(106 days)
No
The device description focuses on the physical characteristics and mechanical function of a catheter, 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 the delivery of saline or diagnostic contrast agents. It does not perform a direct therapeutic function on the patient.
No
The device is a catheter designed to guide and support guidewires, allow for wire exchanges, and provide a conduit for the delivery of substances. Its primary functions are interventional support, not diagnostic data collection or analysis.
No
The device description clearly details a physical catheter with specific materials, dimensions, and features, indicating it is a hardware device, not software-only.
Based on the provided information, the R2P NaviCross is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to guide and support a guidewire during access of the peripheral vasculature. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a guidewire lumen, radiopaque markers for visualization during a procedure, and a hydrophilic coating for easier navigation within the vasculature. These are characteristics of a medical device used for interventional procedures, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
In summary, the R2P NaviCross is a medical device used for interventional procedures within the body, not an IVD device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
R2P NaviCross is indicated to guide and support a guidewire during access of the peripheral vasculature through an access site, including but not limited to the radial artery, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.
Product codes
DQY
Device Description
R2P NaviCross is a low-profile, 4.5Fr, 200cm length catheter. It is intended to guide and support a 0.035" or smaller guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents. The catheter is ethylene oxide sterilized for single use only.
The catheter features a three-layer construction, consisting of a stainless steel double braid mesh sandwiched between an outer and inner layer of polyester elastomer. The mesh is embedded within the catheter wall the entire length of the catheter with the exception of the distal tip. The distal tip is comprised of a polyester elastomer and is offered in both a straight and an angled tip shape. The catheter features three embedded radiopaque markers, one platinum alloy marker located 2mm from the distal tip, and two gold alloy markers. The first gold alloy marker is located 40mm from the distal edge of the platinum alloy marker, and the second gold marker is located 60mm from the distal edge of the first gold marker. There are also two proximal depth markers (pigment), located at 120cm and 150cm, which are there to help with procedural efficiency and minimize the use of fluoroscopy. The distal 40cm portion of the device has a hydrophilic coating. The catheter body is attached to a polyamide hub and a strain relief that contains a polyether block amide (PEBA with colorant and HLS).
The device is offered in an effective length of 200cm. French size and shaft inner diameter are as follows:
French Size: 4.5Fr
Shaft Inner Diameter (mm): 1.05mm +0/- 0.02mm
Shaft Outer Diameter (mm): 1.48 +/- 0.01 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature, including but not limited to the radial artery.
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 that the R2P NaviCross is as substantially equivalent to the predicate device 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 Radiodetectability test, the following performance tests were performed on both non-aged and accelerated aged samples:
Depth Marker Length
Effective Length
Wire Exchange Force
Wire Support
Trackability
Lesion Crossing Force
Torque Response
Flow Rate
Low Pressure Hub Leakage
Aspiration Hub Leakage
Torque Strength
Resistance to Separation from Axial Load
Resistance to Separation from Unscrewing
Resistance to Overriding
Radiodetectability
Lubricity Testing
Hub to Tubing Tensile Strength
Braided to Unbraided Tubing Tensile Strength
Simulated Use and Particulate Testing
Coating Integrity
Leakage Atmospheric
Leakage Sub-Atmospheric
Stress Cracking
Catheter OD (Braided/Unbraided)
Burst Pressure
Flexibility and Kink Testing
Performance testing for t=0 and t=6AA (accelerated age), met the predetermined acceptance criteria and is acceptable for clinical use throughout the shelf life of 6 months. Testing for t=36AA is currently in progress.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
July 27, 2023
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Terumo Medical Corporation Sandeep Chiplonkar Regulatory Affairs Specialist II 950 Elkton Blvd Elkton, Maryland 21921
Re: K231044
Trade/Device Name: R2P Navicross Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 11, 2023 Received: April 12, 2023
Dear Sandeep Chiplonkar:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Samuel G. Raben -S
for Lydia Glaw
Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231044
Device Name R2P NAVICROSS
Indications for Use (Describe)
R2P NaviCross is indicated to guide and support a guidewire during access of the peripheral vasculature through an access site, including but not limited to the radial artery, 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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510(K) SUMMARY
A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92.
