The Talon Surgical 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.

Device Description

The Talon Surgical CardioCurve Steerable Sheath is a 8.5F 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 40, 61, 71 or 82 cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, market cleared guidewire (K935170). A side port with three-way stopcock allows blood aspiration, fluid infusion, and pressure monitoring. An integrated Tuohy Borst adaptor is designed to hold a guidewire or catheter in place. The steerable sheath features distal side holes to facilitate aspiration and minimize cavitation, and a stainless-steel ring for visualization under fluoroscopy.

The handle is equipped with two linked rotating dials used to deflect the tip clockwise and counterclockwise 180°.

The CardioCurve Steerable Sheath shaft is made from barium loaded Pebax and Nylon and 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 Steerable Sheath Dilator can be used with a curved transseptal St. Jude Medical BRKTM type needle with stylet if indicated on the package label.

AI/ML Overview

The provided document is a 510(k) summary for the Talon Surgical CardioCurve™ Steerable Sheath. This specific type of document, primarily focused on demonstrating substantial equivalence to a predicate device for FDA clearance, does not contain the detailed, quantitative performance metrics and study design elements typically associated with acceptance criteria and a detailed study proving a device meets those criteria for AI/ML-driven diagnostics.

The document describes performance testing for a catheter introducer (a physical medical device, not an AI/ML diagnostic). The testing ensures the device meets its design requirements and is safe and effective for its intended use, focusing on physical and biocompatibility attributes.

Therefore, I cannot provide the requested information (Acceptance Criteria, Device Performance Table, Sample Sizes, Expert Ground Truth, Adjudication, MRMC studies, Standalone performance, Training set details) as this document does not pertain to an AI/ML diagnostic device and its performance evaluation in the way you've outlined.

The "Performance Testing" section on page 10 lists various types of tests conducted on the physical device, such as:

Visual Inspection
Dimensions
Guidewire Compatibility
Dilator Compatibility
Deflection and retention
Shaft tip buckle
Air and liquid leakage per ISO 11070:2017
Hub compatibility with ISO 80369-7
Stopcock compliance per ISO 594
Tensile Strength per ISO 11070
Distribution and Packaging Tests per ASTM D4169:2016 and ISO 11607-1
Packaging Aging per ASTM F1980
Biocompatibility per ISO 10993-1 (covering Cytotoxicity, Sensitization, Irritation, Toxicity, Hemocompatibility, and a Thrombogenicity Study in Ovine Model).

The document states: "All testing met the requirements and passed. There are no new questions raised regarding safety or efficacy of the CardioCurve Steerable Sheath."

To reiterate, the information requested is specific to the evaluation of AI/ML diagnostic models, which is not what this FDA 510(k) summary describes.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

August 31, 2021

Talon Surgical Jay Muse President and CEO 6030 West Harold Gatty Drive Salt Lake City, Utah 84116

Re: K210185

Trade/Device Name: CardioCurve™ Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB

Dear Jay Muse:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 23, 2021. Specifically, FDA is updating this SE Letter to include your 510(k) Summary as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Aneesh Deoras, OHT2: Office of Cardiovascular Devices, at 240-402-4363 or aneesh.deoras@gmail.com.

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

July 23, 2021

Talon Surgical Jay Muse President and CEO 6030 West Harold Gatty Drive Salt Lake City, Utah 84116

Re: K210185

Trade/Device Name: CardioCurve™ Steerable Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 17, 2021 Received: June 21, 2021

Dear Jay Muse:

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. 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. You must comply with all the Act's

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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Aneesh S. Deoras -S

Enclosure

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Indications for Use

510(k) Number (if known) K210185

Device Name CardioCurve™ Steerable Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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6030 West Harold Gatty Drive, Salt Lake City, UT 84116 Ph: 801-210-2886 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(K) SUMMARY K210185

Submitter:

Talon Surgical Jay Muse – President and CEO 6030 West Harold Gatty Drive Salt Lake City, UT 84116 Telephone: Email: jay.muse@talonsurgical.com

Primary Contact:

Jay Muse President and CEO 6030 West Harold Gatty Drive Salt Lake City, UT 84116 Telephone: Email: jay.muse@talonsurgical.com

DATE PREPARED:

January 19, 2021

NAME OF MEDICAL DEVICE:

Proprietary Name:	CardioCurve™ Steerable Sheath
Common/Usual Name:	Catheter Introducer
Classification Name:	Introducer, Catheter
510(k) Number:	K210185

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DEVICE CLASSIFICATION:

Classification Panel:	Cardiovascular
Regulatory Class:	II
Product Code:	DYB
Regulation Number:	21 CFR 870.1340

PREDICATE DEVICES:

Proprietary Name:	Agilis NxT Steerable Introducer
Common/Usual Name:	Catheter Introducer
Classification Name:	Introducer, Catheter
510K Number:	K110450

REFERENCE DEVICES:

Proprietary Name:	Agilis PF Introducer System and accessories
Common/Usual Name:	Catheter Introducer
Classification Name:	Introducer, Catheter
510K Number:	K111943
Proprietary Name:	Agilis NxT Steerable Introducer
Common/Usual Name:	Catheter Introducer
Classification Name:	Introducer, Catheter
510K Number:	K081645

DEVICE DESCRIPTION:

The handle is equipped with two linked rotating dials used to deflect the tip clockwise and counterclockwise 180°. The descriptions of the model numbers are listed below.

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Model	CurveLength	WorkingLength(cm)	BRKCompatibility(cm)	9Fr DilatorUsableLength (cm)
TAL3085-001	Small(17mm)	40	N/A	61.7
TAL3085-002	Medium(22.5mm)	40	N/A	61.7
TAL3085-003	Large(50mm)	40	N/A	61.7
TAL3085-004	Small(17mm)	61	89	82.7
TAL3085-005	Medium(22.5mm)	61	89	82.7
TAL3085-006	Large(50mm)	61	89	82.7
TAL3085-007	Small(17mm)	71	98	92.7
TAL3085-008	Medium(22.5mm)	71	98	92.7
TAL3085-009	Large(50mm)	71	98	92.7
TAL3085-010	Small(17mm)	82	N/A	103.7
TAL3085-011	Medium(22.5mm)	82	N/A	103.7
TAL3085-012	Large(50mm)	82	N/A	103.7

The CardioCurve Steerable Sheath Dilator can be used with a curved transseptal St. Jude Medical BRKTM type needle with stylet if indicated on the package label.

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INTENDED USE/INDICATION FOR USE:

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

Technologically the CardioCurve Steerable Sheath is substantially equivalent to Agilis NxT Steerable Introducer, (K110450) in terms of design, materials, technology and performance.

The CardioCurve Steerable Introducer uses the same technology and has the same intended use, fundamental technology and performance as the predicate device and the reference devices. Technological differences are for physician convenience

Characteristic	CardioCurveSteerableIntroducer(Subject Device)	Agilis NxTSteerableIntroducer(K110450)(Predicate)	SubstantialEquivalence Discussion
Intended Use	To provide access tothe heart for use ofcardiovasculardevices.	Identical	N/A, Identical
Indications foruse	The Talon SurgicalCardioCurveSteerable Sheath isindicated whenintroducing variouscardiovasculardevices to theepicardial orendocardial surfacesof the heart,including the leftside of the heartthrough theinteratrial septum.	SimilarThe reference deviceincludes theindication forepicardial access.	The subject device issubstantially equivalentto the predicate deviceand identical to thereference deviceindications.
Technology
Dimensions	Sheath ID = 8.5F(2.9mm)	Sheath ID =8.5F(2.8mm)	The slightly larger IDhas no effect on whichdevices can pass through
Characteristic	CardioCurveSteerableIntroducer(Subject Device)	Agilis NxTSteerableIntroducer(K110450)(Predicate)	SubstantialEquivalence Discussion
	Dilator OD 9F(3mm)	Dilator OD 8.5 F	the sheath, the subjectdevice is substantiallyequivalent to thepredicate device asverified through benchtesting.
	Working Lengths(cm) = 40, 61, 71and 82 cm	Working Length =82cm (referencedevice is 40 cm and71 cm)	The larger dilator ODmatches the ID of thesheath. Bench testingdemonstrates the subjectdevice has substantiallyequivalent insertionforces to the predicatedevice.
	Guidewirecompatible = 0.032"	Guidewirecompatible = 0.032"	Legally marketedreference devicesinclude or bookend thesizes offered by thesubject device, whichhave been verified to besubstantially equivalentto the predicate andreference devicesthrough bench testing.Guidewire compatibilityis identical between thesubject device andpredicate device.
Curve Shape	Bi-directional 180°,small curl (17mm),medium curl(22.5mm), and largecurl (50mm)	180° 1-direction, 90°2nd direction mediumcurl (22.4 mm)	The additional curl sizesare similar to thereference device sizecurls. The difference incurl diameter of lessthan 1mm falls withintypical manufacturingtolerances. Benchtesting raised no newconcerns of safety orefficacy. The bi-directional feature of thesubject device istherefore substantially
Characteristic	CardioCurveSteerableIntroducer(Subject Device)	Agilis NxTSteerableIntroducer(K110450)(Predicate)	SubstantialEquivalence Discussion
Tip	Atraumatic withmarker bands	Identical	N/A, identical
Shaft	Polymer shaft withstainless steel braidreinforcement anddeflection wires.	Identical	N/A, identical
Design	Hemostasis valve	Identical	N/A, identical
	Sideport with 3-waystopcock	Identical	N/A, identical
	Tuohy Borst	N/A	The addition of theTouhy Borst to thesubject device does notaffect the safety orefficacy of the device, asverified through benchtesting, therefore thesubject device issubstantially equivalentto the predicate device.

Packaging	Card mountedinserted in a sterilebarrier pouch andshelf box	PETG Tray insertedin a sterile barrierpouch and shelf box	Packaging testing hasdemonstrated that thesubject devicepackaging configurationprotects the device fromdamage and allows forsterile delivery of theproduct to the field, andis therefore substantiallyequivalent to thepredicate device



Sterilization	Ethylene Oxide	Identical	N/A, identical

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The CardioCurve Steerable Sheaths are substantially equivalent to the predicate device, Agilis NxT Steerable Introducer (K110450) and the reference devices, Agilis PF Delivery System (K111943) and Agilis NxT Introducer (K081645). The CardioCurve

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Steerable Sheath and the Agilis Introducers provide access to the heart for the use of cardiovascular devices. The additional length, ability to deflect 180° in both directions, the ability to deflect from two locations on the handle and the addition of the Tuohy Borst to hold guidewires or catheters in place provide additional flexibility for the physician and do not raise new questions of safety and effectiveness from the predicate.

PERFORMANC TESTING

The CardioCurve Steerable Sheath was thoroughly tested and verifies that it performs as designed and is suitable for its intended use.

Performance Testing included the following:

Visual Inspection ●
Dimensions ●
Guidewire Compatibility ●
Dilator Compatibility ●
Deflection and retention
Shaft tip buckle
Air and liquid leakage per ISO 11070:2017
Hub compatibility with ISO 80369-7 ●
Stopcock compliance per ISO 594
Tensile Strength per ISO 11070 ●
Distribution and Packaging Tests per ASTM D4169:2016 and ISO 11607-1 ●
Packaging Aging per ASTM F1980. o
- o Visual per F1886-98
- Dye Leak per ASTM F 2096-11 o
- o Seal Strength per ASTM F88/F88M-15,

Biocompatibility per ISO 10993-1 for an external communicating device, limited (<24 hour) blood contacting device.

Cytotoxicity: MEM Extraction Cytotoxicity Assay per 10993-5
Sensitization: Guinea Pig Maximization Test per 10993-10 ●
o Irritation: Intracutaneous Reactivity Test per 10993-10
o Toxicity: Materials Mediated Rabbit Pyrogen Test SO 10993-11
Toxicity: Acute Systemic Toxicity per SO 10993-11
Hemocompatibility: ASTM Hemolysis Assay: Direct and Extract Methods per o 10993-4
Hemocompatibility: Complement Activation Assav C3a and SC5b-9 0 Methods per 10993-4
0 Hemocompatibility: Partial Thromboplastin Tine (PTT) Assay per 10993-4:2017
Thrombogenicity Study in Ovine Model per 10993-4:2017 ●

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All testing met the requirements and passed. There are no new questions raised regarding safety or efficacy of the CardioCurve Steerable Sheath.

CONCLUSIONS

The CardioCurve Steerable Sheath is substantially equivalent to the predicate device.

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).