(105 days)
No
The description focuses on the physical construction and function of a catheter for guiding wires and delivering fluids, with no mention of AI or ML capabilities.
No
The device is intended to guide and support a guidewire, allow for wire exchanges, and provide a conduit for delivery of saline or contrast agents. It does not directly treat a disease or condition.
No
The device is described as a guide wire and support catheter for access of the peripheral vasculature and delivery of substances, not for diagnosing conditions. While it can deliver "diagnostic contrast agents," the device itself does not perform diagnostic functions; it acts as a conduit.
No
The device description clearly details a physical, single-use catheter with specific material composition, construction, and lengths, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The NaviCross 0.018" is a catheter intended to be used inside the body (in the peripheral vasculature) to guide wires, allow for exchanges, and deliver substances. It is a tool used in a medical procedure, not a device that performs a diagnostic test on a sample.
- Intended Use: The intended use clearly describes its function within a medical procedure, not a diagnostic test.
- Device Description: The description details its physical construction and how it's used in the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, performing tests, or providing diagnostic information based on biological samples.
Therefore, based on the provided information, the NaviCross 0.018" is a medical device used in interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NaviCross 0.018" is intended to guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
Product codes (comma separated list FDA assigned to the subject device)
DOY
Device Description
The NaviCross 0.018" is a single use, ethylene oxide sterilized device that is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
NaviCross 0.018" features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyamide and an inner layer of polytetrafluoroethylene. It has a distal tip that is comprised of a polyamide. It also has a hydrophilic coating over the distal 40 cm of the catheter.
The device is offered in effective lengths of 65, 90, 135 and 150 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 was conducted to ensure the safety and effectiveness of the NaviCross 0.018" throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radio-detectability test, the following performance tests were performed on non-aged and accelerated aged samples.
Test Items: Radio-detectability, Surface, Peak tensile force, Freedom from leakage, Power injection, Distal tip, Fluid leakage (Hub), Sub-atmospheric pressure air leakage (Hub), Stress cracking (Hub), Resistance to separation from axial load (Hub), Resistance to separation from unscrewing (Hub), Resistance to overriding (Hub), Particulate evaluation, Coating integrity, Torque strength, Distal tip strength, Flow rate, Product dimension, Bending stiffness of catheter shaft, Flexibility and kink test, Torque transmission property, Interior sliding characteristics, Exterior sliding characteristics, Wire support characteristics, Simulated Use - Reachability, Simulated Use - Usability Test.
Key Results: Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 29, 2018
Terumo Medical Corporation Ms. Yuko Watanabe Sr. Regulatory Affairs Specialist 265 Davidson Ave., Suite 320 Somerset, New Jersey 08873
Re: K173799
Trade/Device Name: NaviCross 0.018" Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: March 16, 2018 Received: March 16, 2018
Dear Ms. Watanabe:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Yuko Watanabe
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willhemen
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173799
Device Name NaviCross 0.018"
Indications for Use (Describe)
The NaviCross 0.018" is intended to guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
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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3
510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Yuko Watanabe |
|---|---|
| Senior Regulatory Affairs Specialist | |
| Terumo Medical Corporation | |
| Tel. (732) 302-4900 | |
| Fax (410) 398-6079 |
Prepared for: Owner/Operator
Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo Japan 151-0072 Owner/Operator Number: 801 002 6
Manufacturer and Sterilization Facility (Applicant)
Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 968 183 4
Contact Person: Yuko Watanabe Senior Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (732) 302-4900 Fax (410) 398-6079 E-mail: yuko.watanabe@terumomedical.com
December 13th, 2017 Date prepared:
4
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | NaviCross 0.018" |
|---|---|
| Common Name: | Support Catheter |
| Classification Name: | Percutaneous Catheter |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is:
Predicate Device: K110540 – TERUMO SUPPORT CATHETER, manufactured by Ashitaka Factory of Terumo Corporation.
Reference Devices:
-
- K160884: CXI 0.018" support catheter, Cook, Inc.
-
- K033678: Quick-Cross 0.018" support catheter, Spectranetics, Inc.
-
- K122394: Rubicon 0.018" support catheter, Boston Scientific Corp.
D. REASON FOR 510(k) SUBMISSION
This traditional 510(k) is being submitted for the NaviCross 0.018", which will be a line extension of the currently marketed NaviCross 0.035" (K110540, cleared under the name "Terumo Support Catheter"), for the purposes of establishing substantial equivalence to a legally marketed predicate device.
E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
The NaviCross 0.018" submitted in this 510(k) and its predicate (K110540) are operated by a manual process.
5
Design/Construction
The NaviCross 0.018" is a single use, ethylene oxide sterilized device that is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
NaviCross 0.018" features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyamide and an inner layer of polytetrafluoroethylene. It has a distal tip that is comprised of a polyamide. It also has a hydrophilic coating over the distal 40 cm of the catheter.