Section Contents
| Section | Contents |
|---|---|
| A. | SUBMITTER INFORMATION (807.92(a)(1)) |
| B. | DEVICE NAME (807.92(a)(2)) |
| C. | PREDICATE DEVICE (807.92(a)(3)) |
| D. | REASON FOR 510(k) SUBMISSION |
| E. | DEVICE DESCRIPTION (807.92(a)(4)) |
| F. | INDICATIONS FOR USE (807.92(a)(5)) |
| G. | SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) |
| H. | NON CLINICAL TEST (807.92(b)(1)) |
| I. | CLINICAL TESTS (807.92(b)(2)) |
| J. | CONCLUSION (807.92(b)(3)) |
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510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Sandeep Chiplonkar |
|---|---|
| Regulatory Affairs Specialist II | |
| Terumo Medical Corporation | |
| Tel. (609) 423-9454 | |
| Fax (410) 398-6079 |
Prepared for: Owner/Operator
Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873, USA Registration Number: 2243441
Manufacturer (Applicant)
Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921 USA Registration Number: 1118880
Sterilization Facility Isomedix Operations, Inc. (STERIS) 435 Whitney St
Northborough, MA 01532
Contact Person: Sandeep Chiplonkar Regulatory Affairs Specialist II Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 USA Tel. (609) 423-9454
Terumo Medical Corporation, USA
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Fax (410) 398-6079 E-mail: sandeep.chiplonkar@terumomedical.com
April 11, 2023 Date Prepared:
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | R2P NAVICROSS |
|---|---|
| Common Name: | Support Catheter |
| Classification Name: | Catheter, Percutaneous |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Classification: | Class II |
C. PREDICATE DEVICES (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is:
Predicate Device:
-
K110540, NaviCross ™, Terumo Support Catheter, manufactured by Ashitaka . Factory of Terumo Corporation
Reference Device(s): -
K183000 - ViperCath™ XC Peripheral Exchange Catheter
-
K171491 R2P Destination Slender Guiding Sheath .
D. REASON FOR 510(k) SUBMISSION
This premarket notification 510(k) for R2P NaviCross, manufactured by Terumo Medical Corporation is being submitted for the purposes of establishing substantial equivalence to a legally marketed predicate device.
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E. DEVICE DESCRIPTION (807.92(a)(4))
Principle of Operation Technology
R2P NaviCross submitted in this 510(k) and its predicate (K110540) are operated by a manual process.
Design/Construction
R2P NaviCross is a low-profile, 4.5Fr, 200cm length catheter. It is intended to guide and support a 0.035" or smaller guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents. The catheter is ethylene oxide sterilized for single use only.
The catheter features a three-layer construction, consisting of a stainless steel double braid mesh sandwiched between an outer and inner layer of polyester elastomer. The mesh is embedded within the catheter wall the entire length of the catheter with the exception of the distal tip. The distal tip is comprised of a polyester elastomer and is offered in both a straight and an angled tip shape. The catheter features three embedded radiopaque markers, one platinum alloy marker located 2mm from the distal tip, and two gold alloy markers. The first gold alloy marker is located 40mm from the distal edge of the platinum alloy marker, and the second gold marker is located 60mm from the distal edge of the first gold marker. There are also two proximal depth markers (pigment), located at 120cm and 150cm, which are there to help with procedural efficiency and minimize the use of fluoroscopy. The distal 40cm portion of the device has a hydrophilic coating. The catheter body is attached to a polyamide hub and a strain relief that contains a polyether block amide (PEBA with colorant and HLS).
The device is offered in an effective length of 200cm. French size and shaft inner diameter are as follows:
| French Size | Shaft Inner Diameter (mm) | Shaft Outer Diameter (mm) |
|---|---|---|
| 4.5Fr | 1.05mm +0/- 0.02mm | $1.48 \pm 0.01$ mm |
Materials
The materials for R2P NaviCross are provided in Table 5.1.
