CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. January 31, 2024 CIRCA Scientific Inc. Alice Ouyang Regulatory Affairs Manager 14 Inverness Drive East, Suite H-136 Englewood, Colorado 80112 Re: K240004 Trade/Device Name: CardioCurve™ Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 30, 2023 Received: January 2, 2024 Dear Alice Ouyang: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Aneesh S. Deoras -S Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices {2}------------------------------------------------ Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240004 Device Name CardioCurve™ Steerable Sheath Indications for Use (Describe) The CIRCA Scientific CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the interatrial septum. 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) | # 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." {4}------------------------------------------------ # 510(k) SUMMARY #### 1 Submitter CIRCA Scientific Inc. 14 Inverness Drive East, Suite H-136 Englewood, CO 80112 Phone: (303) 951-8767 Contact: Alice Ouyang Date Prepared: December 28, 2023 #### 2 Device Information | Name of Device: | CardioCurve™ Steerable Sheath | |-----------------------|----------------------------------------| | Common or Usual Name: | Catheter Introducer | | Classification Name: | Introducer, Catheter | | Regulatory Class: | II | | Product Code(s): | DYB | | Regulation Number: | 21 CFR 870.1340 | | Predicate Device: | CardioCurve™ Steerable Sheath, K210185 | #### 3 Device Description The CardioCurve™ Steerable Sheath from CIRCA Scientific is an 8.5 Fr sterile, single-use catheter introducer used for the introduction, withdrawal, and exchange of guidewires and catheters while minimizing blood loss. It is available in lengths of 40cm, 61cm, 71cm, or 82cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, marketed cleared guidewire (K935170). A side port with a 3-way stopcock allows air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle equipped with two linked rotating dials is used to deflect the tip clockwise and counterclockwise 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, and a lubricious coating on the outer surface. The CardioCurve™ Steerable Sheath shaft is made from Pebax and Nylon. The shaft includes a radiopaque tip marker for visibility under fluoroscopy and is braided, except for the distal tip, for kink resistance; the handle is made of ABS. The dilator is made of HDPE that is barium loaded for visibility under fluoroscopy. The CardioCurve™ dilator can be used with a curved transseptal Abbott BRK™ type needle with stylet if indicated on the package label. This Special 510(k) is submitted to support the changes made to the predicate device: the Tuohy Borst adapter in the CardioCurve Steerable Sheath is replaced with a cap; as a result of this {5}------------------------------------------------ change, the dilator shaft usable length is shortened, and the Instruction for Use (IFU) is updated. Verification testing has been conducted to support that the subject device meets the design specifications and is substantially equivalent to the predicate device. ### Indication for Use 4 The CIRCA Scientific CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the heart through the interatrial septum. | Attribute | CardioCurve Steerable<br>Sheath – Predicate (K210185) | CardioCurve Steerable Sheath<br>– Subject Device | Discussion | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Class | II | II | Identical | | Product Code | DYB | DYB | Identical | | Regulation<br>(FDA) | 870.1340 | 870.1340 | Identical | | Intended Use | To provide access to the heart<br>for use of cardiovascular<br>devices. | To provide access to the heart<br>for use of cardiovascular<br>devices. | Identical | | Indications for<br>Use | The Talon Surgical<br>CardioCurveTM Steerable<br>Sheath is indicated when<br>introducing various<br>cardiovascular devices to the<br>epicardial or endocardial<br>surfaces of the heart, including<br>the left side of the heart through<br>the interatrial septum. | The CIRCA Scientific<br>CardioCurveTM Steerable Sheath<br>is indicated when introducing<br>various cardiovascular devices<br>to the epicardial or endocardial<br>surfaces of the heart, including<br>the left side of the heart through<br>the interatrial septum. | Identical<br>(Company name,<br>Talon Surgical, was<br>replaced by CIRCA<br>Scientific) | | Where Used | Endocardial and Epicardial<br>indications | Endocardial and Epicardial<br>indications | Identical | ### Comparison of Technological Characteristics with the Predicate Device 5 {6}------------------------------------------------ | Attribute | CardioCurve Steerable<br>Sheath - Predicate (K210185) | CardioCurve Steerable Sheath<br>- Subject Device | Discussion | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Principles of<br>Operation | Access is obtained, the 0.032"<br>guidewire is inserted and<br>positioned. The CardioCurve<br>Steerable Sheath with dilator is<br>inserted over the guidewire into<br>the desired position. The access<br>needle and dilator are removed.<br>The sheath tip is deflected by<br>turning the actuators to obtain<br>the desired position. Treatment<br>devices are positioned through<br>the sheath. The tip position can<br>be manipulated using the<br>actuators. Rotating actuators<br>deflect the shaft. | Access is obtained, the 0.032"<br>guidewire is inserted and<br>positioned. The CardioCurve<br>Steerable Sheath with dilator is<br>inserted over the guidewire into<br>the desired position. The access<br>needle and dilator are removed.<br>The sheath tip is deflected by<br>turning the actuators to obtain<br>the desired position. Treatment<br>devices are positioned through<br>the sheath. The tip position can<br>be manipulated using the<br>actuators. Rotating actuators<br>deflect the shaft. | Identical | | Target<br>Population | Patients whose doctors need<br>minimally invasive access to<br>the heart. | Patients whose doctors need<br>minimally invasive access to the<br>heart. | Identical | | Placement | Epicardial, endocardial, and<br>intravascular sites | Epicardial, endocardial, and<br>intravascular sites | Identical | | Size | 8.5F (2.9mm) | 8.5F (2.9mm) | Identical | | Curl | Bi-directional 180°, small<br>(17mm), medium (22.5 mm),<br>and large (50mm) curl.<br>Deflectable from 2 linked<br>locations on the handle. | Bi-directional 180°, small<br>(17mm), medium (22.5 mm),<br>and large (50mm) curl.<br>Deflectable from 2 linked<br>locations on the handle. | Identical | | Steerable<br>Sheath Usable<br>Length | 40, 61, 71 and 82 cm | 40, 61, 71 and 82 cm | Identical | | Attribute | CardioCurve Steerable<br>Sheath - Predicate (K210185) | CardioCurve Steerable Sheath<br>- Subject Device | Discussion | | Steerable<br>Sheath Shape | Image: CardioCurve Steerable Sheath - Predicate (K210185) | Image: CardioCurve Steerable Sheath - Subject Device | Modification Design<br>(Shape) to steerable<br>sheath handle<br>(Tuohy Borst<br>adapter replacement<br>by cap and external<br>hemostasis valve due<br>to shortened<br>proximal cone and<br>lengthened shaft<br>housing). Changes to<br>steerable sheath<br>shape do not raise<br>new or different<br>questions of safety<br>and effectiveness. | | Dilator OD | 9F (3mm) | 9F (3mm) | Identical | | Dilator Useable<br>Length | 61.7, 82.7, 92.7, and 103.7 cm | 60.95, 81.95, 91.95, and<br>102.95 cm | Modification in<br>Design (Length) to<br>match modification<br>to steerable sheath<br>shape. Changes to<br>the lengths do not<br>raise new or<br>different questions<br>of safety or<br>effectiveness. | | Design | Sideport with 3-way stopcock<br>Distal holes in the shaft<br>Radiopaque filled sheath<br>Tuohy Borst adapter.<br>Tuohy Borst adapter mates with<br>dilator.<br>Tuohy Borst Material:<br>Makrolon 2458-550115<br>Polycarbonate | Sideport with 3-way stopcock<br>Distal holes in the shaft<br>Radiopaque filled sheath<br>Tuohy Borst adapter not<br>provided. Replaced by Cap.<br>Cap mates with dilator.<br>Cap Material:<br>Makrolon 2458-550115<br>Polycarbonate | Modification in<br>Design (Shape) to<br>steerable sheath<br>handle. Tuohy Borst<br>adapter removal<br>does not raise new or<br>different questions<br>of safety or<br>effectiveness. | | Attribute | CardioCurve Steerable<br>Sheath - Predicate (K210185) | CardioCurve Steerable Sheath<br>- Subject Device | Discussion | | | Transparent hemostasis valve<br>internal to steerable sheath<br>handle.<br>Image: Tuohy Borst<br>Image: Proximal Cone<br>(Hemostasis Valve<br>Internal to Handle) | Transparent hemostasis valve<br>external to steerable sheath<br>handle.<br>Image: External Hemostasis Valve & Cap<br>Image: Shortened Proximal Cone | Modification in<br>Design (Shape) to<br>steerable sheath<br>handle (hemostasis<br>valve). Changes to<br>steerable sheath<br>shape do not raise<br>new or different<br>questions of safety<br>and effectiveness. | | | Proximal shaft braided | Proximal shaft braided | Identical | | | Kink resistant | Kink resistant | Identical | | Materials | Polymer shaft with Stainless<br>Steel braid reinforcement and<br>deflection wires. | Polymer shaft with Stainless<br>Steel braid reinforcement and<br>deflection wires. | Identical | | Guidewire<br>Compatibility | up to 0.032" | up to 0.032" | Identical | | Features | Atraumatic tip Braided shaft for pushability / torqueability Steerable Handle from 2 locations on the handle | Atraumatic tip Braided shaft for pushability / torqueability Steerable Handle from 2 locationss on the handle | Identical | | Sterility | 100% Ethylene Oxide | 100% Ethylene Oxide | Identical | {7}------------------------------------------------ {8}------------------------------------------------ The subject and predicate devices have the same intended use, indications for use, principles of operation, and target patient population. The subject device differs from the predicate as follows: - 1. Design: - Change in steerable sheath shape due to external hemostasis valve and removal of . Tuohy Borst adapter. - o Change in dilator length due to change in steerable sheath shape. - 2. Labeling - . Modification to Instructions for Use (IFU) to remove optional steps related to using the Tuohy Borst adapter due to removing the Tuohy Borst adapter. - Modification to IFU to add verbiage about visually inspecting for air bubbles . inside the clear hemostatic valve housing. {9}------------------------------------------------ The changes made to the predicate device do not raise any significant questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device with regard to intended use, indications for use, and principles of operation. #### Summary of Performance Testing 6 A failure modes and effects analysis (FMEA) of the subject device was conducted in accordance with an internal protocol based on ISO 14971, Medical Devices – Risk Management for Medical Devices, to ensure that the differences posed by the subject design were acceptable and that no new questions of safety and effectiveness were raised. Design verification tests were performed to demonstrate that the subject device, CIRCA Scientific CardioCurve Steerable Sheath, met predetermined performance specifications and to ensure that there were no significantly modified risks associated with the changes to the predicate design. Testing performed demonstrated that the subject device met critical design specifications as well as performance attributes for its intended use. The methods and acceptance criteria were the same or equivalent to the predicate device and are relevant to the changes under review. The testing identified in the list below was based on well-established test methods and requirements. - Packaging Inspection 0 - o Sheath Surface Visual Inspection - Dilator Effective Length ● - Dilator Extension from Sheath 0 - Sheath Deflection Fatigue and Wear ● - Sheath Liner, Deflection Portion, and Coating Integrity - o Sideport Tube Infusion / Aspiration - Sheath Fluid Leak Test Hemostasis valve ● - Sheath Fluid Leak Test – Fluid Path - Air Aspiration Leak Test - Sideport Tube to Shaft Housing Connection - o Dilator Hub to Cap Connection Strength - Sheath Shaft to Handle/Hub Strength . ## 7 Conclusions The subject device has the same intended use, indication for use, and principles of operation as the predicate device. Results from verification testing demonstrated that the different technological characteristics did not raise different questions of safety and effectiveness. Therefore, the subject device, CIRCA Scientific CardioCurve™ Steerable Sheath, is considered substantially equivalent to the predicate, CardioCurve™ Steerable Sheath (K210185).