The device is offered in effective lengths of 65, 90, 135 and 150 cm. French size and shaft inner diameter are as follows:
| French Size | Shaft Inner Diameter (mm) |
|---|---|
| 2.6Fr | $0.55 \pm 0.02$ |
Materials
The materials for the NaviCross 0.018" are provided in the table below.
| No. | Name of Component | Raw material | |
|---|---|---|---|
| 1* | Shaft | Outer layer | Polyamide |
| Pigment | |||
| 2 | Braid† | Stainless steel | |
| 3* | Catheter | Inner layer | Polytetrafluoroethylene |
| 4* | Distal tip† | Polyamide | |
| Pigment | |||
| 5 | Radiopaque marker | Tungsten | |
| 6* | Hydrophilic polymer coating | Dimethyl acrylamide – | |
| glycidyl methacrylate copolymer | |||
| 7 | Quick-drying glue | Cyanoacrylate | |
| 8* | Hub | Polyamide | |
| 9 | Anti-kink protector | Polyester elastomer | |
| Pigment |
Table 5.1: List of Materials
*Blood contacting material.
*Distal-tip is not braided.
6
Specifications
The specifications for the NaviCross 0.018" are provided in the table below.
| Part | Specification |
|---|---|
| Catheter Size | 2.6 Fr. |
| Catheter ID/OD | $0.55 \pm 0.02$ mm/ $0.85 \pm 0.03$ mm |
| Catheter Effective Lengths* | 65 $\pm$ 1.5 cm, 90 $\pm$ 1.5 cm, |
| 135 $\pm$ 1.5 cm, 150 $\pm$ 1.5 cm | |
| Hydrophilic Coating Length | Distal 40 $\pm$ 3cm |
| Maximum guidewire outer diameter | 0.018" |
Table 5.2: NaviCross 0.018" Specifications
*The length from the proximal anti-kink protector to the catheter distal tip.
F. INDICATIONS FOR USE (807.92(a)(5))
The NaviCross 0.018" is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
The indications for use are equivalent to the predicate (K110540).
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The NaviCross 0.018", the subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, K110540 - TERUMO SUPPORT CATHETER, manufactured by Ashitaka Factory of Terumo Corporation.
In addition to the above-listed primary predicate, Terumo has identified the following reference devices. These are market leading devices with the same intended use and basic design as the subject device. Because these devices are frequently used in clinical practice, Terumo felt it was appropriate to use them as references when setting the acceptance criteria for NaviCross 0.018" performance testing.
-
- Cook Inc. CXI 0.018" support catheter (K160884)
-
- Spectranetics, Inc. Quick-Cross 0.018" support catheter (K033678)
-
- Boston Scientific Corp. Rubicon 0.018" support catheter (K122394)
7
A comparison of the technological characteristics is summarized in the table below.
8
Terumo Corporation
Traditional 510(k) – NaviCross 0.01
Section 5 510(k) Summary
| Device
Characteristic | Subject Device:
NaviCross 0.018" | Predicate Device:
TERUMO SUPPORT
CATHETER (NaviCross
0.035") (K110540) | Reference Device #1:
CXI 0.018" support
catheter
(K160884) | Reference Device #2:
Quick-Cross 0.018"
support catheter
(K033678) | Reference Device #3:
Rubicon 0.018"
support catheter
(K122394) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Ashitaka Factory of
Terumo Corporation | Same | Cook Inc. | Spectranetics, Inc. | Boston Scientific Corp. |
| Intended Use
Indications for
Use | It is intended to guide and
support a guide wire
during access of the
peripheral vasculature,
allow for wire exchanges
and provide a conduit for
the delivery of saline or
diagnostic contrast agents. | It is intended to guide and
support a guide wire
during access of the
vasculature, allow for
wire exchanges and
provide a conduit for the
delivery of saline or
diagnostic contrast agents. | It is intended for use in
small vessel or
superselective
anatomy for diagnostic
and interventional
procedures, including
peripheral use. | It is designed for
use in the vascular
system. The catheters
are intended to support a
guidewire during access
of the vasculature, allow
for exchange of
guidewires, and provide
a conduit for the
delivery of saline
solutions or diagnostic
contrast agents. | It is intended to
facilitate placement and
support of guidewires
and other Interventional
devices within the
peripheral vasculature
and to allow for
exchange of guidewires,
and provide a conduit
for the delivery of saline
or contrast solutions. |
| Operation
Principle | Manual | Same | Same | Same | Same |
| Design/
Construction | Three-layer construction
catheter shaft with
hydrophilic coating, distal
tip and hub | Same | Multi layers with
hydrophilic coating,
distal tip and hub | One layer with
hydrophilic coating,
distal tip and hub | Multi layers with