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| No. | Name of Component | Raw Material | |
|---|---|---|---|
| 1* | Catheter | Shaft | |
| Outer layer | Polyester elastomer | ||
| 2 | Mesh Braid | Stainless steel | |
| 3* | Inner Layer | Polyester elastomer | |
| 4* | Distal tip*** | Polyester elastomer | |
| 5 | Radiopaque | ||
| Markers | Distal tip (1) | ||
| Embedded (2) | Platinum alloy | ||
| Gold alloy | |||
| 6* | Proximal depth markers (2) | ||
| (non-radiopaque) | Pigment (White ink) | ||
| 7* | Hydrophilic polymer coating | Dimethylacrylamide | |
| Glycidylmethacrylate - copolymer | |||
| 8** | Quick Drying Glue | Acrylated Urethane | |
| 9** | Hub | Polyamide | |
| 10** | Strain Relief | Polyether block amide (PEBA) | |
| with colorant and HLS |
*Blood contacting material, ** Blood Path Indirect, ***Distal tip is not braided.
Specifications
The specifications for R2P NaviCross are provided in Table 5.2.
| Table 5.2: R2P NaviCross Specifications | ||||
|---|---|---|---|---|
| -- | -- | ----------------------------------------- | -- | -- |
| Part | Specification |
|---|---|
| Catheter French Size | 4.5 Fr. |
| Catheter ID/OD | $1.05 +0/-0.02mm /1.48 \pm 0.01mm$ |
| *Catheter Effective Lengths | 200cm -0/+3cm |
| Hydrophilic Coating Length | Distal $40 \pm 3cm$ |
| Maximum guide wire outer diameter | 0.035" |
*The length from the proximal strain relief to the catheter distal tip.
F. INDICATIONS FOR USE (807.92(a)(5))
R2P NaviCross is indicated to guide and support a guidewire during access of the peripheral vasculature through an access site, including but not limited to the radial artery, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.
The intended use is equivalent to the predicate device (K110540).
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G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
R2P NaviCross, the subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate, K110540, NaviCross ™, Terumo Support Catheter, manufactured by Ashitaka Factory of Terumo Corporation.
In addition to the above listed predicate, Terumo Medical Corporation has identified the following reference device(s). These are market leading devices with the same intended use, basic design, and similar indications for use as the subject device. Since these devices are frequently used in clinical practice, Terumo felt that they were appropriate to use as references.
-
- Cardiovascular Systems, Inc. (K183000) ViperCath™ XC Peripheral Exchange Catheter
- Terumo Medical Corporation (K171491) R2P Destination Slender Guiding Sheath 2.
A comparison of the technological characteristics is summarized in Table 5.3.
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| Device Characteristic | Subject Device:
R2P NAVICROSS | Predicate Device:
NAVICROSS™
Terumo Support
Catheter (K110540) | Reference Device #1:
ViperCath™ XC
Peripheral Exchange
Catheter (K183000) | Reference Device #2:
R2P Destination
Slender Guiding
Sheath (K171491) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical
Corporation, USA | Ashitaka Factory of
Terumo Corporation | Cardiovascular Systems,
Inc. | Terumo Medical
Corporation, USA |
| Intended Use | R2P NaviCross is intended
to guide and support a
guidewire during access of
the vasculature, allow for
wire exchanges and
provide a conduit for the
delivery of saline or
diagnostic contrast agents. | Same. | Same. | Same. |
| Indications for Use | R2P NaviCross is indicated
to guide and support a
guidewire during access of
the peripheral vasculature
through an access site,
including but not limited to
the radial artery, allow for
wire exchanges, and
provide a conduit for the
delivery of saline or
diagnostic contrast agents. | Terumo Support
Catheters are intended to
guide and support a
guidewire during access
of the vasculature, allow
for wire exchanges and
provide a conduit for the
delivery of saline or
diagnostic contrast
agents. | The ViperCath™ XC
Peripheral Exchange
Catheter 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. | R2PTM Destination
Slender™ Guiding
Sheath is indicated to
be used for the
introduction of
interventional and
diagnostic devices in
the lower extremities of
the peripheral
vasculature through an
access site, including
but not limited to the
