The uVue™ HSG/SHG Catheter is a 6.2 French polyurethane catheter molded inside a 9.0 French polyurethane integrated catheter as a single piece. The device has a 26 centimeter working length. Along the distal end of the catheter, there is a silicone radiopaque positioner. In addition, distal from the positioner is a 1.5 milliliter silicone balloon. The catheter consists of three lumens: a closed lumen that contains a stainless steel stylet, an open lumen used to inflate the balloon, and an open lumen used to inject diagnostic media into the uterus. The catheter features a proximal fitting of a double lumen polyurethane hub with a polyethylene and polyetherimide stopcock attached. Both the hub and stopcock accept standard Luer lock or Luer slip syringes.

The purpose of the first luer is to allow for inflation of the balloon with saline via a proximally extending inflation line. The purpose of the second luer to allow for installation of diagnostic media into the uterine cavity. A 3 mL syringe will be provided with the catheter as a set.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a Tyvekpolyethylene peel-open pouch with a two year shelf life.

AI/ML Overview

The document provides information on the uVue™ HSG/SHG Catheter, but it primarily focuses on premarket notification for substantial equivalence to a predicate device and engineering performance testing. It does NOT describe a clinical study involving human patients to prove the device meets acceptance criteria related to its clinical effectiveness or accuracy in diagnosis.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement for clinical performance cannot be extracted from this document, as such a study is not described.

However, I can provide information regarding the engineering performance tests that were conducted and their acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Stated as "Requirement")	Reported Device Performance
Tensile Strength	Tensile force during proper clinical use should not fracture the uVue™ HSG/SHG Catheter materials and bonds.	Predetermined acceptance criteria were met.
Dimensional Analysis	Specific product dimensions should be within set tolerances.	Predetermined acceptance criteria were met.
Balloon Integrity	Balloons should not burst or leak during nominal inflation and after a predetermined time period at nominal inflation in a water bath.	Predetermined acceptance criteria were met.
Balloon Diameter & Max Volume	Balloons, subjected to a desired volume, should achieve a desired diameter while not having any rupture, leakage, or herniation of the entire balloon and/or catheter, or leakage at the hub during placement in a constant temperature bath. Testing continued until maximum burst volume.	Predetermined acceptance criteria were met.
Balloon Deflation Reliability	Balloons, subject to a desired volume and subsequently deflated, should achieve a desired diameter.	Predetermined acceptance criteria were met.
Buckling Force	(Characterization test, no explicit "acceptance criteria" stated, but peak load data was obtained.)	Peak load data provided.
Stylet Puncture Force	Force required to puncture the distal tip of the catheter must be greater than the buckling force.	Predetermined acceptance criteria were met.
Biocompatibility	Conforms with ISO 10993-1:2009 for Cytotoxicity, Sensitization, and Irritation.	Predetermined acceptance criteria were met.
Shelf Life	Maintains mechanical requirements and sterility following aging for two years.	Predetermined acceptance criteria were met.

Regarding Clinical Performance Studies:

The document does not describe any clinical study validating the diagnostic performance (e.g., accuracy in visualizing uterine cavity or fallopian tubes) of the uVue™ HSG/SHG Catheter. The testing described is entirely focused on the physical, mechanical, and biological safety aspects of the device as a medical instrument.

Therefore, the following information is not applicable or not available from the provided text, as it pertains to clinical performance which was not described:

Sample size used for the test set and the data provenance: Not applicable, no clinical test set described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical ground truth established.
Adjudication method for the test set: Not applicable, no clinical test set described.
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 device does not involve AI or human reader interpretation in the context described.
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 algorithm.
The type of ground truth used: Not applicable, no clinical ground truth established.
The sample size for the training set: Not applicable, this is a physical medical device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 6, 2016

Cook Incorporated Kara Kanorr Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404

Re: K160217

Trade/Device Name: uVue™ HSG/SHG Catheter Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: September 7, 2016 Received: September 8, 2016

Dear Kara Kanorr:

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.

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 vours.

For Division

Douglas Silverstein -S 2016.10.06 16:06:16 -04'00'

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) K160217

Device Name uVue™ HSG/SHG Catheter

Indications for Use (Describe) The uVue™ HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG).

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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COOK INCORPORATED 750 DANIELS WAY RLOOMINGTON, IN 47404 USA

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Submitted Bv: Kara Kanorr Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 Phone: (812) 339-2235 x104072 Fax: (812) 332-0281

Date Prepared: October 5, 2016

Device:
Submission:	Traditional 510(k) Premarket Notification, K160217
Trade Name:	uVueTM HSG/SHG Catheter
Common Name:	Intrauterine Catheter
Classification Regulation:	None
Classification Name:	None
Regulatory Class:	Unclassified
Product Code:	LKF (Cannula, Manipulator/Injector, Uterine)

Predicate Device:

The Advance Catheter for HSG and SIS, cleared under 510(k) K123258. This device has not been subject to a design-related recall.

Device Description:

The set will be supplied sterile and is intended for one-time use. The set is packaged in a Tyvekpolyethylene peel-open pouch with a two year shelf life.

Indications for Use:

The uVue™ HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG).

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Comparison to Predicate Devices:

	Predicate Device	Subject Device
	The Advance Catheter forHSG and SIS (K123258)	uVue HSG/SHG Catheter(K160217)
Intended Use
Indications for Use	Delivery of diagnostic contrastmedia or saline duringhysterosalpingoram (HSG) andsaline infusionsonohysterography (SIS) intothe female reproductive tract forexamination of the uterus and/orfallopian tubes.	The uVue™ HSG/SHG Catheteris intended to access the uterinecavity for sonohysterography(SHG) andhysterosalpingography (HSG)
Technology
Size of catheter	5 and 7 Fr	6.2 Fr
Working length	28 cm	26 cm
Balloon size	1.5 ml	1.5 ml
Internal stylet	No	Yes
Tensile testing	Met performance testingrequirements	Met performance testingrequirements
Biocompatible	Yes	Yes
Sterile	Yes	Yes

The table below provides a detailed comparison of the subject and predicate device:

The subject and predicate device have the same intended use - the delivery of contrast agents to the uterine cavity for HSG/SHG procedures.

The subject and predicate device have different technological characteristics, including different catheter sizes, working length, and the inclusion of an internal stylet. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All catheters must independently demonstrate they are biocompatible, sterile, and can maintiain their mechanical characteristics for their expected shelf life.

Performance Testing:

The following testing was performed in order to demonstrate that the uVue™ HSG/SHG Catheter met applicable design and performance requirements.

. Tensile Strength - Testing shows the tensile force during proper clinical use should not fracture the uVue™ HSG/SHG Catheter materials and bonds. The results showed that the predetermined acceptance criteria were met.
. Dimensional Analysis – Testing was performed with the requirement that specific product dimensions should be within set tolerances. The results showed that the predetermined acceptance criteria were met.

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트 Balloon Integrity - Testing was performed with the requirement that the balloons should not burst or leak during nominal inflation and after a predetermined time period at nominal inflation in a water bath. The results showed that the predetermined acceptance criteria were met.
. Balloon Diameter and Maximum Balloon Volume - Testing was performed with the requirement that the balloons, subjected to a desired volume, should achieve a desired diameter while not having any rupture, leakage, or herniation of the entire balloon and/or catheter, or leakage at the hub during placement in a constant temperature bath. Upon achieving the desired diameter, testing continued until maximum burst volume. The results showed that the predetermined acceptance criteria were met.
Balloon Deflation Reliability - Testing was performed with the requirement that the balloons subject to a desired volume and subsequently deflated, should achieve a desired diameter. The results showed that the predetermined acceptance criteria were met.
. Buckling Force - Characterization testing was performed to evaluate the buckling force of the distal length of the catheter. Results of the testing provided us with the peak load data.
트 Stylet Puncture Force – Testing was performed to evaluate the force required to puncture the distal tip of the catheter and to confirm that it was greater than the buckling force. The results showed that the predetermined acceptance criteria were met.
. Biocompatibility – Testing demonstrated that the proposed device conforms with the biocompatibility requirements per ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process based on its intended use. The following biocompatibility tests were performed:
- Cytotoxicity, per ISO 10993-5:2009 (Extraction Method) o
- Sensitiziation, per ISO 10993-10:2010 (Guinea Pig Maximization Sensitization) o
- Irritation, per ISO 10993-10:2010 (Intracutaneous Reactivity) о

All predetermined acceptance criteria were met.

. Shelf life - Testing demonstrated that the proposed device maintained conformed with the mechanical requirements described above and maintained sterility following aging for two years.

Conclusion:

The results of the testing described above demonstrates that the uVue™ HSG/SHG 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.