Aqueduct 200 Cervical Dilation Balloon Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". October 15, 2021 GTIMD LLC Eran Levit CEO 6 Columbia Drive Amherst, NH 03031 Re: K202433 > Trade/Device Name: Aqueduct 200 Cervical Dilation Balloon Catheter Regulation Number: 21 CFR§ 884.4260 Regulation Name: Hygroscopic Laminaria Cervical Dilator Regulatory Class: II Product Code: PON Dated: September 9, 2021 Received: September 13, 2021 Dear Eran Levit: 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. Although this letter refers to your product as a device, please be aware 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. 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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202433 Device Name Aqueduct 200 Cervical Dilation Balloon Catheter Indications for Use (Describe) The Aqueduct 200 Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | X | |----------------------------------------------|---| | 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. 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K202433 Page 1 of 7 # 510(K) SUMMARY - K202433 | I. | Submitter | | |----|----------------------|-------------------------------------| | | Submitter's Name: | GTIMD LLC | | | Address: | 6 Columbia Drive, Amherst, NH 03031 | | | Phone: | (603) 809-3089 | | | Contact Person: | Eran Levit | | | Contact Email: | elevit@gtimd.com | | | Date of Preparation: | October 14, 2021 | - II. Device | Name of Device: | Aqueduct 200 Cervical Dilation Balloon Catheter | |--------------------|---------------------------------------------------------| | Common Name: | Catheter, Balloon, Dilation of the Cervical Canal | | Regulation Number: | 21 CFR 884.4260 | | Regulation Name: | Hygroscopic Laminaria Cervical Dilator | | Regulatory Class: | II | | Product Codes: | PON (Catheter, Balloon, Dilation of the Cervical Canal) | - III. Predicate and Reference Devices ### Predicate Device: Aqueduct 100 Cervical Dilation Balloon Catheter (K160664) manufactured by GTIMD LLC The predicate device has not been subject to a design-related recall. ### Reference Device: Endosee Model 8000 U-scope (K123151) manufactured by Endosee Corp - IV. Device Description The Aqueduct 200 Cervical Dilation Balloon Catheter is a balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The subject device is an updated version of the Aqueduct 100 Cervical Dilation Balloon Catheter cleared under K160664 that merges two separate dilation balloons into one balloon, removes the anchor balloon, replaces the four-way hub with a three-way hub, and removes the stylet from the shaft. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for "GTIMD CATHETER SOLUTIONS". The text "GTIMD" is in a large, sans-serif font and is colored in a light blue. Below this, the text "CATHETER SOLUTIONS" is in a smaller, sans-serif font and is colored in gray. The catheter consists of a 2-lumen shaft. One lumen inflates a cylindrical dilation balloon. A second lumen is for infusion of saline solution and also contains a camera and camera cable. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. Using visual feedback from the forward-looking camera and LED light source the physician advances the catheter through the cervical canal and identifies the end of the canal when entering the internal orifice of the uterus. When the physician identifies the orifice, the catheter is positioned inside the cervix. This aligns the cylindrical dilation balloon at the internal cervical os and external cervical os. The balloon is inflated with 12.5 ml of saline, providing gradual mechanical dilation of the cervix. The camera cable on the catheter connects to a camera module that provides power to the camera and allows connection to an HDMI port on a monitor to assess proper device placement during a clinical procedure. After 3 minutes of dilation of the internal and external orifices of the uterus, a controlled injection of 1-2.5 ml of saline mav be made through the catheter infusion lumen which exits on the distal end of the catheter. Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed exiting through the external opening of the cervix. Optimal dilation of 8-9 mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes. The deflation of the balloon is conducted by attaching a luer lock syringe to the swabable valve and removing saline from the balloon. The subject device is packaged in a mylar/Tyvek pouch and ethylene oxide (EO) sterilized to a SAL 10-6. The packaged device has a shelf-life of 15 months. - V. Indications for Use The Aqueduct 200 Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal. Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for "GTIMD CATHETER SOLUTIONS". The text "GTIMD" is in a large, bold, sans-serif font and is colored in a bright blue. Below "GTIMD" is the text "CATHETER SOLUTIONS" in a smaller, sans-serif font and is colored in gray. - VI. Comparison of Intended Use and Technological Characteristics with the Predicate Device The table below provides a comparison of the intended use and technological characteristics of the subject and predicate device: | | Subject Device | Predicate Device | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Aqueduct 200 Cervical<br>Dilation Balloon Catheter<br>(K202433) | Aqueduct 100 Cervical<br>Dilation Balloon Catheter<br>(K160664) | | Manufacturer | GTIMD LLC | GTIMD LLC | | Regulatory<br>Information | Hygroscopic Laminaria<br>Cervical Dilator (21 CFR<br>884.4260)<br>Product Code: PON<br>Class II | Hygroscopic Laminaria<br>Cervical Dilator (21 CFR<br>884.4260)<br>Product Code: PON<br>Class II | | Indications for<br>Use | The Aqueduct 200 Cervical<br>Dilation Balloon Catheter is<br>intended to be used<br>whenever cervical softening<br>and dilation is desired. Some<br>examples are: treatment of<br>cervical stenosis, IUD<br>placement and removal,<br>Radium placement, drainage<br>of uterine cavity, endometrial<br>biopsy, uterine curettage,<br>suction cannula aspiration,<br>operative hysteroscopy. | The Aqueduct 100 Cervical<br>Dilation Balloon Catheter is<br>intended to be used<br>whenever cervical softening<br>and dilation is desired. Some<br>examples are: treatment of<br>cervical stenosis, IUD<br>placement and removal,<br>Radium placement, drainage<br>of uterine cavity, endometrial<br>biopsy, uterine curettage,<br>suction cannula aspiration,<br>operative hysteroscopy. | | Components | Balloon catheter with an<br>incorporated camera and<br>LED light source, and camera<br>module | Balloon catheter | | Balloon<br>volume(s) | Dilation Balloon: 12.5 mL | Anchor Balloon: 2.5 mL<br>Dilation Balloons: 7.5 mL<br>(combined) | | Balloon burst<br>pressure | Dilation Balloon: > 8 atm | Anchor Balloon: > 2 atm<br>Dilation Balloon: > 2 atm | | Usable Length | 25 cm | 25 cm | | Outer diameter | 3.3 mm deflated and 12 mm | 3.3 mm deflated and 12 mm | | | inflated | inflated | | Shaft type | 2-lumen polycarbonate shaft | 3 lumen Pebax shaft | | Materials | Pebax balloon, polyvinyl<br>chloride hub, polycarbonate<br>catheter, stainless steel | Pebax balloons and Pebax<br>catheter | | Dilation<br>Mechanism | Fixed diameter balloon that<br>expands to 12 mm | Fixed diameter balloons that<br>expand to 12 mm | | Stylet | No | Yes, unremovable | | Shelf Life | 15 months | 2 years | | Dilation Balloon<br>Positioning<br>Method | Optical using a CMOS camera<br>and LED light | Mechanical using an anchor<br>balloon | | Saline flow? | Yes, single lumen for infusion | Yes, single lumen for infusion | | Sterile/Reusable? | Single-use sterile device and<br>reusable camera module | Single-use sterile device | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for "GTIMD CATHETER SOLUTIONS". The text "GTIMD" is in a large, bold, sans-serif font and is colored in a bright blue. Below "GTIMD" is the text "CATHETER SOLUTIONS" in a smaller, sans-serif font and is colored in gray. The indications for use (IFU) for the subject device are identical to the predicate device IFU. Therefore, the intended use is the same – to dilate the cervix. The subject device has different technological characteristics than the predicate device. The subject and predicate device have different device design specifications, number of balloons, materials, and positioning method. The camera is used to position the dilation balloon, similar to the anchor balloon in the predicate device. Both features are used to aid in device placement. These differences in technological characteristics do not raise different questions of safety and effectiveness as compared to predicate device (e.g., can the device be positioned correctly, are the materials biocompatible, can device use result in an injury to cervical or uterine tissues, etc.). Non-clinical performance data was conducted to address the technological differences between the subject and predicate device to demonstrate substantial equivalence. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for "GTIMD CATHETER SOLUTIONS". The text "GTIMD" is in a large, sans-serif font and is colored in a bright blue. Below "GTIMD" is the text "CATHETER SOLUTIONS" in a smaller, sans-serif font and is colored in gray. #### VII. Performance Data To support the substantial equivalence of the subject device, the following performance testing was performed: ### Biocompatibility Testing Biocompatibility tests were conducted on the Aqueduct 200 Cervical Dilation Balloon Catheter according to the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" as follows: - Cytotoxicity (ISO 10993-5:2009) - Sensitization (ISO 10993-10:2010) - Irritation (ISO 10993-10:2010) . The results of this testing demonstrated that the subject device is noncytotoxic, non-irritating, and non-sensitizing. ### Sterilization Validation The subject device is ethylene oxide sterilized. The ethylene oxide sterilization cycle was validated using the overkill method, in accordance with ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. Ethylene oxide residuals were evaluated according to ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. Packaging integrity and shipping testing were completed after accelerated aging to demonstrate the subject device packaging was able to withstand the rigors of shipping and distribution. Testing included seal strength (ASTM F88/F88M), dye penetration (ASTM F1929), shipping testing (ASTM D4169), and a visual inspection. The subject device met all the predetermined acceptance criteria. ## Electrical Safety and Electromagnetic Compatibility (EMC) The subject device was tested for electrical safety and EMC according to the following standards: - . IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance {8}------------------------------------------------ K202433 Page 6 of 7 Image /page/8/Picture/1 description: The image shows the logo for "GTIMD CATHETER SOLUTIONS". The text "GTIMD" is in a large, bold, blue font. Below that, the text "CATHETER SOLUTIONS" is in a smaller, gray font. The logo is simple and modern. 6-B Columbia Drive Amherst, NH 03031 USA Phone: (603) 809-3089 www.gtimd.com - IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests - 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment Part 2-● 18: Particular requirements for the basic safety and essential performance of endoscopic equipment ### Optical Performance The camera was evaluated for the following specifications and met the predetermined acceptance criteria: - Component specifications - Photobiological safety testing - Field of view - Direction of view - Resolution - Depth of field and optimum working distance - Geometric distortion - Noise and dynamic range - Image intensity uniformity ● ### Bench Performance Testing Performance tests were performed on the Aqueduct 200 Cervical Dilation Balloon Catheter according to the requirements of ISO 10555-1:2013 and ISO 10555-4:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements and Part 4: Balloon dilation catheters, and ISO 11737-1:2018 Sterilization of health care products —Microbiological methods Part 1: Determination of a population of microorganisms on products. Performance testing was also conducted on the Aqueduct 200 Cervical Dilation Balloon Catheter following an accelerated aging study to simulate a 15-month shelf life, including: - Dimensional Verification ● - Camera Functionality ● - Balloon Burst Pressure ● - Balloon Fatigue - Balloon Inflation/Deflation Time - Catheter Bond Strength ● - Catheter Flexibility and Pushability ● {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for "GTIMD CATHETER SOLUTIONS". The letters "GTIMD" are in a large, bold, sans-serif font and are colored in a bright blue. Below the letters, the words "CATHETER SOLUTIONS" are in a smaller, sans-serif font and are colored in gray. - Balloon Preparation, Deployment, and Retraction ● The subject device met the predetermined acceptance criteria for each test. - VIII. Conclusion Based on the comparison and analysis above, the Aqueduct 200 Cervical Dilation Balloon Catheter is substantially equivalent to the predicate device.