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.

AI/ML Overview

Here's an analysis of the provided information regarding the Word Catheter-Silicone Bartholin Gland Balloon Set, structured to address your specific requests:

The provided document describes a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical outcomes or performance against a predefined threshold. Instead, it focuses on demonstrating equivalence through technical comparisons and standard engineering/biocompatibility testing.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence rather than a clinical trial demonstrating performance against specific clinical acceptance criteria for a novel device, the "acceptance criteria" are predominantly related to manufacturing and material standards, as well as functional equivalence to predicate devices.

Acceptance Criteria (Study Performed)	Standard/Method Referenced	Reported Device Performance	Comments
Balloon Integrity, Volume, Leak Testing	Modified recommendations from BS EN 1616:1997 (nearly identical to ASTM F623-99)	Assumed to meet the standard and be comparable to predicates.	Bench testing. Specific quantitative results (e.g., leak rate in ml/hr, volume retention percentage) are not provided in this summary.
Balloon Burst Testing	Modified recommendations from BS EN 1616:1997 (nearly identical to ASTM F623-99)	Assumed to meet the standard and be comparable to predicates.	Bench testing. Specific quantitative results (e.g., pressure at burst) are not provided.
Biocompatibility Testing	ISO 10993 series	Compliant with ISO 10993 series.	Conducted using Good Laboratory Practices (GLP). Demonstrates material safety for biological contact.
Sterility Testing	FDA guidances and recognized international standards	Assumed to meet established sterility standards.	Ensures the device is safe for patient use.
Performance Testing	FDA guidances and recognized international standards	Assumed to meet established performance standards and be safe and effective.	General statement indicating overall functionality.
Substantial Equivalence (Overall)	Comparison to predicate devices (K861385, K880497)	Found to be substantially equivalent in technology, materials, intended use, indications for use, patient population, performance, and size.	The FDA concurred with this assessment in their decision letter.

Important Note: The document does not specify quantitative acceptance criteria (e.g., "burst pressure must be > X psi") or quantitative performance results for the device. Instead, it states that the device was tested according to recognized standards and demonstrated substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it meets these standards and is equivalent to a legally marketed device.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify a "test set" of patient data or clinical samples. The testing described is primarily non-clinical (bench testing) and biocompatibility for the device itself.
Data Provenance: Not applicable, as this is a non-clinical submission. The testing was conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission focuses on the technical characteristics and safety of a medical device (catheter) through bench testing and material biocompatibility, not on a diagnostic algorithm or interpretation requiring expert review of data. There is no "ground truth" to be established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. As there is no clinical test set or expert review process, no adjudication method was used.

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

No. This information is not present in the document. The device is a physical medical instrument (catheter), not an AI-assisted diagnostic or interpretive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used

Not applicable. In the context of a medical device like a catheter, "ground truth" often refers to fundamental scientific principles, engineering standards (like those for materials strength or biocompatibility), and the established performance characteristics of the predicate devices. There is no patient-specific "ground truth" in this submission.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set" with ground truth.

Summary

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K102141/
pg. 1 of 3

MAY - 6 2011

Date of Summary:	June 30, 2010
510(k) Submitted byand Primary Contact:	Cindy FooteRegulatory Affairs SpecialistCook Urological, Incorporated1100 West Morgan StreetSpencer, IN 47460Tel: 812-829-4891 x7281cindy.foote@cookmedical.com
Device Name:	Word Catheter-Silicone Bartholin Gland Balloon Set(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

Predicate Devices:

510(k) number: Current Trade Name:

K861385 Word Bartholin Gland Catheter for Cyst and Abscess Drainage

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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-Silicone BartholinGland Balloon Set	Word Bartholin Catheter for Cystand Abscess Drainage	Word BartholinCatheter, 10 French
Manufacturer	Cook Urological,Incorporated	CooperSurgical, Incorporated	Rusch Medical (TeleflexMedical)
Intended Use	Used for treatment ofabscesses and cystsof the Bartholin Gland	Used following an incision and drainage of aBartholin cyst or abscess providingimmediate relief. However, Bartholincysts/abscesses have a high rate ofrecurrence unless the accessory duct isprovided to permanently drain the obstructedacini. This can be accomplished by use ofthe Word Catheter.	Specifically developedfor the treatment ofBartholin gland cysts.
Materials	Silicone balloonSilicone Catheter	Silicone balloonSilicone catheter	Latex balloonSilicone Catheter
Dimensions	15 FR with a 3ccballoon and 5.5 cmlength	15 FR with a 3cc balloon and 5.5 cmlength	10 Fr, 5cm with a 5ccballoon
Components	Syringe with Needleand 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.

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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 +

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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

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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 (800) 638-2041 or (301) 796-7100 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

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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
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ﭘﯿﻨﮯ ﮐﮯ ﻧﺎﻡ

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.