COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

K102141 · Cook Urological, Inc. · KNA · May 6, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K102141
• Device Name: COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
• Applicant: Cook Urological, Inc.
• Product Code: KNA · Obstetrics/Gynecology
• Decision Date: May 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Used for the treatment of abscesses and cysts of the Bartholin gland.

Device Story

Manual surgical instrument set for Bartholin gland cyst/abscess drainage; includes 15 FR silicone balloon catheter (3 ml capacity, 5.5 cm length), 1" 21 gauge needle, and scalpel with #1 blade. Used by clinicians in clinical settings. Procedure involves lancing cyst/abscess with scalpel; inserting catheter; inflating balloon via syringe/needle to secure position. Catheter remains in situ for up to 28 days to facilitate duct re-epithelialization and permanent drainage. Provides immediate relief and prevents recurrence by maintaining patency of accessory duct.

Clinical Evidence

Bench testing only. Testing included balloon integrity, volume, and leak testing per BS EN 1616:1997/ASTM F623-99; balloon burst testing; and biocompatibility testing per ISO 10993 series. No clinical data presented.

Technological Characteristics

Silicone balloon catheter (15 FR, 5.5 cm length, 3cc balloon). Includes stainless steel scalpel and needle. Biocompatibility per ISO 10993. Performance testing per BS EN 1616:1997 and ASTM F623-99. Sterile, single-use device.

Indications for Use

Indicated for patients requiring treatment of Bartholin gland abscesses or cysts.

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

• Word Bartholin Gland Catheter for Cyst and Abscess Drainage (K861385)
• Word Bartholin Catheter, 10 French (K880497)

Submission Summary (Full Text)

{0}------------------------------------------------

K102141/
pg. 1 of 3

## MAY - 6 2011

| Date of Summary: | June 30, 2010 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitted by<br>and Primary Contact: | Cindy Foote<br>Regulatory Affairs Specialist<br>Cook Urological, Incorporated<br>1100 West Morgan Street<br>Spencer, IN 47460<br>Tel: [phone] x7281<br>[e-mail] |
| Device Name: | Word Catheter-Silicone Bartholin Gland Balloon Set<br>(final trade name yet to be determined) |
| Classification Name: | Instrument, Manual, Specialized Obstetric-Gynecologic |
| Panel: | Obstetrics/Gynecology |
| Regulation Number: | 21 CFR 884.4530 |
| Regulation Description: | Obstetric-gynecologic specialized manual instrument |
| Device Class: | Class II |
| Product Code: | KNA |
| Indication for Use: | |

Used for the treatment of abscesses and cysts of the Bartholin gland.

### Device Description:

510(k) SUMMARY

The Word Catheter-Silicone Bartholin Gland Balloon Set is used for treatment of abscesses and cysts of the Bartholin gland. The Word Catheter-Silicone Bartholin Gland Balloon Set is a 3 ml balloon catheter which is 5.5 cm in length and constructed of silicone. The catheter is sold with a 1" 21 gauge needle and a scalpel with a # 1 blade is used to lance the Bartholin gland cystlabscess, the syringe with needle is used to inflate the balloon catheter, and the catheter is placed in the cyst or abscess remaining for up to 28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use. Tim

## Predicate Devices:

510(k) number: Current Trade Name:

K861385 Word Bartholin Gland Catheter for Cyst and Abscess Drainage

{1}------------------------------------------------

K102/41
page 2 of 3

Distributed by: 510(k) Applicant: CooperSurgical Incorporated Milex Products Incorporated

510(k) number: Current Trade Name: Distributed by: 510(k) Applicant:

K880497 Word Bartholin Catheter Rusch Medical (A Teleflex Medical Company) Hoosier Specialties Incorporated

The Cook Word Bartholin Gland Catheter Set is equivalent in technology, materials, and intended use as the Word Bartholin Catheter for Cyst and Abscess Drainage manufactured by CooperSurgical Incorporated, The Cook Word Bartholin Gland Catheter Set is equivalent in technology and intended use as the Word Bartholin Catheter, 10 French manufactured by Rusch (Teleflex Medical) Medical.

