Kolplast Cervical Sample Collection Kit

K153128 · Kolplast CI SA · HHT · Jan 13, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K153128
• Device Name: Kolplast Cervical Sample Collection Kit
• Applicant: Kolplast CI SA
• Product Code: HHT · Obstetrics/Gynecology
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

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.

Device Story

Manual gynecological kit for cervical cell collection; consists of nylon-bristled cervical brush and plastic spatula. Brush collects endocervical cells; spatula collects ectocervical cells. Used by clinicians in clinical settings. Samples transferred to glass slides for conventional Pap smear or into preservative fluid for liquid-based cytology. Device facilitates specimen acquisition for subsequent laboratory analysis to aid in cervical health assessment.

Clinical Evidence

Clinical testing performed for collection of cervical specimens using both conventional Pap Smear and Liquid-Based Pap Test methods. No specific performance metrics (sensitivity/specificity) provided.

Technological Characteristics

Manual, single-use, non-sterile gynecological instrument. Materials: Polystyrene/High Impact Polystyrene (handle), Polycarbonate (tip protection), Nylon (bristles), Stainless Steel 304 (bristle support), Polypropylene (spatula). Dimensions: Spatula length 7.2 inches; Brush length 7.2 inches. No energy source, software, or connectivity.

Indications for Use

Indicated for women older than 21 years of age undergoing routine gynecological evaluation for collection of cytological specimens from the ectocervix and endocervix. Not intended for use in pregnant women. For prescription use by clinical or qualified health professionals only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Pap Smear Kit (K861389)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM

A. 510(k) Number:
K153128

B. Purpose for Submission:
New device

C. Measurand:
Not applicable

D. Type of Test:
Not applicable

E. Applicant:
KOLPLAST CI SA

F. Proprietary and Established Names:
Kolplast Cervical Sample Collection Kit

G. Regulatory Information:

1. Regulation section:
21 CFR §884.4530 Obstetric-gynecologic specialized manual instrument

2. Classification:
Class II

3. Product code:
HHT – Spatula, cervical, cytological

4. Panel:
Obstetrics/Gynecology

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H. Intended Use:

1. Intended use(s):

See Indications for use below.

2. Indication(s) for use:

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.

3. Special conditions for use statement(s):

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.

4. Special instrument requirements:

Not applicable

I. Device Description:

The Kolplast Cervical Sample Collection Kit is a single use, non-sterile, disposable manual gynecological device intended for collection of cervical cells from the cervix for Pap Test analysis. It is composed of a cervical brush and a plastic spatula.

- The cervical brush has a white nylon bristle head, which is secured by stainless steel to the plastic handle. It is intended for the collection of cytological specimens from the endocervix.
- The plastic spatula has a handle with a notched end that corresponds to the contour of the cervix. It is intended for the collection of cytological specimens from the ectocervix.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Pap Smear Kit

2. Predicate 510(k) number(s):

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K861389

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Kolplast Cervical Sample Collection Kit (Candidate Device) k153128 | Pap Smear Kit (Predicate) k861389 |
| Intended Use | 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. | For collection and transportation of gynecological smears used in Papanicolaou's Exfoliative Cytology Test. |
| Device components | Brush and spatula | Brush and spatula |
| Composition | Brush: Plastic handle and a head with woven nylon interlaced in a stainless steel twisted wire; Spatula: plastic. | Same |
| Material | Brush head: Nylon and stainless steel 304; Brush handle: plastic; Spatula: plastic. | Same |
| Spatula Dimensions | Overall length: 7.2 inches Concave edge length: 0.82 inches | Same |
| Supplied | Non-sterile, disposable | Same |
| Differences | | |
| --- | --- | --- |
| Item | Kolplast Cervical Sample Collection Kit (Candidate Device) k153128 | Pap Smear Kit (Predicate) k861389 |
| Brush Dimensions | Head length: 0.08 inches Head diameter: 0.27-0.19 inches overall length: 7.2 inches | Head length: 0.09 inches Head diameter: 0.27-0.19 inches Overall length: 7.7 inches |

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K. Standard/Guidance Document Referenced (if applicable):

ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for *in vitro* cytotoxicity (2009).

ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization (2010)

ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference material (2012).

