(85 days)
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.
This document is a 510(k) summary for a medical device called the "Distal Access Catheter." It describes non-clinical performance testing and biocompatibility testing conducted to demonstrate that the device is substantially equivalent to a predicate device.
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Test Method / Applicable Standard) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Verify dimensions using specified measurement tool. | Pass |
| Tip Configuration | Visually inspect distal tip at 10x magnification. | Pass |
| Surface Integrity | Inspect catheter surface. ISO 10555-1:2013 | Pass |
| Tip Buckling | Use a testing apparatus to measure the maximum force required to cause a test sample to buckle at 5 mm, 10 mm and 20 mm from distal tip. | Pass |
| Luer Connector Tests | ISO 80369-7: 2021 | Pass |
| Flexural Fatigue | After ten runs of the Distal Access Catheter with the accessories in the simulated use model, remove the test sample and inspect the sample for kinks or damage. | Pass |
| Trackability | Test the peak tracking force and the compatibility with the ancillary devices during insertion and retraction of the catheter in the simulated use model. | Pass |
| Catheter Lubricity and Durability | Use friction tester to measure the frictional force of the test samples when pulled between two clamped pads. Record the peak frictional force over 5 cycles. | Pass |
| Particulate and Coating Integrity Test | Measure the size and number of particulates generated during simulated use and conduct visual inspection at 50x and 200x magnification of the outer surface of the catheter after simulated use. | Pass |
| Tensile Strength Test | ISO 10555-1:2013 | Pass |
| Air Leakage | ISO 10555-1:2013 | Pass |
| Liquid Leakage | ISO 10555-1:2013 | Pass |
| Torque Resistance | Fix the distal tip of the Distal Access Catheter and rotate the proximal end until the Distal Access Catheter shows kink or other signs of failure. | Pass |
| Kink Resistance Test | Visually inspect whether the Distal Access Catheter kinks or not when wrapped around mandrels with diameters 1 mm to 10 mm (in 1 mm increments). | Pass |
| Catheter Tip and Lumen Integrity | After simulated use, aspirate test sample for 10 sec using a 60 cc syringe during retrieval device withdrawal. Visually inspect the test sample to verify absence of tip or lumen collapse. | Pass |
| Corrosion Resistance Test | ISO 10555-1:2013 | Pass |
| Tip Flexibility Test | Use a mechanical force meter to push the tip from left to right at 5 mm, 10 mm, and 20 mm from the distal tip. | Pass |
| Radiopacity | ASTM F640-12 | Pass |
| Static Burst Pressure | ISO 10555-1:2013 | Pass |
| Compatibility Test | The compatibility of the Distal Access Catheter with a marketed introducer sheath, guide catheter, guidewire, micro guidewire, microcatheter, and stent-retriever is evaluated. | Pass |
| Flow Rate | Use a flow rate tester to measure the flow rate of the Distal Access Catheter. | Pass |
| Biocompatibility Tests | ||
| Cytotoxicity | Viability > 70% (ISO 10993-5: 2009, MTT Method) | Pass |
| Skin Sensitization | Magnusson & Kligman grades < 1 (ISO 10993-10: 2010, Guinea Pig Maximization Test (GPMT)) | Pass |
| Intracutaneous Reactivity Test | Score < 1.0 (ISO 10993-10: 2010, Intracutaneous Reactivity Study (Dermal)) | Pass |
| Acute Toxicity | No acute toxicity (ISO 10993-11: 2017, Acute Toxicity in Mice) | Pass |
| Rabbit Pyrogen | None of the animals showed a significantly greater reaction than the corresponding control animals. (ISO 10993-11: 2017, Rabbit Pyrogen Study, Material Mediated) | Pass |
| Complement Activation | The thrombus formation score shall not be higher than control. (ISO 10993-4: 2017, In Vivo Thromboresistance Study in the Dog NAVI Mode) | Pass |
| In Vivo Thromboresistance | The thrombus formation score shall not be higher than control. (ISO 10993-4: 2017, In Vivo Thromboresistance Study in the Dog NAVI Mode) | Pass |
| ASTM Hemolysis | Hemolytic Index 0 - < 2% Non-Hemolytic (ASTM F756-2017, ASTM Hemolysis Study Direct Contact and Indirect Contact) | Pass |
| Bacterial Reverse Mutation | No mutation effects (ISO 10993-3: 2014, Bacterial Reverse Mutation Test) | Pass |
| In Vitro Mammalian Cell Mutation | No mutation effect (ISO 10993-3: 2014, Thymidine Kinase Gene) | Pass |
| Partial Thromboplastin Time Study | No statistically significant difference between test article and control article or the negative reference control. (ISO 10993-4: 2017, ASTM F2382-2018, Partial Thromboplastin Time Study) | Pass |
| Sterilization & Shelf Life | ||
| Sterilization Assurance Level (SAL) | 10⁻⁶ (ISO 11135:2014) | Achieved |
| EO and ECH Residuals | Below limits specified in ISO 10993-7:2008 | Below specified limits |
| Bacterial Endotoxin Levels | Below 2.15 EU/device (USP <85>) | Below 2.15 EU/device |
| Shelf-life | Device performs as intended to support the proposed 2-year shelf-life. | Demonstrates 2-year shelf-life |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical (bench and in vitro) and biocompatibility testing. It does not mention a "test set" in the context of patient data or clinical images. Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable here.
