PAPCONE

K083012 · Otto Bock Pur Life Science GmbH · HHT · Apr 9, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K083012
• Device Name: PAPCONE
• Applicant: Otto Bock Pur Life Science GmbH
• Product Code: HHT · Obstetrics/Gynecology
• Decision Date: Apr 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Real-World Evidence, 3rd-Party Reviewed

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K083012 · Apr 9, 2009	PAPCONE	Otto Bock Pur Life Science GmbH	Clinical performance evaluation (Sander H. et al., 2007) of 31,000 routine gynecological smears	The study evaluated the PapCone device in a clinical setting, comparing it to standard spatula/brush and cotton tip methods. It assessed handling, sampling time, patient acceptance, and cytological detection rates.	Clinical performance evaluation; Routine gynecological examination; Cytological sampling

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Sander H. et al.: Sampling devices for cytological examinations, 2007; Comparative clinical evaluation; Study Period: 2007	Patients undergoing routine gynecological examinations; Sample Size: 31,000 smears	Combination of spatula and brush, and cotton tip	Handling (sampling and smear), time needed for sampling, patient acceptance, and statistical detection rate of positive cytological findings

Indications for Use

PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.

Device Story

PapCone® is a manual cervical cell scraper consisting of an axially symmetric polystyrene grip and a porous polyurethane foam cone (PUR Foam B 2240). Used by medical professionals during gynecological examinations; the foam cone is inserted into the cervical canal and rotated twice to collect cells from the endocervix and ectocervix. Collected cells are transferred to a glass slide by rotating the device against the slide surface. The foam design prevents cell distortion and ensures uniform distribution. Benefits include reduced iatrogenic bleeding and increased representative sampling compared to traditional methods. The device is non-sterile and intended for single use.

Clinical Evidence

Clinical performance evaluation (SANDER H. et. al, 2007) compared PapCone® to spatula/brush combinations and cotton tips in 31,000 smears. Results showed PapCone® had equal statistical detection rates for positive cytological findings, improved physician-patient compliance due to reduced iatrogenic bleeding, and increased representative sampling (higher cell count).

Technological Characteristics

Manual cervical scraper; polystyrene shaft with polyurethane foam (B 2240) tip. Surface device; limited contact duration (<24h). Biocompatibility per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/hypersensitivity), and ISO 10993-12 (extractables/GC/MS). Non-sterile.

Indications for Use

Indicated for collection of exfoliated cervical cells for Pap smear analysis in non-pregnant women.

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

• Cervex-Brush® (K930955)
• Puritan Foam Tip Swab Model 2197 (K961934)

Submission Summary (Full Text)

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Otto Bock®

EST IN FOA

K083012

## APR - 9 2009

# 5. 510(k) Summary

[As required by 21 CFR 807.92(c)]

| Submitter: | Otto Bock PUR Life Science GmbH<br>Max-Naeder-Str. 15<br>37115 Duderstadt<br>Germany |
|------------|--------------------------------------------------------------------------------------|
|------------|--------------------------------------------------------------------------------------|

#### Contact Person:

| Germany: | Mr. Christian Schulte, Product Manager<br>Phone: [phone] / Fax: [phone] |
|----------|----------------------------------------------------------------------------------------------------|
| USA: | Mr. Dustin Levinger, Technical Sales Engineer<br>Phone: [phone] / Fax: [phone] |

Date prepared: February 04, 2009

#### Device Name

PapCone® Proprietary Name: Common/Usual Name: Cervical Cell Scraper Cervical Cytological Endocervical Brush Classification Name:

#### Predicate Devices

Cervex-Brush® (Rovers Medical Devices B.V., K930955) Puritan Foam Tip Swab Model 2197 (Hardwood Products Company LP, K961934)

#### Device Description

The PapCone® consists of an axially symmetric polystyrene grip with a round platform carrying a foam cone (PUR Foam B 2240), which is intended to collect exfoliated epithelial cervical cells for andysis by Pap smear methods. Due to its shape, dimension and the porosity of the foam used for PapCone® it is possible to obtain cells from the endocervix and the ectocervix.

