(179 days)
No
The device description and performance testing focus on the mechanical and material properties of a steerable sheath, with no mention of AI/ML capabilities or data processing.
No.
The device is an introducer sheath used to facilitate the introduction and exchange of other devices for cardiovascular procedures. It does not provide therapy itself.
No
The device is a steerable sheath used to introduce other cardiovascular devices or guidewires/catheters; it does not collect or analyze data for diagnosis.
No
The device description clearly details a physical catheter introducer with various hardware components (sheath, dilator, guidewire, handle, stopcock, etc.) and materials. It is not solely software.
Based on the provided information, the Talon Surgical CardioCurve™ Steerable Sheath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for "introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart." This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a physical device (catheter introducer, sheath, dilator, guidewire) designed for insertion into the body.
- Anatomical Site: The specified anatomical site is the heart, which is within the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device does not perform such analysis on specimens.
Therefore, the Talon Surgical CardioCurve™ Steerable Sheath is a medical device used for interventional procedures within the body, not an IVD.
N/A
Intended Use / Indications for Use
The Talon Surgical CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the leart through the interatrial septum.
Product codes
DYB
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 descriptions of the model numbers are listed below.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
epicardial or endocardial surfaces of the heart, including the left side of the heart through the interatrial septum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Visual per F1886-98
- Dye Leak per ASTM F 2096-11
- Seal Strength per ASTM F88/F88M-15,
Biocompatibility per ISO 10993-1 for an external communicating device, limited (
§ 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).
0
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
1
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
2
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
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
Enclosure
3
Indications for Use
510(k) Number (if known) K210185
Device Name CardioCurve™ Steerable Sheath
Indications for Use (Describe)
The Talon Surgical CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the leart through the interatrial septum.
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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4
Image /page/4/Picture/1 description: The image is a logo for Talon Surgical. The logo features a stylized image of a talon above the company name. The word "TALON" is in a larger, bolder font than the word "SURGICAL", which is placed below it. The background is a solid orange color, while the logo and text are white.
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 |
5
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 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 descriptions of the model numbers are listed below.
6
| Model | Curve
Length | Working
Length
(cm) | BRK
Compatibility
(cm) | 9Fr Dilator
Usable
Length (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 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.
7
INTENDED USE/INDICATION FOR USE:
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.
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 | CardioCurve
Steerable
Introducer
(Subject Device) | Agilis NxT
Steerable
Introducer
(K110450)
(Predicate) | Substantial
Equivalence Discussion |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To provide access to
the heart for use of
cardiovascular
devices. | Identical | N/A, Identical |
| Indications for
use | 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. | Similar
The reference device
includes the
indication for
epicardial access. | The subject device is
substantially equivalent
to the predicate device
and identical to the
reference device
indications. |
| Technology | | | |
| Dimensions | Sheath ID = 8.5F
(2.9mm) | Sheath ID =8.5F
(2.8mm) | The slightly larger ID
has no effect on which
devices can pass through |
| Characteristic | CardioCurve
Steerable
Introducer
(Subject Device) | Agilis NxT
Steerable
Introducer
(K110450)
(Predicate) | Substantial
Equivalence Discussion |
| | Dilator OD 9F
(3mm) | Dilator OD 8.5 F | the sheath, the subject
device is substantially
equivalent to the
predicate device as
verified through bench
testing. |
| | Working Lengths
(cm) = 40, 61, 71
and 82 cm | Working Length =
82cm (reference
device is 40 cm and
71 cm) | The larger dilator OD
matches the ID of the
sheath. Bench testing
demonstrates the subject
device has substantially
equivalent insertion
forces to the predicate
device. |
| | Guidewire
compatible = 0.032" | Guidewire
compatible = 0.032" | Legally marketed
reference devices
include or bookend the
sizes offered by the
subject device, which
have been verified to be
substantially equivalent
to the predicate and
reference devices
through bench testing.
Guidewire compatibility
is identical between the
subject device and
predicate device. |
| Curve Shape | Bi-directional 180°,
small curl (17mm),
medium curl
(22.5mm), and large
curl (50mm) | 180° 1-direction, 90°
2nd direction medium
curl (22.4 mm) | The additional curl sizes
are similar to the
reference device size
curls. The difference in
curl diameter of less
than 1mm falls within
typical manufacturing
tolerances. Bench
testing raised no new
concerns of safety or
efficacy. The bi-
directional feature of the
subject device is
therefore substantially |
| Characteristic | CardioCurve
Steerable
Introducer
(Subject Device) | Agilis NxT
Steerable
Introducer
(K110450)
(Predicate) | Substantial
Equivalence Discussion |
| Tip | Atraumatic with
marker bands | Identical | N/A, identical |
| Shaft | Polymer shaft with
stainless steel braid
reinforcement and
deflection wires. | Identical | N/A, identical |
| Design | Hemostasis valve | Identical | N/A, identical |
| | Sideport with 3-way
stopcock | Identical | N/A, identical |
| | Tuohy Borst | N/A | The addition of the
Touhy Borst to the
subject device does not
affect the safety or
efficacy of the device, as
verified through bench
testing, therefore the
subject device is
substantially equivalent
to the predicate device. |
| | | | |
| Packaging | Card mounted
inserted in a sterile
barrier pouch and
shelf box | PETG Tray inserted
in a sterile barrier
pouch and shelf box | Packaging testing has
demonstrated that the
subject device
packaging configuration
protects the device from
damage and allows for
sterile delivery of the
product to the field, and
is therefore substantially
equivalent to the
predicate device |
| | | | |
| | | | |
| | | | |
| Sterilization | Ethylene Oxide | Identical | N/A, identical |
8
9
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
10
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 (