For the non-clinical and biocompatibility tests, the sample sizes are not explicitly stated for each individual test. The document generally states "test sample" or refers to the number of cycles/animals without specifying the exact number for statistical power. The tests are performed on the device itself or its extracted components, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a submission for a physical medical device (catheter) based on non-clinical and biocompatibility testing, not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As noted above, there is no "test set" in the context of clinical data for expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/software device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI/software device. The performance reviewed here is the physical device's standalone performance under various bench and in vitro conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical and biocompatibility tests are defined by the established industry standards and test methods (e.g., ISO 10555-1:2013, ISO 10993 series, ASTM F640-12). The acceptance criteria outlined within these standards serve as the "truth" against which the device's performance is measured. For example, for cytotoxicity, the ground truth is "Viability > 70%."
8. The sample size for the training set:
Not applicable. There is no training set as this is not an AI/software device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
December 22, 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 and 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.
Shanghai HeartCare Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K233205
Trade/Device Name: Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: September 25, 2023 Received: September 28, 2023
Dear Diana Hong:
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.
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).
{1}------------------------------------------------
Your device is also subject to, among other requirements, the Quality System (OS) 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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K233205
Device Name Distal Access Catheter
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
{3}------------------------------------------------
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21 CFR 807.92.
510(k) Number: K233205
Date of Preparation: 12/19/2023
Sponsor Identification 1.
Shanghai HeartCare Medical Technology Co., Ltd.
590 Ruiging Rd, Building 4, Suite 201, East Zhangjiang High-Tech Park, Shanghai, P.R. China
Contact Person: Hong Tianrong
Position: Senior RA Manager
Tel: +86-13671683981
Email: trhong@heartcare.com.cn
Designated Submission Correspondent 2.
Ms. Diana Hong (Primary Contact Person)
Ms. Tingting Su (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850,
Fax: 360-925-3199
Email: info@mid-link.net
Identification of Proposed Device 3.
Trade Name: Distal Access Catheter Common Name: Percutaneous Catheter Regulatory Information Primary Product Code: QJP Classification Name: Catheter, Percutaneous, Neurovasculature Classification: II Regulation Number: 21 CFR 870.1250
{4}------------------------------------------------
Review Panel: Neurology
Secondary Product Code: DQY Classification Name: Catheter, Percutaneous Classification: II Regulation Number: 21 CFR 870.1250 Review Panel: Cardiovascular
4. Identification of Predicate and Reference Devices
Predicate Device: K151667 Device Name: AXS Catalyst™ Distal Access Catheter
Reference Device: K183463 Device Name: AXS Catalyst Distal Access Catheter (AXS Catalyst 7)
5. Device Description
The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.