L. Test Principle:

For collection of cytological specimens from the ectocervix, the plastic spatula notched end is placed against the ectocervix and rotated around the circumference of the ectocervix. For collection of cytological specimens from the endocervix, the head of the cervical brush is inserted into the cervix, rotated $\frac{1}{4}$ to $\frac{1}{2}$ turn via the handle and removed from the cervix. The collected endocervical or ectocervical cell sample is then transferred to a glass slide by smearing, or to preservative fluid in a container by swirling.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

i. Performance Testing

To assess the safety of the device, the following performance tests were conducted on candidate devices:

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| Test | Component | Acceptance Criteria | Number of items tested | Number of items failed | Results |
| --- | --- | --- | --- | --- | --- |
| Traction Resistance | Brush | Should not break with 7 kg force applied | 315 | 0 | Passed |
| | Spatula | | 315 | 0 | Passed |
| Bending Resistance | Brush | Should not break when bend and pass through a guide tube* | 315 | 0 | Passed |
| | Spatula | | 315 | 0 | Passed |
| Head-Stem Fixing Strength | Brush | Should not break with 7 kg force applied | 315 | 0 | Passed |
| Nylon Bristles Decoupling Rotation** | Brush | Bristles should not detach from the head | 315 | 0 | Passed |

* The tube is about 2.25 inches in length and 1.375 inch in diameter.

** Brush head is inserted into rubber block (two stached rubber pieces) with 2.85 kgf applied, rotated 10 times clockwise and removed from the rubber block while pressure still applied.

ii. Shelf-life stability

To assess a shelf-life of five years, the same performance bench tests as summarized above in section (M.1.c.i) were conducted on real time aged devices.

| Test | Component | Acceptance Criteria | Number of items tested | Number of items failed | Results |
| --- | --- | --- | --- | --- | --- |
| Traction Resistance | Brush | Should not break with 7 kg force applied | 315 | 0 | Passed |
| | Spatula | | 315 | 0 | Passed |

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| Bending Resistance | Brush | Should not break when bend and pass through a guide tube* | 315 | 0 | Passed |
| --- | --- | --- | --- | --- | --- |
| | Spatula | | 315 | 0 | Passed |
| Head-Stem Fixing Strength | Brush | Should not break with 7 kg force applied | 500 | 0 | Passed |
| Nylon Bristles Decoupling Rotation** | Brush | Bristles should not detach from the head | 500 | 0 | Passed |

* The tube is about 2.25 inches in length and 1.375 inch in diameter.
** Brush head is inserted into rubber block (two stached rubber pieces) with $2.85\mathrm{kgf}$ applied, rotated 10 times clockwise and removed from the rubber block while pressure still applied.

# iii. Biocompability

Cytotoxicity, sensitization and irritation potential of the device were assessed for biocompatibility. The material specifications are shown in the table below.

| Component | Material Name | Function | Patient Contact (Direct/Indirect) |
| --- | --- | --- | --- |
| Kolplast Cervical Brush Protected Tip | | | |
| Handle | Polystyrene | Handle | Indirect |
| | Polystyrene High Impact | Handle | Indirect |
| Head | Polycarbonate Adhesive | Protection of tip | Direct |
| | Nylon | Collecting of endocervical cells | Direct |
| | Stainless Steel | Nylon support | Direct |
| Kolplast Cervical Plastic Spatula | | | |
| Spatula (curve and long edge + handle) | Polypropylene | Handle and collecting samples | Direct |

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# Cytotoxicity

Cytotoxicity testing was conducted on the Kolplast Cervical Brush Protected Tip and the Kolplast Cervical Plastic Spatula, per ISO 10993-5:2009, using the MEM Elution Method. A single preparation of the test extract was extracted in single strength Minimum Essential Medium (1x MEM) at 37°C for 24 hours, along with negative control, reagent control and positive control extracted similarly. Triplicate monolayers of L-929 mouse fibroblast cells were dosed with test extract and controls and incubated at 37°C (5% CO₂) for 48 hours. Following incubation, the cell monolayers were examined microscopically for abnormal cell morphology and cellular degeneration. The cell monolayers treated with test extract and controls showed no evidence of causing cell lysis or toxicity. The testing results demonstrated the candidate device is non-cytotoxic.

# Sensitization

Sensitization testing was conducted on the Kolplast Cervical Brush Protected Tip and the Kolplast Cervical Plastic Spatula, per ISO 10993-10:2010, using the Guinea Pig Maximization Test (GPMT) on both polar and non-polar extracts. In each test, 15 male animals were used with 10 in the test group and 5 in the control group. The test substance was extracted in an incubator shaker (100 RPM) at 121°C for 1 hour at concentration of 0.2 g/ml in 0.9% Sodium Chloride solution (polar extract) or cotton seed oil (non-polar extract). The test substance was injected intradermally, 0.1 mL, and later topically on the dermis of the test animals. No change was observed on the test area (Magnusson and Klingman score = 0) 48 and 72 hours for polar extraction or 24 hours and 48 hours for non-polar extraction after application of test substance. After 7 days of the injection, gauzes saturated (0.5 mL) with the test substance and control substance was applied on the skin of test animal and control animal respectively. The animals appeared normal with no death. The testing results demonstrated the candidate device is non-sensitizing.

