(29 days)
No
The device description focuses on mechanical components and materials. There is no mention of AI, ML, or any software-driven analysis or decision-making. The changes described are purely mechanical (replacement of a Tuohy Borst adapter with a cap).
No.
The CIRCA Scientific CardioCurve™ Steerable Sheath is a catheter introducer accessory used to facilitate the introduction and exchange of other cardiovascular devices, not to directly treat a condition or disease.
No
The device is an introducer sheath used to facilitate the placement of other cardiovascular devices, not to diagnose a condition. Its function is to provide access to anatomical sites, not to identify or characterize diseases.
No
The device description clearly details a physical, sterile, single-use catheter introducer with various hardware components (sheath, dilator, guidewire, handle, stopcock, etc.) made of specific materials. It is a tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The CIRCA Scientific CardioCurve™ Steerable Sheath is a surgical tool used to introduce other devices into the heart. It is used in vivo (within the living body) to facilitate procedures, not to analyze samples in vitro (outside the living body).
- Intended Use: The intended use clearly states it's for introducing cardiovascular devices to the heart's surfaces. This is a procedural function, not a diagnostic one based on analyzing samples.
- Device Description: The description details its physical components and how it's used for access and manipulation within the body. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the CIRCA Scientific CardioCurve™ Steerable Sheath is a surgical/interventional device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DYB
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. Verification testing has been conducted to support that the subject device meets the design specifications and is substantially equivalent to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epicardial or endocardial surfaces of the heart, including the left side of 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)
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
- Sheath Surface Visual Inspection
- Dilator Effective Length
- Dilator Extension from Sheath
- Sheath Deflection Fatigue and Wear
- Sheath Liner, Deflection Portion, and Coating Integrity
- 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
- Dilator Hub to Cap Connection Strength
- Sheath Shaft to Handle/Hub Strength
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CardioCurve™ Steerable Sheath, K210185
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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) |
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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
Sheath – 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 heart
for use of cardiovascular
devices. | To provide access to the heart
for use of cardiovascular
devices. | Identical |
| Indications for
Use | The Talon Surgical
CardioCurveTM 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. | The CIRCA Scientific
CardioCurveTM 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. | Identical
(Company name,
Talon Surgical, was
replaced by CIRCA
Scientific) |
| Where Used | Endocardial and Epicardial
indications | Endocardial and Epicardial
indications | Identical |
Comparison of Technological Characteristics with the Predicate Device 5
6
| Attribute | CardioCurve Steerable
Sheath - Predicate (K210185) | CardioCurve Steerable Sheath
- Subject Device | Discussion |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of
Operation | Access is obtained, the 0.032"
guidewire is inserted and
positioned. The CardioCurve
Steerable Sheath with dilator is
inserted over the guidewire into
the desired position. The access
needle and dilator are removed.
The sheath tip is deflected by
turning the actuators to obtain
the desired position. Treatment
devices are positioned through
the sheath. The tip position can
be manipulated using the
actuators. Rotating actuators
deflect the shaft. | Access is obtained, the 0.032"
guidewire is inserted and
positioned. The CardioCurve
Steerable Sheath with dilator is
inserted over the guidewire into
the desired position. The access
needle and dilator are removed.
The sheath tip is deflected by
turning the actuators to obtain
the desired position. Treatment
devices are positioned through
the sheath. The tip position can
be manipulated using the
actuators. Rotating actuators
deflect the shaft. | Identical |
| Target
Population | Patients whose doctors need
minimally invasive access to
the heart. | Patients whose doctors need
minimally invasive access to the
heart. | Identical |
| Placement | Epicardial, endocardial, and
intravascular sites | Epicardial, endocardial, and
intravascular 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 linked
locations on the handle. | Bi-directional 180°, small
(17mm), medium (22.5 mm),
and large (50mm) curl.
Deflectable from 2 linked
locations on the handle. | Identical |
| Steerable
Sheath Usable
Length | 40, 61, 71 and 82 cm | 40, 61, 71 and 82 cm | Identical |
| Attribute | CardioCurve Steerable
Sheath - Predicate (K210185) | CardioCurve Steerable Sheath - Subject Device | Discussion |
| Steerable
Sheath Shape | Image: CardioCurve Steerable Sheath - Predicate (K210185) | Image: CardioCurve Steerable Sheath - Subject Device | Modification Design
(Shape) to steerable
sheath handle
(Tuohy Borst
adapter replacement
by cap and external
hemostasis valve due
to shortened
proximal cone and
lengthened shaft
housing). Changes to
steerable sheath
shape do not raise
new or different
questions of safety
and effectiveness. |
| Dilator OD | 9F (3mm) | 9F (3mm) | Identical |
| Dilator Useable
Length | 61.7, 82.7, 92.7, and 103.7 cm | 60.95, 81.95, 91.95, and
102.95 cm | Modification in
Design (Length) to
match modification
to steerable sheath
shape. Changes to
the lengths do not
raise new or
different questions
of safety or
effectiveness. |
| Design | Sideport with 3-way stopcock
Distal holes in the shaft
Radiopaque filled sheath
Tuohy Borst adapter.
Tuohy Borst adapter mates with
dilator.
Tuohy Borst Material:
Makrolon 2458-550115
Polycarbonate | Sideport with 3-way stopcock
Distal holes in the shaft
Radiopaque filled sheath
Tuohy Borst adapter not
provided. Replaced by Cap.
Cap mates with dilator.
Cap Material:
Makrolon 2458-550115
Polycarbonate | Modification in
Design (Shape) to
steerable sheath
handle. Tuohy Borst
adapter removal
does not raise new or
different questions
of safety or
effectiveness. |
| Attribute | CardioCurve Steerable
Sheath - Predicate (K210185) | CardioCurve Steerable Sheath - Subject Device | Discussion |
| | Transparent hemostasis valve
internal to steerable sheath
handle.
Image: Tuohy Borst
Image: Proximal Cone
(Hemostasis Valve
Internal to Handle) | Transparent hemostasis valve
external to steerable sheath
handle.
Image: External Hemostasis Valve & Cap
Image: Shortened Proximal Cone | Modification in
Design (Shape) to
steerable sheath
handle (hemostasis
valve). Changes to
steerable sheath
shape do not raise
new or different
questions of safety
and effectiveness. |
| | Proximal shaft braided | Proximal shaft braided | Identical |
| | Kink resistant | Kink resistant | Identical |
| Materials | Polymer shaft with Stainless
Steel braid reinforcement and
deflection wires. | Polymer shaft with Stainless
Steel braid reinforcement and
deflection wires. | Identical |
| Guidewire
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:
-
- 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.
-
- 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).