6. Indications for Use
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
{5}------------------------------------------------
7. Comparison of Technological Characteristics
| ITEM | Subject Device K233205Distal Access Catheter | Predicate Device K151667AXS Catalyst™ Distal Access Catheter | Reference Device K183463AXS Catalyst Distal AccessCatheter (AXS Catalyst 7) | Remark |
|---|---|---|---|---|
| Classification | II | II | II | Same |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Same |
| Code | QJP, DQY | DQY | DQY | Same |
| Indication for Use | The Distal Access Catheter is indicatedfor use in facilitating the insertion andguidance of appropriately sizedinterventional devices into a selectedblood vessel in the peripheral andneurovascular systems. The DistalAccess Catheter is also indicated for useas a conduit for retrieval devices. | The AXS Catalyst Distal Access Catheteris indicated for use in facilitating theinsertion and guidance of appropriatelysized interventional devices into aselected blood vessel in the peripheral andneurovascular systems. The AXS CatalystDistal Access Catheter is also indicatedfor use as a conduit for retrieval devices. | The AXS Catalyst Distal AccessCatheter is indicated for use infacilitating the insertion and guidanceof appropriately sized interventionaldevices into a selected blood vessel inthe peripheral and neurovascularsystems. The AXS Catalyst DistalAccess Catheter is also indicated foruse as a conduit for retrieval devices. | Same |
| Inner Diameter (ID) | 0.058 inch; 0.071 inch | 0.058 inch; 0.060 inch | 0.068 inch | Similar |
| Outer Diameter (OD) | 5.4F (0.071 inch); 6.3F (0.083 inch) | Distal: 5.3F (0.069 inch); 5.4F (0.071 inch)Proximal: 5.6F (0.073 inch); 6F (0.079 inch) | Distal: 6.2F (0.082 inch)Proximal: 6.3F (0.0825 inch) | Similar |
| Effective Length | 95 cm; 105 cm; 115 cm; 125 cm; 130 cm | 115 cm; 132 cm | 115 cm; 125 cm; 132 cm | Similar |
| Radiopaque Marker | Yes | Yes | Yes | Same |
| Single Use | Yes | Yes | Yes | Same |
| Accessories | None | Rotating Hemostasis Valve (RHV)Tuohy Borst valve with sideportTwo peel away introducer sheaths | RHVTuohy Borst valve with sideportPeel away introducer sheath | N/A |
| Maximum GuidewireOD | 0.035 inch | 0.038 inch | 0.038 inch | Similar |
| Table 1: Comparison of Technological Characteristics | ||
|---|---|---|
{6}------------------------------------------------
| Materials | ||||
|---|---|---|---|---|
| Shaft (OuterSurface) | Pebax; Nylon; ThermoplasticUrethanes (TPU) | Pebax; Nylon; Tecoflex | Pebax; Nylon; Tecoflex | The differencesdo not raise newquestions ofsafety oreffectiveness. |
| Shaft (Metal Braid) | Nickel-Titanium alloy | Stainless steel, Nitinol wire, and polymerfiber | Nitinol wire and polymer fiber | |
| Shaft (Inner Lumen) | Polytetrafluoroethylene (PTFE) | PTFE | PTFE | |
| Hydrophilic Coating | Polyvinylpyrrolidone (PVP) | Hydrophilic coating | Hydrophilic coating | The subjectdevice has beenevaluated |
| Marker | Platinum-Tungsten alloy | Platinum/Iridium | Platinum/Iridium | |
| Hub | Polycarbonate (PC) | Nylon | Nylon | through bench |
| Heat Shrink Tubeand Stainless SteelDiffusion Tube | Polyolefin and 304 Stainless Steel | Thermoplastic rubber(Santoprene) | Thermoplastic rubber(Polyolefin) | andbiocompatibilitytesting. |
| Sterilization | ||||
| Method | Ethylene Oxide (EO) sterilized | EO sterilized | EO sterilized | Same |
| Sterility AssuranceLevel (SAL) | 10-6 | 10-6 | 10-6 | Same |
{7}------------------------------------------------
8. Non-Clinical Performance Testing
The results of verification and validation testing conducted on the Distal Access Catheter demonstrate that it performs as designed and is substantially equivalent to the predicate. A summary of the tests performed is provided in the table below:
| Test | Test Method / Applicable Standard | TestResults |
|---|---|---|
| DimensionalVerification | Verify dimensions using specified measurement tool. | Pass |
| Tip Configuration | Visually inspect distal tip at 10x magnification. | Pass |
| Surface Integrity | Inspect catheter surface. ISO 10555-1:2013 | Pass |
| Tip Buckling | Use a testing apparatus to measure the maximum forcerequired to cause a test sample to buckle at 5 mm, 10 mmand 20 mm from distal tip. | Pass |
| Luer Connector Tests | ISO 80369-7: 2021 | Pass |
| Flexural Fatigue | After ten runs of the Distal Access Catheter with the accessoriesin the simulated use model, remove the test sample and inspectthe sample for kinks or damage. | Pass |
| Trackability | Test the peak tracking force and the compatibility with theancillary devices during insertion and retraction of the catheterin the simulated use model. | Pass |
| Catheter Lubricity andDurability | Use friction tester to measure the frictional force of the testsamples when pulled between two clamped pads. Record thepeak frictional force over 5 cycles. | Pass |
| Particulate and CoatingIntegrity Test | Measure the size and number of particulates generated duringsimulated use and conduct visual inspection at 50x and 200xmagnification of the outer surface of the catheter aftersimulated use. | Pass |
| Tensile Strength Test | ISO 10555-1:2013 | Pass |
| Air Leakage | ISO 10555-1:2013 | Pass |
| Liquid Leakage | ISO 10555-1:2013 | Pass |
| Torque Resistance | Fix the distal tip of the Distal Access Catheter and rotate theproximal end until the Distal Access Catheter shows kink orother signs of failure. | Pass |
| Kink Resistance Test | Visually inspect whether the Distal Access Catheter kinks ornot when wrapped around mandrels with diameters 1 mmto 10 mm (in 1 mm increments). | Pass |
| Catheter Tip andLumen Integrity | After simulated use, aspirate test sample for 10 sec using a60 cc syringe during retrieval device withdrawal. Visuallyinspect the test sample to verify absence of tip or lumencollapse. | Pass |
{8}------------------------------------------------
| Corrosion ResistanceTest | ISO 10555-1:2013 | Pass |
|---|---|---|
| Tip Flexibility Test | Use a mechanical force meter to push the tip from left toright at 5 mm, 10 mm, and 20 mm from the distal tip. | Pass |
| Radiopacity | ASTM F640-12 | Pass |
| Static Burst Pressure | ISO 10555-1:2013 | Pass |
| Compatibility Test | The compatibility of the Distal Access Catheter with amarketed introducer sheath, guide catheter, guidewire, microguidewire, microcatheter, and stent-retriever is evaluated. | Pass |
| Flow Rate | Use a flow rate tester to measure the flow rate of the Distal AccessCatheter. | Pass |
Biocompatibility
The Distal Access Catheter is categorized as Externally Communicating Device, Limited Contact (≤ 24 hours) with Circulating Blood, per ISO 10993-1, the following tests were conducted:
| Standard Utilized / | Test Results | |||
|---|---|---|---|---|
| Test | Section | Method | Acceptance Criteria | (Pass/Fail) |
| Cytotoxicity | ISO 10993-5: 2009 | MTT Method | Viability > 70% | Pass |
| Skin Sensitization | ISO 10993-10: 2010 | Guinea Pig Maximization Test(GPMT) | Magnusson & Kligman grades < 1 | Pass |
| IntracutaneousReactivity Test | ISO 10993-10: 2010 | Intracutaneous Reactivity Study(Dermal) | Score < 1.0 | Pass |
| Acute Toxicity | ISO 10993-11: 2017 | Acute Toxicity in Mice | No acute toxicity | Pass |
| Rabbit Pyrogen | ISO 10993-11: 2017 | Rabbit Pyrogen Study, MaterialMediated | None of the animals showed asignificantly greater reaction than thecorresponding control animals. | Pass |
| ComplementActivation | ISO 10993-4: 2017 | In Vivo ThromboresistanceStudy in the Dog NAVI Mode | The thrombus formation score shall notbe higher than control. | Pass |
| In VivoThromboresistance | ISO 10993-4: 2017 | In Vivo ThromboresistanceStudy in the Dog NAVI Mode | The thrombus formation score shall notbe higher than control. | Pass |
| ASTM Hemolysis | ASTM F756-2017 | ASTM Hemolysis Study DirectContact and Indirect Contact | Hemolytic Index 0 - < 2%Non-Hemolytic | Pass |
| Bacterial ReverseMutation | ISO 10993-3: 2014 | Bacterial Reverse Mutation Test | No mutation effects | Pass |
| In VitroMammalian CellMutation | ISO 10993-3: 2014 | Thymidine Kinase Gene | No mutation effect | Pass |
| PartialThromboplastinTime Study | ISO 10993-4: 2017ASTM F2382-2018 | Partial Thromboplastin TimeStudy | No statistically significant differencebetween test article and control article orthe negative reference control. | Pass |
Sterilization and Shelf Life
The Distal Access Catheter sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10 6. EO and Ethylene
{9}------------------------------------------------
Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 2.15 EU/device in accordance with USP <85>. Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 2-year shelf-life.
Clinical Performance Testing 9.
No clinical studies were necessary to demonstrate substantial equivalence.
10. Conclusion
The subject device, Distal Access Catheter, has similar technological characteristics and the same intended use as the predicate device, AXS Catalyst Distal Access Catheter (K151667). The differences in technological characteristics do not raise new or different questions of safety or effectiveness. The successful completion of bench performance, biocompatibility, and sterility testing demonstrates that the subject device performs as intended and is substantially equivalent to the predicate.
§ 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).