# Irritation

Irritation testing was conducted on the Kolplast Cervical Brush Protected Tip and the Kolplast Cervical Spatula, per ISO 10993-10:2010, using the vaginal mucosal irritation test on both polar and non-polar extracts. In each test, 15 nulliparous and non-pregnant female rats (Rattus norvegicus, aged 4-6 weeks, weighted about 200 g) were used with 10 in the test group and 5 in the control group. The test extract was extracted in an incubator at 121°C for 1 hour in purified water (polar extract) or cotton seed oil (non-polar extract). The test extract and control substance (purified water for polar test and cotton seed oil for non-polar test) were applied to the middle part of the animals vagina, through a urethral probe. The application was repeated three times a day for four consecutive days. Necropsies were performed to examine the genital tract of test and control animals and vaginal irritation indices were

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calculated. In a scale of 4.00, the irritation index of the test group is 0.17 for polar extract and 0.00 for non-polar extract. The testing results demonstrated the candidate device is non-irritant.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

To assess clinical performance, cytological specimens collected by using the subject device and slides were prepared for both conventional Pap Smear method and ThinPrep® liquid-based Pap Test.

i. Conventional Pap Smear testing

Cytological specimens from 422 patients were collected and slides were prepared for conventional Pap Smear, according to the Instructions for Use of the Kolplast

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Cervical Sample Collection Kit. Prepared slides were analyzed by two certified cytotechnologists and reviewed by one pathologist. The inclusion criteria were women older than 21 years of age who are scheduled for routine gynecological evaluations. Patients were excluded if they refused to sign informed consent and denied participating in the study, or if they had a history using ointments, creams, vaginal douches or transvaginal ultrasound within the two days prior to the gynecological examination. The study results are shown in the table below:

| Results | Cases (%) |
| --- | --- |
| Total number | 422 (100%) |
| Normal | 199 (47.1%) |
| Positive Atypical Cells | 10 (2.37%) |
| Inflammatory | 213 (50.4%) |
| ASC-US | 5 (1.4%) |
| ASC-H | 1 (0.2%) |
| LSIL | 1 (0.2%) |
| HSIL | 3 (0.7%) |
| Cancer | 0 |
| AGS-US | 0 |
| AGC-H | 0 |
| Unsatisfactory | 0 |

Specimen adequacy evaluation is summarized in the table below:

| Criteria for inadequacy | Number of cases (%) |
| --- | --- |
| Total number | 422 (100%) |
| Insufficient cellular material present | 0 |
| Separated superficial cells suggesting vaginal sampling only | 0 |
| Obscured by blood and/or inflammatory exudates | 10 (2.37%) |
| Too thickly spread for assessment | 13 (3.08%) |
| EC/TZ component not identified: absence of columnar cells | 131 (31.04%) |

ii. Liquid-based Pap Test

Cytological specimens from 579 patients were collected and preserved in ThinPrep® PreservCyt® solution, according to the Instructions for Use of the candidate device and ThinPrep® PreservCyt® solution. Slides were prepared by using the ThinPrep® Liquid-based method and analyzed by two certified cytotechnologists and reviewed by one pathologist. The inclusion criteria were women older than 21 years of age who are scheduled for routine gynecological evaluations. Patients were excluded if they did not want to participate in the study

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or if there was a history using ointments, creams, vaginal douches or transvaginal ultrasound within two days prior to the gynecological examination. The first 214 patients were selected for the evaluation of specimen adequacy. Out of 579 collected cases, eight cases had sampling artifacts and were excluded from the study. The results from 571 cases are shown in the table below:

| Results | Cases (%) |
| --- | --- |
| Total number | 571 (100%) |
| Normal | 408 (71.5%) |
| Positive Atypical Cells | 19 (3.3%) |
| Inflammatory | 144 (25.2%) |
| ASC-US | 11 (1.9%) |
| ASC-H | 0 (0%) |
| LSIL | 7 (1.2%) |
| HSIL | 1 (0.2%) |
| Cancer | 0 |
| AGS-US | 0 |
| AGC-H | 0 |
| Unsatisfactory | 0 |

Specimen adequacy evaluation is summarized in the table below:

| Criteria for inadequacy | Number of cases (%) |
| --- | --- |
| Total number | 214 (100%) |
| Insufficient cellular material present | 0 |
| Separated superficial cells suggesting vaginal sampling only | 0 |
| Obscued by blood and/or inflammatory exudates | 2 (0.93%) |
| Too thickly spread | 1 (0.47%) |
| EC/TZ component not identified: absence of columnar cells | 17 (7.94%) |

The study results summarized in this section demonstrate that the cervical samples collected with the Kolplast Cervical Sample Collection Kit are adequate for cytological evaluation with conventional Pap Smear method and liquid-based Pap test method.

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

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N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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