(442 days)
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.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated with numerical targets) | Reported Device Performance (Implied) |
|---|---|---|
| Effectiveness in Specimen Collection | Ability to collect adequate cytological specimens for: |
- 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.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.