| Device | Word Catheter-<br>Silicone Bartholin<br>Gland Balloon Set | Word Bartholin Catheter for Cyst<br>and Abscess Drainage | Word Bartholin<br>Catheter, 10 French |
|--------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Manufacturer | Cook Urological,<br>Incorporated | CooperSurgical, Incorporated | Rusch Medical (Teleflex<br>Medical) |
| Intended Use | Used for treatment of<br>abscesses and cysts<br>of the Bartholin Gland | Used following an incision and drainage of a<br>Bartholin cyst or abscess providing<br>immediate relief. However, Bartholin<br>cysts/abscesses have a high rate of<br>recurrence unless the accessory duct is<br>provided to permanently drain the obstructed<br>acini. This can be accomplished by use of<br>the Word Catheter. | Specifically developed<br>for the treatment of<br>Bartholin gland cysts. |
| Materials | Silicone balloon<br>Silicone Catheter | Silicone balloon<br>Silicone catheter | Latex balloon<br>Silicone Catheter |
| Dimensions | 15 FR with a 3cc<br>balloon and 5.5 cm<br>length | 15 FR with a 3cc balloon and 5.5 cm<br>length | 10 Fr, 5cm with a 5cc<br>balloon |
| Components | Syringe with Needle<br>and Scalpel | Syringe with Needle | None known |

#### Device Comparison

There are few differences between the Word Catheter-Silicone Bartholin Gland Set offered by Cook Urological, Incorporated, the Word Bartholin Catheter for Cyst and Abscess Drainage offered by CooperSurgical, Incorporated, and the Word Bartholin Catheter, 10 French offered by Rusch Medical. The material used to construct the balloon of the Rusch Balloon is different as it is Latex as opposed to silicone, which is used for the Cook and CooperSurgical Word Balloon. The dimensions of the Rusch balloon catheter are slightly different from the Cook and CooperSurgical balloon catheters, which are identical. The Word Catheter-Silicone Bartholin Gland Set is sold with a syringe with a needle and a scalpel, the Word Bartholin Catheter for Cyst and Abscess Drainage is sold with a needle by CooperSurgical, Incorporated. The Word Bartholin Catheter is sold as a stand alone device by Rusch Medical.

{2}------------------------------------------------

K102141
pg. 3 of 3

## Summary of Testing:

The Word Catheter-Silicone Bartholin Gland Balloon Set was tested by the following non-clinical methods to demonstrate that the device is substantially equivalent to the predicate devices in functionality, safety and effectiveness

- . Balloon Integrity, Volume, Leak Testing, using modified recommendations from BS EN 1616; 1997 (which is nearly identical to ASTM F623-99)
- Balloon Burst Testing, using modified recommendations from BS EN 1616:1997 (which is nearly . identical to ASTM F623-99)
- Biocompatibility testing methods as outlined in the ISO 10993 series, conducted using Good . Laboratory Practices (GLP).

Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards.

## Comparison with Predicate Devices:

The results of non-clinical and bench testing indicate that the Word Catheter-Silicone Bartholin Gland Balloon Set is as safe and effective as the predicate devices. The Word Cathefer-Silicone Bartholin Gland Balloon Set is similar to the predicate devices in terms of technical characteristics, design, Indications for Use, patient population, performance, and size. The data that was presented for the Word Catheter-Silicone Bartholin Gland Balloon Set prove substantial equivalence to the product devices, prove that the products are safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness.

The Word Catheter-Silicone Bartholin Gland Balloon Set is comparable with respect to intended use to the published predicate device descriptions and meets the requirements for 510(k) substantial equivalence.

1:7 +

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle with three lines extending from its head, symbolizing health, services, and people.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G( Silver Spring, MD 20993-0002

Ms. Cindy Foote Regulatory Affairs Specialist Cook Urological, Incorporated Cook Women's Health 1100 West Morgan. Street SPENCER IN 47460

MAY - 6 2011

Re: K102141

Trade Name: Word Catheter-Silicone Bartholin Gland Balloon Set Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: KNA Dated: April 18, 2011 Received: April 19, 2011

Dear Ms. Foote:

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 informations related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleding.

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 offecting 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 Patt 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related

{4}------------------------------------------------

Page 2

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutliDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliante. 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 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 Small Manufacturers, International and Consumer Assistance at its toll the [phone] or [phone] or at its Internet address

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

Sincerely yours,

Hubert Leuner MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

:

| 510(k) Number (if known): | K102141 |
|---------------------------|-----------------------------------------------------------------------|
| Device Name: | Word Catheter-Silicone Bartholin Gland Balloon Set |
| Indications for Use: | Used for the treatment of abscesses and cysts of the Bartholin gland. |

Prescription Use? X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and

Urological Devices

| 510(k) Number: | K102141 |
|----------------|---------|
|----------------|---------|

ﭘﯿﻨﮯ ﮐﮯ ﻧﺎﻡ

.

.

: