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.

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 change, the dilator shaft usable length is shortened, and the Instruction for Use (IFU) is updated.

AI/ML Overview

This document describes the premarket notification for the CardioCurve™ Steerable Sheath (K240004), which is a modification of a previously cleared device (K210185). The key changes are the replacement of a Tuohy Borst adapter with a cap and a resulting shortening of the dilator shaft usable length, along with an updated Instruction for Use (IFU).

Based on the provided text, the device in question is a physical medical device (a catheter introducer), not an AI/software-based device. Therefore, the questions related to AI/algorithm performance (e.g., ground truth, training set, MRMC study, standalone performance, experts for ground truth) are not applicable to this submission. The validation for this medical device focuses on physical performance testing to demonstrate that the design changes do not raise new questions of safety or effectiveness.

Here's the information that can be extracted relevant to the physical device's acceptance criteria and study, followed by an explanation of why AI-specific questions are not applicable:

Acceptance Criteria and Device Performance (for a physical medical device):

The document references a "Summary of Performance Testing" which includes a list of tests. It states: "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."

Since specific numerical acceptance criteria and reported performance values are not explicitly provided in the text for each test, the table reflects the types of tests conducted and infers that the device met the criteria, as it received clearance.

Acceptance Criterion (Type of Test)	Reported Device Performance (Implied)
Packaging Inspection	Met predetermined performance specifications; no significantly modified risks from changes.
Sheath Surface Visual Inspection	Met predetermined performance specifications; no significantly modified risks from changes.
Dilator Effective Length	Met predetermined performance specifications; no significantly modified risks from changes. (Specifically, the change in length was validated as not raising new safety/effectiveness questions).
Dilator Extension from Sheath	Met predetermined performance specifications; no significantly modified risks from changes.
Sheath Deflection Fatigue and Wear	Met predetermined performance specifications; no significantly modified risks from changes.
Sheath Liner, Deflection Portion, and Coating Integrity	Met predetermined performance specifications; no significantly modified risks from changes.
Sideport Tube Infusion / Aspiration	Met predetermined performance specifications; no significantly modified risks from changes.
Sheath Fluid Leak Test Hemostasis valve	Met predetermined performance specifications; no significantly modified risks from changes. (Specifically, the change to the hemostasis valve was validated as not raising new safety/effectiveness questions).
Sheath Fluid Leak Test – Fluid Path	Met predetermined performance specifications; no significantly modified risks from changes.
Air Aspiration Leak Test	Met predetermined performance specifications; no significantly modified risks from changes.
Sideport Tube to Shaft Housing Connection	Met predetermined performance specifications; no significantly modified risks from changes.
Dilator Hub to Cap Connection Strength	Met predetermined performance specifications; no significantly modified risks from changes. (Specifically, the change to the cap was validated as not raising new safety/effectiveness questions).
Sheath Shaft to Handle/Hub Strength	Met predetermined performance specifications; no significantly modified risks from changes.

Study Details (for a physical medical device):

Sample sizes used for the test set and data provenance:
The document states "Verification testing has been conducted to support that the subject device meets the design specifications and is substantially equivalent to the predicate device." It also mentions "Design verification tests were performed to demonstrate that the subject device...met predetermined performance specifications."
However, the exact sample sizes for each test (e.g., number of units tested for fatigue, leak, etc.) and the data provenance (e.g., specific country of origin for test materials or retrospective/prospective nature of the physical tests) are not specified in the provided text. These tests would typically be performed in a lab setting rather than on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not Applicable. This is a physical medical device. "Ground truth" in the context of physical medical devices typically refers to engineering specifications, material properties, and established test methods, not expert consensus on medical images or clinical outcomes. The testing is based on "well-established test methods and requirements," implying engineering and quality control expertise, but not necessarily a panel of medical experts for "ground truth" establishment in the way it's understood for AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This device undergoes physical performance testing against engineering specifications, not human interpretation against a medical standard.
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. An MRMC study is relevant to AI-assisted diagnostic devices. This is a physical catheter introducer, not a diagnostic AI tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not Applicable. This refers to AI algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As explained in point 2, "ground truth" for this physical device refers to engineering specifications, design requirements, and established testing standards. The document mentions an FMEA (Failure Modes and Effects Analysis) and that testing "met critical design specifications as well as performance attributes for its intended use."
The sample size for the training set:
Not Applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
Not Applicable.

Summary of Device, Study, and Why AI-specific Questions are Not Applicable:

The CardioCurve™ Steerable Sheath is a Class II medical device, specifically a catheter introducer. The submission is a Special 510(k) to support changes to a previously cleared predicate device. The changes are physical design modifications (replacement of a Tuohy Borst adapter with a cap and resulting dilator length adjustment).

The "study" described is a series of design verification tests conducted to ensure that these physical changes do not negatively impact the device's safety and effectiveness. This is a standard process for physical medical device modifications.

The questions regarding "ground truth," "training set," "experts," "adjudication," and "MRMC studies" are typically applied to diagnostic AI/machine learning devices where the output is an interpretation of data (e.g., medical images), and human performance or algorithmic performance needs to be evaluated against a clinical standard. Since the CardioCurve™ Steerable Sheath is a physical, interventional device, these AI-centric questions do not apply to its regulatory clearance process as described in this document. The "acceptance criteria" relate to engineering and performance specifications, and the "study" involves physical bench testing.

Summary

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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.

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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

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Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240004

Device Name CardioCurve™ Steerable Sheath

Indications for Use (Describe)

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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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™ 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

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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

Attribute	CardioCurve SteerableSheath – Predicate (K210185)	CardioCurve Steerable Sheath– Subject Device	Discussion
Class	II	II	Identical
Product Code	DYB	DYB	Identical
Regulation(FDA)	870.1340	870.1340	Identical
Intended Use	To provide access to the heartfor use of cardiovasculardevices.	To provide access to the heartfor use of cardiovasculardevices.	Identical
Indications forUse	The Talon SurgicalCardioCurveTM SteerableSheath is indicated whenintroducing variouscardiovascular devices to theepicardial or endocardialsurfaces of the heart, includingthe left side of the heart throughthe interatrial septum.	The CIRCA ScientificCardioCurveTM Steerable Sheathis indicated when introducingvarious cardiovascular devicesto the epicardial or endocardialsurfaces of the heart, includingthe left side of the heart throughthe interatrial septum.	Identical(Company name,Talon Surgical, wasreplaced by CIRCAScientific)
Where Used	Endocardial and Epicardialindications	Endocardial and Epicardialindications	Identical

Comparison of Technological Characteristics with the Predicate Device 5

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Attribute	CardioCurve SteerableSheath - Predicate (K210185)	CardioCurve Steerable Sheath- Subject Device	Discussion
Principles ofOperation	Access is obtained, the 0.032"guidewire is inserted andpositioned. The CardioCurveSteerable Sheath with dilator isinserted over the guidewire intothe desired position. The accessneedle and dilator are removed.The sheath tip is deflected byturning the actuators to obtainthe desired position. Treatmentdevices are positioned throughthe sheath. The tip position canbe manipulated using theactuators. Rotating actuatorsdeflect the shaft.	Access is obtained, the 0.032"guidewire is inserted andpositioned. The CardioCurveSteerable Sheath with dilator isinserted over the guidewire intothe desired position. The accessneedle and dilator are removed.The sheath tip is deflected byturning the actuators to obtainthe desired position. Treatmentdevices are positioned throughthe sheath. The tip position canbe manipulated using theactuators. Rotating actuatorsdeflect the shaft.	Identical
TargetPopulation	Patients whose doctors needminimally invasive access tothe heart.	Patients whose doctors needminimally invasive access to theheart.	Identical
Placement	Epicardial, endocardial, andintravascular sites	Epicardial, endocardial, andintravascular sites	Identical
Size	8.5F (2.9mm)	8.5F (2.9mm)	Identical
Curl	Bi-directional 180°, small(17mm), medium (22.5 mm),and large (50mm) curl.Deflectable from 2 linkedlocations on the handle.	Bi-directional 180°, small(17mm), medium (22.5 mm),and large (50mm) curl.Deflectable from 2 linkedlocations on the handle.	Identical
SteerableSheath UsableLength	40, 61, 71 and 82 cm	40, 61, 71 and 82 cm	Identical
Attribute	CardioCurve SteerableSheath - Predicate (K210185)	CardioCurve Steerable Sheath- Subject Device	Discussion
SteerableSheath Shape	Image: CardioCurve Steerable Sheath - Predicate (K210185)	Image: CardioCurve Steerable Sheath - Subject Device	Modification Design(Shape) to steerablesheath handle(Tuohy Borstadapter replacementby cap and externalhemostasis valve dueto shortenedproximal cone andlengthened shafthousing). Changes tosteerable sheathshape do not raisenew or differentquestions of safetyand effectiveness.
Dilator OD	9F (3mm)	9F (3mm)	Identical
Dilator UseableLength	61.7, 82.7, 92.7, and 103.7 cm	60.95, 81.95, 91.95, and102.95 cm	Modification inDesign (Length) tomatch modificationto steerable sheathshape. Changes tothe lengths do notraise new ordifferent questionsof safety oreffectiveness.
Design	Sideport with 3-way stopcockDistal holes in the shaftRadiopaque filled sheathTuohy Borst adapter.Tuohy Borst adapter mates withdilator.Tuohy Borst Material:Makrolon 2458-550115Polycarbonate	Sideport with 3-way stopcockDistal holes in the shaftRadiopaque filled sheathTuohy Borst adapter notprovided. Replaced by Cap.Cap mates with dilator.Cap Material:Makrolon 2458-550115Polycarbonate	Modification inDesign (Shape) tosteerable sheathhandle. Tuohy Borstadapter removaldoes not raise new ordifferent questionsof safety oreffectiveness.
Attribute	CardioCurve SteerableSheath - Predicate (K210185)	CardioCurve Steerable Sheath- Subject Device	Discussion
	Transparent hemostasis valveinternal to steerable sheathhandle.Image: Tuohy BorstImage: Proximal Cone(Hemostasis ValveInternal to Handle)	Transparent hemostasis valveexternal to steerable sheathhandle.Image: External Hemostasis Valve & CapImage: Shortened Proximal Cone	Modification inDesign (Shape) tosteerable sheathhandle (hemostasisvalve). Changes tosteerable sheathshape do not raisenew or differentquestions of safetyand effectiveness.
	Proximal shaft braided	Proximal shaft braided	Identical
	Kink resistant	Kink resistant	Identical
Materials	Polymer shaft with StainlessSteel braid reinforcement anddeflection wires.	Polymer shaft with StainlessSteel braid reinforcement anddeflection wires.	Identical
GuidewireCompatibility	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

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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.
1. 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.

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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).

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).