The design of the foam prevents distortion of the cells during sampling and transfer. During a gynecological examination the foam cone portion of the PapCone® is inserted for \$1/3 into the cervical canal and is rotated two times for collection of cervical cells are transferred to a glass slide by applying gentle pressure and rotating the PapCone® evenly against the direction of streak on the slide, this allows for a uniform distribution of cells on the slide. To ensure the adequate coverage of the periphery of the transition zone, it is generally recommended to swap the periphery additionally with a second instrument (e.g. PapCone® or a spatula). Transfer these cells to the same glass slide. The device is offered non sterile.

#### Intended Use Statement

PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.

### Technological Characteristics and Substantial Equivalence

The Cervex-Brush® consists of a multi-bristled soft plastic broom mounted onto the end of a plastic handle. The Cervex-Brush® is used for the conventional smear as well as for the iquid based cytology.

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Otto Bock®

BEST IN FOA

The substantial equivalence is given by the shape of the resulting simultaneous sampling of endo- and ectocervix.

The Puritan Foam Tip Swab Model 2197 consists of a cylindrical polyurethane foam tip bonded to a polystyrene shaft. The device is used for the endocervical sampling. The substantial equivalence is given by the materials and usage of foam as sampling material.

The PapCone® is substantially equivalent in terms of intended use and principles of operation to the Cervex-Brush® and to the Puritan Foam Tip Swab Model 2197 for materials and principles of operation. None of the devices are intended for the use in pregnant women.

#### Performance testing (bench testing)

The substantial equivalence of the three devices has been shown by a bench test. During this test, the technical function to obtain and to release particles with diameters ranging from 20 μm to 100 µm within a viscous suspension has been compared. The viscosity of this suspension has been comparable to the viscosity of cervical mucus. All three devices have performed within the same range.

| Device | Mean value | Standard<br>dev. | Max. | Min. | Spread |
|-----------------|------------|------------------|------|------|--------|
| Cervex-Brush® | 241 | 54 | 377 | 166 | 3,89 |
| FT Modell 2197® | 205 | 57 | 349 | 118 | 4.04 |
| PapCone® | 273 | 50 | 378 | 177 | 4.06 |

#### Clinical performance data

After its legal marketing in Europe PapCone® has been the subject of a clinical performance evaluation (SANDER H. et. al: Sampling devices for cytological examinations, 2007 - see attachment E). PapCone® has been compared to the combination of spatula and brush and to the cotton tip. In this comparison 31,000 smears have been taken and compared. The evaluation of PapCone® concerning the handling (sampling and smear), the time needed for the sampling and the acceptance by the patient has shown a good acceptance of the PapCone® by medical professionals and by the patients. This comparison has shown the following advantages of PapCone®:

better physician-patient-compliance due to reduced iatrogenic bleeding ー

increased representative sampling due to increased number of cells

The statistical detection rate of positive cytological findings was equal for the compared instruments.

#### Risk management

During the process of development of PapCone® a risk management according to ISO 14791 has been established. The evaluation of the potential risk for the user or the patient has shown no evidence of harmful potential if the device is used according to its instruction for use by medical professionals.

#### Biocompatibility

The intended contact of PapCone® and the human body is the foam cone (made from B 2240) and the mucosal membrane of the female cervix. Therefore PapCone® is a surface device. The duration of the contact is limited (less than 24 h, approximately less than 1 minute).

The PapCone® has been proven to be physiologically harmless through external testing. ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and delayed type hypersensitivity) testing was performed on the B 2240 foam. The complete PapCone (shaft and foam) was tested in accordance to ISO 10993-5 (Cytotoxicity) and ISO 10993-12 (investigation of extractable organic substance and GC/MS fingerprint).

The results of these tests indicated the patient will have no harmful reactions when using the PapCone®.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Otto Bock Pur Life Science GmbH c/o Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW, Ste. 104 NEW BRIGHTON MN 55112-1891

APR - 9 2009

Re: K083012

Trade/Device Name: PapCone® Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HHT Dated: March 23, 2009 Received: March 27, 2009

Dear Mr. Preiss:

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 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 Part 801); 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Otto Bock®

BEST IN FOAM

## 4. Indication for Use

510(k) Number (if known): K083012

Device Name: PapCone®

Indication for Use:

PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Remen

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K083012