hydrophilic coating,
distal tip and hub |
| Device
Characteristic | Subject Device:
NaviCross 0.018" | Predicate Device:
TERUMO SUPPORT
CATHETER (NaviCross
0.035") (K110540) | Reference Device #1:
CXI 0.018" support
catheter
(K160884) | Reference Device #2:
Quick-Cross 0.018"
support catheter
(K033678) | Reference Device #3:
Rubicon 0.018"
support catheter
(K122394) |
| | Catheter shaft
Outer layer*:
Polyamide w/
pigment | Catheter shaft
Outer layer*:
Polyester | Information not
publicly available. | Information not publicly
available. | Information not publicly
available. |
| | Mesh braid: Stainless
steel | Mesh braid: Stainless
steel | | | |
| | Inner layer*:
Polytetrafluoroethyle
ne | Inner layer*:
Polyester
elastomer/tungsten | | | |
| Materials | Hydrophilic coating*:
Dimethyl acrylamide-
glycidyl methacrylate
copolymer
Three radiopaque
markers: Tungsten | Hydrophilic coating*:
Dimethyl acrylamide-
glycidyl methacrylate
copolymer
Three radiopaque
markers*: Platinum
alloy | | | |
| | Distal Tip*:
Polyamide w/
pigment
Hub*: Polyamide
Anti-kink protector:
Polyester elastomer
w/ pigment
Adhesive:
Cyanoacrylate
: blood contacting
material | Hub: Polyamide
Anti-kink protector:
Polyester elastomer
w/ pigment
Adhesive:
Cyanoacrylate
*: blood contacting
material | | | |
| Device
Characteristic | Subject Device:
NaviCross 0.018" | Predicate Device:
TERUMO SUPPORT
CATHETER (NaviCross
0.035") (K110540) | Reference Device #1:
CXI 0.018" support
catheter
(K160884) | Reference Device #2:
Quick-Cross 0.018"
support catheter
(K033678) | Reference Device #3:
Rubicon 0.018"
support catheter
(K122394) |
| Package | Individual package on
which the product
label and the peel-off
labels are attached 1 unit per package | Same | Same | Same | Same |
| Specifications | Effective lengths: 65,
90, 135 and 150 cm French size: 2.6Fr
(0.85 mm) O.D.: 0.85 mm I.D.: 0.55 mm Maximum guidewire
outer diameter: 0.018" Distal tip shape:
straight/angled Maximum injection
pressure: 300 psi | Effective lengths: 65,
90, 135 and 150 cm French size: 4Fr
(1.39 mm) O.D.: 1.39 mm I.D.:1.05 mm Maximum guidewire
outer diameter: 0.035" Distal tip shape:
straight/angled Maximum injection
pressure: 750 psi | 90, 150 cm 2.6 Fr O.D.: 0.87 mm I.D.: unknown Same (0.018") Same
(straight/angled) 1200 psi | 90, 135 and 150 cm 3.4 Fr O.D.: 1.12 mm
(Proximal shaft) I.D.: unknown Same (0.018") Straight only Same (300 psi) | 90, 135 and 150 cm 4.0 Fr O.D.: 1.35 mm
(Proximal shaft) I.D.: unknown Same (0.018") Straight only Same (300 psi) |
| Sterilization | Ethylene oxide | Same | Same | Radiation | Same |
| Shelf life | 36 months | Same | Unknown | Unknown | Unknown |
9
Terumo Corporation
Traditional 510(k) — NaviCross 0.01
Section 5 510(k) Summary
10
Terumo Corporation
Traditional 510(k) — NaviCross 0.01
Section 5 510(k) Summary
Page 8 of 11
11
H. NON CLINICAL TESTS (807.92(b)(1))
Performance Testing
Performance testing was conducted to ensure the safety and effectiveness of the NaviCross 0.018" throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radio-detectability test, the following performance tests were performed on non-aged and accelerated aged samples. The following table provides a list of performance tests that were performed on the NaviCross 0.018".
| Test Item |
|---|
| Radio-detectability |
| Surface |
| Peak tensile force |
| Freedom from leakage |
| Power injection |
| Distal tip |
| Fluid leakage (Hub) |
| Sub-atmospheric pressure air leakage (Hub) |
| Stress cracking (Hub) |
| Resistance to separation from axial load (Hub) |
| Resistance to separation from unscrewing (Hub) |
| Resistance to overriding (Hub) |
| Particulate evaluation |
| Coating integrity |
| Torque strength |
| Distal tip strength |
| Flow rate |
| Product dimension |
| Bending stiffness of catheter shaft |
| Flexibility and kink test |
| Torque transmission property |
| Interior sliding characteristics |
| Exterior sliding characteristics |
| Wire support characteristics |
| Simulated Use - Reachability |
| Simulated Use - Usability Test |
| Table 5.4: Summary of Performance Testing | |||
|---|---|---|---|
| -- | -- | ------------------------------------------- | -- |
1 Only non-aged sample was tested since the amount of contrast media contained in the product would not change over time.
12
Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
Biocompatibility
In accordance with ISO 10993-1, the NaviCross 0.018" is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (