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 Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 13, 2017

KOLPLAST CI SA c/o Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K153128

Trade/Device Name: Kolplast Cervical Sample Collection Kit Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HHT Dated: December 27, 2016 Received: December 27, 2016

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Yun-fu Hu -S

for

Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Kolplast Cervical Sample Collection Kit

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) Owner:

KOLPLAST CI SA Estrada Municipal IVA 136. No. 418 Barrio da Mina ltupeva - SP Brazil 13295-000 (Tel): +55 11 4961 0972 / +55 11 4961 0920 (Fax): +55 11 4961 0930

Contact Person:	Daniela Feracin
Preparation Date:	December 21, 2016

Device Information:

Trade Name:	Kolplast Cervical Sample Collection Kit
Common/Usual Name:	Cervical Collection Kit
Classification Name:	Obstetric-Gynecologic Specialized Manual Instrument
Regulation Number:	21 CFR 884.4530
Product Code:	HHT
Device Class:	Class II

Predicate Devices:

Pap Smear Kit (K861389)

Device Description:

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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.

Indications for Use:

For prescription use only.

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

Item	Proposed Device	Predicate Device
Device name	Kolplast Cervical Sample CollectionKit	Pap Smear Kit
510(k) number	K153128	K861389
Product Code	HHT	Same
Reguation No.	21 CFR §884.4530	Same
Intended Use	The Kolplast Cervical SampleCollection Kit is intended forcollection of cytological specimensfrom the ectocervix and theendocervix for conventional PapSmear Test or Liquid-BasedThinPrep® Pap Test withPreservCyt® solution.For prescription use only.It is not intended for use inpregnant women and should beused by a clinical or other qualifiedhealth professional only.	For collection and transportationof gynecological smears used inPapanicolaou's ExfolativeCytology Test.

Comparison with Predicate Device:

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Item	Proposed Device	Predicate Device
Device components	Brush and spatula	Brush and spatula
Composition	Brush: Plastic handle and a headwith woven nylon interlaced in astainless steel twisted wire; Spatula:plastic.	Same
Material	Brush head: Nylon and stainlesssteel 304; Brush handle: plastic;Spatula: plastic.	Same
Dimensions	BrushHead length: 0.08 inchesHead diameter: 0.27-0.19 inchesOverall length: 7.2 inches.SpatulaOverall length: 7.2 inches Concaveedge length: 0.82 inches.	BrushHead length: 0.09 inchesHead diameter: 0.27-0.19 inchesOverall length: 7.7 inches.SpatulaOverall length: 7.2 inchesConcave edge length: 0.82inches.
Supplied	Non-sterile, disposable	Same

Non-Clinical Tests Performed:

The following biocompatibility tests were conducted on this device to ensure safety:

Cytotoxicity MEM Elution (ISO 10993-5:2009) ●
Sensitization - Guinea Pig Maximization (ISO 10993-10:2010)
Irritation - Skin Irritation (ISO 10993-10:2010)

The following mechanical tests were conducted on this device to ensure performance:

Tensile strength test evaluating break and displacement in cervical brush and spatula ●
Decoupling rotation test evaluating the fixing resistance of the nylon bristles against rotation and shear force
. Shelf-life test - The shelf life of the subject device is 5 years. This is based on the results of real time aging studies that demonstrated that the device maintains its specifications over the duration of its shelf life

Clinical Tests Performed:

The following clinical tests were conducted on this device to ensure effectiveness:

Collection of cervical specimens for conventional Pap Smear Method
Collection of cervical specimens for Liquid-Based Pap Test Method

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Substantial Equivalence Discussion

The subject and predicate devices have the same intended use and technological characteristics (design and material). They also have comparable dimensions. The minor differences in dimensions do not raise any concerns. The non-clinical tests and clinical tests were conducted to ensure safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.

Regulation Number and Section

§ 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.