The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.

Device Description

The Cook® Silicone Balloon HSG Catheter is a dual lumen polyurethane catheter that is manufactured in 5.0 or 7.0 French (Fr) sizes and is 30 cm in length. The Cook® Silicone Balloon HSG Catheter is available with an open-end tip, or a closed-end tip with a single side port. The silicone balloon is designed with a balloon volume of 1.0 mL (5.0 Fr) or 1.5 mL (7.0 Fr). Depending upon the device a 1 or 3 mL syringe is provided with the balloon catheter.

The Cook® Silicone Balloon HSG Catheter will be supplied sterile (ethylene oxide) and is intended for one-time use. The set is packaged in a peel-open pouch. The 5.0 Fr size catheter has a three-year shelf-life, and the 7.0 Fr size catheter has a two-year shelf-life.

AI/ML Overview

This document describes the safety and effectiveness testing for the Cook® Silicone Balloon HSG Catheter, but it is not an AI/ML medical device submission. Therefore, it does not contain the specific information requested about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details), which are typically required for AI/ML device submissions.

The provided document is a 510(k) Premarket Notification for a physical medical device. It demonstrates substantial equivalence to a predicate device through bench performance studies and other non-clinical tests.

However, I can extract and present the available information in a format that addresses some aspects of your request, even if it doesn't align with an AI/ML context:

Acceptance Criteria and Device Performance (Based on available information for a physical device)

Test Category	Acceptance Criteria (Pre-defined Specifications)	Reported Device Performance
Sterilization Validation	Per ISO 11135-1:2007 requirements	All predetermined acceptance criteria were met.
Biocompatibility	Per ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization, Intracutaneous Irritation) requirements	All predetermined acceptance criteria were met for Cytotoxicity, Guinea Pig Maximization Sensitization, and Intracutaneous Irritation testing.
Transportation Simulation	Per ASTM D4169-16 requirements	All predetermined acceptance criteria were met.
Package Integrity	Per ASTM F2096-11 (Bubble Leak), ASTM F88-09 (Seal Strength), ASTM F1866-09 (Visual Inspection) after aging (2 or 3 years shelf-life)	All predetermined acceptance specifications were met for Bubble Leak test, Seal Strength testing, and Visual Inspection after aging.
Simulated Use	Catheter able to be inserted through cervical canal of nulliparous cervix model, syringe able to mate with check valve, inflate balloon to labeled volume, and deflate fully.	Testing demonstrated that the catheter was able to be inserted through the cervical canal of a model of a nulliparous cervix, the syringe was able to mate with catheter check valve, inflate balloon to labeled volume, and deflate balloon fully. (All predetermined acceptance specifications were met).
Balloon Integrity Test	Catheter and balloon show no abnormalities (breakage, leakage, cracking at joint/material) when filled to labeled volume. No leakage after 10 mins in 37°C water bath.	Testing demonstrated that the catheter and balloon did not show any abnormalities such as breakage, leakage, or cracking at the balloon joint or balloon material when filled to the labeled volume. It also demonstrated that the catheter and balloon did not leak after being filled to the labeled volume and submerging in a 37°C water bath for a minimum of 10 minutes. (All predetermined acceptance specifications were met).
Balloon Diameter & Max. Balloon Volume	Test results meet pre-defined acceptance specifications for balloon diameter with max fill, and max balloon pressure/volume at catastrophic failure.	Test results met the pre-defined acceptance specifications for these devices (balloon diameter when filled with maximum fill volume, and maximum balloon pressure and volume at catastrophic failure). (All predetermined acceptance specifications were met).
Lumen Patency & Liquid Leakage	Fluid path is patent and does not leak under a predetermined injection pressure.	Testing demonstrated that the fluid path of the catheter was patent and did not leak under a predetermined injection pressure. (All predetermined acceptance specifications were met).
Tensile Testing	Peak load value greater than predetermined acceptance specification for hub to shaft, shaft, shaft to manifold, extension tubing to manifold.	Testing demonstrated that the peak load value was greater than the predetermined acceptance specification. (All predetermined acceptance specifications were met).

Summary of Study Details (for a physical medical device, not AI/ML):

Sample Size used for the test set and data provenance:
- The document implies that an adequate number of units were tested to demonstrate statistical significance and meet pre-defined acceptance criteria for bench performance and other non-clinical tests.
- Specific numerical sample sizes for each test are not provided in this summary.
- Data Provenance: The tests are described as "Performance Data" and "Bench Performance studies," indicating the data was generated from laboratory testing of the physical catheter devices. Country of origin for data or retrospective/prospective nature is not applicable as this is not a clinical study on patient data.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. This is not an AI/ML device that generates diagnostic outputs requiring expert interpretation for ground truth. The "ground truth" for this physical device is defined by the physical properties and performance specifications of the device itself (e.g., balloon inflates, no leaks, proper tensile strength).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML device or a clinical study requiring adjudication of diagnostic interpretations.
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:
- Not applicable. This is a physical medical device, not an AI/ML software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an AI/ML software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering specifications and testing standards (e.g., ISO, ASTM standards, pre-defined internal acceptance specifications).
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.

Conclusion from the document:

"The results of the performance testing described above demonstrates that the Cook® Silicone Balloon HSG Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence." (Page 6)

Summary

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October 26, 2018

Cook Incorporated Yan Li Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

Re: K180291

Trade/Device Name: Cook® Silicone Balloon HSG Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 24, 2018 Received: September 25, 2018

Dear Yan Li:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

for

Benjamin R. Fisher, Ph.D. Director 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) K180291

Device Name Cook® Silicone Balloon HSG Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 201 Subpart D)
☐ Over-The-Counter Use (21 CFR 201 Subpart C)

| X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a red background. The red background is shaped like a trapezoid.

COOK INCORPORA 750 DANIELS WAY, P.O. BC BLOOMINGTON, IN 47402-048 12.339.2235 TOLL FREE: 800.457 WWW.COOKMEDICAL.CO

K180291 Page 1 of 4

510(k) Summary Cook® Silicone Balloon HSG Catheter Date Prepared: October 26, 2018

Submitted By:
Applicant:	Cook Incorporated
Contact:	Yan Li
	Rohini Patel
Applicant Address:	Cook Incorporated
	750 Daniels Way
	Bloomington, IN 47404
Contact Phone:	(812) 339-2235 x104987
Contact Fax:	(812) 332-0281
Device Information:
Trade Name:	Cook® Silicone Balloon HSG Catheter
Device Common Name:	HSG Catheter
Regulation Number:	21 CFR §884.4530
Regulation Name:	Obstetric-Gynecologic Specialized Manual Instrument
Product Code:	LKF (Cannula, Manipulator/Injector, Uterine)
Device Classification:	Class II

Predicate Device:

u Vue® HSG/SHG Catheter, Cook Incorporated, K160217

The predicate device has not been subject to any design-related recalls.

Device Description:

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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 48 BLOOMINGTON, IN 47402-0489 U.S 812.339.2235 TOLL FREE: 800.457 WWW.COOKMEDICAL.COM

Indications for Use:

Comparison to Predicate Device:

The following table compares the Cook® Silicone Balloon HSG Catheter to the predicate device:

DeviceCharacteristics	K180291Cook® SiliconeBalloon HSG Catheter	K160217uVue® HSG/SHGCatheter	Comparison
Indications forUse	The Cook® SiliconeBalloon HSG Catheteris used for delivery ofcontrast medium orsaline into the uterinecavity and fallopiantubes for the evaluationof tubal patency usinghysterosalpingography,or to access the uterinecavity for salineinfusionsonohysterography.	The uVue™ HSG/SHGCatheter is intended toaccess the uterinecavity forsonohysterography(SHG) andhysterosalpingography(HSG).	Same intended use: Bothdevices are intended for usein delivery of contrastmedium or saline to theuterine cavity for HSG andsonohysterographyprocedures
BalloonMaterial	Silicone	Silicone	Same
Balloon Volume(mL)	5.0 Fr: 1 mL7.0 Fr: 1.5 mL	1.5 mL	Different: The subject deviceincludes a smaller diameterdevice version. Thisdifference does not raisedifferent questions of safetyand effectiveness (S&E).
CatheterTubing Material	Polyurethane	Polyurethane	Same
CatheterTubing OuterDiameter (Fr)	5.0 and 7.0	6.2	Different: The subject devicecatheter diameters are smallerand larger than the predicatedevice. This difference doesnot raise different questionsof S&E.
Length (cm)	30	26	Different: The subject deviceis longer than the predicatedevice. This difference doesnot raise different questionsof S&E.
Lumen Number	2	3	Different: Both devices havetwo functional lumens forballoon inflation and contrastmedium/saline infusion. Thethird lumen of the predicatedevice contains the internal
DeviceCharacteristics	K180291Cook® SiliconeBalloon HSG Catheter	K160217uVue® HSG/SHGCatheter	Comparison
RadiopaquePositioner	None	Yes	stylet. This difference doesnot raise different questionsof S&E.
Internal Stylet	None	Yes	Different: The subject devicedoes not include a positioneralong the catheter shaft. Thisdifference does not raisedifferent questions of S&E.
			Different: The subject devicedoes not include an internalstylet in the catheter shaft.This difference does not raisedifferent questions of S&E.
			Different: The 5 Fr device issupplied with a 1.0 mL

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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S. 312.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

syringe. The inclusion of a

smaller syringe does not raise different questions of S&E.

Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font in the upper portion of the image. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font.

IR P

Accessory

3 mL syringe

As shown above, the subject and predicate device have intended use. In regards to technological characteristics, the subject and predicate device are similar in that they utilize comparable materials and are both supplied with syringes for inflation of the silicone balloons. However, differences do exist as described in the table above (e.g., dimensions, balloon volume, lumen number, lack of a stylet and positioner in the subject device, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.

Performance Data:

The following testing was performed to demonstrate that the Cook® Silicone Balloon HSG Catheter met applicable design and performance requirements. All predetermined acceptance criteria were met in the following tests.

. Sterilization Validation testing per ISO 11135-1:2007
. Biocompatibility studies, as follows:
- Cytotoxicity testing per 10993-5:2009 o

1 or 3 mL syringe

Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 o
Intracutaneous Irritation testing per ISO 10993-10:2010 o
Transportation Simulation study per ASTM D4169-16
트 Package Integrity testing after aging to two (7.0 Fr) or three (5.0 Fr) years:
- Bubble Leak test per ASTM F2096-11 O

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o Seal Strength testing per ASTM F88-09
MEDICA
Visual Inspection per ASTM F1866-09 O
트 Bench Performance studies before and after aging to two (7.0 Fr) or three (5.0 Fr) years demonstrated that all predetermined acceptance specifications were met in the following tests:
- o Simulated Use: Testing demonstrated that the catheter was able to be inserted through the cervical canal of a model of a nulliparous cervix, the syringe was able to mate with catheter check valve, inflate balloon to labeled volume, and deflate balloon fully.
- Balloon Integrity Test: Testing demonstrated that the catheter and balloon did not o show any abnormalities such as breakage, leakage, or cracking at the balloon joint or balloon material when filled to the labeled volume. It also demonstrated that the catheter and balloon did not leak after being filled to the labeled volume and submerging in a 37°C water bath for a minimum of 10 minutes.
- Balloon Diameter and Maximum Balloon Volume Testing: Testing assessed the o balloon diameter when filled with the maximum fill volume (i.e., 1.0 or 1.5 mL), and the maximum balloon pressure and volume at catastrophic failure of the test articles. Test results met the pre-defined acceptance specifications for these devices.
- Lumen Patency and Liquid Leakage Test: Testing demonstrated that the fluid path of the catheter was patent and did not leak under a predetermined injection pressure.
- Tensile Testing (hub to shaft, shaft, shaft to manifold, extension tubing to o manifold): Testing demonstrated that that the peak load value was greater than the predetermined acceptance specification.

Conclusion:

The results of the performance testing described above demonstrates that the Cook® Silicone Balloon HSG Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.