radial artery. |
| Operation Principle | Manual | Same | Same | Same |
| Design/Construction | Three-layer construction
catheter shaft with
hydrophilic coating, distal
tip and hub. | Same | Information not publicly
available. | Sheath, Dilator,
Hemostatic Valve with
side tube and three-way
stopcock |
| Device Characteristic | Subject Device:
R2P NAVICROSS | Predicate Device:
NAVICROSSTM
Terumo Support
Catheter (K110540) | Reference Device #1:
ViperCath™ XC
Peripheral Exchange
Catheter (K183000) | Reference Device #2:
R2P Destination
Slender Guiding
Sheath (K171491) |
| Materials | Catheter shaft Outer layer*: Polyester
elastomer/tungsten Braid: Stainless steel Inner layer*: Polyester
elastomer/Tungsten Hydrophilic coating*:
Dimethylacrylamide
Glycidylmethacrylate-
copolymer Three radiopaque
markers: 1: Platinum
Alloy, 2: Gold Two Proximal depth
markers* (non-
radiopaque): Pigment Hub**: Polyamide Strain Relief**:
Polyether block amide
(PEBA), with colorant
and HLS Adhesive**: Acrylated
Urethane : blood contacting
material
: blood path indirect | Catheter shaft Outer layer:
Polyester
elastomer/tungsten Mesh braid:
Stainless steel Inner layer:
Polyester
elastomer/tungsten Hydrophilic
coating: Dimethyl
acrylamide-glycidyl
methacrylate
copolymer Three radiopaque
markers*: Platinum
alloy Hub*: Polyamide Anti-kink protector:
Polyester elastomer
w/pigment Adhesive:
Cyanoacrylate *: blood contacting
material | Information not publicly
available. | Sheath Assembly
Tubing:
Inner Layer: PTFE
Middle Coil Layer:
Stainless Steel
Outer Layer: Nylon
Radiopaque Tip: Nylon
with Tungsten
Hydrophilic Coating:
Polyvinylpyrrolidone-
based coating
Hub: Nylon
Anti-kink protector:
Nylon
Dilator Assembly
Tubing: Polypropylene
Hub: Polypropylene/
/Thermoplastic
Elastomer Blend
Coating: Silicone
Caulking Pin: Stainless
steel
Cross Cut Valve
Valve Assembly:
Housing:
Polypropylene
Cap: Polypropylene
Luer Lock Collar: |
| Device Characteristic | Subject Device:
R2P NAVICROSS | Predicate Device:
NAVICROSS™
Terumo Support
Catheter (K110540) | Reference Device #1:
ViperCath™ XC
Peripheral Exchange
Catheter (K183000) | Reference Device #2:
R2P Destination
Slender Guiding
Sheath (K171491) |
| | | | | Polycarbonate
Valve: Silicone Rubber
Elastomer
Sidetube: polybutadiene
Silicone: Non-reactive
silicone oil 1000cst
Side Tube Assembly:
Body: Polybutadiene
3Way (3WSC)
Stopcock Assembly:
Body: Polycarbonate
Locking Pin:
Polyethylene
Cap: Polyethylene and
Colorant
Handle: Polyethylene
and Colorant |
| Package | Individual package on which the product label and the peel-off labels are attached 1 unit per package | Same | Same | Unit Pouch
Shelf Box
Shipping Carton |
| Specifications | Effective length(s): 200cm French size: 4.5Fr O.D.: 1.48 mm | Effective length(s): 65, 90, 135 and 150 cm French size: 4Fr O.D.: 1.39 mm | Effective length(s): 200cm French size: 5Fr O.D.: Unknown | Sheath Size: 6 Fr. Sheath ID/OD (nominal): 6Fr.: 0.087"/0.100" (2.2mm /2.5mm) |
| Device Characteristic | Subject Device:
R2P NAVICROSS | Predicate Device:
NAVICROSS™
Terumo Support
Catheter (K110540) | Reference Device #1:
ViperCath™ XC
Peripheral Exchange
Catheter (K183000) | Reference Device #2:
R2P Destination
Slender Guiding
Sheath (K171491) |
| | • I.D.: 1.05 mm
• Maximum guidewire outer diameter: 0.035"
• Distal tip shape: straight/angled
• Maximum injection pressure: 600 psi | • I.D.: 1.05 mm
• Maximum guidewire outer diameter: 0.035"
• Distal tip shape: straight/angled
• Maximum injection pressure: 750 psi | • I.D.: Unknown
• Maximum guidewire outer diameter: 0.035"
• Distal tip shape: straight/angled
• Maximum injection pressure: 600 psi | • Sheath Length:
119cm, 149cm
• Hydrophilic Coating: full effective length
Distal Shape:
Straight
• Dilator ID/OD (nominal):
0.039"/0.086"
• Dilator Extended Length: 5cm |
| Sterilization | Ethylene oxide | Same | Same | Same |
| Shelf Life | *6 months | 36 months | Unknown | 30 months |
Table 5.3: Summary of Comparative Information
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Terumo Medical Corporation, USA
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*This 510(k) is being submitted with T=6AA testing completed. The subject device will have an ultimates squivalent to the predicate device.
