Search Results

The Kolplast Cervical Sample Collection Kit is intended for collection of cytological specimens from the ectocervix and the endocervix for conventional Pap Smear Test or Liquid-Based ThinPrep® Pap Test with PreservCyt® solution.

For prescription use only.

It is not intended for use in pregnant women and should be used by a clinical or other qualified health professional only.

The Kolplast Cervical Sample Collection Kit is composed of the Kolplast Cervical Brush Protected Tip and the Kolplast Cervical Plastic Spatula and is a single use, non-sterile, disposable manual gynecological device. The Cervical Brush Protected Tip is intended for the collection of cytological specimens from the endocervix and the Cervical Plastic Spatula is intended for the collection of cytological specimens from the ectocervix. The Cervical Brush Protected Tip has a head consisting of white nylon bristles, and secured by stainless steel to the plastic handle. During collection of endocervical cells, the Cervical Brush Protected Tip is inserted into the cervix, rotated once via the handle and removed from the cervix. The collected cytological specimen is then transferred to the glass slide by smearing, or to the preservative fluid in a container by rotating the tip 10 times while pushing against the container wall. The Kolplast Plastic Spatula is made of plastic and incorporates a long edge and a notched end. During collection of ectocervical cells, the notched end is put against and rotated 360° around the circumference of the ectocervix. The retained cytological specimen is then transferred to the same glass slide by smearing, or to the preservative fluid in the same container by swirling 10 times. The collected samples on glass slide, or in preservative fluid in a container will be sent to a cytology lab for Pap Test analysis.

This document describes a 510(k) premarket notification for the "Kolplast Cervical Sample Collection Kit," a Class II medical device. The submission aims to demonstrate substantial equivalence to a predicate device, the "Pap Smear Kit (K861389)."

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria for the clinical performance. Instead, it describes clinical tests conducted to ensure "effectiveness." The reported performance is that these tests were conducted and support the device's substantial equivalence to the predicate.

• Conventional Pap Smear Test
• Liquid-Based ThinPrep® Pap Test with PreservCyt® solution | Clinical tests were conducted to ensure effectiveness in collecting cervical specimens for both conventional Pap Smear Method and Liquid-Based Pap Test Method. The results supported substantial equivalence. |
  | Biocompatibility | No cytotoxicity, sensitization, or irritation | Met ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization), and ISO 10993-10:2010 (Irritation) standards. |
  | Mechanical Performance | Adequate tensile strength (break/displacement), fixing resistance of bristles (decoupling rotation) | Mechanical tests conducted included tensile strength and decoupling rotation, ensuring performance. |
  | Shelf-Life | Maintains specifications for 5 years | Real-time aging studies demonstrated the device maintains specifications over a 5-year shelf life. |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document mentions "clinical tests were conducted on this device to ensure effectiveness" but does not provide any details regarding the sample size, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

The document does not provide any information about the number of experts used, their qualifications, or how ground truth was established for the clinical effectiveness studies. Clinical tests for Pap smears typically involve cytopathologists, but this is not specified here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not provide any information regarding the adjudication method used for the clinical effectiveness studies.

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:

This device is a manual cervical sample collection kit, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

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

This device is a manual tool. Therefore, a standalone (algorithm only) performance assessment is not applicable and was not performed.

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

While not explicitly stated, for Pap Smear effectiveness studies, the ground truth would typically be established by cytopathology results from the collected specimens. However, the document does not confirm this.

8. The sample size for the training set:

As this is a manual medical device and not a machine learning algorithm, there is no concept of a "training set" in the context of this submission. The effectiveness is demonstrated through standard clinical performance tests.

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

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

Ask a specific question about this device