Margolin HSG Cannula, Goldstein Sonohysterography Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180300 Device Name Margolin HSG Cannula Goldstein Sonohysterography Catheter Indications for Use (Describe) 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). Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |---------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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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 Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 | | Contact Phone Number: | (812) 335-3575 x10-4371 | | Contact Fax Number: | (812) 332-0281 | #### Device Information: | Trade Name: | Margolin HSG Cannula<br>Goldstein 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: 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below that, the word "MEDICAL" is written in smaller, white block letters. 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). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font, with a registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is also in white, bold, sans-serif font, but smaller in size. 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: | Device<br>Characteristics | Subject Device<br>(K180300)<br>Margolin | Subject Device<br>(K180300)<br>Goldstein | K083594 - The<br>Foam Seal<br>SIS/HSG<br>Catheter | Comparison | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The Margolin HSG<br>Cannula is for the<br>delivery of contrast<br>media or saline into the<br>uterine cavity during<br>Hysterosalpingography<br>(HSG) or<br>Sonohysterography<br>(SHG) for examination<br>of the uterus and<br>fallopian tubes. When<br>used for HSG, the<br>Margolin HSG<br>Cannula can be used<br>for evaluation of tubal<br>patency. | The Goldstein<br>Sonohysterography<br>Catheter is used to<br>access the uterine<br>cavity for the<br>delivery of saline<br>for<br>Sonohysterography<br>(SHG). | The Foam Seal<br>SIS/HSG Catheter is<br>intended for<br>introduction of liquid<br>into the uterine cavity<br>for ultrasonogram and<br>radiology procedure<br>of the uterus and<br>fallopian tubes. | Same intended use:<br>Both devices are<br>intended for use in<br>delivery of contrast<br>medium or saline to<br>the uterine cavity for<br>HSG and SHG<br>procedures | | Catheter Material | Polyurethane | Polyethylene or<br>Teflon | Unspecified plastic | Different: The<br>catheter material is<br>not known for the<br>predicate device.<br>Differences in<br>device materials<br>between the subject<br>and predicate device<br>do not raise different<br>questions of safety<br>and effectiveness<br>(S&E). | | Positioner/Cervical<br>Seal | Yes | Yes | Yes | Same | | Positioner/Cervical<br>Seal Material | Silicone | Silicone | Unspecified Foam | Different: The<br>positioner/seal<br>material is not<br>known for the<br>predicate device.<br>Differences in<br>device materials<br>between the subject<br>and predicate device<br>do not raise different<br>questions of S&E. | | Catheter Length | 25 cm | 26 cm to 36 cm | 37 cm | Different: The<br>subject devices are<br>shorter than the<br>predicate device. | | | | | | This difference does<br>not raise different<br>questions of S&E. | | Tip Size | 8.76 Fr | 5.2 Fr to 5.4 Fr | 1.6mm to 3 mm<br>(4.8 Fr to 9.0 Fr) | Different: Tip sizes<br>are different<br>between the subject<br>and predicate<br>devices. These<br>differences do not<br>raise different<br>questions of S&E. | | Distal Tip<br>Configuration | 19-guage dual oval<br>side ports, closed<br>ended. | 3 mm single side<br>port, closed ended | open ended | Different:<br>Differences in<br>placement of fluid<br>outflow openings in<br>the tip of the subject<br>and predicate<br>devices do not raise<br>different questions<br>of S&E. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font at the top, and the word "MEDICAL" is in a smaller, white, sans-serif font at the bottom. 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 {7}------------------------------------------------ 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.