Pivet and Soft-Pass Embryo Transfer Catheter Sets

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of it. April 13, 2018 Cook Incorporated Naomi Funkhouser, MBA Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402-0489 Re: K173103 Trade/Device Name: Pivet and Soft-Pass Embryo Transfer Catheter Sets Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MOF Dated: March 9, 2018 Received: March 14, 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 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. {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); 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. 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. 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, Charles Viviano -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) K173103 Device Name Pivet and Soft-Pass Embryo Transfer Catheter Sets Indications for Use (Describe) Used to place in vitro fertilized (IVF) embryos into the uterine cavity. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">[X]</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">[ ]</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white block letters. The logo is simple and clean, with a focus on the company name. # 510(k) Summary - K173103 | Submitted By: | | |----------------------------|---------------------------------------------------| | Applicant: | Cook Incorporated | | Contacts: | Naomi Funkhouser | | | Rohini Patel | | Applicant Address: | Cook Incorporated | | | 750 Daniels Way | | | Bloomington, IN 47404 | | Contact Phone: | (812) 339-2235 x104371 | | Contact Fax: | (812) 332-0281 | | Date Prepared: | April 11, 2018 | | Device Information: | | | Trade Names: | Pivet and Soft-Pass Embryo Transfer Catheter Sets | | Common Name: | Embryo Transfer Catheter | | Classification Name: | Assisted Reproduction Catheters (21 CFR 884.6110) | | Classification Regulation: | MQF (Catheter, Assisted Reproduction) | | Regulatory Class | II | | Predicate Device: | | Embryo Transfer Catheter/Sets (K983594) manufactured by Cook Ob/Gyn. This predicate device has not been subject to any design related recalls. # Device Description: The Pivet and Soft-Pass Embryo Transfer Catheter Sets are a group of devices consisting of embryo transfer catheter and guide catheter or trial/mock catheter and guide catheter, as outlined in the table below. | Product number | Device name | Component | |--------------------|------------------------------------------------|------------------------------------------------| | K-PETS-5000 | Pivet Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SP-681700-ET | Soft-Pass EchoTip Embryo Transfer Catheter | Embryo transfer catheter<br>and guide catheter | | K-J-SPPE-681200-ET | Soft-Pass EchoTip Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SPPE-681210-ET | Soft-Pass EchoTip Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SPPE-681700-ET | Soft-Pass EchoTip Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SPPE-681710-ET | Soft-Pass EchoTip Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. | J-SPPE-681700-MC | Soft-Pass Embryo Mock Transfer Catheter Set | Guide catheter and<br>trial/mock catheter | |---------------------|-------------------------------------------------------------------|------------------------------------------------| | J-SPPE-681210-ET-MC | Soft-Pass Embryo Mock Transfer Catheter Set with<br>Echogenic Tip | Guide catheter and<br>trial/mock catheter | | J-SPPE-681710-ET-MC | Soft-Pass Embryo Mock Transfer Catheter Set with<br>Echogenic Tip | Guide catheter and<br>trial/mock catheter | | K-J-SP-681200 | Soft-Pass Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SP-681700 | Soft-Pass Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SP-681710 | Soft-Pass Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SPPE-681200 | Soft-Pass Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SPPE-681700 | Soft-Pass Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | | K-J-SPPE-681710 | Soft-Pass Embryo Transfer Catheter Set | Embryo transfer catheter<br>and guide catheter | These devices are made of polyethylene and polyurethane in a variety of sizes. The transfer catheters range in diameter from 2.8 to 4.4 Fr and range in length from 19.7 to 24.7 cm. Guide catheters measure 6.8 to 7 Fr and are 12 to 17.3 cm in length. Transfer catheters may have a supporting stainless steel cannula, depth indicators, open ends with side ports, or an echogenic band on the distal tip. Trial/mock catheters aid in verifying access and positioning of embryo transfer catheters prior to to placing transfer catheters containing embryos into the uterine cavity. The trial/mock catheters are the same as the transfer catheters they represent, except that they have a closed end without a side port. All of the subject devices are single-use devices and sterilized by ethylene oxide exposure. These products, except trial/mock catheters that will not contact embryos during use, undergo lot release Mouse Embryo Assay (MEA) testing for embryo toxicity and USP endotoxin (LAL) testing for pyrogenicity. The subject devices are packaged in peel-open sterile barrier pouches with a three-year shelf life. # Indications for Use: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. {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, and above the word "MEDICAL" which is also in white. # Comparison of Intended Use and Technological Characteristics with the Predicate Device: | Parameter | K173103 (subject device) | K983594 (predicate device) | |-------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Indcations for Use | Used to place in vitro fertilized (IVF)<br>embryos into the uterine cavity. | The embryo transfer catheters/sets are used<br>to place embryos in the uterine cavity. | | Design – transfer<br>catheter | Same as the predicate | With or without graduation marks Open or closed end with side port Locking hubs With or without positioner With or without EchoTip | | Design – guide<br>catheter | Same as the predicate | With graduation marks Locking hubs Without positioner With or without EchoTip Straight | | Design – trial/mock<br>catheter | Identical to subject transfer catheters, except<br>that they have closed ends without side ports | N/A | | Dimension – transfer<br>catheter | OD 2.8-4.4 Fr<br>Length 19.7-24.7 cm | OD 2-8 Fr<br>Length 12-30 cm | | Dimensions – guide<br>catheter | OD 6.8-7.0 Fr<br>Length 12-17.3 cm | OD 5-8.5 Fr<br>Length 12-30 cm | | Dimensions –<br>trial/mock catheter | Identical to subject transfer catheters | N/A | | Materials – transfer<br>catheter | Polyethylene, Polyurethane, Stainless Steel,<br>marker ink | Polyethylene, Teflon, Stainless Steel | | Materials – guide<br>catheter | Polyethylene, Polyurethane, Silicone,<br>Polytetraflouroethylene, Polymethylpentene | Polyethylene, Echosight Polyethylene,<br>Teflon, Stainless Steel | | Materials – trial/mock<br>catheter | Identical to subject transfer catheters | N/A | The subject and predicate devices have the same intended use (placing embryos into the uterine cavity) and comparable designs. There are differences in dimensions and materials between the subject and predicate devices, but these differences do not raise different questions of safety and effectiveness. The difference in dimensions can be addressed by bench performance testing. The differences in materials can be evaluated by biocompatibility testing and Mouse Embryo Assay (MEA) testing. The subject devices include versions with trial/mock catheters, whereas the predicate devices do not. The inclusion of trial/mock catheters do not raise different questions of safety and effectiveness as they have the same design and materials as the transfer it represents, except that it has a closed end without a side port. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The red background for the word "MEDICAL" is in a rectangular shape with a diagonal cut on the left side. ### Summary of Non-Clinical Performance Testing: The following studies have been performed to support substantial equivalence to the predicate device: - Sterilization Validation testing per ISO 11135-1:2007 ● - Biocompatibility studies, as follows: . - Cytotoxicity testing per 10993-5:2009 o - Guinea Pig Maximization Sensitization testing per ISO 10993-10:2002 or ISO 10993o 10:2010 - Intracutaneous Irritation testing per ISO 10993-10:2002 or ISO 10993-10:2010 o - Endotoxin testing per USP <85> and AAMI/ANSI ST72:2011/(R)2016 (<20 EU/device) . - Transportation Simulation study per ASTM D4169-05 ● - . Package Integrity testing after real-time aging: - Bubble Leak test per ASTM F2096-04 o - Seal Strength testing per ASTM F88-09 o - Visual Inspection: No package displayed damage (tears, folds, puncture holes, etc.) o - Mouse Embryo Assay (MEA) before and after aging: ● One-cell mouse embryos were exposed to subject devices and cultured at 37℃ in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The testing demonstrated that the devices met acceptance criterion of "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours." - Bench Performance studies before and after aging demondtrated that all predetermined ● acceptance criteria were met in the following tests: - Dimensional verification of catheter Catheters are measured and verified against o device input requirements. - Transfer Catheter Aspiration Test Testing ensures there is no air leaking into the o syringe through the transfer catheter. - Transfer Catheter Leak Test Testing ensures that fluid path catheter assembly O does not leak under a predetermined injection pressure. - Tensile Testing (Catheter Hub- shaft) Testing demonstates that the tensile o strength value is greater than the predetermined acceptance criterion. - Echotip Band Test Testing ensures that the outer diameter of the band does not o impede smooth passage through the guide catheter. - Echotip Band Echogenicity Test Visual comparison testing by ultrasound imaging o of catheters with and without an EchoTip band verified that the band provides increased brightness. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, bold, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, white, sans-serif font. The words are set against a red background. The bottom left corner of the red background is cut off at an angle. COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA NE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM # Conclusion: The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.