 0.90-1.03)
Ratio of sensitivities for ≥CIN2: 1.0 (95% CI: 0.94-1.06)
Ratio of specificities for ≤CIN1: 0.97 (95% CI: 0.81-1.12)
Ratio of false positive rates for ≤CIN1: 1.01 (95% CI: 0.95-1.08)
Usability/User Comprehension	High user comprehension and ability to execute procedural steps (self-collection to sponge transfer) demonstrated in a study of 601 participants.
Success in completing at-home tasks (unbox, prepare for mailing) demonstrated in a second study with 56 participants.
Device Robustness	All specified elements met clinically relevant specifications: force to break, sheath pull off, rotor/dial pull out, petal pull off, petal spread width, force to deploy, torque to rotate, force to retract, sponge deflection, sponge pull off, foam shear, device tumble/drop, and package testing. Device deemed robust for intended use.
Biocompatibility	Acceptable results for cytotoxicity, skin sensitization, vaginal irritation, and ethylene oxide sterilization residual tests.

Study Details Proving Device Acceptance

1. Sample Size Used for the Test Set and Data Provenance:

Clinical Study (Agreement with Clinician-Collected):
- Total Participants Enrolled: 609
- Participants Included in Analysis: 582 (after exclusions for not meeting inclusion criteria or invalid results)
- Data Provenance:
  - Country of Origin: US (16 enrollment sites across 14 US states)
  - Retrospective/Prospective: Prospective (participants enrolled and specimens collected between November 20, 2023, and April 5, 2024).
Clinical Study (Sensitivity/Specificity vs. Histopathology):
- Sub-cohort of the clinical study; participants from the enriched cohort had histopathology results available as part of their standard of care. The exact number of participants from the enriched cohort who had histopathology results used for this analysis is not explicitly stated, but the enriched cohort had 348 participants in total.
Usability Studies:
- First Study: 601 participants (from the clinical study).
- Second Study: 56 participants.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

The ground truth for the clinical effectiveness comparison was the cobas HPV assay results from clinician-collected cervical specimens using Rovers Cervex-Brush. This is an FDA-approved method.
For the sensitivity and specificity analysis, the ground truth was histopathology results (CIN3, ≥CIN2, ≤CIN1) which are established by medical professionals (pathologists). The specific number and qualifications of pathologists are not detailed in this summary.

3. Adjudication Method for the Test Set:

The document does not describe any specific expert adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth. The ground truth for the clinical comparison was the result of a pre-approved, standard-of-care laboratory assay (cobas HPV on clinician-collected cervical specimens), and for clinical outcome correlation, it was histopathology. These methods inherently have their own established and often standardized interpretation and reporting protocols rather than a "consensus" process for each individual case in the context of device evaluation.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This evaluation is for a device (specimen collection and transport) used for an assay, not an AI algorithm that assists human readers in interpretation. The study compares the performance of specimens collected by the Teal Wand to clinician-collected specimens with a single assay (cobas HPV) which serves as the "reference standard." Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

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

Yes, in essence. The Teal Wand itself is a standalone collection device. The primary clinical study evaluated the performance of the specimens collected by the Teal Wand when processed by an existing, approved assay (cobas HPV), without human interpretation as part of the device's performance characteristic aside from the lab workflow. The device does not involve an AI algorithm for diagnostic interpretation that would typically require a standalone performance evaluation.

6. The Type of Ground Truth Used:

Clinical Study (Agreement): The ground truth was based on FDA-approved HPV molecular assay results (cobas HPV) from clinician-collected cervical specimens (Rovers Cervex-Brush). This represents a "standard-of-care comparative" ground truth.
Clinical Study (Sensitivity/Specificity): The ground truth was histopathology results (pathology-confirmed diagnoses of CIN3, ≥CIN2, ≤CIN1). This represents "outcomes data" or "pathology confirmed" ground truth.

7. The Sample Size for the Training Set:

Not applicable / Not explicitly stated. This document describes the evaluation of a medical device for specimen collection, not a machine learning or AI algorithm. Therefore, there is no "training set" in the sense of data used to train an AI model. All data described appears to be for verification and validation of the device's performance.

8. How the Ground Truth for the Training Set Was Established:

Not applicable. As noted above, there is no "training set" for an AI algorithm in this context. The physical and chemical properties of the device are evaluated against engineering specifications and analytical performance characteristics, and the clinical performance is evaluated against established clinical collection methods and histopathological outcomes.

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K Number

DEN240062

Device Name

Minder System

Manufacturer

Epi-Minder PTY LTD

Date Cleared

2025-04-17

(181 days)

Product Code