(442 days)
No
The device description and performance studies focus on the physical components and manual collection process, with no mention of AI/ML or related concepts like image processing, training/test sets, or specific performance metrics associated with algorithmic analysis.
No
The device is described as a collection kit for cytological specimens for diagnostic purposes (Pap Test analysis), not for treating any condition.
No
The device is a collection kit for cytological specimens, which are then sent to a lab for analysis. It does not perform the diagnostic analysis itself.
No
The device description clearly states it is composed of physical components (Cervical Brush Protected Tip and Cervical Plastic Spatula) and is a manual gynecological device. It does not mention any software component.
Based on the provided information, the Kolplast Cervical Sample Collection Kit is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- IVD devices are used in vitro (outside the body) to examine specimens derived from the human body. They are used to provide information about a physiological state, health, or disease.
- The Kolplast Cervical Sample Collection Kit is a tool used to collect the specimen. It is used in vivo (inside the body) to gather cells from the cervix.
- The collected specimens are then sent to a laboratory for in vitro analysis (the Pap Test). The Pap Test itself, which analyzes the collected cells, is an IVD procedure.
The device's intended use clearly states it is for the "collection of cytological specimens." It is the means of obtaining the sample that will be used in an IVD test.
Therefore, the Kolplast Cervical Sample Collection Kit is a medical device used for specimen collection, but it is not an IVD device.
N/A
Input Imaging Modality: Not Found
Mentions AI, DNN, or ML: Not Found
Mentions image processing: Not Found
Intended Use / 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.
Product codes
HHT
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.
Anatomical Site
ectocervix and the endocervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical or other qualified health professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three parallel lines curving upwards and to the right.
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.
1
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)
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.
| 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:
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
4
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:
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.
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 Collection | |
| Kit | Pap Smear Kit | |
| 510(k) number | K153128 | K861389 |
| Product Code | HHT | Same |
| Reguation No. | 21 CFR §884.4530 | Same |
| Intended 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. | For collection and transportation
of gynecological smears used in
Papanicolaou's Exfolative
Cytology Test. |
Comparison with Predicate Device:
5
| Item | Proposed Device | Predicate Device |
|---|---|---|
| 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 | |
| Dimensions | Brush | |
| Head length: 0.08 inches | ||
| Head diameter: 0.27-0.19 inches | ||
| Overall length: 7.2 inches. |
Spatula
Overall length: 7.2 inches Concave
edge length: 0.82 inches. | Brush
Head length: 0.09 inches
Head diameter: 0.27-0.19 inches
Overall length: 7.7 inches.
Spatula
Overall length: 7.2 inches
Concave edge length: 0.82
inches. |
| 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
6
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.