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H. NON CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure that the R2P NaviCross is as substantially equivalent to the predicate device 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 Radiodetectability test, the following performance tests were performed on both non-aged and accelerated aged samples. Table 5.4 provides a list of performance tests that were performed on R2P NaviCross.
| Test Item |
|---|
| Depth Marker Length |
| Effective Length |
| Wire Exchange Force |
| Wire Support |
| Trackability |
| Lesion Crossing Force |
| Torque Response |
| Flow Rate |
| Low Pressure Hub Leakage |
| Aspiration Hub Leakage |
| Torque Strength |
| Resistance to Separation from Axial Load |
| Resistance to Separation from Unscrewing |
| Resistance to Overriding |
| Radiodetectability |
| Lubricity Testing |
| Hub to Tubing Tensile Strength |
| Braided to Unbraided Tubing Tensile Strength |
| Simulated Use and Particulate Testing |
| Coating Integrity |
| Leakage Atmospheric |
| Leakage Sub-Atmospheric |
| Stress Cracking |
Table 5.4: Summarv of Performance Testing
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| Test Item |
|---|
| Catheter OD (Braided/Unbraided) |
| Burst Pressure |
| Flexibility and Kink Testing |
Performance testing for t=0 and t=6AA (accelerated age), met the predetermined acceptance criteria and is acceptable for clinical use throughout the shelf life of 6 months. Testing for t=36AA is currently in progress.
Biocompatibility
Biocompatibility classification is based on the FDA Guidance - Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process".
In accordance with ISO 10993-1, R2P NaviCross is classified as an Externally Communicating Device with Limited Contact (≤24 hours) with Circulating Blood.
Table 5.6 provides a list of biocompatibility testing conducted on R2P NaviCross.
| Non-aged, sterile, whole device | Applicable Standard(s) |
|---|---|
| Chemical Characterization | ISO 10993-18:2020, USP |
| Cytotoxicity | EN ISO 10993-5:2009 |
| Sensitization | ISO 10993-10:2021 |
| Irritation or Intracutaneous Reactivity | ISO 10993-23:2021 |
| Material Mediated Pyrogenicity | ISO 10993-11:2017, USP Pyrogen Test |
| Acute Systemic Toxicity | ISO 10993-11:2017 |
| Hemocompatibility | ISO 10993-4:2017 |
Table 5.6: Summary of ISO 10993 Biocompatibility Testing
Results of the testing demonstrate biocompatibility of the finished R2P NaviCross.
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices.
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The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.
R2P NaviCross 035 is a limited exposure device. After 24 hours of heated aeration, the level of residual EO and ECH do not exceed an average daily dose of 4mg and 9mg respectively, per EN ISO 10993-7.
CLINICAL TESTS (807.92(b)(2)) I.
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, R2P NaviCross, subject of this traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device (K110540) - NaviCross ™, Terumo Support Catheter, manufactured by Ashitaka Factory of Terumo Corporation.
TMC contends that the differences in indications for use from the subject device and predicate and reference devices does not alter the intended use of the devices.