The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency.

The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

Device Description

The Margolin HSG Cannula and Goldstein Sonohysterography Catheter are single lumen uterine catheters that facilitate access to the uterus to deliver fluid (contrast media or saline) during diagnostic procedures. Both feature a silicone "acom" wedge that seals the cervical canal and maintains the position of the catheter during the procedure.

AI/ML Overview

This is a 510(k) summary for medical devices (Margolin HSG Cannula and Goldstein Sonohysterography Catheter) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for novel performance metrics with acceptance criteria, expert ground truth, or statistical power.

Therefore, many of the requested data points (e.g., effect size of human readers with/without AI, sample size for training set, specific study design for clinical performance against pre-defined acceptance criteria, detailed ground truth establishment for a test set) are not presented in this document because they are not typically required for a 510(k) submission for these types of devices. The "performance data" section rather lists engineering and biocompatibility tests.

However, based on the provided text, I can extract the following information:

1. A table of acceptance criteria and the reported device performance

The document states: "All predetermined acceptance specifications were met in the following tests." However, the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. The performance is reported as meeting these unspecified specifications.

Test Category	Acceptance Criteria (Not Explicitly Stated Numerically)	Reported Device Performance
Sterilization Validation	Per ISO 11135-1:2007 requirements	Met applicable design and performance requirements
Transportation Simulation	Per ASTM D4169-16 requirements	Met applicable design and performance requirements
Package Integrity	Per ASTM F2096-11 (Bubble Leak), ASTM F88-09 (Seal Strength), ASTM F1866-09 (Visual Inspection) requirements after aging to three years	Met applicable design and performance requirements
Biocompatibility	Per ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization), ISO 10993-10:2010 (Irritation)	Met applicable design and performance requirements
Dimensional Verification	Conformance with Cook's predetermined acceptance specifications for catheter, stylet, ink marker bands, silicone positioner dimensions	Verified conformance to predetermined acceptance specifications
Lumen Patency and Liquid Leakage Test	Fluid path of catheter patent and no leakage from joints/parts at predetermined injection pressure	Fluid path was patent and did not leak
Tensile Testing	Peak load value greater than predetermined acceptance specification (for hub to shaft (both devices), hub to stylet wire (Margolin HSG Cannula), and tip to shaft (Margolin HSG Cannula))	Peak load value was greater than the predetermined acceptance specification
Positioner Force to Displace	Conformance to Cook requirements for force needed to displace movable silicone positioner (Goldstein Sonohysterography Catheter)	Predetermined acceptance specification was met
Stylet Compatibility Testing	Stylet fits within catheter lumen and does not extend beyond tip (Margolin HSG Cannula)	Predetermined acceptance specification was met

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the "performance data" tests. The data provenance is not mentioned, as these are primarily engineering and bench tests, not clinical studies in a specific geographical location. The studies are prospective in the sense that they are conducted on manufactured devices to test design specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. These are engineering performance tests, not clinical performance studies requiring expert ground truth for interpretation (e.g., image analysis, diagnosis).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to clinical studies where multiple reviewers' opinions need to be reconciled to establish a ground truth, which is not the case for these bench tests.

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

Not applicable. These are medical devices (cannulas and catheters) used for fluid delivery, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study related to human readers improving with AI assistance is entirely irrelevant to this document.

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

Not applicable. As stated above, these are physical medical devices, not algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests listed, the "ground truth" is defined by the technical specifications and standards (e.g., ISO 11135-1:2007 for sterilization, ASTM D4169-16 for transportation, ASTM F2096-11 for bubble leak, ISO 10993 series for biocompatibility, and "Cook's predetermined acceptance specifications" for dimensional, patency, tensile, and force tests). There's no clinical ground truth established by experts or pathology for these types of tests.

8. The sample size for the training set

Not applicable. There is no AI or machine learning model being "trained" for these medical devices.

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

Not applicable for the same reason as point 8.

Summary

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October 26, 2018

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

Re: K180300

Trade/Device Name: Margolin HSG Cannula, Goldstein Sonohysterography Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 26, 2018 Received: September 27, 2018

Dear Naomi Funkhouser:

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) K180300

Device Name Margolin HSG Cannula Goldstein Sonohysterography Catheter

Indications for Use (Describe)

The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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COOK INCORPORATED Page 1 of 5 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 12.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

K180300

510(k) SUMMARY

Margolin HSG Cannula Goldstein Sonohysterography Catheter Date Prepared: October 26, 2018

Submitted By:

Applicant:	Cook Incorporated
Contact:	Naomi Funkhouser, Rohini Patel
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x10-4371
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Margolin HSG CannulaGoldstein Sonohysterography Catheter
Common Name:	HSG, SHG Catheters
Regulation Number:	21 CFR §884.4530
Regulation Name:	Obstetric-gynecologic specialized manual instrument
Classification Product Code:	LKF – Cannula, Manipulator/Injector, Uterine
Device Classification:	Class II

Predicate Devices:

K083594 - Foam Seal Catheter from OBG Products

The predicate device has not been subjected to a design-related recall.

Device Description:

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BLOOMINGTON, IN 47402-0489 U.S.A 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Margolin HSG Cannula

The Margolin HSG Cannula is comprised of a cannula and stylet. The cannula is made of polyurethane with a stationary silicone wedge at the distal end that maintains the position of the catheter in the external cervical os and 9.0 French tip which is approximately 2 cm in length. The wedge, characterized by an acorn shape features two 180° opposed sideports. The proximal end of the cannula is designed with a female luer lock-style adaptor. The Margolin HSG Cannula is provided with a stainless-steel stylet. The stylet is designed with a female luer lock-style plug proximal fitting. The Margolin HSG Cannula is 25 cm in length, is supplied sterile (ethylene oxide), and intended for one-time use.

Goldstein Sonohysterography Catheter

The Goldstein Sonohysterography Catheter includes four versions that range in size from 5.2 to 5.4 French. The 5.2 French catheters are made of polytetrafluoroethylene tubing and the 5.3 and 5.4 French catheters are made of polyethylene tubing. The 5.4 French catheter is designed with an additional polyurethane support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable silicone acorn wedge is placed on the catheter shaft proximal to an ink band that is 7 cm from the distal tip of the catheter. The silicone acorn maintains placement of the catheter against the external cervical os, and a luer lock-style adapter is available for compatibility with luer lock syringes. The Goldstein Sonohysterography Catheter is 26 to 36 cm in length, supplied sterile (ethylene oxide), and intended for one-time use. Additional information on the different device versions is provided below:

J-GSHC-522620 5.2 French and 26 cm long .
J-GSHC-523620 5.2 French and 36 cm long .
J-GSHC-532600 5.3 French and 26 cm long .
J-GSHC-542600-SV 5.4 French and 26 cm long .

Indications for Use:

The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency.
The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the . delivery of saline for Sonohysterography (SHG).

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K 180300 COOK INCORPORATED Page 3 of 5 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Comparison to Predicate Device:

The following table compares the Margolin HSG Cannula and Goldstein Sonohysterography Catheter to the predicate device:

DeviceCharacteristics	Subject Device(K180300)Margolin	Subject Device(K180300)Goldstein	K083594 - TheFoam SealSIS/HSGCatheter	Comparison
Indication for Use	The Margolin HSGCannula is for thedelivery of contrastmedia or saline into theuterine cavity duringHysterosalpingography(HSG) orSonohysterography(SHG) for examinationof the uterus andfallopian tubes. Whenused for HSG, theMargolin HSGCannula can be usedfor evaluation of tubalpatency.	The GoldsteinSonohysterographyCatheter is used toaccess the uterinecavity for thedelivery of salineforSonohysterography(SHG).	The Foam SealSIS/HSG Catheter isintended forintroduction of liquidinto the uterine cavityfor ultrasonogram andradiology procedureof the uterus andfallopian tubes.	Same intended use:Both devices areintended for use indelivery of contrastmedium or saline tothe uterine cavity forHSG and SHGprocedures
Catheter Material	Polyurethane	Polyethylene orTeflon	Unspecified plastic	Different: Thecatheter material isnot known for thepredicate device.Differences indevice materialsbetween the subjectand predicate devicedo not raise differentquestions of safetyand effectiveness(S&E).
Positioner/CervicalSeal	Yes	Yes	Yes	Same
Positioner/CervicalSeal Material	Silicone	Silicone	Unspecified Foam	Different: Thepositioner/sealmaterial is notknown for thepredicate device.Differences indevice materialsbetween the subjectand predicate devicedo not raise differentquestions of S&E.
Catheter Length	25 cm	26 cm to 36 cm	37 cm	Different: Thesubject devices areshorter than thepredicate device.
				This difference doesnot raise differentquestions of S&E.
Tip Size	8.76 Fr	5.2 Fr to 5.4 Fr	1.6mm to 3 mm(4.8 Fr to 9.0 Fr)	Different: Tip sizesare differentbetween the subjectand predicatedevices. Thesedifferences do notraise differentquestions of S&E.
Distal TipConfiguration	19-guage dual ovalside ports, closedended.	3 mm single sideport, closed ended	open ended	Different:Differences inplacement of fluidoutflow openings inthe tip of the subjectand predicatedevices do not raisedifferent questionsof S&E.

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COOK INCORPORATED Page 4 of 5 BLOOMINGTON, IN 47402-0489 U.S.A 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

As shown above, the indication for use of the subject devices, Margolin HSG Cannula and the Goldstein Sonohysterography Catheter, as compared to the predicate device, the Foam Seal Catheter (K083594), is not identical; however, the differences do not alter the intended use of the devices, which are the same (i.e., delivery of contrast medium or saline to the uterine cavity for HSG and SHG procedures).

Regarding technological characteristics, the subject and predicate devices are similar in general design. However, differences do exist as described in the table above (e.g., dimensions, materials, tip configuration, 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 tests were performed to demonstrate that the Margolin HSG Cannula and Goldstein Sonohysterography Catheter met applicable design and performance requirements. All predetermined acceptance specifications were met in the following tests:

. Sterilization Validation testing per ISO 11135-1:2007
Transportation Simulation study per ASTM D4169-16 ●
Package Integrity testing after aging to three years:
- o Bubble Leak test per ASTM F2096-11
- Seal Strength testing per ASTM F88-09 o
- Visual Inspection per ASTM F1866-09 O

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Image /page/7/Picture/1 description: The image shows the logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font on the top half. There is a registered trademark symbol to the right of the word "COOK". The bottom half of the logo is a smaller red rectangle with the word "MEDICAL" in white, sans-serif font.

Biocompatibility studies, as follows:
- o Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010 o
- 0 Irritation per ISO 10993-10:2010
. Performance studies before and after aging to three years. The testing below was conducted on the Margolin HSG Cannula and the Goldstein Sonohysterography Catheter unless stated otherwise:
- o Dimensional Verification: Testing verified that the catheter, stylet, ink marker bands and silicone positioner dimensions are in conformance with Cook's predetermined acceptance specifications.
- o Lumen Patency and Liquid Leakage Test: Testing demonstrated that the fluid path of the catheter was patent and did not leak from any joints parts when tested with a predetermined injection pressure.
- Tensile Testing (hub to shaft [both devices], hub to stylet wire [Margolin o HSG Cannula], and tip to shaft [Margolin HSG Cannula]): Testing demonstrated that that the peak load value was greater than the predetermined acceptance specification.
- o Positioner Force to Displace: Testing was conducted to assess the force needed to displace the movable silicone positioner of the Goldstein Sonohysterography Catheter. In conformance to Cook requirements, the predetermined acceptance specification was met.
- Stylet Compatibility Testing was conducted to demonstrate that the stylet is o compatible with the Margolin HSG Cannula (i.e., fits within the catheter lumen and does not extend beyond the tip of the catheter). In conformance to Cook requirements, the predetermined acceptance specification was met.

Conclusion:

The results of the performance testing described above demonstrates that the subject devices Margolin HSG Cannula and the Goldstein Sonohysterography Catheter are 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.