R2P Navicross

{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): | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The swoosh starts thin on the left and gets thicker as it curves over the word. # 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)) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word. # 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh is curved and points to the right. 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh starts thin on the left and gets thicker as it moves to the right. ## 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and bolded. | No. | Name of Component | | Raw Material | |------|------------------------------------------------|--------------------------------|--------------------------------------------------------| | 1* | Catheter | Shaft<br>Outer layer | Polyester elastomer | | 2 | Mesh Braid | | Stainless steel | | 3* | Inner Layer | | Polyester elastomer | | 4* | Distal tip*** | | Polyester elastomer | | 5 | Radiopaque<br>Markers | Distal tip (1)<br>Embedded (2) | Platinum alloy<br>Gold alloy | | 6* | Proximal depth markers (2)<br>(non-radiopaque) | | Pigment (White ink) | | 7* | Hydrophilic polymer coating | | Dimethylacrylamide<br>Glycidylmethacrylate - copolymer | | 8** | Quick Drying Glue | | Acrylated Urethane | | 9** | Hub | | Polyamide | | 10** | Strain Relief | | Polyether block amide (PEBA)<br>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). {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO." # 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. - 1. 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. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the Terumo logo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a dynamic and recognizable brand symbol. | Device Characteristic | Subject Device:<br>R2P NAVICROSS | Predicate Device:<br>NAVICROSS™<br>Terumo Support<br>Catheter (K110540) | Reference Device #1:<br>ViperCath™ XC<br>Peripheral Exchange<br>Catheter (K183000) | Reference Device #2:<br>R2P Destination<br>Slender Guiding<br>Sheath (K171491) | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Terumo Medical<br>Corporation, USA | Ashitaka Factory of<br>Terumo Corporation | Cardiovascular Systems,<br>Inc. | Terumo Medical<br>Corporation, USA | | Intended Use | R2P NaviCross is intended<br>to guide and support a<br>guidewire during access of<br>the vasculature, allow for<br>wire exchanges and<br>provide a conduit for the<br>delivery of saline or<br>diagnostic contrast agents. | Same. | Same. | Same. | | Indications for Use | R2P NaviCross is indicated<br>to guide and support a<br>guidewire during access of<br>the peripheral vasculature<br>through an access site,<br>including but not limited to<br>the radial artery, allow for<br>wire exchanges, and<br>provide a conduit for the<br>delivery of saline or<br>diagnostic contrast agents. | Terumo Support<br>Catheters are intended to<br>guide and support a<br>guidewire during access<br>of the vasculature, allow<br>for wire exchanges and<br>provide a conduit for the<br>delivery of saline or<br>diagnostic contrast<br>agents. | The ViperCath™ XC<br>Peripheral Exchange<br>Catheter is intended to<br>guide and support a guide<br>wire during access of the<br>vasculature, allow for<br>wire exchanges and<br>provide a conduit for the<br>delivery of saline or<br>diagnostic contrast<br>agents. | R2PTM Destination<br>Slender™ Guiding<br>Sheath is indicated to<br>be used for the<br>introduction of<br>interventional and<br>diagnostic devices in<br>the lower extremities of<br>the peripheral<br>vasculature through an<br>access site, including<br>but not limited to the<br>radial artery. | | Operation Principle | Manual | Same | Same | Same | | Design/Construction | Three-layer construction<br>catheter shaft with<br>hydrophilic coating, distal<br>tip and hub. | Same | Information not publicly<br>available. | Sheath, Dilator,<br>Hemostatic Valve with<br>side tube and three-way<br>stopcock | | Device Characteristic | Subject Device:<br>R2P NAVICROSS | Predicate Device:<br>NAVICROSSTM<br>Terumo Support<br>Catheter (K110540) | Reference Device #1:<br>ViperCath™ XC<br>Peripheral Exchange<br>Catheter (K183000) | Reference Device #2:<br>R2P Destination<br>Slender Guiding<br>Sheath (K171491) | | Materials | Catheter shaft Outer layer*: Polyester<br>elastomer/tungsten Braid: Stainless steel Inner layer*: Polyester<br>elastomer/Tungsten Hydrophilic coating*:<br>Dimethylacrylamide<br>Glycidylmethacrylate-<br>copolymer Three radiopaque<br>markers: 1: Platinum<br>Alloy, 2: Gold Two Proximal depth<br>markers* (non-<br>radiopaque): Pigment Hub**: Polyamide Strain Relief**:<br>Polyether block amide<br>(PEBA), with colorant<br>and HLS Adhesive**: Acrylated<br>Urethane *: blood contacting<br>material<br>**: blood path indirect | Catheter shaft Outer layer*:<br>Polyester<br>elastomer/tungsten Mesh braid:<br>Stainless steel Inner layer*:<br>Polyester<br>elastomer/tungsten Hydrophilic<br>coating*: Dimethyl<br>acrylamide-glycidyl<br>methacrylate<br>copolymer Three radiopaque<br>markers*: Platinum<br>alloy Hub*: Polyamide Anti-kink protector:<br>Polyester elastomer<br>w/pigment Adhesive:<br>Cyanoacrylate *: blood contacting<br>material | Information not publicly<br>available. | Sheath Assembly<br>Tubing:<br>Inner Layer: PTFE<br>Middle Coil Layer:<br>Stainless Steel<br>Outer Layer: Nylon<br>Radiopaque Tip: Nylon<br>with Tungsten<br>Hydrophilic Coating:<br>Polyvinylpyrrolidone-<br>based coating<br>Hub: Nylon<br>Anti-kink protector:<br>Nylon<br>Dilator Assembly<br>Tubing: Polypropylene<br>Hub: Polypropylene/<br>/Thermoplastic<br>Elastomer Blend<br>Coating: Silicone<br>Caulking Pin: Stainless<br>steel<br>Cross Cut Valve<br>Valve Assembly:<br>Housing:<br>Polypropylene<br>Cap: Polypropylene<br>Luer Lock Collar: | | Device Characteristic | Subject Device:<br>R2P NAVICROSS | Predicate Device:<br>NAVICROSS™<br>Terumo Support<br>Catheter (K110540) | Reference Device #1:<br>ViperCath™ XC<br>Peripheral Exchange<br>Catheter (K183000) | Reference Device #2:<br>R2P Destination<br>Slender Guiding<br>Sheath (K171491) | | | | | | Polycarbonate<br>Valve: Silicone Rubber<br>Elastomer<br>Sidetube: polybutadiene<br>Silicone: Non-reactive<br>silicone oil 1000cst<br><br>Side Tube Assembly:<br>Body: Polybutadiene<br><br>3Way (3WSC)<br>Stopcock Assembly:<br>Body: Polycarbonate<br>Locking Pin:<br>Polyethylene<br>Cap: Polyethylene and<br>Colorant<br>Handle: Polyethylene<br>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<br>Shelf Box<br>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:<br>R2P NAVICROSS | Predicate Device:<br>NAVICROSS™<br>Terumo Support<br>Catheter (K110540) | Reference Device #1:<br>ViperCath™ XC<br>Peripheral Exchange<br>Catheter (K183000) | Reference Device #2:<br>R2P Destination<br>Slender Guiding<br>Sheath (K171491) | | | • I.D.: 1.05 mm<br>• Maximum guidewire outer diameter: 0.035"<br>• Distal tip shape: straight/angled<br>• Maximum injection pressure: 600 psi | • I.D.: 1.05 mm<br>• Maximum guidewire outer diameter: 0.035"<br>• Distal tip shape: straight/angled<br>• Maximum injection pressure: 750 psi | • I.D.: Unknown<br>• Maximum guidewire outer diameter: 0.035"<br>• Distal tip shape: straight/angled<br>• Maximum injection pressure: 600 psi | • Sheath Length:<br>119cm, 149cm<br>• Hydrophilic Coating: full effective length<br>Distal Shape:<br>Straight<br>• Dilator ID/OD (nominal):<br>0.039"/0.086"<br>• 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 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the Terumo logo. The logo consists of a red arc above the word "TERUMO" in green. The font is sans-serif and the letters are bold. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is curved and positioned above the left side of the word. Terumo Medical Corporation, USA {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO." *This 510(k) is being submitted with T=6AA testing completed. The subject device will have an ultimates squivalent to the predicate device. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and positioned above and to the left of the word. # 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 {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO." | 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 <661> | | 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 <151> 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. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO." 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.